CEN/TC 146/WG 1 N 187

Transcription

1 CEN/TC 146/WG 1 N 187 CEN/TC 146/WG 1 Preformed rigid container packaging machines of Secretary: matthias.balley_vdma.org@livelink.din.de Secretariat: DIN CEN-TC146-WG1 N0185 startdoc 19th meeting V7akz Date of document Expected action Reply Due Date Background Start document for the 19th meeting for commenting and discussion under TOP 4 of the agenda of that meeting. Please note, that there are still open some To-Do's, according to document N 182, e.g. as show below, but also older tasks. Please deliver content for that as part of your comments.

2 CEN/TC 146 Date: pren 415-2: CEN/TC 146 Secretariat: UNI Safety of packaging machines Part 2: Packaging machines for preformed rigid containers Sicherheit von Verpackungsmaschinen Teil 2: Verpackungsmaschinen für vorgefertigte formstabile Behälter Sécurité des machines d'emballage Partie 2 : Machines d'emballage pour contenants rigides préformés ICS: Descriptors: Document type: European Standard Document subtype: Document stage: Working Document Document language: E T:\NuV\Allgemein\Aktenplan\Normung\Normung VPM ab \EN (WG 1)\European_Group TC146-WG1\19. Sitzung 19_ Mannheim\N0187 CEN-TC146- WG1_N0185 startdoc_19th_meeting_ V7akz.docx STD Version 2.7g

3 Contents Page 1 Scope Normative references Terms and definitions General Definitions of terms programmable electronic system (PES) pre-formed rigid container carousel counter pressure filling cleaning soil sanitizing aseptic filling container lift star wheel air conveyor neck gripper conveyor walking beam conveyor container stop gripper chain conveyor magnetic belt conveyeor cascaded pusher In-line machine Rotary machine Oscillating label magazines Multi-functional machine Inherent safe design fixed or interlocked guards Instructions Description of packaging machines for pre-formed rigid containers and their function units Plastic bottle unscrambling machine Cap removing machine Sleeve label removing machine Container cleaning and sanitizing machines Filling machines Capping, closing and sealing machines Closure securing machine Labelling or decorating machine Coding machine

4 Heating or cooling machine for packed product working at atmospheric pressure Inspection machine List of significant hazards Hazards that occur on most machines in the scope of this standard Equipment Conveyors Vacuum transfer conveyor Dispose or eject device (pusher) Keg stopping device Keg lift and inverting machine Extraction or ventilation system or blower Hoppers Rotary mechanisms Coding and marking equipment incorporated in a packaging machine Hot foil coder Laser coder Ink jet coder Emboss coder Plastic bottle unscrambling machine Machines for applying caps or removing packaging components or materials from containers Screw cap removing machine, screw capping machine, crown capping machine, rollon capping machine and plugging/corking machine Crown cork removing machine Sleeve label removing machine Container cleaning machines Cleaning machine for bottles and jars (bottle washing machine) Rotary keg cleaning, filling or combined cleaning and filling machine In-line keg cleaning, filling and combined cleaning and filling machine Semi-automatic keg cleaning, filling and combined cleaning and filling machine (single head machine) Crate washing machine Cap sanitizing machine Filling machines Rotary rinsing, filling and capping machine In-line filling machine Sealing, seaming, crimping, flanging machine Foil sealing machine Can filling and seaming machine Closure securing machine / cork wiring machine Labelling and decorating machines Rotary labelling machine In-line labelling machine Heating or cooling machine for packed product working at atmospheric pressure (Pasteurizer) Inspection equipment

5 5 Safety requirements General requirements Mechanical Hazards - Moving Parts Slip, Trip or Fall Hazards Different Hazards - Pneumatic or Hydraulic Equipment Electrical Hazards - Electrical Equipment Electrical Hazards - Electrostatic Phenomena Thermal Hazards Noise Hazards Radiation Hazards Chemical Hazards Biological Hazards Ergonomic Hazards Different Hazards Hydraulic and Pneumatic Equipment Equipment Conveyors Dispose or eject device Keg stopping device Keg lift and inverting machine Extraction or ventilation system or blower Hoppers Rotary mechanisms Coding and marking equipment incorporated in a packaging machine Radiation Hazards Hot foil coder Laser coder Ink jet coder Emboss coder Plastic bottle unscrambling machine Mechanical Hazards Where whole body access is possible under lifted parts of the lifting and tilting mechanism the following measures shall be taken against uncontrolled lowering complying with the requirements stated in 5.1.3, 5.3.2, and of EN 415-4:2018, e.g. by a self-locking lift gear or a mechanical arrester.noise Hazards Different Hazards - Safety functions Machines for applying caps or removing packaging components or materials from containers Screw cap removing machine, screw capping machine, crown capping machine, rollon capping machine and plugging/corking machine Crown cork removing machine Sleeve label removing machine Container cleaning machines Cleaning machine for bottles and jars (bottle washing machine) Rotary keg cleaning, filling and combined cleaning and filling machine In-line keg cleaning, filling and combined cleaning and filling machine Semi-automatic keg cleaning, filling and combined cleaning and filling machine (single head machine) Crate washing machine

6 5.6.6 Cap sterilising machine Filling machines Rotary rinsing, filling and capping machine In-line filling machine Sealing, seaming, crimping, flanging machine Foil sealing machine Can filling and seaming machine Closure securing machine / cork wiring machine Labelling and decorating machines Rotary labelling machine In-line labelling machine Heating or cooling machine for packed product working at atmospheric pressure (pasteurizer) General Mechanical Hazards Slip, Trip or Fall Hazards Thermal Hazards Chemical Hazards - Biocides Biological Hazards - Germs Inspection equipment Verification of safety requirements and measures General Visual inspections with the machine stopped Mechanical parts Pneumatic systems Hydraulic systems Electrical systems Safeguards Design requirements Marking and warning signs Measurements with the machine stopped Safeguards Electrical testing Visual inspections with the machine running Safeguards Interlocking devices Dissipation of stored energy Measurements with the machine running Measurement and declaration of noise emission Temperature Verification procedures Information for use General Marking Signals and warning signs Instructions

7 7.4.1 General Additional information for specific machines Annex A (normative) Noise test code A.1 Scope A.2 Terms and definitions A.3 Determination of emission sound pressure level at the work station Additionally: on the platform of the bottle in-feed in front of the bottle table, in the middle the machines width on double end machines additionally at the bottle discharge, in the middle the machines width A.4 Determination of the sound power level A.5 Alternative method for very large machines A.6 Installation and mounting conditions A.7 Operating conditions A.8 Measurement uncertainties A.9 Information to be recorded A.10 Information to be reported A.11 Declaration and verification of noise emission values Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 2006/42/EC

8 European Foreword This document (pren 415-2:2017.8) has been prepared by Technical Committee CEN/TC 146 Safety of packaging machines, the secretariat of which is held by UNI. This document is a working document. This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive(s). For relationship with EU Directive(s), see informative Annexes ZA and ZB which are an integral part of this document. Other standards produced by this Technical Committee are: EN 415, Safety of packaging machines; Part 1: Part 3: Part 4: Part 5: Part 6: Part 7: Part 8: Part 9: Terminology and classification of packaging machines and associated equipment Form, fill and seal machines Palletisers and depalletizers Wrapping machines Pallet wrapping machines Group and secondary packaging machines Strapping machines Noise measurement methods for packaging machines, packaging lines and associated equipment, grade of accuracy 2 and 3 Part 10: General Requirements Introduction [MUST MAYBE CLAUSE 1 IN NEW TEMPLATE, IF SO TO BE CHANGED LATER] Packaging machines are used extensively in Europe, in an increasingly wide range of industries. They contain several significant hazards and have the potential to cause serious injury. This document is a type C standard as defined in the Introduction of EN ISO 12100:2010. The machinery concerned and the extent to which hazards, hazardous situations and events are covered are indicated in the scope of this standard. When provisions of this type C standard are different from those, which are stated in type A or B standards, the provisions of this type C standard take precedence. 7

9 1 Scope This standard applies to the following machines and to machines which incorporate more than one function as listed below. The standard also applies to partly completed machinery as far as conformity is claimed for certain essential health and safety requirements. This standard deals with machines with the following functions: handling, cleaning, sanitizing, a pasteurizing, filling, labelling, closing, sealing or inspecting pre-formed rigid containers including their closures except cups or trays or tubs made of a foil of plastic, aluminium or paper. Machines are Unscrambling machines Cap removing machines Container cleaning machines Crate washing machine Rinsing machines Additive application machines Filling machines Capping, closing and sealing machines Closure securing machines Inspection machines Labelling machines Decorating machines Heat treatment and back-cooling machines for containers, working at atmospheric pressure Sterilising machines (others than heat treatment)... The individual machines are described in 3.3. For all packaging machines within the scope of this standard EN shall apply, too. This standard describes the additional or specific hazards for packaging machines for pre-formed rigid containers. The requirements of this standard will take precedence over the requirements set out in EN This standard deals with safety requirements for machine design, construction and information applicable to installation, commissioning, operation, adjustment, maintenance, cleaning, dismantling and disposal of packaging machines for pre-formed rigid containers. The extent to which hazards, hazardous situations and events are covered are indicated in clause 4. Note: The hazards on a specific machine can vary depending on: its working principle; the type, size and mass of the product; the packaging material; auxiliary equipment attached to the machine and the environment in which the machine is used. If the machine presents hazards that are not covered by this standard or EN , the manufacturer should assess these hazards and take measures by using the principles detailed in EN ISO

10 Exclusions This standard is not applicable to the following machines: Machines that were manufactured before the date of publication of this document by CEN. Aerosol filling and sealing machines Filling machines for gas Filling machines for powder or similar products Autoclaves Conveyor systems which link packaging machines but are not integrated in packaging machines or part of packaging machines Blow moulding machines (see EN 422) This standard does not consider the following hazards: the use of packaging machines in potentially explosive atmospheres not generated by the machine itself hazards associated with packing explosives hazards arising from ancillary equipment which is not part of the machine, e. g. equipment for evacuating gases, for cooling or refrigeration, for the supply of steam, energy or product NOTE When an assembly of machinery or partly completed machinery (multi functional machine) contains a part which is covered by an other standard the risk assessment and measures for this machine part should comply with the relevant standard. In addidion the risks presentd by the combination of the parts which is not covered by one of the standards -should be considered. The manufacturer should follow the instructions of EN ISO Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) shall apply. EN 285:2006; Sterilisation -. Steam sterilizers large sterilizers EN 349:1993 +A1:2008, Safety of machinery minimum gaps to avoid crushing of parts of the human body EN 415-1:2000+A1:2009, Safety of packaging machines Part 1: Terminology and classification for packaging machines and associated equipment pren :2011, Safety of packaging machines Part 10: General requirements EN 574: A1:2008, Safety of machinery Two-hand control devices Functional aspects Principles for design 9

11 EN 614-1:2006 A1:2009, Safety of machinery Ergonomic design principles Part 1: Terminology and general principles EN 619: A1:2010, Continuous handling equipment and systems Safety and EMC requirements for equipment for mechanical handling of unit loads EN 626-1: A1:2008 Safety of machinery reduction of risks to health from hazardous substances emitted by machinery Part 1: Principles and specifications for machinery manufacturers EN 626-2: A1:2008, Safety of machinery reduction of risks to health from hazardous substances emitted by machinery Part 2: Methodology leading to verification procedures EN 842: A1:2008, Safety of machinery visual danger signals; general requirements, design and testing EN 894-1:1997, Safety of machinery Ergonomics requirements for the design of displays and control actuators - Part 1: General principles for human interactions with displays and control actuators EN 894-2: A1:2008, Safety of machinery Ergonomics requirements for the design of displays and control actuators - Part 2: Displays EN 894-3: A1:2008, Safety of machinery Ergonomics requirements for the design of displays and control actuators Part 3: Control actuators EN 953: A1:2009, Safety of machinery General requirements for the design and construction of fixed and moveable guards EN 982: A1:2008, Safety of machinery Safety requirements for fluid power systems and components hydraulics EN 983: A1:2008, Safety of machinery Safety requirements for fluid power systems and components pneumatics EN : A1:2008, Safety of machinery Human physical performance Part 2: Manual handling of machinery and component parts of machinery EN : A1 2008, Safety of machinery Human physical performance Part 3: Recommended force limits for machinery operation EN : A1:2008, Safety of machinery Human physical performance Part 4: Evaluation of working postures and movements in relation to machinery EN 1037: A1:2008. Safety of machinery Prevention of unexpected start-up EN 1088: A2:2008, Safety of machinery Interlocking devices associated with guards general principles for design and selection EN :2009; Safety of machinery Evaluation of the emission of airborne hazardous substances Part 1: Selection of test methods 10

12 EN :2011; Explosives atmosphere explosion prevention and protection Part 1 Basic concepts and methodology EN : A1:2009, Food processing machinery Basic concepts Part 2: Hygiene requirements EN : A1:2009, Safety of machinery Pressure sensitive protective devices Part 1: General principles for design and testing of pressure-sensitive mats and pressure-sensitive floors EN : A1:2009, Safety of machinery Pressure sensitive protective devices Part 2: General principles for design and testing of pressure-sensitive edges and pressure sensitive bars EN : A1:2009, Safety of machinery Pressure sensitive protective devices Part 3: General principles for the design and testing of pressure sensitive bumpers, plates, wires and similar devices EN 1837: A1:2009, Safety of machinery Integral lighting of machines EN 13478: A1:2008, Safety of machinery Fire prevention and protection EN : A1:2009, Safety of machinery Electrical equipment of machines Part 1: General requirements EN :2002, Graphical symbols for use on equipment Part 1: Overview and application EN 60529: A1:2000 Specification for degrees of protection provided by enclosures (IP code) EN : A1:2005 Low voltage switchgear and controlgear Part 5-5: Control circuit devices and switching elements Electrical emergency stop device with mechanical latching function EN 61012:1998; Filters for the measurement of audible sound in the presence of ultrasound EN :2008, Safety of machinery; Indication marking and actuation Part 1: Requirements for visual, auditory and tactile signals EN :2008, Safety of machinery Indication marking and actuation Part 3: Requirements for the location and operation of actuators EN : A1:2008, Safety of machinery Electro-sensitive protective equipment Part 1: General requirements and testing EN :2013; Electroacoustics sound level meters Part 1: specifications EN 62061:2005, Safety of machinery Functional safety of safety-related electrical, electronic and programmable electronic control systems EN ISO 3744:2010, Acoustics Determination of sound power levels of noise sources using sound pressure Engineering method in an essentially free field over a reflecting plane 11

13 EN ISO 3746: 2010, Acoustics Determination of sound power levels of noise sources using sound pressure Survey method using an enveloping measurement surface over a reflecting plane EN ISO 3747:2000, Acoustics Determination of sound power levels of noise sources using sound pressure Comparison method for use in situ EN ISO 4871:1996, Acoustics Declaration and verification of noise emission values of machinery and equipment EN ISO 7731:2008, Ergonomics Danger signals for public and work areas Auditory danger signals (ISO 7731:2003) EN ISO :1996, Acoustics Determination of sound power levels of noise sources using sound intensity Part 2: Measurement by scanning EN ISO :2011, Robots for industrial environments Safety requirements Part 1: Robot EN ISO 11201:2010, Acoustics Noise emitted by machinery and equipment Measurement of emission sound pressure levels at a work station and at other specified positions Engineering method in an essentially free field over a reflecting plane EN ISO 11202:2010, Acoustics Noise emitted by machinery and equipment Measurement of emission sound pressure levels at a work station and at other specified positions Survey method in situ EN ISO 11203:1995, Acoustics Noise emitted by machinery and equipment Measurement of emission sound pressure levels at a work station and at other specified positions from the sound power level EN ISO 11204:2010, Acoustics Noise emitted by machinery and equipment Measurement of emission sound pressure levels at a work station and at other specified positions Method requiring environmental corrections EN ISO :2005; Safety of machinery Laser processing machines Part 1: General safety requirements EN ISO 12001:1996, Acoustics Noise emitted by machinery and equipment - rules for the drafting and presentation of a noise test code EN ISO 12100:2010, Safety of machinery; Risk assessment and risk reduction EN ISO :2008, Ergonomic of the thermal environment Methods for the assessment of human responses to contact with surfaces Part 3: Hot surfaces EN ISO :2008, Ergonomic of the thermal environment Methods for the assessment of human responses to contact with surfaces Part 3: Cold surfaces EN ISO :2008, Safety of machinery Safety related parts of control systems Part 1: General principles for design EN ISO 13850: 2008, Safety of machinery Emergency stop Principles for design 12

14 EN ISO 13855: , Saftey of machinery Positioning of safeguards with respect of the approach speeds of part of human body EN ISO 13857:2008: Safety of machinery safety distances to prevent danger zones being reached by upper and lower limbs EN ISO : A1:2010, Safety of machinery Permanent means of access to machines and industrial plants Part 1: Choice of a fixed means of access between two levels EN ISO : A1:2010, Safety of machinery Permanent means of access to machines and industrial plants Part 2: Working platforms and walkways EN ISO : A1:2010, Safety of machinery Permanent means of access to machines and industrial plants Part 3: Stairways, stepladders and guard-rails EN ISO :2004, Safety of machinery Permanent means of access to machines and industrial plants Part 4: Fixed ladders IEC 60417/ISO 7000-DB:2004, Graphical symbols for use on equipment IEC :2008, Safety of machinery Electro-sensitive protective equipment Part 3: Particular requirements for Active Opto-electronic Protective Devices responsive to Diffuse Reflection (AOPDDR) EN :2007, Adjustable speed electrical power drive system Part 5-2: Safety requirements Functional (IEC :2007) 3 Terms and definitions 3.1 General For the purposes of this document, the terms and definitions given in EN ISO 12100, in EN 415-1, in EN and the following apply. Where definitions of this standard differ from those in the standards listed above the definitions of this standard have precedence over the definitions of those listed in the standard above for purposes of this standard. 3.2 Definitions of terms programmable electronic system (PES) system for control, protection or monitoring dependent for its operation on one or more programmable electronic devices, including all elements of the system such as power supplies, sensors and other input devices, contactors and other output devices ( of EN ISO :2006) pre-formed rigid container Rigid container formed to its final shape before it is handled by the machine 13

15 Note 1 to entry: Examples of preformed rigid containers are: bottles, cans, cups, jars, pots, ampoules, vials or kegs,, made of e.g. glass, metal, plastics, fibreboard, wood, ceramic material or composite materials carousel Rotating machine element which locates and transports containers through one or more processes in a packaging machine counter pressure filling Container filling where the container is presented to a filling nozzle and first filled with gas (usually carbon dioxide or nitrogen) under pressure, and the gas is then displaced by the product being filled cleaning removing of soils NOTE to entry: see EN soil any unwanted matter, including product residues, micro-organisms, residual detergent or disinfecting agents NOTE to entry: see EN sanitizing Physical or chemical germ reduction procedure performed with liquid agents for example peracetic acid or performed with gaseous agents for example H 2O 2or performed with radiation, e. g. ultraviolet rays or performed with heat or performed by a combination of some of these methods which are used to reduce germs on product, containers, closures or other packaging means by a number of log rates Note 1 to entry: Examples are: Immersion bath in the sterilising agent with drying by means of germ-reduced hot air and/or UV light. Dry germ reduction procedure and degrading of the sterilising agent with germ-reduced water. These germ reduction procedures can be used for: Packaging (bottles, cans, kegs, containers, closures). 14

16 Machine surfaces in the food industry, splash area. Conveyor area of germ-reduced packaging disinfection Inactivation of all pathogenic and product-damaging microbes to a level that complies with the respective hygiene requirements sterilisation Destruction or removal of microorganisms, including bacterial spores present in products or on the surfaces of materials and products. Note 1 to entry: In difference to disinfection, the target of the sterilisation process is killing / deactivation of all microorganisms and spores pasteurization Moderate heat treatment of packed product can destroy product-damaging microbes and reduce their quantity to an acceptable limit, in order to obtain a microbiological stable product within the chosen minimum shelf life aseptic filling Filling of a germ reduced product in a germ reduced package with the aim of avoiding recontamination of the product container lift machine assembly which lifts or lowers a container star wheel Star shaped component with caverns fitting to the shape of containers for spacing them whilst they are transported in a circular arc air conveyor Machine or functional unit that conveys containers or components by the means of air flow along a guide rail neck gripper conveyor Machine or functional unit which transports containers, usually plastic bottles, by the means of gripping devices fixed on a driven chain or belt 15

17 walking beam conveyor Machine or functional unit which transports containers step by step by a reciprocating motion. Key 1 roller conveyor 2 walking beam conveyor 3 keg 4 directions of walking beam movement container stop Figure 1 Principle of an walking beam transport (side view) Machine assembly for blocking movement of containers on a conveyor gripper chain conveyor Machine or functional unit which transports containers or crates by friction applied laterally by parallel running chains fitted with rubber grippers magnetic belt conveyeor Machine or functional unit which transports components or containers applying magnetic force to increase the friction cascaded pusher Machine or functional unit which positions conveyed crates or containers to different lanes using a row of pushers moving in a sequence In-line machine Machine in which processing operations on a container are performed whilst the container is transported through the machine in a straight line. 16

18 Rotary machine Machine in which processing operations on a container are performed whilst the container is transported through the machine in a circular path. Figure 14 rotary mechanism (top view) shows the main rotary units of a rotary labelling machine Oscillating label magazines Label magazine which oscillates back and forward about a fixed point or pivot Multi-functional machine Machine which combines several functional units which are arranged and controlled as an integral whole. NOTE NOTE 2 Examples of typical multi-functional machines are: Filling capping machines Rinsing filling capping machines Aseptic machines with sterilizing filling- capping Blowing moulding filling capping machine Filling capping labelling machine Some functional units of combined machines may be covered by other standards Inherent safe design Use of methods and values complying with of EN : fixed or interlocked guards Safeguards complying with and of EN :2014. NOTE Interlocked guards are designated as interlocking guards, too Instructions all non-verbal information needed for safe use of the machine NOTE Instructions can be given in any visible and durable form, e.g. as a user manual (instruction manual) on paper or data medium or as video or photo etc. 17

19 3.3 Description of packaging machines for pre-formed rigid containers and their function units Plastic bottle unscrambling machine machine which accepts a bulk supply of randomly oriented plastic bottles and dispenses the containers in a predetermined orientation Cap removing machine Machine which removes a cap from a container. Figure 17 shows the mechanismas of a capping machine. Figure 18 shows an example of a crown cork decapping machine Sleeve label removing machine Machine that removes sleeve labels from containers Container cleaning and sanitizing machines Bottle washing machine machine which cleans the inside and outside of rigid containers, usually with water and detergent NOTE can also remove lables Cleaning machine for kegs or casks with a keg fitting Machine in which re-usable containers are conveyed through the machine while they are sprayed with or dipped into different substances like caustic soda, hot water, acid or detergent to remove contaminants and labels Crate washing machine machine which cleans crates, usually with water and detergent NOTE This standard deals with washing machines for crates for re-usable bottles or other rigid containers. The requirements can also be used for machines which clean crates used in the food industry which are similar in material and size Rinsing machine rinsing machine machine which cleans the inside of a rigid container by injecting a liquid or gas into the inverted container Closure sanitizing machine Machine in which closures are fed through and treated with radiation or agents). Figure 27shows an example of a cap rinsing machine. 18

20 NOTE Agents can be water, clean air, ionised air. Vaporized agents (e.g. H2O2 or peracetic acid) can be applied for germ reduction procedures. There are also examples which transport the caps through a dipping bath Tunnel sterilizing machines for containers machine which sterilizes, sanitizes or disinfects empty containers NOTE This machine usually is part of an aseptic multifunctional machine. Typically sterilization is done by heat Filling machines Filling machines for bottles, jars or cans machine in which bottles, jars or cans are first filled with a product and then fitted with a closure. Figure 29shows an example of a rotary rinsing, filling and capping machine. NOTE products are usually liquid or pasteous Cask or keg fill and seal machine machine in which casks or kegs are first filled with a product and then closed Capping, closing and sealing machines Crown capping machine Closing machine which places a pre-formed metal cap over the mouth of a rigid container, before crimping the edges of the cap to secure it to the container Plugging, corking machine Closing machine which pushes a plug or cork into the mouth of a rigid container NOTE The plug can be made from plastic, cork, artificial cork, plastic covered glass, etc Screw capping machine Closing machine which applies a threaded cap or lid to a rigid container. NOTE Note: The working principle is similar to a screw cap removing machine Roll-on capping machine Closing machine which places a deformable closure over the mouth of a rigid container, before rolling the capsule to form a thread and securing the capsule to the container. 19

21 Swing stopper closing machine Closing machine which places a clusure which is fitted to the container by a wire bow onto the mouth of a rigid container Foil sealing machine Machine which applies a reel fed foil or plastic cover to a rigid container, sealing it to the container by the application of heat NOTE 1 gluing The foil can be made of plastic, aluminium, etc. The sealing method can be e.g. ultrasonic, thermal or NOTE 2 Often a cap is applied after foil sealing. The foil can also be part of the cap. In this case its is sealed by induction after the cap is applied Can seaming machine- Closing machine which places a pre-formed lid onto the mouth of a can and rolls the edges of them together before rolling the capsule to form a thread and securing the capsule to the container to form a seam Closure securing machine Machine which places a securing element, e.g. wire-hood, cord, sleeve or fibre filament, over a bottle and the closure and then secures it e.g. by twisting (wire) or shrinking (capsule) Labelling or decorating machine Machine which applies labels or tags onto containers. NOTE machine For the different kinds of labelling or decorating machines see 3.3 of EN 415-1:2014Coding and marking Coding machine Machine which applies a code to a container, packaging component or material NOTE The code can also be a symbol. It can be applied in different ways (see of EN 415-1:2014) Heating or cooling machine for packed product working at atmospheric pressure A heating machine/cooling machine applies heat/cold to filled containers under controlled conditions while the containers are conveyed or in batch mode. NOTE 1 For definition of pasteurising see regulation 853/2004 EC laying down specific hygiene rules for food of animal origin NOTE 2 For hygiene risks concerning autoclaves see EN 285+A2: Inspection machine Machine which inspects containers for some attribute. 20

22 NOTE Attributes can be e.g. size, wall thickness or cleanliness. The inspection can be done e.g. by light, radiation, high frequency, camera systems. 4 List of significant hazards 4.1 Hazards that occur on most machines in the scope of this standard Table 1 lists the hazards which are present on most machines within the scope of this standard. These hazards and the corresponding references to the measures listed in the column "reference to safety requirement" shall be used where no specific hazards are listed in this standard. Hazards which are significant and specific to the machines in the scope and the corresponding sources of the hazards and hazardous situations are listed in clauses 4.2 to Where this standard doesn't list specific hazards for a machine in the scope of this standard, the respective clause of EN shall apply. The relevant phases of the machine life cycle, hazardous situations and events considered are: phases of the machine life cycle: installation, assembly, dismantling operation (e.g. automatic mode, manual feeding, process intervention) changeover fault finding / trouble-shooting / setting / adjustment cleaning maintenance hazardous situations, events: unintended contact exposure staying in the vicinity intended function unexpected start-up malfunction Particular situations are described within the tables for the specific machines. Table 1 Common hazards on packaging machines for pre-formed rigid containers source of hazards, hazardous elements hazards reference to safety requirement 1. mechanical hazards moving machine or moving parts of the machine as gears, drive belts, shafts, couplings, cutting Mechanical hazards according to 4.2, or of EN : , 5.1.3, , , ,

23 source of hazards, hazardous elements hazards reference to safety requirement equipment, handles or hand wheels loss of stability of the machine or machine parts moving, falling, ejected product broken or damaged product, packaging material Pneumatic equipment or hydraulic equipment Mechanical hazards according to 4.2 and 4.9.1d) of EN :2014 cutting or stabbing e.g. according to 4.9 of EN :2014 Mechanical hazards, ejections of air, whiplash of pipes and slipping or falling, noise according to 4.3 of EN : , 5.1.3, , , , high level access points EN electrical hazards electrical equipment, conductive parts of the machine electrostatic discharge of product or packaging material 3. Thermal Hazards surfaces with high or low temperature substances with high or low temperature 4. noise hazards machine, parts of the machine, product, equipment associated to the machine (impact, friction, excitation) 5. vibration hazards Electric shock according to 4.4 of EN :2014 Electric shock according to 4.5, 4.9.1e) or 4.9.2e) of EN : hot or cold burn according to 4.6 of EN :2014 cold burn or scalding noise according to 4.7 of EN : radiation hazards equipment for coding or checking product or packages using radiation 7. chemical hazards radiation hazards according to 4.8 of EN :

24 source of hazards, hazardous elements hazards reference to safety requirement product, substances used with the machine, emission of harmful substances 8. fire, explosion hazards product, substances used with the machine, emission of harmful substances 9. biological hazards germs from returnable containers or from pollutant from cleaning processes germs, debris or hazardous substances in the product 10. ergonomic hazards mass, shape or dimensions of the machine or machine parts or auxiliary equipment, design or position of displays, actuators or other points of access, hazards to health, chemical burn e.g. according to 4.9, , or of EN :2014 fire, explosion, e.g. according to 4.9, , or of EN :2014 hazards to health for operators in the vicinity of the machine according to 4.11 of EN :2014 hazards to health for consumers due to neglecting hygienic design principles according to 4.11 of EN :2014 fatigue, physical strain, mental stress, occupational diseases e.g. according to 4.10 of EN : packaging material, product ergonomic hazards according to 4.10 of EN : poor lighting fatigue, mental stress, generation of accidents 11. hazards associated with the environment in which the machine is used combination of hazards 23

25 source of hazards, hazardous elements hazards reference to safety requirement 4.2 Equipment Conveyors Gripper chain conveyor Gripper chain conveyors usually are used to feed crate cleaning machines with high level in-feed or to invert containers or crates. Figure 2 shows the hazards on a gripper chain conveyor and Figure 3 shows the working principle of and the hazards on a gripper chain conveyor. Table 2 lists the hazards of a gripper chain conveyor. 24

26 Key: 1 slat band conveyor 2 crate transfer (in-feed) 3 gripper chain 4 machine frame 5 crate 6 drive shaft Figure 2 Example of a gripper chain conveyor side view 25

27 Key: 1 slat band conveyor 2 crate transfer 3 gripper chain 4 machine frame 5 crate 6 drive shaft Figure 3 Example of a gripper chain conveyor top view Hazard zone. source of hazard, hazardous element 1. mechanical hazards Table 2 Hazards on a gripper chain conveyor hazards hazardous situation / phase of life cycle reference to safety requirement 2 in-running crates or containers drawing-in, crushing contact with moving crate moving crates or containers impact falling crates, e.g. because of misalignment or during manual removing of jams

28 3 Hazard zone. source of hazard, hazardous element in-running nips on drive rolls and deflector rolls hazards hazardous situation / phase of life cycle drawing-in, crushing reference to safety requirement narrowing gaps between elements at deflection moving chain elements along machine frame and stabilization elements or safeguard elements moving gripper element crushing, entanglement shearing entanglement gripper chains crushing, trapping narrow distance moving together during automatic adjustment drive shaft entanglement Air conveyor Figure 4 shows an example of an air conveyor for empty plastic bottles. The hazards on this machine are listed in Table 3. 27

29 Key: 1 guide rail 2 PET bottle 3 electrical cabinet 4 fan 5 filter 6 air duct 7 guide rail for neck 8 air outlet Figure 4 Example of an air conveyor for PET bottles side view hazard zone. source of hazard, hazardous element 1. mechanical hazards Table 3 Hazards on an air conveyor hazards hazardous situation / phase of life cycle reference to safety requirement 1-8 high level position fall from height driven movement or crushing, shearing, moving fan blade movement by external air impact flow 2. noise hazards 4, 8 blowers, air jet (flow noise), nozzles noise according to 4.7 of EN :

30 hazard zone. source of hazard, hazardous element 2 containers hitting at each other hazards hazardous situation / phase of life cycle noise according to 4.7 of EN :2014 reference to safety requirement chemical hazards 2,4, 5, 8 debris cleaning or disinfection substances hazards to health, chemical burn e.g. according to 4.9, , or of EN :2014 contamination of the product contact with or inhalation of substances during automatic or manual cleaning biological hazards 2, 5 germs from returnable containers or from pollutant from cleaning processes 2, 5 germs, debris or hazardous substances in the product hazards to health hazards to health for consumers due to neglecting hygienic design principles according to 4.11 of EN : Neck gripper conveyor shows the hazards on a neck gripper conveyor. 29

31 Key: 1 neck gripper 2 drive wheel 3 in-running nip 4 transport chain or belt 5 deflection wheel 6 machine frame 7 entry of gripper into machine frame Figure 5 Hazards on a neck gripper conveyor Table 4 lists the hazards of a neck gripper conveyor. 30

32 hazard zone. source of hazard, hazardous element 1. mechanical hazards 1 in-running grippers 7 in-running containers or grippers 3, 5 in-running nips on drive rolls and deflector rolls 1 gripping devices moving against other machine parts like star wheels 2. noise hazards 1-7 friction, impact of parts on each other or of containers on machine parts Table 4 Hazards on a neck gripper conveyor hazards hazardous situation / phase of life cycle shearing, drawing-in, entanglement reference to safety requirement crushing, drawing-in drawing-in, crushing entanglement, crushing, shearing, drawing-in noise according to 4.7 of EN : Vacuum transfer conveyor Figure 12 shows an example of a vacuum transfer conveyor usually used for the in-feed of empty cans to a can blowing or filling machine.. Table 9 lists the hazards on a vacuum transfer conveyor. 31

33 Key: 1 conveyor 2 porous vacuum belt conveyor 3 vacuum 4 vacuum blower 5 container (can) Figure 6 Example of a vacuum transfer conveyor Table 5 Hazards on a vacuum transfer conveyor hazard zone. source of hazard, hazardous element 1. mechanical hazards 5 mass of product hazards hazardous situation / phase of life cycle crushing, impact, cutting (e.g. broken glass) (risk depends on mass and shape of product and falling height) reference to safety requirement product crushing 2. noise hazards while placed or dropped on support porous vacuum belt conveyor noise according to 4.7 of EN :2014 air stream

34 hazard zone. source of hazard, hazardous element 4 vacuum blower hazards hazardous situation / phase of life cycle noise according to 4.7 of EN :2014 excitation of air reference to safety requirement product noise according to 4.7 of EN :2014 while dropping on support equipment 1, 2 belt conveyor hazards according to of EN : Dispose or eject device (pusher) Figure 6 and Figure 7 show the working principle and the hazards on a pusher attached to a conveyor. These devices change the direction of the movement of a product using driven mechanical means like levers or pushers or compressed air. Figure 6 shows an example of a mechanical sorting device which pushes products, e.g. containers or crates, to different transport lanes. Table 5 lists the hazards on this device. 33

35 Key: 1 product 2 conveyor 3 guide rails 4 gap 5 pneumatic cyliner 6 pusher rod9 inspection device Figure 7 Working principle and hazards of a dispose device (cascaded pusher) 34

36 Key: 1 container 2 conveyor 3 guide rail 4 gap 5 pneumatic cylinder 6 pusher rod 7 cabinet / machine frame 8 pusher plate Figure 8 Example of a pusher attached to a conveyor 35

37 Key: 1 container 2 conveyor 3 guide rail 4 gap 5 pneumatic cyliner 6 pusher rod 7 cabinet / machine frame 8 pusher plate Figure 9 Example of a crate / keg pusher attached to a conveyor hazard zone. source of hazard, hazardous element Table 6 Hazards on a divert or eject device hazards 1. mechanical hazards moving levers or 3, 4, 6 pushing fingers or plates, moving against fixed or other moving parts crushing, shearing, impact of upper limbs 1 container impact, cutting 2. noise hazards 1, 3, 5, 6 impact of mechanisms on containers or machine parts, 5 air exhaust from vessels noise according to 4.7 of EN :2014 noise according to 4.7 of EN :2014 hazardous situation / phase of life cycle falling product, removing shards reference to safety requirement

38 4.2.4 Keg stopping device Figure 9 shows an example of a keg stopper with a keg. The stopper will be combined with a conveying system of a rotary keg cleaning or filling machine. Table 6 lists the hazards on a keg stopper. Key: 1 movable stop mechanism 2 shaft of movable levers 3 keg 4 movable lever 5 pneumatic drive 6 drive rod Figure 10 Example of a keg stopper Table 7 Hazards on a keg-stopper hazard zone. source of hazard, hazardous element 1. mechanical hazards hazards hazardous situation / phase of life cycle reference to safety requirement 1, 4 5, 6 moving levers or stopping fingers against keg or parts of the conveyor crushing, shearing, impact

39 3 hazard zone. source of hazard, hazardous element subsequent kegs moving against other kegs crushing hazards hazardous situation / phase of life cycle reference to safety requirement noise hazards 1,3 levers, keg noise according to 4.7 of EN : subsequent kegs moving against other kegs noise according to 4.7 of EN : ergonomic hazards 3 mass of keg ergonomic hazards according to 4.10 of EN :2014 manual handling e.g. during trouble shooting Keg lift and inverting machine Figure 10 shows an example of a lifting and inverting machine for kegs or barrels which normally is used in combination with in-line keg cleaning or filling machines. Table 7 lists the hazard on this machine. 38

40 Key: 1 conveyor 2 lifting / inverting mechanism 3 drive 4 Keg hazard zone. source of hazard, hazardous element 1. mechanical hazards Figure 11 Example of a keg lifting and inverting machine Table 8 Hazards on a keg lifting and inverting machine hazards hazardous situation / phase of life cycle reference to safety requirement 2 drive shaft of turning mechanism, turning mechanism moving against fixed parts or kegs, mass of moving keg crushing, shearing, entanglement powered movement, uncontrolled movement e.g. in case of failure or loss of energy e.g. operation, cleaning, maintenance keg crushing 1, 2, 4 keg crushing 2. noise hazards keg falling from high level in-running into turning mechanism, tilting during transport

41 hazard zone. source of hazard, hazardous element machine, parts of the machine, product, equipment associated to the machine, kegs hazards noise according to 4.7 of EN :2014 hazardous situation / phase of life cycle Impact, friction, reference to safety requirement Extraction or ventilation system or blower Figure 11 shows an example of an extraction system. The hazards on this machine are listed in Table 8. Key: 1 extraction mouth/air nozzle 2 filter 3 fan 4 piping 5 bend Figure 12 Example of an extraction system side view hazard zone. source of hazard, hazardous element 1. mechanical hazards Table 9 Hazards on an extraction system hazards hazardous situation / phase of life cycle reference to safety requirement 1-4 high level position of parts fall from height

42 hazard zone. source of hazard, hazardous element 3 moving fan blade crushing, shearing, impact 2. noise hazards 1-5 air jet, air flow nozzles, 3, 4 resonance of pipes or enclosures hazards hazardous situation / phase of life cycle noise according to 4.7 of EN :2014 noise according to 4.7 of EN : blowers noise according to 4.7 of EN : chemical hazards 1, 2 extracted harmful substances 4. fire or explosion hazards extraction of combustible substances hazards to health, e.g. according to 4.9, , or of EN :2014 driven movement or movement by external air flow exposure to substances during cleaning or filter changing combustible substances exposed to an ignition source 5. biological hazards 2, 5 germs hazards to health during cleaning or filter changing exposure to extracted germs or germs grown due to poor maintenance NOTE EN is helpful to identify ignition sources reference to safety requirement Hoppers Figure 13 shows an example of a hopper, usually used for closures. The hopper can be at low, medium or high level. 41

43 Key: 1 closure feed 2 hopper 3 closure 4 oriented closure feed 5 height of hopper 6 level of hopper (above plane of access) Figure 13 Example of a hopper Table 10 lists the hazards on hoppers usually used for closures. Table 10 Hazards on hoppers hazard zone. source of hazard, hazardous element 1. mechanical hazards hazards hazardous situation / phase of life cycle reference to safety requirement 5, 6 high position or height of the hopper fall from height manual feeding, cleaning, changeover noise hazards 2, 3 closures or containers hitting against hopper noise according to 4.7 of EN :2014 automatic feed of closures (closures falling from height or fed pneumatically),

44 2 hazard zone. source of hazard, hazardous element vibration of the hopper (for separating and feeding closures) hazards hazardous situation / phase of life cycle noise according to 4.7 of EN :2014 closures falling from height or fed pneumatically, manual feeding of closures, process intervention reference to safety requirement ergonomic hazards 5, 6 high position or height of the hopper musculo-skeletal disorders awkward posture or unnatural movements Rotary mechanisms Figure 14 shows the mechanisms and hazards of a rotary mechanism which is used in rotary machines. Table 11 lists the hazards of rotary mechanisms. 43

45 Key: 1 in-feed conveyor 2 scroll 3 in-feed star wheel 4 carousel 5 containers 6 discharge star wheel 7 discharge conveyor Figure 14 rotary mechanism (top view) Key: 11 in-feed scroll 12 bottle infeed star wheel 13 tensioner for anti-rotation belt 14 container rotation/anti-rotation belt 15 bottle discharge star wheel 44

46 Figure 15 example of a container rotation/anti-rotation device on a rotary mechanism (top view) hazard zone. source of hazard, hazardous element 1. mechanical hazards Table 11 Hazards on rotary mechanisms hazards hazardous situation / phase of life cycle reference to safety requirement 3, 4 6, 12, 15 rotating devices such as carousels, or star wheels crushing, shearing, entanglement, drawing-in, impact ejected containers impact gripping devices, container lifting devices or other container handling crushing, shearing, 5 devices on the entanglement, carousel, moving drawing-in, filling valves or other trapping tools fitted to the carousel, e.g. screwing tools 3, 4, 5, 6 mass of change parts crushing manual handling noise hazards 1, 3, 4, 6, 7 drive mechanisms:, drives with frequency converters 3. ergonomic hazards noise according to 4.7 of EN :2014 friction , 4, 5, 6 mass of change parts, inconvenient position of parts, bad posture, bad access fatigue, physical strain, mental stress, occupational diseases e.g. according to 4.10 of EN :2014 manual handling equipment 1, 7 slat band (chain) conveyor hazards according to of EN :

47 hazard zone. source of hazard, hazardous element hazards hazardous situation / phase of life cycle reference to safety requirement 1, 7 roller conveyor hazards according to of EN : , 11 scroll hazards according to of EN : , 14 device for rotating containers or prevention of container (tensioner) drawing-in Coding and marking equipment incorporated in a packaging machine Hot foil coder Table 12 lists the specific hazards on a hot foil coder. hazard zone. source of hazard, hazardous element 1. mechanical hazards Table 12 hazards on a hot-foil coder hazards hazardous situation / phase of life cycle reference to safety requirement rollers, coding mechanism drawing-in, crushing Thermal Hazards high temperature of printing head burn unintended contact even if energy is switched off (residual energy) during feeding foil

48 4.3.2 Laser coder Table 13 lists the hazards on a laser coder. hazard zone. source of hazard, hazardous element 1. mechanical hazards Table 13 hazards on a laser coder hazards hazardous situation / phase of life cycle reference to safety requirement high position of parts, e.g. filter fall from height falling from high level position, e.g. during change of filter noise hazards air flow from nozzles noise according to 4.7 of EN : radiation hazards highly collimated light burns, loss of vision 4. chemical hazards unexpected emission of a light beam, e.g. by reflection or misalignment dust or fume from etching of labels or containers 5. fire, explosion hazards health hazards exposure to generated combustion products, e.g. because: no extraction, filter defect, filter not changed (no flow), no filter inserted 5.3.2, laser energy and product fire overheating of material e.g. due to malfunction and laser energy applied to combustible product, e.g. labels, coding acrylic which generates combustible gas

49 hazard zone. 6. equipment source of hazard, hazardous element hazards hazardous situation / phase of life cycle reference to safety requirement extraction of fume and dust by vacuum Ink jet coder Table 14 lists the hazards on an ink-jet coder. hazard zone. source of hazard, hazardous element 1. chemical hazards Table 14 hazards on an ink-jet coder hazards hazardous situation / phase of life cycle reference to safety requirement toxic or harmful, solvents of ink or cleaning solvents, e.g. degreasing solvents health hazards, skin defect due to degreasing, chemical burn eye or skin contact, or inhalation e.g. by overspray, or during manual cleaning fire, explosion hazards flammable solvents of ink or cleaning solvents fire, explosion concentration of solvent within explosion limits, e.g. by the necessary amount of ink or bad ventilationand presence of an ignition source Emboss coder Table 15 lists the hazards on an emboss coder for cold embossing. hazard zone. source of hazard, hazardous element 1. mechanical hazards Table 15 hazards on an emboss coder hazards hazardous situation / phase of life cycle reference to safety requirement 48

50 hazard zone. source of hazard, hazardous element movement of product against coder (roller) or vice versa hazards hazardous situation / phase of life cycle crushing, drawing-in reference to safety requirement Plastic bottle unscrambling machine Figure 16 shows an example of a plastic bottle unscrambling machine. Key: 1 containers 2 rotary disk 3 funnel 4 carousel 5 discharge conveyor 6 star wheel 7 hopper 8 lifting and tilting mechanism Figure 16 example of a plastic bottle unscrambling machine Table 16 shows the hazard on a plastic bottle unscrambling machine. 49

51 hazard zone. Table 16 Hazards on an unscrambling machine source of hazard, hazards hazardous situation / phase hazardous element of life cycle 1. mechanical hazards reference to safety requirement 2 moving disk, gap to other machine parts, shape of disk crushing, shearing, friction, entanglement reaching the rotating disk lifting and tilting mechanism and its movement against fixed parts or floor crushing, shearing, impact e.g. lowering by gravity tipping device for containers (e.g. pusher), star wheel, driven movement against fixed parts crushing parts moving against other parts equipment 7 hopper shall apply shall apply shall apply 5 conveyor hazards according to of EN : , 6 rotary mechanisms (carousel) shall apply shall apply shall apply 4.5 Machines for applying caps or removing packaging components or materials from containers Screw cap removing machine, screw capping machine, crown capping machine, roll-on capping machine and plugging/corking machine Figure 17 shows the hazards on a capping machine. 50

52 Key: 1 carousel 2 cap feed 3 capping/uncapping/plugging head 4 thread roller, capping/uncapping/plugging mechanism 5 container 6 hopper 7 rotating disk for cap separation and transport 8 cap stopper 9 in-feed scroll 10 conveyor Figure 17 Example of mechanisms of a capping machine (sectional view) Table 17 lists the hazards on a rotary screw cap removing machine, screw capping machine, crown capping machine, roll-on capping machine and a plugging/corking machine. Key no. Table 17 Hazards on a rotary capping/plugging/corking or de-capping machine source of hazard, hazardous element 1. mechanical hazards hazards hazardous situation / phase of life cycle reference to safety requirement 51

53 Key no. source of hazard, hazardous element hazards hazardous situation / phase of life cycle reference to safety requirement 3, 4, 2 8 capping/de-capping tools, pick-and-place device for positioning caps stopper for caps at discharge of the cap container movement of capping tool by residual compressed air, mechanical hazards residual energy due to blocked spring during process intervention, e.g. removing of jams or blocked caps crushing, shearing shards 2. Thermal Hazards cutting, stabbing, impact ejected parts of broken containers during operation or cleaning with water jet, manual removal of shards hot surfaces burn machines using steam or hot air or electric energy to heat the container or closures hot air or steam scalding machines using steam or hot air or to heat the container or closures 3. noise hazards , 7 separation or transport of caps by air, impact of caps noise according to 4.7 of EN : vibratory bowl feeders noise according to 4.7 of EN :2014 hitting of caps against each other or against machine parts closures, machine parts noise according to 4.7 of EN :2014 closures hitting on machine parts, e.g. hopper, pipe

54 Key no. source of hazard, hazardous element 4. biological hazards hazards hazardous situation / phase of life cycle reference to safety requirement germs in and on the surface of returnable bottles in de-capping machines hazards to health for operators in the vicinity of the machine due to neglecting hygienic design principles according to 4.11 of EN :2014 exposure due to emission of contaminated air from the extraction of caps, exposure during changing of the cap container equipment 6 hopper shall apply shall apply , 3, 4, 7 rotary disk shall apply shall apply 5.1.1shall apply 9 in-feed scroll shall apply shall apply conveyor hazards according to of EN : Crown cork removing machine Figure 18 shows the hazard zones on a crown cork removing machine. The hazards are listed in Table

55 Key: 1 rotating cylinder with crown cork removing tools 2 conveyor 3 bottle 4 crate 5 machine frame Figure 18 Example of a crown cork removing machine (sectional view) hazard zone. source of hazard, hazardous element 1. mechanical hazards Table 18 Hazards on a crown cork removing machine hazards hazardous situation / phase of life cycle reference to safety requirement 4, 5 4 crates, parts of the machine crates approaching stopped crates crushing, shearing, crushing moving crates passing fixed parts of the machine,, impact of stopping crates, risk increased especially when the conveyor has carriers or rubber belts

56 1 hazard zone. source of hazard, hazardous element sharp edges of decapping tool cutting hazards hazardous situation / phase of life cycle unintended contact to moving or standing tool during access manual handling of caylinder or decapping tools reference to safety requirement mass of uncapping cylinder impact, crushing, installation, assembly, dismantling changeover maintenance e.g. crushing or dropping during handling of the cylinder ejected caps on the floor slip, trip ejected removed caps in the vicinity noise hazards 1 bottles hitting at crates while these are conveyed noise according to 4.7 of EN : crates hitting each other when stopping noise according to 4.7 of EN : contact and friction of decapping tool with bottles noise according to 4.7 of EN : closures dropping in hopper or container noise according to 4.7 of EN : biological hazards germs in and on the surface of returnable bottles crates hazards to health for operators in the vicinity of the machine due to

57 hazard zone. source of hazard, hazardous element hazards hazardous situation / phase of life cycle neglecting hygienic design principles according to 4.11 of EN :2014 reference to safety requirement 4. ergonomic hazards 1 mass of de-capping cylinder musculo skeletal diseases manual handling of the cylinder radiation hazards 2 magnet 6. equipment potential of malfunction of implanted electronic devices person with implanted electronic medical devices staying very close to magnet, e.g. magnetic discharge conveyor 2 belt/slat band conveyor hazards according to of EN : rotary de-capping tool shall apply shall apply Sleeve label removing machine Figure 19 shows the working principle of a sleeve label removing machine. The hazards on the machine are listed in Table

58 Key: 1 movable cutter 2 bottle fixture 3 label extraction Figure 19 Working principle of a sleeve label removing machine (sectional view) Table 19 Hazards on a sleeve label removing machine hazard zone. source of hazard, hazardous element 1. mechanical hazards hazards hazardous situation / phase of life cycle reference to safety requirement 1 cutting tool (blade) cutting, stubbing, puncturing e.g. touching during cleaning or manual removing of labels, or maintenance like change of tool mechanism for moving the blade up and down crushing, shearing automatic movement or by gravity noise hazards 57

59 hazard zone. source of hazard, hazardous element vacuum extraction for labels hazards hazardous situation / phase of life cycle noise according to 4.7 of EN :2014 reference to safety requirement equipment rotary mechanisms shall apply shall apply conveyors Container cleaning machines Cleaning machine for bottles and jars (bottle washing machine) Figure 20 shows an example of a single end bottle cleaning machine. Table 20 lists the hazards on a bottle cleaning machine. 58

60 Key: 1 bottle in-feed 2 accumulation table 3 foreign objects discharge 4 waste container for foreign objects 5 soaking tank with caustic soda solution 6 man access hatches 7 waste label container 8 label press and extraction 9 steam pipes 10 deflector roll 11 spraying nozzles 12 spraying zones (caustic soda, agents, water) 13 extraction system 14 inspection window 15 bottle discharge 59

61 16 discharge conveyor 17 transport chain 18 bottle basket Figure 20 Example of a single end bottle cleaning machine (sectional side view) Table 20 Hazards on a bottle cleaning machine hazard zone. source of hazard, hazardous element hazards hazardous situation / phase of life cycle reference to safety requirement 1. mechanical hazards 1 in-feed shaft with oscillating fingers crushing, shearing, trapping, entanglement especially on double end machines from starting the machine as the danger zone at the opposite side is not within the vision of the operator discharge shaft with oscillating fingers crushing, shearing, trapping, entanglement especially on double end machines from starting the machine as the danger zone at the opposite side is not within the vision of the operator , 17 transport chain with container carriers, in-running chain on deflection rollers crushing, shearing, trapping, drawingin, entanglement foreseeable misuse: access through apertures, interior inspection by persons conveyed through the machine height of the machine or high position of machine parts or access points fall from height working on high position places , 4, 7, 8 liquid, pollutant spilling onto traffic areas and work places slip, trip

62 hazard zone. source of hazard, hazardous element hazards hazardous situation / phase of life cycle reference to safety requirement 2, 3, 4, 6 shards cutting 2. Thermal Hazards touching during cleaning or manual removing of labels or broken containers especially in the in-feed area , 6, 9 5, 6, 12, 14 5, 6, 12, 14 hot surfaces (pipes of heatings, surfaces of containers with hot fluids) hot fluids jets of hot liquid or steam 3. noise hazards burn scalding scalding narrow work places and platforms for taking samples, actuators etc. near hot surfaces, traffic areas next to hot surfaces spilling fluid during operation spilling fluid because of opening of hatches or windows or other access doors or covers or adding of powdery soda release of steam trough valves foreseeable misuse, e.g. inspection windows not closed properly , 2, 4, 13, 16 transported containers noise according to 4.7 of EN :2014 in-running containers hitting at each other or containers fed into carriers hitting against carriers or discharged containers dropped on the discharge conveyor hitting against it chemical hazards 61

63 hazard zone. source of hazard, hazardous element hazards hazardous situation / phase of life cycle reference to safety requirement 5, 6, 11, 12, 14 jets of hazardous liquid Table 1 shall apply foreseeable misuse, e.g. inspection windows not closed properly taking samples, correction of concentration (topping up) , 6, 7, 8, 11, 12, 14 caustic soda and other caustic chemical substances chemical burn, e.g. loss of vision NOTE: using high concentrations or solids is more serious than using liquid with lower concentration NOTE The risk (severity of injury) is increased when solvents are heated (usually the temperature of caustic soda is 80 C foreseeable misuse, e. g. opening of hatches for quick release of fluids 12, 14 chlorine dioxide / sodium hypochlorite (commonly used concentration up to 10 ppm or peracetic acid (commonly used concentration up to 50 ppm) or hydrogen peroxide (commonly used concentration up to 50 ppm) in tanks, cleaning zone, waste label press and discharge chemical burn, e.g. damage of respiratory system and lung, loss of vision contact with machine tank liquid handling the substance during topping, taking samples cleaning, e.g. entering the machine for interior cleaning maintenance e.g. interior inspection opening of hatches or other access doors or covers chlorine gas chemical burn, e.g. damage of inhalation of chlorine when hypochlorite

64 hazard zone. source of hazard, hazardous element hazards hazardous situation / phase of life cycle reference to safety requirement 5. fire, explosion respiratory system and lung comes into contact with acid topping up manually inadvertency 5 hydrogen from chemical reaction of aluminium on bottle necks with soda (sodium hydroxide) explosion cleaning bottles with aluminium capsules with a machine that is not designed for that biological hazards 1, 3, 4 germs generated by bottles in the infeed area, waste, debris, germs in used water from the machine, pollutant hazards to health for operators in the vicinity of the machine according to 4.11 of EN :2014 contact, ingestion, inhalation of emitted aerosols, e.g due to open waste discharge containers, when removing waste, especially at the waste fluid discharge ergonomic hazards 1, 2, 16 bottle in-feed, bottle discharge fatigue, physical strain, mental stress, occupational diseases e.g. according to 4.10 of EN :2014 bad access, awkward posture during process intervention, e.g. erection of fallen containers, removal of broken glass, due to dimensions of container in-feed combination of hazards 5, 9 hot parts (e.g. piping) on low level in traffic area burn unintended contact:

65 hazard zone. source of hazard, hazardous element hazards hazardous situation / phase of life cycle reference to safety requirement increased contact time when falling on hot parts (longer contact) 16 combination of emitted humidity and high temperature physical fatigue strain, equipment 2, 16 in-feed or discharge conveyors (slat chain conveyor) , 8, 12 conveyors for debris removal (inrunning filter band) and waste label discharge band or screw or cylinder 4.2.1and chemical and biological hazards (see above) extraction system

66 4.6.2 Rotary keg cleaning, filling or combined cleaning and filling machine Key: 1 keg in-feed conveyor, chain or roller 2 keg in-feed stopper 3 in-feed star wheel 4 carousel 5 discharge star wheel 6 in-feed guide rail 7 discharge guide rail 8 keg clamping device 9 discharge conveyor 10 machine frame/support 11 spraying zone 12 position for mounting cip caps 13 Keg Figure 21 Example of a rotary keg cleaning machine (top view) Table 21 Hazards on a rotary keg cleaning machine 65

67 hazard zone. source of hazard, hazardous element 1. mechanical hazards hazards hazardous situation / phase of life cycle reference to safety requirement 1, 2, 3, 5, 6, 7, 9, 10 high position of machine parts fall from height 11 liquid, pollutant slip, trip 8 clamping head crushing, shearing, trapping interior inspection, change of chain climbing on machine parts or using inappropriate means of access liquid spilled onto traffic areas and work places manual feeding, e.g. handling of kegs when loading semiautomatic machines process intervention e.g. clearing jams by manual removing of kegs mass of keg impact, crushing 2. Thermal Hazards 5, 9, 11 hot water, steam scalding 5, 9, 11 hot surfaces (pipes, surfaces of kegs with hot fluids) burn falling keg (insufficient guiding, jam) jetting fluid, if the suction pipe doesn't plug the keg properly or during external cleaning, during CIPcleaning when the closures of the pipes are not fitted properly fitting cip caps onto the nozzles narrow work places, actuators etc. near hot surfaces, traffic routes next to hot surfaces, careless contact with surfaces that are not

68 hazard zone. source of hazard, hazardous element hazards hazardous situation / phase of life cycle permanently hot, e.g. during cip cleaning reference to safety requirement 3. noise hazards 1, 2, 3, 5, 6, 7, 8 in-running kegs hitting against each other or machine parts noise according to 4.7 of EN : clamps and clamping head hitting against kegs noise according to 4.7 of EN : chemical hazards 11 caustic soda and other caustic chemical substances 5. ergonomic hazards chemical burn spilling or jetted fluid, if the suction pipe doesn't plug the keg properly or during external cleaning, during CIPcleaning when the closures of the pipes are not fitted properly fitting cip caps onto the nozzles mass of kegs musculo-skeletal disorder manual handling of kegs, e.g. trouble shooting equipment 1, 9 conveyors 4.2.1shall apply keg stopper shall apply shall apply , 4, 5 rotary mechanisms shall apply shall apply and

69 hazard zone. source of hazard, hazardous element hazards hazardous situation / phase of life cycle fitting cip caps onto the nozzles unintentional contact e.g. during cleaning under the machine reference to safety requirement In-line keg cleaning, filling and combined cleaning and filling machine Figure 22 shows an example of an in-line keg cleaning and filling machine. Figure 23 shows an example of an in-line exterior keg cleaning machine. Table 22lists the hazards on these machines. 68

70 Key: 1 conveyor 2 keg 3 filling head 4 machine frame 5 sterilisation head 6 cleaning heads 7 keg transfer mechanism (walking beam) 8 direction of keg conveying 9 keg inverter 10 conveyor Figure 22 Example of an in-line keg cleaning and filling machine with walking beam transport (sectional side view) 69

71 Key: 21 spraying zone 22 spray nozzle 23 keg 24 conveyor 25 circulation pump 26 cleaning agent Figure 23 Example of an in-line exterior keg cleaning machine (sectional view of the spray zone) Figure 24 shows an example of a walking beam conveyor which is often used with in-line keg-machines. 70

72 Key: 2 keg 4 machine frame 7 walking beam 10 roller conveyor 11 drive mechanism 12 sequence of movement hazard zone. Figure 24 Example of a walking beam conveyor side view Table 22 Hazards on an in-line keg cleaning and filling machine source of hazard, hazardous element 1. mechanical hazards hazards hazardous situation / phase of life cycle 3, 5, 6, 21 liquid, pollutant slip reference to safety requirement 1 clamping head crushing, shearing, trapping manual feeding, e.g. handling of kegs when loading semiautomatic machines process intervention e.g. clearing jams by manual removing of kegs

73 hazard zone. source of hazard, hazardous element 23 mass of keg crushing, impact 2. Thermal Hazards hazards hazardous situation / phase of life cycle manual handling on semi-automatic machines; conveyed kegs passing fixed parts reference to safety requirement , 5, 6, 21 hot water, steam scalding 2, 3, 5, 6, 22, noise hazards hot surfaces (pipes, surfaces of kegs with hot fluids) burn spilling fluid, if the suction pipe doesn't plug the keg properly or during external cleaning, during CIP-cleaning when the closures of the pipes are not fitted properly unexpected jets of fluid during fitting cip caps onto the nozzles narrow work places, actuators etc. near hot surfaces, careless contact with not permanently hot surfaces, e.g. during cip cleaning , 23 in-running kegs hitting against each other or against machine parts noise according to 4.7 of EN : clamps and clamping head hitting against kegs noise according to 4.7 of EN : chemical hazards 72

74 hazard zone. 3, 5, 6, 21, 22 source of hazard, hazardous element caustic soda and other caustic chemical substances 5. ergonomic hazards hazards hazardous situation / phase of life cycle chemical burn spilling fluid, if the suction pipe doesn't plug the keg properly or during external cleaning, during CIP-cleaning when the closures of the pipes are not fitted properly fitting cip caps onto the nozzles reference to safety requirement mass of kegs 6. equipment musculo skeletal disorders manual handling of kegs, awkward position , 24 7 slat chain conveyor, roller conveyor walking beam conveyor crushing, shearing keg stopper shall apply keg inverter 0 shall apply Semi-automatic keg cleaning, filling and combined cleaning and filling machine (single head machine) Figure 25 shows an example of a semi-automatic keg cleaning and filling machine. Table 23 lists the hazards on a semi-automatic keg cleaning or filling machine. 73

75 Key: 1 clamping device 2 cylinder for clamping device 3 clamping device 4 keg 5 filling station 6 keg support, table 7 movable filling nozzle 8 cylinder for nozzle movement 9 valve manifold 10 piping for cleaning agents and product 11 movable cleaning nozzle 12 cleaning station Figure 25 Example of a semi-automatic keg cleaning and filling machine 74

76 Table 23 Hazards on semi-automatic keg cleaning or filling machine 75

77 hazard zone. source of hazard, hazardous element 1. mechanical hazards hazards hazardous situation / phase of life cycle reference to safety requirement 4, 5, 7, 11, 12 liquid, pollutant 3 clamping head slip crushing, shearing, trapping 4 mass of keg crushing, impact unintended contact e.g. liquid spilled onto traffic areas and work places manual handling of kegs when loading semiautomatic machines manual handling on semi-automatic machines; Thermal Hazards 5, 7, 11, 12 hot water, steam scalding spilling fluid, if the suction pipe doesn't plug the keg properly or during external cleaning, during CIP-cleaning when the closures of the pipes are not fitted properly , 7, 9, 10, 11 hot surfaces (pipes, surfaces of kegs with hot fluids) burn unintended contact, e.g. because of narrow work places, actuators etc. near hot surfaces or kegs noise hazards 3, 4 clamps and clamping head hitting against kegs, mechanisms noise according to 4.7 of EN : , 11 streaming liquid or vapour noise according to 4.7 of EN : chemical hazards 76

78 hazard zone. 5, 6, 7, 11, 12 source of hazard, hazardous element caustic soda and other caustic chemical substances 5. ergonomic hazards chemical burn hazards hazardous situation / phase of life cycle spilling fluid, if the suction pipe doesn't plug the keg properly or during external cleaning, during CIPcleaning when the closures of the pipes are not fitted properly fitting cip caps onto the nozzles reference to safety requirement mass of kegs musculo skeletal disorders manual feeding and discharge high position of keg support musculo skeletal disorders manual feeding and discharge, awkward posture Crate washing machine Figure 26 shows an example of a crate washing machine. Table 24 lists the hazards on a crate cleaning machine. 77

79 Key: 1 in-feed (or discharge) 2 conveyer 3 soaking bath with cleaning agent 4 spraying zone with nozzles 5 rinsing fluid 6 discharge (or in-feed) 7 inspection window 8 slide conveyor 9 frame Figure 26 Example of a crate washing machine (side view) Table 24 Hazards on a crate washing machine hazard zone. source of hazard, hazardous element 1. mechanical hazards hazards hazardous situation / phase of life cycle reference to safety requirement 4 jetted liquid 6 falling crates, falling objects from debris removal by gravity impact, injection of liquid windows not closed properly, access while spraying impact, crushing high position of machine parts Slip, trip or fall hazards according to

80 hazard zone. source of hazard, hazardous element hazards hazardous situation / phase of life cycle of EN :2014 reference to safety requirement liquid, pollutant spilling onto traffic areas and work places Slip, trip or fall hazards according to of EN : Thermal Hazards hot surfaces (pipes of heatings, surfaces of conveyors, machine frame) burn hot fluids scalding noise hazards 1 in-running crates noise according to 4.7 of EN :2014 crates hitting at each other crates conveyed from high level by gravity noise according to 4.7 of EN :2014 crates fed into carriers hitting against carriers ventilation systems noise according to 4.7 of EN : chemical hazards 3, 4, 6 caustic soda and other caustic chemical substances chemical burn spilling or jetted fluid, if the suction pipe doesn't plug the keg properly or during external cleaning, during CIPcleaning when the closures of the pipes are not fitted properly

81 hazard zone. source of hazard, hazardous element hazards hazardous situation / phase of life cycle fitting cip caps onto the nozzles reference to safety requirement 6 aerosols with cleaning agents hazard to respiratory system biological hazards germs generated by waste, germs from the crate, germs in used water from the machine, pollutant hazards to health for operators in the vicinity of the machine according to 4.11 of EN :2014 inhalation of germs, especially at the in-feed and waste discharge combination of hazards hot parts on low level burn unintended contact: increased contact time when falling on hot parts (longer contact) equipment slat chain conveyor, conveyor of waste label or debris discharge band gripper chain conveyor Cap sanitizing machine Cap sanitizing machine using vaporised hydrogen peroxide Figure 27 shows an example of a cap sterilizer using vaporized H 2O 2. Table 25 lists the hazards on this machine. 80

82 Key: 1 cap feeder 2 thermal evaporator 3 treatment chamber with H 2O 2 4 cap 5 fixing unit for caps 6 exhaust pipe 7 cap unscramble 8 hopper Figure 27 Example of a cap sanitizing machine using vaporized agents (sectional view) hazard zone. Table 25 Hazards on a cap sterilizer using vaporized H 2O 2 source of hazard, hazardous element 1. mechanical hazards hazards hazardous situation / phase of life cycle reference to safety requirement 1, 3, 6, 7 high position of closure in-feed, injection chamber, hopper or fan fall from height

83 hazard zone. source of hazard, hazardous element hazards hazardous situation / phase of life cycle 8 hopper shall apply shall apply Thermal Hazards reference to safety requirement 2, 3, 4, 5, 6 hot external and internal surfaces hot burn opening the vaporisation or treatment chamber for process intervention chemical hazards 1, 2, 3, 6 vaporized or liquid hazardous H 2O 2 chemical burn, hazards to respiratory system and lung inhalation, e.g. when opening the vaporisation or treatment chamber for process intervention Cap sanitizing machine using dip Figure 28 shows a cap sterilising dip tank. Key: 1 cap feeder 2 tank 3 sanitizing agent 4 cap 5 cap transport 6 drainage pipe Figure 28 Example of a cap sanitizing machine using vaporized agents (sectional view) 82

84 Table 26lists the hazards on a cap sterilizer using dip. hazard zone. source of hazard, hazardous element 1. mechanical hazards Table 26 Hazards on a cap sterilizer using dip hazards hazardous situation / phase of life cycle reference to safety requirement high position of closure in-feed fall from height chemical hazards 1, 2, 3, 6 H 2O 2, peracetic acid (PAE) solution chemical burn liquid drained by open duct , 2, 3, 6 H 2O 2, peracetic acid (PAE)aerosol hazards to respiratory system and lung inhalation, opening of the cover liquid drained by open duct Cap sanitizing machine using ultra violet light Table 27 Hazards on a cap sterilizer using lists the hazards on a cap sterilizer using ultra violet light. hazard zone. Table 27 Hazards on a cap sterilizer using ultra violet light source of hazard, hazardous element 1. mechanical hazards hazards hazardous situation / phase of life cycle reference to safety requirement high level position of treatment area fall from height intervention on high level Thermal Hazards lamps hot burn chemical hazards ozone chemical burn to respiratory system or mucosa exposure, e.g. during intervention

85 hazard zone. source of hazard, hazardous element 4. radiation hazards hazards hazardous situation / phase of life cycle reference to safety requirement lamps eye sunburn, skin sunburn intervention Filling machines Rotary rinsing, filling and capping machine Figure 29 shows an example of a rinsing, filling and capping machine which is a combined machine. When these machines are used in aseptic filling they present additional hazards due to germ reduction. Table 28 lists the hazards of an aseptic machine, too. 84

86 Key: 1 operator panel 2 rinser 3 filler 4 capper 5 valve manifold filler 6 valve manifold rinser 7 electrical cabinet 8 bottle in-feed, scroll 9 filler carousel 10 rinser carousel 11 rotary bottle transport 12 conveyors 13 hygiene zone Figure 29 Example of a rotary rinsing, filling and capping machine 85

87 Table 28 Hazards on a rotary rinsing, filling and capping machine Hazard zone. source of hazard, hazardous element hazards hazardous situation / phase of life cycle reference to safety requirement 1. mechanical hazards 2, 3, 9, 10 flying shards from glass bottles damaged by pressurized gas, flying containers released from rotary mechanisms cutting, stabbing, impact operation, intervention, manual cleaning high position of machine parts (filters on the top of the machine, closure unscrambler Fall from height operations in high positions liquid spillage onto traffic areas and work places slip, fall operation, filling nozzles stabbing 3, 9 shards cutting Thermal Hazards 2, 3, 9, 10 hot surfaces burn 2, 3, 9, 10 substances or product with high temperature scalding cleaning, maintenance, changeover touching during cleaning or manual removal of broken bottles touching during hot filling or automatic cleaning (CIP) or hot motors contact with hot substances (steam, pressurised hot water (140 C), hot air combined with evaporated H 2O 2, or heated peracetic 5.7.3, 5.7.3,

88 Hazard zone. source of hazard, hazardous element hazards hazardous situation / phase of life cycle acid, the filling area is treated e.g. with hot air) or product during trouble shooting reference to safety requirement 3. noise hazards high pressure injection of hot water (generation of foam to remove oxygen from the bottle neck using), contact with liquid nitrogen during injection into bottles 9, 10 rotary mechanisms shall apply shall apply bursting containers Noise according to 4.7 of EN415-10:2014 Operation, mal function, maintenance compressed air or gas Noise according to 4.7 of EN415-10:2014 Operation, closure unscrambler 4.2.7shall apply 4.2.7shall apply radiation hazards 2, 3, 4 ultra violet light (used for disinfection of machine or containers) sunburn, loss of vision exposure to UV-light sources e.g. during intervention or chemical hazards 87

89 Hazard zone. 2, 3, 9, 10 3, 9 source of hazard, hazardous element Sanitizing, disinfection or rinsing agents such as peracetic acid or hydrogen peroxide, cleaning or disinfection agents in aseptic filling (e.g. water with additives of ozone or chlorine) carbon dioxide CO 2 hazards chemical burn, hazards to respiratory system and lung oxidizing exothermic spontaneous decomposition due to pollution intoxication, asphyxiation hazardous situation / phase of life cycle Hazardous conditions: Contact with or inhalation of aerosols or vapours during intervention, opening a guard during operation or automatic cleaning, unintended release of substances while dismounting connections or closures of piping, by failures manual cleaning of machine parts taking samples, leakage process intervention, maintenance, operation,, malfunction of valves, reference to safety requirement , 9 product hazardous to health allergy, acute or chronic intoxication, depending on the characteristics Operation, maintenance, process intervention, function mal 5.7.1, fire, explosion hazards 3, 4, 9 flammable product fire, explosion process intervention changeover fault finding / trouble-shooting / setting / adjustment cleaning maintenance, intended function malfunction

90 Hazard zone. 2, 3, 4, 9, 10 source of hazard, hazardous element H 2O 2, peracetic acid hazards fire or detonation hazardous situation / phase of life cycle quick chemical decomposition, especially where the substances are polluted reference to safety requirement biological hazards 3, 4, 5 pathogen product infection Cleaning, maintenance, operation, intervention , 4, 5 pathogen accumulation of germs hazards to health for consumers of the product, hazards to health for operators machine has not been cleaned properly, Cleaning, maintenance, intervention ergonomic hazards 9. equipment closure unscrambler shall apply shall apply closure disinfection 4.6.6shall apply 4.6.6shall apply air conveyor shall apply shall apply neck gripper conveyor shall apply shall apply slat chain/slat band conveyor Drawing-in Operation, cleaning maintenance Scroll Drawing-in Operation, cleaning maintenance , 3, 4, 9, 10, 11 rotary mechanisms, 4.2.8shall apply 4.2.8shall apply

91 Hazard zone. source of hazard, hazardous element movement of filling or rinsing nozzles against containers, lifting or inverting mechanism for containers hazards hazardous situation / phase of life cycle reference to safety requirement NOTE CIP: Cleaning In Place In-line filling machine Figure 30 shows an example of an in-line filling machine. The hazards on these machines are listed in Table

92 Key: 1 conveyor 2 filling nozzles 3 pressurized product 4 pressure control valve 5 product in-feed 6 rechanisms for vertical movement of filling heads 7 container 8 electrical cabinet and operator panel 9 machine frame Figure 30 Example of an in-line filling machine side view 91

93 Table 29 Hazards on an in-line filling machine 92

94 hazard source of hazard, zone. hazardous element 1. mechanical hazards hazards hazardous situation / phase of life cycle reference to safety requirement 2, 6, 7 vertical movement of filling heads against containers and machine frame crushing, shearing filling cannulas stabbing 2, 4, 7 compressed air eye injuries unintended contact, unintended contact, person staying next to rinsed bottles while compressed air is released flying shards from glass bottles damaged by pressurized gas cutting, stabbing, impact , 7 falling containers, shards impact, cutting, slip , 5 high position of machine parts (filters, valves on the top of the machine) liquid spillage onto traffic areas and work places slip, fall Thermal Hazards 2, 3, 4, 5, 6, 7 surfaces with permanent or temporary high temperature, e.g. pipes or containers with heated product or cleaning or disinfection agent

95 hazard zone. 2, 3, 9, 10 source of hazard, hazardous element substances with high temperature, steam hazards hazardous situation / phase of life cycle reference to safety requirement noise hazards 7 bursting containers , 4 compressed air or gas impact of in-running bottles 4. chemical hazards , 3, 4, 5 cleaning or disinfection agents, e.g. H2O2, peracetic acid, water with additives of ozone or chlorine 5.7.1, , 3, 4, 5 carbondioxide CO , 3, 4, 5 nitrogen N fire, explosion hazards flammable product ergonomic hazards 94

96 hazard zone. 1, 2, 3, 4, 5, 6, 7, 8, 9 source of hazard, hazardous element filling heads of multi-lane fillers, drives, machine elements like filters, lighting, electrical cabinet, instruments not within comfortable reach distance: hazards hazardous situation / phase of life cycle reference to safety requirement inconvenient position of parts, bad posture, bad access mass of change parts 1. equipment 1 conveyor Sealing, seaming, crimping, flanging machine Foil sealing machine Figure 31 shows an example of an in-line foil sealing machine. There exist also rotary machines. When the foil is fitted to a lid the machine usually comprises a lid applicator and the uses method of induction sealing. Where the foil is applied directly it can be fes pre-cut or it is fed from a coil and cut in the machine. The sealing can be don by heat or induction. Table 30 lists the hazards of a foil sealing machine. 95

97 Key: 1 filling station 2 foil/cap application 3 container 4 conveyor 5 sealing head 6 discharge Figure 31 Example of a foil sealing machine Table 30 Hazards on a foil sealing machine hazard zone. source of hazard, hazardous element 1. mechanical hazards hazards hazardous situation / phase of life cycle reference to safety requirement moving sealing head crushing 5.8 mass of sealing head crushing handling of sealing head reel fed foil: cutting mechanism cutting unintended contact during process intervention or cleaning, manual handling during maintenance electrical hazards sealing head electrical shock electrical cables moving under power may lead to break of isolation

98 hazard zone. source of hazard, hazardous element 3. Thermal Hazards conduction sealing: hot surfaces of sealing head 4. noise hazards mechanisms for movement of sealing head sealing head hitting against containers 5. radiation hazards hazards hazardous situation / phase of life cycle reference to safety requirement induction sealing: electro magnetic field health hazards malfunction of implanted medical devices fire, explosion hazards conduction sealing: hot sealing head, foil fire overheating of the foil, also residual energy in case of loss of energy or other unintended stop ergonomic hazards mass of sealing head position of access points equipment conveyors rotary mechanisms

99 4.8.2 Can filling and seaming machine Figure 32 schematic drawing of a can seaming mechanism (top view) shows the hazards on the rotary mechanisms of a can seaming machine, Figure 33 seaming process: - working principle of crimping shows the principle of the seaming and the hazards presented by the seaming tools. Table 31 Hazards on a can seaming machine lists the hazards on can seaming machines. For hazards related to filling see 4.7. Key: 21 can infeed 22 transfer chain 23 lid transfer wheel 24 lid feeding system 25 seaming mechanism (see also next detail figure) 26 discharge star wheel 27 can discharge Figure 32 schematic drawing of a can seaming mechanism (top view) pre-roll pressing 98

100 Key: 1 pre-roll 2 press roll 3 seaming head 4 contailer lift / table 5 can 6 cover Figure 33 seaming process: - working principle of crimping Table 31 Hazards on a can seaming machine hazard zone. source of hazard, hazardous element 1. mechanical hazards hazards hazardous situation / phase of life cycle reference to safety requirement 1, 2, 3, 6 movement of cans against rolls drawing-in, crushing , 6 lift mechanisms and can moving against other parts crushing shearing noise hazards 21, 22, 23, 25, 26 friction and impact of mechanisms, cans and lids chemical hazards 3. equipment 99

101 hazard zone. 23, 25, 26 source of hazard, hazardous element hazards hazardous situation / phase of life cycle rotary mechanisms shall apply shall apply reference to safety requirement conveyors emboss coder shall apply shall apply ink jet coder shall apply shall apply Closure securing machine / cork wiring machine Figure 34 shows an example of a cork wiring machine. Table 32 lists the hazards associated with this machine. Key: 1 container 2 carousel 3 conveyor 4 wire hoods 5 wire applicator Figure 34 Schematic drawing of a cork wiring machine Table 32 lists the hazards on closure securing/cork wiring machines. 100

102 hazard zone. source of hazard, hazardous element 1. mechanical hazards Table 32 hazards on a closure securing machine hazards hazardous situation / phase of life cycle reference to safety requirement 5 moving parts of wire brace handover mechanism trapping, shearing and entanglement moving parts of wire or cord twisting mechanism trapping, shearing and entanglement noise hazards 2 rotary mechanisms shall apply shall apply 1. equipment 3 conveyor rotary mechanisms Labelling and decorating machines Rotary labelling machine Figure 35 shows an example of a rotary labelling machine for roll fed labels. Figure 36 shows an example of a rotary labelling machine for pre-cut labels which are usually applied by hot or wet glue. The machine usually comprises a laser or ink-jet coder. Table 33 hazards on a rotary labelling machine lists the hazards on all types of rotary labelling machine. 101

103 Key: 1 container in-feed 2 separating screw (scroll) 3 in-feed star wheel 4 magazines with different labels 5 carousel and container carrier 6 discharge star wheel 7 container discharge Figure 35 Example of a rotary labelling machine (3 labelling modules) 102

104 Key: 1 label magazine 2 label transfer 3 gluing 4 carousel 5 coder 6 container 7 container lift 8 rotary mechanisms of label transfer Figure 36 Example of a rotary labelling machine for pre-cut labels Table 33 hazards on a rotary labelling machine hazard zone. source of hazard, hazardous element 1. mechanical hazards hazards hazardous situation / phase of life cycle reference to safety requirement 4 oszillating label magazine crushing, shearing, entanglement, drawing-in accidental contact during manual operations, e.g. loading labels

105 4 hazard zone. source of hazard, hazardous element automatic label splicing unit cutting hazards hazardous situation / phase of life cycle accidental contact during process intervention or cleaning, reference to safety requirement 5.10 label cutting device, sleeve cutting device cutting 5.10 spillage of wet glue from reservoir slip, fall spillage of liquid product from broken containers slip, fall ejected shards from broken containers impact, cutting, slip, fall ejected containers impact electrical hazards hot melt equipment, non isolated power electric shock touching parts under power Thermal Hazards 4 hot-melt gluing equipment surfaces of heat seeling devices for sleeve labels scalding, burning burning shrink tunnel burning noise hazards air jetted on labels or bottles ergonomic hazards 4 design or position of label magazine or reel support, mass or position of change manual feeding, changeover, threading label web

106 hazard zone. source of hazard, hazardous element parts like star wheels, mass or shape of label reels, design of web feed mechanism hazards hazardous situation / phase of life cycle reference to safety requirement 6. equipment 1, 2, 7 conveyors , 4, 5, 6 rotary mechanisms with attached mechanisms like label cutting, cam rollers, label presses, transfer forks for sleeves, label transfer with glue rollers, pallets or gripper cylinders, drive unit and feed rollers for label web, application unit for reel-fed sleeve labels, sleeve stretch and transfer mechanism shall apply laser coder ink jet coder In-line labelling machine Figure 37 Example of an in-line labelling machine shows an example of an in-line labelling machine for roll fed labels. For hazards presented by the drive and transport mechanisms see For hazards presented by the mechanisms for labelling see

107 Key: 1 container conveyor 2 container 3 machine frame 4 in-feed star wheel (container spacing) 5 label applicator 6 waste label carrier take-up 7 label dispensing reel 8 operator panel 9 lateral conveyor Figure 37 Example of an in-line labelling machine 4.11 Heating or cooling machine for packed product working at atmospheric pressure (Pasteurizer) Figure 38 shows an example of a double deck pasteurizer. Table 34 lists the hazards on pasteurizer. 106

108 Key: 1 water circulation pump 2 water basin 3 water ring 4 lower Deck 5 upper Deck 6 water diverting system 7 spray nozzle 8 conveyor Figure 38 Principle of a continuous double deck pasteurizer Hazard zone. 1. mechanical hazards Table 34 hazards on a pasteurizer hazards source of hazard, hazardous element hazardous situation / phase of life cycle reference to safety requirement Height of the machine or high position of machine parts or access points Fall from height operations in high positions

109 Hazard zone. source of hazard, hazardous element Liquid spilling onto traffic areas and work places hazards Slip, trip hazardous situation / phase of life cycle staying in the vicinity reference to safety requirement 5.11 bursting containers injuries from being hit by shards trying to cool down the containes quickly for intervention Thermal Hazards hot surfaces of conveyors and other machine parts, hot containers hot burn contact, especially during process intervention , 2, 6 hot liquid (water, condensate), hot product Scalding unintentional contact, especially during process intervention, trying to cool down the containers quickly for intervention noise hazards 1 Blowers, pumps 4. chemical hazard Noise according to 4.7 of EN :2014 operation , 2, 3, 6 Biocides Allergies, acute and chronic intoxication contact during maintenance, cleaning, intervention inhalation of aerosol staying in the vicinity biological hazard 108

110 Hazard zone. 1, 2, 3, 6 source of hazard, hazardous element Germs (e.g. moulds, legionella and pseudomonads in water, biofilms and bio aerosols) hazards disease of skin, ear and respiratory system, allergies hazardous situation / phase of life cycle Skin contact and Inhalation of bio aerosol during staying in the vicinity, cleaning and maintenance; skin contact with biofilms during cleaning, intervention, maintenance and dismantling reference to safety requirement equipment Conveyors Inspection equipment While containers are conveyed through the machine they are inspected for some attribute, e.g. size, wall thickness or cleanliness. Containers which fall outside pre-set values are ejected. The inspection can use light, radiation, camera systems or contamination detection systems. shows an example of Table 35 lists the hazard on inspection machines for returned containers, empty containers, filled containers, labelled containers and crates, including the conveyors and dispose or eject devices assemblied with the detection equipment. Table 35 hazards on an inspection machine hazard zone. source of hazard, hazardous element 1. mechanical hazards 2. radiation hazards hazards hazardous situation / phase of life cycle reference to safety requirement visible light hazards to helth by stroboscope effects, glare

111 hazard zone. source of hazard, hazardous element uv-light hazards hazardous situation / phase of life cycle health hazards like sunburn, eye damage reference to safety requirement 5.12 x-ray radiation radiation injury 5.12 magnetic radiation potential of malfunction of implanted electronic devices person with implanted electronic medical devices staying very close to magnet, e.g. magnetic discharge conveyor biological hazards debris from returnable containers health hazards, especially for respiratory system equipment conveyors shall apply shall apply pushers shall apply rotary mechanisms shall apply Safety requirements 5.1 General requirements The following safety measures apply to the hazards described in clause 4. All machines in the scope of this standard shall comply with the safety requirements in clause 5.1 and the relevant machine specific clauses where the equivalent hazard exists. Deviating or additional measures described in Clauses 5.2 to 5.12 take precedence of those in 5.1, and the requirements in 5.1 take precedence of those in EN Where a machine presents hazards which are not typical on a machine in the scope of this standard and so no specific requirements are stated in this standard, the machine shall be designed according to EN : NOTE Some components or equipment may be partly completed machinery which does not fulfil the essential health and safety requirements of this standard before they are incorporated in or completed 110

112 to a machine. Guidance for the combination of machines or partly completed machinery can be found in EN ISO Mechanical Hazards - Moving Parts Inherently safe design Inherently safe design measures shall be applied as far as possible to eliminate or reduce mechanical risks, and shall comply with the requirements of clause of EN :2014. Mechanisms of the machine where inherently safe design measures can typically be applied, for example by limiting the forces applied to the mechanisms, are indicated in Clauses 5.2to Mechanisms of the machine where inherently safe design measures can typically be applied, for example by limiting the forces applied to the mechanisms, are indicated in clauses 5.2to Design of guards Guards shall comply with Clauses , and of EN :2014. Moving guards shall comply with of EN :2014 shall apply. Guards shall retain any spilled or jetted liquids and resist the substances which are intended to be used with the machine. When a guard is opened, it shall not be possible to reach a danger zone before the hazardous movement has stopped. Where this objective is not achieved, a guard locking device or internal baffle which prevents direct access to the danger zone shall be fitted. Where guards are made of a transparent material and there is a risk of someone walking into the open guard, the guard shall be marked or fitted with features which make the guard clearly visible when it is open. In order to prevent injuries or product contamination by flying shards, guards shall not be made from tempered safety glass but from laminated safety glass. Where regular access through any safeguard is foreseeably necessary once per week or more often, this safeguard shall be designed as or fitted with an interlocking guard. Where magnetic interlocking devices are used, they shall not be cascaded and shall each have their own evaluation device. Simple coded switches must not be used. Where a machine has more than five interlocking guards or ESPE or where these guards are not easily to reach, the control system shall signal which guard is open or is in a defective state Mechanical Hazards containers, packaging components , and of EN :2014 shall apply. 111

113 Mechanical Hazards - Loss of Stability of EN :2014 shall apply Slip, Trip or Fall Hazards of EN :2014 shall apply. Machine parts that are foreseen to be used as steps or platforms shall comply with EN ISO and EN ISO Different Hazards - Pneumatic or Hydraulic Equipment All pneumatic components and piping shall conform to the requirements of EN ISO All hydraulic components and piping shall conform to the requirements of EN ISO Where the machine is designed to pack foodstuffs, cosmetics, pharmaceuticals or other products where contamination is a significant risk, the design shall ensure that hydraulic oil or pneumatic lubricating oil cannot come into contact with the product Electrical Hazards - Electrical Equipment 5.5 of EN :2014 shall apply Electrical Hazards - Electrostatic Phenomena 5.6 of EN :2014 shall apply Thermal Hazards 5.7 and of EN :2014 shall apply Noise Hazards For prevention of noise emission the manufacturer shall follow the design principles given in EN ISO and EN ISO and 5.8 of EN :2014. In addition the following methods shall be used where applicable: i) Movable parts shall be guided by rollers, preferably made from thermoplastic Polyurethane elastomer or by recirculating ball bearing guides ii) For drives belts shall be used instead of chains iii) For chains drives low noise chains with thermoplastic plain bearings shall be used and they shall be guided in plastic guides iv) Rack and pinion drives shall be capsuled v) Where glass or metal containers are handled, contact surfaces such as guide rails, grippers or stopping devices shall be made from plastic vi) Vessels shall be fitted with silencers vii) Low noise nozzles shall be used and the air stream shall be adjusted so that only the intended objects will be hit 112

114 viii) Vacuum shall be generated preferably decentral using ejectors instead of using a permanent operating central vacuum pump Radiation Hazards 5.9 of EN :2014 shall apply. Radiation emissions (ionising and non-ionising) from inspection and coding devices shall be no higher than given by category 1 as defined in clause 7 of EN : Chemical Hazards General 5.9.2, 5.10, of EN :2014 and the following shall apply Substances used to sterilise packaging materials and components Machines using hazardous substances (for example hydrogen peroxide) to sanitize, sterilize or disinfect packaging materials and components shall be designed so that all foreseen interventions can be carried out safely and so that airborne emissions of the sterilising substance from the machine to the work area around the machine are kept to a minimum. The sterilising substance shall be kept in as closed a system as possible, and the seals and gaskets fitted to guard doors and other possible leakage points shall be made of materials that resist the sterilising substance being used. Movable guards shall be interlocked with guard locking devices to prevent access to areas of the machine that contain a hazardous concentration of the sterilising substance. The guard locking shall be controlled either by automatic concentration measurement device or by time. Where time is used the time delay shall be determined for the worst case conditions. If interventions are foreseen in an area while a hazardous concentration of the sterilising substance exists, suitable additional measures shall be provided, such as: - fitting the machine with an extraction system to evacuate the sterilising substance; - spraying the area with water to absorb the sterilising substance into water; or - fitting the machine with glove boxes. Where measures such as extraction or spraying systems are provided for the above purpose, these shall be dimensioned to function under the worst -case conditions and shall be interlocked to prevent access to the area if the extraction or spraying system is not functioning. The supply system of the sterilising substance shall be designed to safely contain the sterilising substance. Pipe connections shall be used that can only be dismounted using tools. If the sterilising substance is 113

115 supplied from an external source (i.e. not from a container) the machine shall be fitted with an isolation valve that can be locked in the off position. Where airborne emissions of the sterilising substance occur, for example at discharge points, measures shall be provided to prevent the build-up of hazardous levels of the substance in the vicinity ofnear the machine, such as: - providing extraction systems at e.g. discharge tunnels; - providing automatic cleaning systems for conveyors that normally will be contaminated and reach out of the machine cabinet NOTE in order to avoid carryover of the substances by the conveyors the transfer from the discharge conveyor should be positioned within the machine or the discharge tunnel. - ducting air streams to points where they can be connected to an extraction system; and - rinsing sterilising substances from the outside of packages within the machine. The user instructions shall contain the following information, where it isas relevant: - intervals and criteria for inspection and replacement of seals and gaskets to prevent leakage of sterilising substances; - instructions for inspection and maintenance of any fitted extraction or spraying system; - safe working procedures for access to areas where hazardous concentrations of sterilising substances may occur; - safe working procedures to conduct maintenance on the supply system of the sterilising substance; - the technical specifications for the room ventilation in the area where the machine will be installed; and - the specifications of any personal protective equipment to be used Cleaning or germ reduction on machines Only materials suitable for these substances shall be used if they can come into contact. The design of the machine shall prevent contact of H 2O 2 or peracetic acid with lubricants. On machines that use hazardous substances such as hydrogen peroxide or peracetic acid to sterilise packaging materials or components or the interior of the, the design and control system shall ensure that hazardous concentrations of these substances (higher than 0,5 ppm for hydrogen peroxide, higher than 0,6 ppm for peracetic acid, measured in a radial distance of 500 mm to every aperture where these substances are likely to be emitted, such as product exit or access doors) do not build up. This includes using the minimum concentration of cleaning agent, e.g. hydrogen peroxide that is still effective for sterilisation 114

116 keeping the cleaning agent enclosed in the machine using seals which are persistent against it using pipe connections which can only be dismounted with tools providing interlocking guards with guard locking for closures of pipe screens fitting the machine with glove boxes where intervention is foreseeable while a hazardous concentration of hydrogen peroxide exists glove boxes shall be interlocked where mechanical hazards are present using hydrogen peroxide from a tank ducted to the machine in pipes. Where this is not possible and a container is used, the machine design shall allow storing the container in a ventilated cabinet. providing access doors with interlocking guards which initiate a safe cut-off of the cleaning agent supply using at least 2 valves. where hazardous amounts of gases or aerosols can persist in the machine providing the interlocking system with guard locking in order to prevent access as long as a dangerous level exists. The guard locking can be controlled by measurement of the concentration or by time control. The time shall be long enough to ensure non-hazardous concentrations and it shall be determined by measurements under worst case conditions. Adjusting a delay time below the minimum time required shall be prevented by technical means. for the extraction system shall apply rinsing and drying the surface of containers inside the machine providing a tunnel guard with an aspiration system for residual cleaning agent as shown in Figure 39 Extraction of hazardous substances at the container in-feed or discharge 115

117 Figure 39 Extraction of hazardous substances at the container in-feed or discharge Cleaning in place, strainers On machines where parts have to be dismounted or mounted and missing or misaligned parts may lead to emissions or jets of hazardous substances, these parts shall be interlocked with the cleaning process. Caps on fillers or rinsers need not to be interlocked but a cold water test shall be performed at the beginning of the cleaning procedure and in case of leakage the cleaning process shall be stopped automatically. Where means of access or movable guards may expose to hazardous substances, these shall be interlocked with the hazardous function, e.g. pumping of liquid. Where strainers have to be removed regularly they shall be interlocked with the pumps and guard locking shall prevent opening of the fixture as long as liquid under pressure is present. Residual liquid shall be drained safely and independently from will during opening of the fixture, e.g. by a drainage whole that ducts liquid away from the operator. The design and position shall prevent spillage to any work places or traffic routes. Strainer units shall be fitted with a form fit opening mechanism that forces the pulling out the strainer from the pipe to prevent unexpected movement and liquid escape. The instructions shall inform of the correct use of this mechanism. Strainers shall be positioned no higher than 1,2 m over access level. The instruction shall detail the procedures and specify the necessary personal protective equipment Biological Hazards 5.10 and 5.12 of EN :2014 shall apply Ergonomic Hazards 5.11 and of EN :2014 and the following apply. On machines where change parts are used, hazards from excessive effort or strain shall be eliminated or reduced by the following measures: a) Change parts shall be designed in compliance with EN so that they can be lifted, installed and removed easily. Mref in table 1 of EN :2008 is 25 kg; b) Where the design of the machine and of the change parts allows two people to lift the parts into place, 40 c) kg may be taken as Mref. If two people are required to lift or fit change parts this shall be stated clearly in the instruction manual. 116

118 d) Where the measures described in a) and b) are not possible for technical reasons, the manufacturer shall provide suitable mechanical lifting or handling equipment to move the part; e) Change parts with a mass greater than 25 kg shall be listed in the instruction manual. All machine elements and operation panels which will foreseeably be handled with personal protective equipment and displays and control actuators shall be designed so that they can be used with the foreseeable PPE where it is needed. Where machines are foreseeably used with glass containers the manufacturer shall consider the use of cut-resistant gloves and protective goggles Different Hazards Hydraulic and Pneumatic Equipment Pneumatic components and piping shall comply with the requirements of EN ISO Hydraulic components and piping shall comply with the requirements of EN ISO Where control functions are performed by hydraulic or pneumatic systems, these circuits shall comply with the requirements of clauses 5.14 and 5.15 of EN :2014. Where the machine is designed to pack foodstuffs, cosmetics, pharmaceuticals or other products where contamination is a significant risk, the design shall ensure that hydraulic oil or pneumatic lubricating oil cannot come into contact with the product. In particular, compressed air shall be filtered but not lubricated and exhausts shall be directed away from the product. Each machine shall be equipped with isolation devices for pneumatic and hydraulic energy. These isolation devices shall be readily accessible from outside the machine s guards, clearly labelled, indicate the method of operation of the device, and be lockable in the off position. The machine shall have the facility to release stored pneumatic and hydraulic energy. Pneumatic isolation valves shall comply with clause of EN ISO 4414:2010 and hydraulic isolation valves shall comply with clause of EN ISO 4413: Equipment Conveyors General of EN :2014 and the following clauses apply Gripper chain conveyor The manufacturer shall minimise the drawing-in and crushing risk between containers and the gripper chains by the following design measures: The minimum adjustable gap (designated as w in Figure 40) between the parallel lateral grippers shall not be less than 70 mm. Where the conveyor is foreseen for non-deformable containers, the minimum length of the rubber grippers shall not be less than 40 mm. 117

119 At the deflection rolls the maximum gap (designated as d in Figure 40) between the solid parts of two gripper chains shall not exceed 5 mm. Where one of these conditions cannot be fulfilled, the conveyor shall be safeguarded by fixed or interlocked guards with a tunnel guard according to or of EN :2014. The minimum distance between the tunnel guard and the grippers (designated as a in Figure 40) shall not be less than 100 mm where the drawing-in zone can be reached with hands only and not be less than 50 mm where the drawing-in zone can be reached with fingers only. NOTE For reach distances see EN ISO Where the gripper chain is not enclosed in the machine's safeguards, the manufacturer shall safeguard the gripper chains along their run by a top and bottom plates which cover the chain. The design of the safeguards shall comply with of EN :

120 Key: 1 slat band conveyor 2 crate transfer 3 gripper chain 4 machine frame 5 crate 6 tunnel guard a distance between grippers and safeguard d distance between two gripper elements w distance between the parallel gripper chains Figure 40 Measures on a gripper chain conveyor top view Where crates are conveyed over accessible areas, the manufacturer shall provide suitable means like nets to catch the crates. These devices for containment shall be easily accessible to remove caught crates. The manufacturer shall provide cleaning information for these devices of containment in order to minimise biological risks Different Hazards - Safety functions The safety related control systems shall as a minimum comply with the following performance levels of EN ISO :

121 Air conveyor Noise Hazards The manufacturer shall minimise the emission of noise according to f) Methods of reducing noise on this machine are g) enclosing fans in sound attenuating material h) using filters made from sound attenuating material or design i) enclosing the area of bottle transport, e.g. by transparent plastic material Chemical Hazards of EN EN :2014 shall apply Biological Hazards 5.10 and 5.12 of EN :2014 and the following shall apply. Where contaminated containers (e.g. returnable bottles) are blown, the design shall reduce the emission of germs to a non-harmful level for persons in the vicinity of the conveyor and the instructions shall detail the methods and means of cleaning the conveyor. The instructions shall detail the characteristics of filters to be used and the intervals for checking the filters and the criteria or intervals for changing the filters Neck gripper conveyor The drive mechanisms and deflection rolls shall be safeguarded complying with Where the gripping force of the pliers exceeds the values for fingers of table B.1 of EN :2014 or if their shape is likely to cause entanglement the container transfer areas (in-feed and discharge) shall be safeguarded complying with Where the energy of a moving container exceeds 4 J or where the gripping fingers are likely to cause entanglement the neck gripper conveyor as a whole shall be safeguarded complying with Different Hazards - Safety functions The safety related control systems shall as a minimum comply with the following performance levels of EN ISO :

122 Vacuum transfer conveyor Mechanical Hazards and the following shall apply. Where the vacuum transfer conveyor is not able to hold masses greater than 50 g, no measures against falling containers need to be taken except it is foreseeable that breakable containers can be conveyed Noise Hazards and the following shall apply. The dropping height of the containers shall be minimised in order to avoid the generation of noise. The manufacturer shall minimise the emission of noise from vacuum generating equipment by adopting measures listed in clause and the area of bottle transport shall be completely enclosed, e.g. by acrylic glass Dispose or eject device Mechanical Hazards Crushing or shearing hazards between moving and fixed parts and between the pusher plate and the container shall be prevented by protective structures or reduction of speed, force and energy in accordance with For the gaps between the pushing plate and the conveyor or fixed parts of the pusher this shall be achieved by ensuring that the maximum gap between fixed and moving parts is no greater than 4 mm and the minimum gap between the pusher plate and guide rails is no less than 50 mm. The pusher rod shall not protrude from the fixed parts of the device. If inherent safe design is not possible, e.g. due to the high mass of the container, the device shall be safeguarded by fixed or interlocked guards according to Where foreseeably breakable containers will be ejected, the manufacturer shall prevent ejection of shards by solid safeguards. If specific collection containers are necessary to retain containers or materials the manufacturer shall supply these containments with the machine. Otherwise he shall give detailed information about the characteristics of containments and about the safe way to use it with the device. The safeguards shall be solid and in relation to the collection container be designed to retain any ejected product or shards. Where the pusher presents a mechanical risk it shall be guarded by fixed or interlocked guards. 121

123 Key: 1 container 2 conveyor 3 guide rail 4 gap 5 pneumatic cyliner 6 pusher rod 7 cabinet / machine frame 8 pusher plate Noise Hazards Figure 41 Example for safe design of a pusher (sectional view) and the following shall apply. To minimise the generation of noise by falling containers, the collection container shall be made of noise damping material, e.g. of multi-layer sheet or being fitted with reinforcements or with noise reducing material to avoid acoustic vibrations. Noise emission by the impact of containers on containers shall be minimised by a small falling distance or using braking gravity chutes. The generation of noise by the impact of the pusher on the container shall be prevented by reduction of the pushing speed and energy to the minimum value necessary for the function and the contact area of the pusher plate shall be made of low-noise material and have structures that avoid the generation of noise.

124 Noise emission of pneumatic cylinders shall be minimised by silencers. If the measures above are not sufficient, the device and collection container shall be enclosed in noise reducing guards Different Hazards - Safety functions The safety related control systems shall as a minimum comply with the following performance levels of EN ISO :2015 i. safety related stop: PLr=c ii. prevention of unexpected start-up: PLr=d iii. emergency stop: PLr=c Keg stopping device Mechanical Hazards and the following shall apply. Where the keg stopping device cannot achieve the requirements of inherent safe design, e.g. where positive conveyors or rubber conveyors are used which usually generate higher forces, the device shall be guarded by a combination of fixed and interlocked guards or ESPE. Dimensioning the safeguards shall consider the crushing risk caused by subsequent kegs Noise Hazards and the following shall apply. The contact areas of the stoppers shall be made of noise reducing material. In-running kegs shall be decelerated or impact of kegs shall be prevented in order to minimise noise generated by the impact energy Different hazards - safety functions The safety related control systems shall as a minimum comply with the following performance levels of EN ISO :2015 i. safety related stop: PLr=c ii. prevention of unexpected start-up: PLr=d iii. emergency stop: PLr=c 123

125 5.2.4 Keg lift and inverting machine Mechanical Hazards and the following shall apply. A device operating automatically shall be guarded by a combination of fixed and interlocked guards or ESPE. Dimensioning the safeguards shall consider the crushing risk caused by subsequent kegs. If the operator has to start every single movement of the device, this shall be performed by a hold-to-run control from a position with a clear view to all danger zones of the device. In this case no safeguards are necessary. To prevent uncontrolled movement e.g. during cleaning or maintenance a positive mechanical locking device shall be provided Noise Hazards and the following shall apply. The contact areas of the stoppers shall be made of noise reducing material. In-running kegs shall be decelerated or impact of kegs shall be prevented in order to minimise noise generated by the impact energy Safety functions The safety related control systems shall as a minimum comply with the following performance levels of EN ISO : Extraction or ventilation system or blower General The extraction system shall deliver a run-signal to the machine Mechanical Hazards and the following shall apply. Where the fan can be reached after opening an interlocked guard this guard shall be fitted with interlocking with guard locking. Where there is a hazard of uncontrolled movement of the fan by air flow the fan shall be fitted with a brake. Preferably the filters of the extraction system shall be positioned so that they can be reached from floor level. If this is not possible, stairs and platforms shall comply with of EN :

126 Noise Hazards Noise emission shall be minimised according to Especially the following methods are known to be effective: 1. reducing the working pressure and differential pressure to the minimum which is necessary for the process 2. avoiding obstacles in the fluid stream 3. avoiding excitation of air columns 4. reducing the peripheral speed of rotors to a minimum 5. enclosing the blower in noise damping or isolating material avoiding any gaps in the enclosure 6. designing the extraction system including the extraction mouth, the piping and the blower shall minimise the noise emission by the air flow 7. reducing excitation of piping for air transport of components by using or fitting sound damping material such as multi-layer sheet 8. minimising the flow velocity of the transport air 9. avoiding bends in the piping for components If this is not possible avoiding small radiuses of bends (e.g. 800 mm) to reduce the impact energy of components hitting on the pipe wall 10. avoiding noise transmission by fitting connections of elements with elastic material so that rigid components have no contact with other rigid components 11. stopping the extraction system shall when the machine is not in operation 12. avoiding fluctuation of pressure of air columns 13. avoiding resonance of material, e.g. by using sandwich material or perforated metal plate or by applying noise damping material NOTE 1 NOTE 2 This list is not exhaustive. For choice of methods and calculation EN should be used Chemical Hazards 5.9.2, 5.10, of EN :2014 and the following apply. 125

127 Where the extraction equipment is needed to extract hazardous substances it shall not be possible to start the attached machine without the extraction system in operation. The manufacturer shall provide means to avoid the emission of hazardous substances from the extraction system to the working environment, e.g. by filters. In addition to the measures according to 5.9.2, 5.10, of EN :2014 the instructions shall detail the necessary intervals and the procedures of monitoring and filter changing and specify the characteristics of necessary personal protective equipment. Where the machine is foreseen to be connected to the user's extraction system, the manufacturer shall provide sufficient information to allow the connection to this extraction system. This may include information on the necessary air flow Biological Hazards 5.10 and 5.12 of EN :2014 and the following shall apply. In addition to the measures according to 5.10 and 5.12 of EN :2014the instructions shall detail the necessary intervals and the procedures of monitoring and filter changing and specify the characteristics of necessary personal protective equipment Fire or Explosion Hazards 5.9.2, 5.10, and of EN :2014 and the following shall apply. The extraction system shall be capable of extraction of the flammable substances for which it is foreseen without the build-up of explosive atmosphere. If explosive atmosphere can be present all components in the fluid stream shall be designed for the use in the foreseeable explosion zone all piping shall be of conductible material, connected by conductible means and earthed properly and monitoring and controlling the relevant parameters, e.g. concentration, pressure, temperature or air flow and the extraction system shall be fitted with an emergency power supply if the loss of energy would lead to dangerous explosive atmosphere the extraction system shall provide a safety related run signal 126

128 The instructions shall inform of the intervals and extent of checks and controls of the protective measures Different Hazards - Safety functions The safety related control systems shall as a minimum comply with the following performance levels of EN ISO :2015 i) stopping of hazardous movements by ESPE or interlocking systems: PLr=d ii) prevention of unexpected start-up/ opening of the shutter: PLr=d iii) emergency stop: PLr=c Hoppers Slip, Trip or Fall Hazards and the following shall apply. Where the hopper cannot be refilled manually from floor level, automatic feeders (e. g. conveyors) shall be provided. Alternatively, suitable working platforms and means of access complying with EN parts 1 to 3 shall be provided to enable the operator to work safely when feeding the caps into a cap hopper. The operator shall not be able to reach dangerous parts of the machine from the platform or means of access Noise Hazards and the following shall apply. The dropping height of the containers or packaging components shall be minimised in order to avoid the generation of noise. Where components such as closures are fed pneumatically, the bend radius of pipes shall be at least 800 mm and bends of pipes shall be covered by noise damping material. The components shall be conveyed into the hopper tangentially Ergonomic Hazards and the following shall apply. Automatic feeders (e. g. conveyors) shall be provided. Alternatively, suitable working platforms and means of access complying with EN parts 1 to 3 shall be provided to enable the operator to work safely when feeding the caps into a cap hopper. The manufacturer shall inform of the need of lifting equipment such as lifting and tilting mechanisms where it is foreseeable that the hopper will be fed from containers which shall not be lifted manually according to

129 5.2.7 Rotary mechanisms Mechanical Hazards Rotary mechanisms shall be guarded complying with Fixed guard 2 tunnel guard 3 interlocked guard Figure 42 Example of safeguarding a rotary machine (schematic, top view) Noise Hazards shall apply. 5.3 Coding and marking equipment incorporated in a packaging machine Radiation Hazards 5.9 of EN :2014 shall apply. Radiation emissions (ionising and non-ionising) from coding devices shall be no higher than given by category 1 as defined in clause 7 of EN :

130 5.3.2 Hot foil coder Mechanical Hazards and the following hall apply. Where the coder is enclosed in the safeguards of the machine the hazardous functions of the coder shall stop together with the hazardous machine functions Thermal Hazards shall apply Different Hazards - Safety functions Where interlocked guards are used to stop hazardous movements of rollers the performance level required shall be PL r=c Laser coder General of EN :2014 and the following shall apply Noise Hazards For the extraction system shall apply. For extraction system system shall apply Radiation Hazards Where the laser has a class higher than 1 the following shall apply: While the machine or the coder is in a stop condition, the laser beam shall be in a safe stop condition or the emission of radiation shall be prevented, e.g. by a shutter Chemical Hazards The extraction and cooling system shall comply with Different Hazards - Safety functions The safety related control systems shall as a minimum comply with the following performance levels of EN ISO :2015 i) Closing of shutter by ESPE or interlocking systems: PLr=d ii) prevention of unexpected start-up/ opening of the shutter: PLr=d 129

131 iii) prevention of laser start without running the extraction system: PLr=d iv) emergency stop: PLr=c Ink jet coder General of EN :2014 and the following shall apply Slip, Trip or Fall Hazards Jetting ink on traffic areas or work places shall be prevented, e.g.by screens. The design shall allow fixing the ink tank in a stable position to avoid tilting and spillage of ink Chemical Hazards 5.9.2, 5.10, of EN :2014 and the following apply. about the instructions shall detail the safe handling of ink and safe cleaning methods and the characteristics of required personal protective equipment Fire or Explosion Hazards 5.9.2, 5.10, and of EN :2014 and the following shall apply. Where flammable ink is intended or foreseeable to be used with the piping shall be isolated from any source of ignition, e. g. by enclosing these components in a separate cabinet. The piping shall be as short as possible and fixed so that damage and spillage to traffic or work areas by fault is prevented. Where the amount of ink could generate hazardous explosive atmosphere, the spraying zone shall be well ventilated in order to keep the concentration below the lower explosion limit. The design shall allow fixing the ink tank in a stable position to avoid tilting and spillage of ink. The instructions shall detail the necessary measures to avoid hazardous amounts and concentrations of the flammable substance and to avoid ignition sources in the hazard zone Different Hazards - Safety functions The safety related control systems shall as a minimum comply with the following performance levels of EN ISO :

132 5.3.5 Emboss coder Mechanical Hazards shall apply Noise Hazards Different Hazards - Safety functions The safety related control systems shall as a minimum comply with the following performance levels of EN ISO :2015 i) safety related stop: PLr=c ii) prevention of unexpected start-up: PLr=c iii) emergency stop: PLr=c 5.4 Plastic bottle unscrambling machine Mechanical Hazards and the following shall apply. The rotary disk shall be designed smooth without protruding parts and the gap between the disk and other parts of the machine or the sorting mechanism shall not exceed 4 mm. Otherwise the disk shall be safeguarded according to Semi-automatic lifting and tilting mechanisms shall either be operated by a hold-to-run control located outside the hazard zone and where the operator has a clear view to all hazard zones. Automatic lifting and tilting mechanisms shall be guarded by a combination of fixed and interlocked guards according to Where whole body access is possible under lifted parts of the lifting and tilting mechanism the following measures shall be taken against uncontrolled lowering complying with the requirements stated in 5.1.3, 5.3.2, and of EN 415-4:2018, e.g. by a self-locking lift gear or a mechanical arrester.noise Hazards Different Hazards - Safety functions The safety related control systems shall as a minimum comply with the following performance levels of EN ISO :

133 i) stopping of lifting and tilting mechanism by ESPE or interlocking systems: PLr=d ii) stopping of hazardous rotary movements by ESPE or interlocking systems: PLr=d iii) prevention of unexpected start-up: PLr=d iv) emergency stop: PLr=c 5.5 Machines for applying caps or removing packaging components or materials from containers Screw cap removing machine, screw capping machine, crown capping machine, roll-on capping machine and plugging/corking machine Figure 43 shows an example of a rotary capping machine with safeguards. 132

134 Key: 1 carousel 2 cap feed 3 capping/uncapping/plugging head 4 thread roller, capping/uncapping/plugging mechanism 5 container 6 hopper 7 cap unscrambler 8 cap stopper 9 in-feed scroll 10 tunnel guard 11 conveyor 12 interlocked door 13 fixed and interlocking guards 14 interlocking device Figure 43 Example of a rotary capping machine (schematic front view) Mechanical Hazards and the following shall apply. Where a means of access is necessary to reach the hopper it shall not give access to hazardous functions of the machine or hopper Noise Hazards Noise emission shall be minimised according to and the following measures: 1) apertures in guards shall be as small as possible to retain noise 2) for the transport of caps blowers shall be used instead of compressed air. 3) the safeguards shall be solid to prevent noise emission to the work places 4) the apertures in guards shall be as small as possible NOTE These lists are not exhaustive. Preferably the exhaust air of the extraction system for removed caps on de-capping machines shall be conducted to the open. The manufacturer shall provide the necessary means and the instruction shall detail the requirements for the exhaust system. 133

135 Otherwise the extraction system shall be fitted with filters for the exhaust air to prevent contamination of the working area by germs. The instructions shall detail the necessary intervals and the procedure of filter changing and specify the characteristics of necessary personal protective equipment Different Hazards - Safety functions The safety related control systems shall as a minimum comply with the following performance levels of EN ISO :2015 i) stopping of hazardous movements by ESPE or interlocking systems: PLr=d ii) prevention of unexpected start-up: PLr=d iii) emergency stop: PLr=d Crown cork removing machine Mechanical Hazards Figure 44 shows the safety measures on a crown cork removing machine. 134

136 Key: 1 rotating cylinder with crown cork removing tools 2 conveyor 3 bottle 4 crate 5 machine frame 6 operator panel 7 fixed guard 8 tunnel guard 9 crown cork conveyor 10 crown cork 11 crown cork container Figure 44 safety measures on a crown cork removing machine (sectional view) and the following shall apply. The minimum distance between the safeguard around the aperture or the in-feed tunnel and the passing crate shall be 60 mm to 80 mm to avoid crushing or shearing of fingers or hands. Where crates run on each other the impact energy, force and pressure shall be reduced to the values for inherent safe design, e.g. by using a conveyor with low friction. Where a stopper is used that is not inherent safe, shall apply..where the wate cap container is part of the safeguard it shall be interlocked with the hazardous functions of the machine. The instructions shall detail the use and characteristics of tools and personal protective equipment which are needed especially for trouble shooting, cleaning or maintenance of the rotary de-capping tool Slip, Trip or Fall Hazards and the following shall apply. The removed caps shall be collected in a container. The design of the machine shall allow the easy positioning of a container for the removed caps Ergonomic Hazards and the following shall apply. Where the rotating cylinder has to be changed for format changing 5.11 and of EN :2014 apply Noise Hazards and the following shall apply: 135

137 1. to minimise the impact of crates the acceleration of the crates shall be controlled by the control system 2. the falling height of removed caps shall be minimised 3. the cylinder shall be designed to minimise generation of noise due to excitation of air from the rotary movement 4. the impact energy of the tools on the crown corks shall be minimised by the design of the tools and of the cylinder 5. the rotary speed of the cylinder shall be reduced to a minimum Where crown corks are extracted by vacuum the respective requirements of shall apply Different Hazards - Safety functions The safety related control systems shall as a minimum comply with the following performance levels of EN ISO :2015 i) stopping of hazardous movements by ESPE or interlocking systems: PLr=d ii) prevention of unexpected start-up: PLr=d iii) emergency stop: PLr=c Sleeve label removing machine Mechanical Hazards 5.1.1and the following shall apply. The cutting risks shall be prevented as follows: 1. the design shall ensure that the cutting device cannot move unexpectedly, e.g. due to stored energy.5.13, 5.14, 5.15 and 5.16 of EN :2014 shall apply); and 2. the design and position of the cutting tool shall minimise the risk of injury during intervention, e.g. by designing the cutting mechanism so that the cutting surfaces are protected when the machine stops; and 3. the cutting tools shall be designed or provided with auxiliary devices so that they can be installed and removed from the machine without any hazard. Auxiliary devices may include handles, clamping devices, gripping or holding tools 4. the instructions shall detail the use and characteristics of personal protective equipment against cutting Noise Hazards shall apply. 136

138 Different Hazards - Safety functions The safety related control systems shall as a minimum comply with the following performance levels of EN ISO :2015 i) stopping of hazardous movements by ESPE or interlocking systems: PLr=d ii) prevention of unexpected start-up: PLr=d iii) emergency stop: PLr=c 5.6 Container cleaning machines Cleaning machine for bottles and jars (bottle washing machine) Mechanical Hazards Moving Parts in general 5.1.1and the following shall apply. 1. The machine shall be fitted with a reset button for the each AOPD or interlocking guards next to this device but not reachable from the danger zone. 2. Starting of the machine shall only be possible when all AOPD and interlocking guards have been reset and are in operation. 3. Where all hazardous functions are safeguarded so that undetected access without stopping the hazardous functions is not possible, it is allowed to use a start device on each end of the machine. 4. On double end machines an emergency stop button shall be attached to the machine at both ends. 5. Removing of any collection containers used with the machine shall not lead to exposure to hazardous functions. Otherwise the container shall be interlocked with the hazardous functions. 6. For hatches shallapply. 7. For windows shall apply 8. The design of the machine shall allow internal inspection without the need of operator access to the interior of the machine, e.g. by using camera systems. 9. Where access is necessary to the interior for maintenance, the manufacturer shall provide safe means of access and the instructions shall detail how the machine shall be brought into a safe condition (e.g. cooling down, cleaning from hazardous substances, prevention of 137

139 unexpected start-up etc.) and a safe working procedure including suitable means of communication between maintenance stuff in the interior and the exterior of the machine. 10. The instructions shall detail the requirements for safe change of carriers. 11. The machine design shall allow the removal of shards with tools or water jet. The instructions shall detail the procedure of removing shards and characteristics of personal protective equipment to be used Moving Parts in the in-feed area for containers To allow safe intervention under safe conditions and to avoid machine stops due to falling drops of liquid, the in-feed of the machine shall be guarded by a combination of fixed guards and AOPD. to which the following requirements apply. Figure 45 illustrates an example of the safety measures specified below. 1. The AOPD shall be a light curtain. The distance between the beams of the light curtain shall be 30 mm. 2. The distance between the bottom beam of the light curtain and the top of the highest bottle to be processed (designated as a in Figure 45) shall not exceed 60 mm and 250 mm of the lowest bottle.. 3. The distance between the bottom beam of the light curtain and the conveying plane (designated as b in Figure 45) shall not exceed 500 mm. 4. The distance between the bottom beam of the light curtain and the outer edge of the bottle carrier (designated as c in Figure 45) shall be no less than 600 mm. 5. The distance between the top beam of the light curtain and the outer edge of the bottle carrier (designated as c in Figure 45) shall be no less than 1000 mm. 6. The stopping time shall not exceed the values resulting from these distances and calculated according to EN Gaps between fixed parts, e.g. fixed guards and the carrier of the AOPD, shall comply with table 4 of EN 13857: To avoid machine stops due to dropping liquid the light curtain shall have a slope of 60 in relation to the conveying plane and a machine stop shall only be generated when at least two beams are interrupted. 138

140 c b a b Key: 1 in-feed conveyor 2 lane dividing fingers 3 rotary in-feed pusher 4 pusher drive 5 in-feed slide sheet 6 bottle carrier 7 working platform 8 AOPD 9 machine frame and lateral guard Figure 45 Example of safeguarding the bottle in-feed of a single end bottle washing machine Slip, Trip or Fall Hazards and the following shall apply. The design shall ensure that no piping or other machine part crosses or protrudes into traffic ways. The machine design shall allow collecting any debris that is discharged or emitted from the machine in suitable containments so that spillage or contamination of traffic or work areas is minimised. Means of access shall be designed to avoid slip hazards, e.g. non-slip surfaces and drainage. 139

141 Where access is required above floor level permanent means of access according to EN ISO and EN ISO shall be attached to the machine. The means of access shall be chosen following EN Falling from the machine top shall be prevented by railing positioned at the outer edge of the machine and around any zones that are not stable enough for access. Where stairs to higher levels stand on a platform, additional railing shall be attached complying with of EN :2010. Examples of measures against falling from height are shown in Figure 46. Key: 1 machine body 2 means of access, e.g. stairways 3 platform 4 railing 5 additional railing 6 means of access, e.g. step ladder with hand rail Figure 46 Example for measures against falling from height on a bottle cleaning machine Thermal Hazards shall apply Noise Hazards and the following shall apply. Noise emission at the in-feed area shall be minimised by one or more of the following methods 1. controlling the movement of all in-feed conveyors in order to avoid impact between containers by decreasing the transport speed of conveyors before the impact of bottles. 140

142 2. minimising the accumulation pressure of in-running bottles, e.g. by minimizing the speed of the in-feed conveyor, design and dimension of the accumulation table or guide chains 3. minimising the falling height of bottles into the carriers 4. avoiding any spaces where bottles might accelerate 5. using material which is not easily caused to resonate for the in-feed fingers, carriers and all other parts to control the movement of the bottles 6. fitting sound damping material at the in-feed or discharge area which is easy to clean (e.g. micro perforated metal sheet) 7. installation of a movable screen. This screen shall be driven powered or counterweighted if its mass presents an ergonomic hazard and it shall be interlocked so that the machine will stop when the screen is open for more than 30 s. NOTE It is also possible to use more than one interlocked screen to reduce the mass of the screen and to increase the opening speed. Noise emission at the discharge area shall be minimised by one or more of the following methods: I. smooth dropping of bottles by reduction of dropping height II. adjusting the movement of the discharge conveyors in relation to the discharge of the carriers in order to avoid impact between containers, e.g. avoiding impact of bottles by discharging the bottles before the next row of bottles is put on the conveyor. III. using solid guards at the discharge area with a minimum of apertures Chemical Hazards and the following shall apply. The machine shall be provided with facilities to empty all tanks through pipes directly into containers or into the waste water system by a central or separate discharge line which allows emptying as quickly as possible under safe conditions. Valves or taps shall be provided for safe topping-up and taking samples of cleaning solutions. Means to take samples shall be easily accessible. Where there is a risk of unintended opening, e.g. if the means are positioned next to a traffic way, these means shall be protected against it, e.g. by requiring two different movements to actuate them. The instructions shall detail the safe procedure sample taking and specify the characteristics of necessary personal protective equipment. The instructions shall inform of the cleaning and sterilisation agents intended to be used and detail their safe use. The instructions shall indicate that any deviation from the intended cleaning substances or their mixing may lead to a hazardous situation (e. g. hypochlorite based bleaching agents and acids generate gaseous chlorine when mixed). 141

143 The instructions shall give detailed information on the kind and characteristics of personal protective equipment which is necessary for operations with chemical risk such as cleaning or entering machine parts that could be contaminated. The instructions must inform of the need of body and eye safety shower. For hatches shall apply. For windows shall apply Fire or Explosion Hazards The extraction system shall comply with Measures shall be taken to prevent hazards by operating the cleaning machine without the operation of the extraction system. In case of malfunction of the extraction system the machine shall be stopped and potential electrical ignition sources shall be switched off. The extraction system shall be started before the machine in order to extract possible accumulation of hydrogen. The extraction system shall operate continuously or be started when a detection system indicates that the number of bottles fitted with aluminium may lead to a hazardous amount of hydrogen Biological Hazards General 5.10 and 5.12 of EN :2014 and the following shall apply Re-used, re-circulated water Machines shall be designed to enable the control of water borne pathogens (e. g. Legionella) by minimising dead spaces where debris can accumulate (see EN ), providing monitoring, dosing, cleaning and drainage facilities. Information on monitoring and control of water pathogens including recommended dosing requirements and cleaning procedures shall be provided in the user instructions for the machine. The machine shall be provided with means to duct all liquids into the user's waste water system. For waste or debris discharge which may present a biological hazard, a closed system or covered containers shall be provided with the machine. Containers shall be equipped with means for drainage and shall be designed such that they can be emptied and cleaned easily. The instructions shall detail handling and cleaning of the containers and the use of personal protective equipment Ergonomic Hazards and the following shall apply. 142

144 The machine shall be designed to allow the safe removal of waste without excessive effort or bad posture. The process for safe removal of waste including the information on suitable tools and the specification of necessary personal protective equipment shall be described in the instructions Combined hazards Hatches Where opening of hatches exposes to hazardous functions or emissions like jets of chemicals or hot water these hatches shall be interlocked with the hazardous functions according to An example is shown in Figure Hatches to tanks with harmful liquids that could jet out due to gravity shall be fitted with an opening mechanism that forces the opening of the door to prevent hatches from adhering to the frame and allow residual liquid to be drained without jetting. The instructions shall inform of the correct use of this mechanism. To avoid malfunctions of interlocking devices resulting from the high temperatures and caustic atmosphere mechanical locks with a trapped key system according to EN ISO may be used as an alternative. NOTE For further information on trapped key system see ISO TS Key: 1 door 2 interlocking device 3 movable fixing bracket 4 means for opening Figure 47 Example of an interlocked hatch 143

145 Where a chemical or scalding hazard is presented by a static liquid column, the hatches with guard locking shall be used which prevent opening of the hatch as long as the hazard by the liquid column persists. In addition the hatch shall be fixed by a threaded spindle and a hand wheel which ensures that opening of the hatch is forced by turning off the hand wheel. The instructions shall inform that opening of the hatch shall be stopped immediately when liquid seeps out. An example of this mechanism is shown in Figure 48. Key: 1 door 2 machine frame 3 ridge 4 forcing opening mechanism 5 hand wheel 6 threaded spindle 7 securing bar Inspection windows Figure 48 Example of spindle fixture of a hatch To avoid access to hazard zones during inspection, the manufacturer shall provide inspection windows which allow visual inspection of critical components from outside the machine. Additional facilities to aid inspection may include internal lighting or, where condensation obscures vision, an internal wiper. Where opening of the windows exposes to hazardous functions, jetted hazardous liquid or other hazardous emissions they shall be interlocked with the hazardous function according to where regular access is foreseeable. Measures shall be taken to avoid immediate spraying when opening an inspection window, e.g. guard locking of an interlocked guard or progressive opening of a fixed guard. Where inspection windows are designed as fixed guards the windows shall not be removable by only loosening the fixtures. An example is given in Figure

146 Key: 1 machine frame 2 inspection window 3 fixture (clamp) 4 window support Figure 49 Example of a fixture of an inspection window Different Hazards - Safety functions The safety related control systems shall as a minimum comply with the following performance levels of EN ISO :2015 i) stopping of hazardous functions by ESPE or interlocking system: PL r=d i) stopping hazardous jets of liquid by ESPE or interlocking system: PL r=d ii) prevention of unexpected start-up: PL r=d iii) emergency stop: PL r=c 145

147 5.6.2 Rotary keg cleaning, filling and combined cleaning and filling machine Mechanical Hazards Figure 50 shows the safeguarding of a rotary keg cleaning/filling machine. Key: 1 platform 2 tunnel guard 3 interlocked guard 4 fixed guard 5 spray protection Figure 50 Example of safeguarding of a rotary keg cleaning/filling machine (top view) 5.1.1, and the following shall apply. For operations with open guards of EN :2014 shall apply with the following addition. 146

148 For applying or dismounting the caps for cip cleaning the manufacturer shall provide a hold to-run control function complying with of EN :2014. This control shall only move the carousel step by step. Container feed and discharge points shall be guarded by tunnel guards which are as small as possible consistent with the containers handled but with a distance to the container of 60 to 80 mm to avoid crushing or shearing of fingers or hands. Conveyors for kegs shall be fitted with guide rails to prevent tilting and falling of kegs onto traffic or work areas Chemical Hazards and the following shall apply. In the spraying zone these safeguards shall be solid to prevent overspray of jetted liquid to the work or traffic area. Hazards by jetting or spilling of hazardous substances like cleaning agents shall be prevented by the following measures: interlocking of the spray heads for the internal cleaning system in such a way that cleaning fluid or steam can only emerge when the spray head is located in the vessel to be cleaned; the tight connection of the container and the nozzle shall be detected. If the connection is not tight, the flow of hazardous substances shall be stopped; the tight connection of the cip caps on the nozzle shall be detected. If the connection is not tight, the flow of hazardous substances shall be prevented; cold water shall be used during the first step of the cip cleaning cycle; if the spray pressure is likely to change the position of the vessel to be cleaned, facilities to secure the vessel in place shall be provided. Such facilities shall not create any additional hazards; safeguards that are capable to retain spilling or jetting cleaning substances. The flow of hazardous substances shall not be possible if loss of pressure signals that the connection of machine and container is not tight Noise Hazards and the following shall apply. Noise emission can be minimised by the following methods: 147

149 1. controlling the movement of the in-feed conveyor in order to avoid impact between containers and of containers and machine parts. Preferably crates ; 2. avoiding any spaces where kegs might accelerate; 3. using noise damping material for the rotary transport mechanisms, guiding and other components that have contact with kegs; 4. using valves with silencers for dissipating compressed gas Ergonomic Hazards and the following shall apply. The distance between the carousel and safeguards shall be at least 800 mm ta allow convenient intervention, cleaning and maintenance Different Hazards - Safety functions The safety related control systems shall as a minimum comply with the following performance levels of EN ISO :2015 i) stopping of hazardous movements by ESPE or interlocking system: PL r=d ii) stopping hazardous jets of liquid by ESPE or interlocking system: PL r=d iii) prevention of unexpected start-up: PL r=d iv) emergency stop: PL r=c In-line keg cleaning, filling and combined cleaning and filling machine Mechanical Hazards shall apply.chemical Hazards shall apply Ergonomic Hazards shall apply Different Hazards - Safety functions The safety related control systems shall as a minimum comply with the following performance levels of EN ISO :2015 i) stopping of hazardous movements by ESPE or interlocking system: PL r=d 148

150 ii) stopping hazardous jets of liquid by ESPE or interlocking system: PL r=d iii) prevention of unexpected start-up: PL r=d iv) emergency stop: PL r=c Semi-automatic keg cleaning, filling and combined cleaning and filling machine (single head machine) Mechanical Hazards Key: 1 interlocking guard 2 fixed or interlocking guard Figure 51 Guarding of a semi-automatic keg cleaning or filling machine and the following shall apply. These safeguards shall allow the observation of the process Chemical Hazards and the following shall apply. Safeguards for areas where jetting of hazardous liquids cannot be excluded, e.g. because of misalignment of the keg on the nozzles shall be capable of retaining any liquid spillage. They shall be resistant against all foreseeably used cleaning or disinfection agents and filled products. 149

151 To avoid spillage of fluid or emission of steam the spray heads shall be interlocked in such a way that cleaning fluid or steam can only emerge when the spray head is located in the vessel and if the safeguards are closed. If the spray pressure is likely to change the position of the vessel to be cleaned, means to hold the vessel in place shall be provided, e.g. holding clamps. These means shall either be designed inherently safe or be guarded according Where the flow of cleaning substances of the CIP process is chosen by manual connection of connecting panels, the connections shall be guarded to retain jets of cleaning agents. The CIP cleaning shall be started with cold water Thermal Hazards and the following shall apply. The safeguards shall be designed to prevent from touching surfaces higher than the burn thresholds given in EN ISO Ergonomic Hazards In addition to the machine shall be fitted with a lifting aid for the manual keg handling. A ball table shall be used as to support kegs during horizontal transfer Different Hazards - Safety functions The safety related control systems shall as a minimum comply with the following performance levels of EN ISO :2015 i) stopping of hazardous movements by ESPE or interlocking system: PL r=d ii) stopping hazardous jets of liquid by ESPE or interlocking system: PL r=d iii) prevention of unexpected start-up: PL r=d iv) emergency stop: PL r=c Crate washing machine Mechanical Hazards and the following shall apply. Removing of crates or opening of drawers shall not lead to exposure to hazardous functions. Otherwise the container or drawer shall be interlocked with the hazardous functions. For hatches shall apply. For inspection windows shall apply. 150

152 Slip, Trip or Fall Hazards 5.1.2and the following applies. The design shall ensure that no piping or other machine part crosses or protrudes into traffic ways. The machine design shall allow collecting any debris that is discharged or emitted from the machine in suitable containments so that spillage or contamination of traffic or work areas is minimised Thermal Hazards shall apply Noise Hazards 5.1.7and the following shall apply. Noise emission at the in-feed area can be minimised by the following methods; 1. controlling the movement of all in-feed conveyors in order to avoid impact between crates by decreasing the transport speed of conveyors before the impact of crates; 2. minimising the falling height of crates when they are tilted; 3. designing the discharge of slide conveyors so that crates do not hit on each other; 4. using noise noise damping material for guide rails, slide conveyors, stoppers and all other parts to control or guide the movement of the crates; 5. fitting sound attenuating material which is easy to clean (e.g. micro perforated metal sheet); 6. apertures in guards shall be as small as possible Chemical Hazards and the following shall apply. The machine shall be provided with facilities to empty all tanks through pipes directly into containers or into the waste water system by a central or separate discharge line which allows emptying as quick as possible. The machine shall be provided with means to extract any emissions of vapour or aerosols into the open. The manufacturer shall ensure a sufficient air flow to avoid contamination of the work area. The instructions shall inform of the cleaning and sterilisation agents and detail their use. The instructions shall also detail the use of any incompatible substances (e. g. hypochlorite based bleaching agents and acids generate gaseous chlorine when mixed). Where hazards could be generated by substances that are foreseeable but not foreseen to be used, the instructions shall detail the consequences of their use. Valves or taps shall be provided for safe topping-up and taking samples of cleaning solutions. Means to take samples shall be easily accessible. They shall be designed so that two different movements are 151

153 necessary to open them. The instructions shall detail the safe procedure sample taking and specify the characteristics of necessary personal protective equipment Ergonomic Hazards and the following shall apply. The machine shall be designed to allow the safe removal of waste without excessive effort or bad posture. The process for safe removal of waste including the information on suitable tools and the specification of necessary personal protective equipment shall be described in the instructions Different Hazards - Safety functions The safety related control systems shall as a minimum comply with the following performance levels of EN ISO :2015 i) stopping of hazardous movements by ESPE or interlocking system: PL r=d ii) stopping hazardous jets of liquid by ESPE or interlocking system: PL r=d iii) prevention of unexpected start-up: PL r=d iv) emergency stop: PL r=c Cap sterilising machine Cap sterilising machine using vaporised hydrogen peroxide Chemical Hazards and the following shall apply. The treatment chamber shall be safeguarded by fixed and interlocked guards complying with These safeguard shall prevent emission of hazardous substances and be resistant against these substances. Where interventions in the treatment chamber are necessary the manufacturer shall install glove boxes or the access door shall be fitted with guard locking which ensures that the door cannot be opened as long as hazardous amounts of harmful substances are present. In the case of using glove boxes the design of the chamber and the cap guiding shall allow handling with gloves. The device shall be fitted with an extraction system which allows extracting hazardous substances to the open. For the extraction system shall apply. The manufacturer shall state in the instructions that caps shall be automatically inspected and damaged caps shall be ejected before the entry into the treatment chamber in order to avoid access to the treatment chamber. 152

154 The instructions shall give detailed information on the kind and characteristics of personal protective equipment which is necessary for operations with chemical risk such as cleaning or entering machine parts that could be contaminated Cap sterilising machine using dip Chemical Hazards and the following shall apply. The container with the sterilising liquid shall be completely closed and fitted with seals so that no vapours of disinfection agent will be emitted. Hazardous vapours shall be extracted by an extraction system before opening the container. Hazardous liquid shall be dumped in closed piping. The point of transfer to the main drainage system shall be designed in order to prevent emissions of hazardous substances. Any residual emissions shall be extracted by an extraction system. For extraction systems shall apply. The instructions shall give detailed information on the kind and characteristics of personal protective equipment which is necessary for operations with chemical risk such as cleaning or entering machine parts that could be contaminated. Figure 52 shows an example of safety measures on a sterilising dip tank. 153

155 Key: 1 pipe of extraction system 2 lid and pipe penetration with seals 3 pipe for drainage Figure 52 Example of safety measures on a cap sterilising dip tank (side view) Cap sterilising machine using ultra violet light Thermal Hazards 5.1.6and the following shall apply. Lamps shall be positioned or guarded so that they cannot be touched during intervention Chemical Hazards and the following shall apply. For prevention of ozone emissions the sterilising chamber shall be enclosed in a cabinet and the device shall be fitted with an extraction system complying with that prevents hazardous amounts of ozone in the vicinity and during intervention. Access to the treatment chamber shall require an interlocked guard with guard locking Radiation Hazards and the following shall apply. Access to the treatment chamber shall require an interlocked guard which ensures that the ultra violet lamp will be switched off or will be covered by a shutter before a person can enter. The design of infeed and discharge of caps must be fitted with non-reflecting material to avoid emission of ultra violet radiation. The treatment chamber shall be designed with an extraction system to remove ozone. Compounds of elastomer and plastics which can have contact with ultra violet light and ozone must be suitable for these influences Different Hazards - Safety functions The safety related control systems shall as a minimum comply with the following performance levels of EN ISO :2015 i) switching off the lamp by interlocked guard PLr=c ii) closing of the shutter PLr=c 154

156 5.7 Filling machines Rotary rinsing, filling and capping machine General Figure 53 shows an example for the safeguarding measures on a rotary rinsing filling and capping machine. 155

157 1. operator panel 2. rinser 3. filler 4. capper 5. valve manifold filler 6. valve manifold rinser 7. electrical cabinet 8. interlocked guard 9. filling carousel 10. rinsing carousel 11. rotary container transport 12. conveyor 13. hygiene area, hazard zone 14. tunnel guard 15. in-feed scroll Figure 53 Example of safeguarding of a rotary rinsing filling and capping machine (top view) For rotary mechanisms shall apply. For the capping station 5.5 shall apply. For conveyors shall apply Mechanical Hazards In addition to the following applies: Where the top of the machine is not designed inherent safe measures shall be taken to prevent the machine from running while persons are staying in the hazard zone. Especially where the machine top is accessible through a platform, access from this platform shall be prevented by safeguards complying with Fehler! Verweisquelle konnte nicht gefunden werden..guards shall be capable of holding back any flying objects released from the machine. The instructions shall state the need of eye protection for operators in the vicinity of the machine and for intervention Thermal Hazards and the following applies. Parts which do not have to be touched during intervention, which can be hot e.g. during normal operation, cleaning or disinfection shall be positioned or isolated or guarded so that they cannot be touched unintentionally. 156

158 The machine shall be designed to hold back splashes of hot liquid. Steam jets shall not be released to traffic ways or working places, e.g. by pressure relief valves. Drain cocks for hot fluid shall be designed so that they cannot be opened unintentionally, e.g. by requiring unlocking. They shall be positioned not higher than 120 mm over access (foot) level and face downward. The instructions shall detail how to prevent injuries from shards, e.g. during cleaning or interventions Chemical Hazards General 5.1.9and the following shall apply. Where an extraction system is used to control the emission of hazardous substances it shall comply with and the machine shall not operate without the extractions system running. For ventilation Systems the instructions shall give detailed information on the installation conditions, the necessary air exchange rate and the necessary air flow at the mouth of the extraction system Carbon Dioxide During the filling process emissions of carbon dioxide shall be extracted so that no hazardous concentration builds up in the vicinity. At least 2 valves shall be used to close the supply of CO 2. All valves shall be closed when a machine stop is initiated by an operator or an interlocked guard is opened so that the CO 2 supply will stop. Where operators can be exposed to hazardous amounts of CO 2, interlocked guards with guard locking shall be used in order to prevent access as long as a dangerous level of CO 2exists. The guard locking shall be controlled by measurement of the concentration or by time control. The time shall be long enough to ensure non-hazardous concentrations and it shall be determined by measurements under worst case conditions. Adjusting a delay time below the minimum time required shall be prevented by technical means Fire or Explosion Hazards 5.9.2, 5.10, and of EN :2014 and the following shall apply. Where an extraction system is provided, shall apply. Where the product has the potential to build up hazardous explosive atmosphere, this shall be prevented by a combination of the following measures: 1. containers and piping shall be technically leakproof 157

159 2. measures shall be taken to keep safely under the lower explosion limit, e.g. by a. filling flammable liquids at a temperature at least 15 K below the flash point b. using an extraction or ventilation system 3. in the interior of components the concentration can be held over the upper explosion limit, but care shall be taken of the escape of product and where in some situations the concentration could be between the explosion limits, measures of avoiding ignition sources shall be taken 4. the build-up of aerosols shall be prevented, e.g. by filling flammable liquids under mirror Where the build-up of hazardous explosive atmosphere cannot be excluded, there shall be no ignition sources in the hazard zone and measures shall be taken to reduce the consequences of a possible explosion by one or more of the following measures. I. all components in the fluid stream shall be designed for the use in the foreseeable explosion zone II. all piping shall be of conductible material, connected by conductible means and earthed properly III. IV. any energy which can be an ignition source shall be avoided, e.g. electrostatic discharge, hot surfaces, mechanical sparks, radiation, electromagnetic fields or radiation, ultrasonic the contact of product and oxygen shall be prevented, e.g. by filling the product under inerting atmosphere V. the volumes of possible explosive atmosphere shall be as small as possible VI. the relevant parameters, e.g. concentration, pressure, temperature or air flow shall be monitored and controlled and measures to avoid an explosion shall be taken automatically when the predetermined thresholds are reached The instructions shall inform of the intervals and extent of checks and controls of the protective measures Different Hazards - Safety functions The safety related control systems shall as a minimum comply with the following performance levels of EN ISO :2015 i) stopping of hazardous movements by ESPE or interlocking system: PL r=d ii) stopping hazardous jets of liquid by ESPE or interlocking system: PL r=d

160 iii) prevention of unexpected start-up: PL r=d iv) run detection of an extraction system: PL r=c (minor consequences) or d ( consequences like explosion)serious v) emergency stop: PL r=c In-line filling machine General Figure 54 shows an example of safeguarding an in-line filling machine 1. combination of fixed and interlocked guards 2. tunnel guard 3. operator panel Figure 54 Example of safeguarding an in-line filler Mechanical Hazards shall apply.. For conveyors shall apply. 159

161 Thermal Hazards shall apply Chemical Hazards shall apply Fire or Explosion Hazards shall apply Different Hazards - Safety functions The safety related control systems shall as a minimum comply with the following performance levels of EN ISO :2015 i) stopping of hazardous movements by ESPE or interlocking system: PL r=d ii) stopping hazardous jets of liquid by ESPE or interlocking system: PL r=d iii) prevention of unexpected start-up: PL r=d iv) run detection of an extraction system: PL r=c (minor consequences) or d ( consequences like explosion)serious v) emergency stop: PL r=c 5.8 Sealing, seaming, crimping, flanging machine Foil sealing machine Mechanical Hazards 5.1.1, and shall apply Thermal Hazards shall apply.fire and Explosion Hazards 5.9.2, 5.10, and of EN :2014 and the following shall apply. The instructions shall detail which sealing temperatures shall be used for the intended packaging material and foil and which kinds of material or foil shall not be used with the machine. 160

162 Different Hazards - Safety functions The safety related control systems shall as a minimum comply with the following performance levels of EN ISO :2015 i) stopping of hazardous functions by ESPE or interlocking system: PL r=d ii) stopping flow of gas by ESPE or interlocking system or leakage detection: PL r=d iii) prevention of unexpected start-up: PL r=d iv) run detection of an extraction system: PL r=c v) emergency stop: PL r=c Can filling and seaming machine 5.1.1, and shall apply. i) stopping of hazardous functions by ESPE or interlocking system: PL r=d ii) stopping flow of gas by ESPE or interlocking system or leakage detection: PL r=d iii) prevention of unexpected start-up: PL r=d iv) run detection of an extraction system: PL r=c v) emergency stop: PL r=c Different Hazards - Safety functions The safety related control systems shall as a minimum comply with the following performance levels of EN ISO :

163 5.9 Closure securing machine / cork wiring machine 5.1.1, and shall apply Different Hazards - Safety functions The safety related control systems shall as a minimum comply with the following performance levels of EN ISO :2015 i) stopping of hazardous functions by ESPE or interlocking system: PL r=d ii) stopping flow of gas by ESPE or interlocking system or leakage detection: PL r=d iii) prevention of unexpected start-up: PL r=d iv) run detection of an extraction system: PL r=c v) emergency stop: PL r=c 5.10 Labelling and decorating machines Rotary labelling machine Mechanical Hazards 5.1.1, and the following shall apply. If the machine has more than one labelling station, interlocked safeguards or interlocked label feeders shall safeguard the stations not in use Electrical Hazards and the following shall apply: When for the hot melt equipment a separate isolated power source is used to control the heated parts, there shall be a notice "Warning - separate power supply" in the language of the user's country Thermal Hazards For machines with hot melt adhesive equipment of EN :2014 and the following shall apply. The application area shall be safeguarded by solid fixed or interlocked guards complying with

164 Noise Hazards shall apply Chemical Hazards Different Hazards - Safety functions The safety related control systems shall as a minimum comply with the following performance levels of EN ISO : In-line labelling machine Mechanical Hazards 5.1.1, and the following shall apply. If the machine has more than one labelling station, interlocked safeguards or interlocked label feeders shall safeguard the stations not in use Electrical Hazards 5.1.4, and the following shall apply. When for the hot melt equipment a separate isolated power source is used to control the heated parts, there shall be a notice "Warning - separate power supply" in the language of the user's country Thermal Hazards For machines with hot melt adhesive equipment of EN :2014 and the following shall apply. The application area shall be safeguarded by solid fixed or interlocked guards complying with Fehler! Verweisquelle konnte nicht gefunden werden Different Hazards - Safety functions The safety related control systems shall as a minimum comply with the following performance levels of EN ISO :2015 i) stopping of hazardous functions by ESPE or interlocking system: PL r=d i) stopping flow of gas by ESPE or interlocking system or leakage detection: PL r=d ii) prevention of unexpected start-up: PL r=d iii) run detection of an extraction system: PL r=c 163

165 iv) emergency stop: PL r=c 5.11 Heating or cooling machine for packed product working at atmospheric pressure (pasteurizer) General Figure 55 shows an example of a double deck pasteurizer Mechanical Hazards shall apply Slip, Trip or Fall Hazards 5.1.2and the following shall apply. Piping or other machine parts shall not cross traffic ways. Facilities for collecting debris are necessary. To prevent liquid from flowing over work places or traffic ways the manufacturer shall design the machine so that all liquid emissions of the machine can be discharged by pipes into the waste water system. The instructions shall detail the positions of drainage inlets next to the machine. Permanent means of access according to EN ISO and EN ISO shall be attached to the machine where access is required over floor level e.g. at a cooling tower. Where the top of the machine will foreseeably be accessed for other purposes than mounting, repair or dismounting, falling from the machine top (e.g. cooling tower) shall be prevented by railing positioned at the outer edge of the machine and around any zones that are not stable enough for access e.g. roofs. Where stairs to higher levels stand on a platform, additional railing shall be attached complying with of EN ISO Thermal Hazards and the following shall apply. Hot liquids shall be ducted in pipes. Containers or dips with shall be covered by lids and a warning sign warning of the risk of high temperatures and substances as shown in 7.3 shall be attached on the lid. Handles shall be designed and mounted so that their temperature will not exceed 48 C Chemical Hazards - Biocides and the following shall apply. The instructions shall inform of any hazards presented by biocides which are foreseen to be used or which will foreseeably be used with the machine and detail the safe use of these substances. The instructions shall detail which kind of personal protective equipment has to be used. 164

166 Biological Hazards - Germs 5.10 and 5.12 of EN :2014 and the following shall apply. The machine shall be designed so that it can be cleaned and sanitized properly following the design principles given in EN Main biological risk zones are the dips with the sieves on the sides of the pasteurizer and cooling towers of evaporative cooling systems. The manufacturer shall provide a closed system without direct contact between cooling system and air. NOTE Good hygiene practice of operation is described in VDI Guideline 2047 Sheet 2 Open re-cooler systems Securing hygienically sound operation of evaporative cooling systems (VDI Cooling Tower Code of Practice) from January The instructions shall inform of the need to remove organic substances from the surface of filled containers by a pre-wash unit before the passage through the pasteurizer. The instruction shall inform that stagnation of water or standstill shall be avoided. The instructions shall give all information about periodic technical maintenance, hygiene inspections, hygiene checks and qualification of workers as well as of necessary cleaning intervals and procedures for the foreseen products Measures to minimise risks for respiratory system An evaporation cooling system shall be drained completely in closed piping. Droplet emission shall be minimised by the use of drift eliminators or other measures to the same effect. Drift eliminators shall be removable for cleaning and maintenance. Pumps shall be provided with facilities to be purged with makeup-water before they are handled. The instructions shall inform of the necessity is necessary that the whole system has to be drained in case of standstill. The design of the machine shall prevent deposits on surfaces in raw-water and circulatingwater treatment Measures to minimise risks for skin The instructions shall detail which kind of personal protective equipment as gloves has to be used for handling of sieves, drift eliminators and other parts of the machine. 165

167 Key: 1 Water circulation pump 2 Water basin 3 Water ring 4 Lower Deck 5 Upper Deck 6 Water diverting system 7 Spray nozzle 8 conveyor Figure 55 Principle of a continuous double deck pasteurizer Different Hazards - Safety functions The safety related control systems shall as a minimum comply with the following performance levels of EN ISO :2015 i) stopping of hazardous functions by ESPE or interlocking system: PL r=d ii) stopping flow of gas by ESPE or interlocking system or leakage detection: PL r=d iii) prevention of unexpected start-up: PL r=d iv) run detection of an extraction system: PL r=c v) emergency stop: PL r=c 166

168 5.12 Inspection equipment Noise Hazards shall apply Radiation Hazards 5.9 of EN :2014 shall apply. Radiation emissions (ionising and non-ionising) from inspection devices shall be no higher than given by category 1 as defined in clause 7 of EN :2000. Systems using visible or ultraviolet light shall be fitted with screens that prevent glare and radiation hazards. For machines that use stroboscopic light the instructions shall warn of the stroboscopic effect, especially of the possibility of attacks of epileptics Biological Hazards 5.10 and 5.12 of EN :2014 and the following shall apply. The machine shall be designed so that it can be cleaned and sanitized properly following the design principles given in EN Different Hazards - Safety functions The safety related control systems shall as a minimum comply with the following performance levels of EN ISO :2015 i) stopping of hazardous functions by ESPE or interlocking system: PL r=d ii) closing a shutter by triggering an interlocking guard PL r=d iii) stopping flow of gas by ESPE or interlocking system or leakage detection: PL r=d iv) prevention of unexpected start-up: PL r=d v) emergency stop: PL r=c 6 Verification of safety requirements and measures 6.1 General A manufacturer or supplier, who wishes to claim conformity to this standard, shall first verify that the machine fulfils the safety requirements and measures. 167

169 The following verification procedures shall be adhered to for each machine unless stated otherwise hereafter. 6.2 Visual inspections with the machine stopped Mechanical parts Check that mechanical components are securely fixed and all unnecessary sharp edges have been removed Pneumatic systems Check that pneumatic components and piping conform to the safety requirements of EN 983 and are correctly installed Hydraulic systems Check that hydraulic components and piping conform to the safety requirements of EN 982 and are correctly installed Electrical systems Check that the electrical equipment and installation is in compliance with the technical documentation described in clause 17 of EN : Safeguards Check that all safeguards are in place and securely fixed and that the safeguards and their dimensions are suitable for the hazards expected and their dimension are according to the design. Check that all interlocking devices are fitted. Check that adjustable guards can be properly adjusted to the foreseen products and pack sizes Design requirements Check for each type of machine, that the design features stipulated in 5 have been incorporated. Check for each type of machine, that the appropriate design requirements for the packaging materials foreseen to be used and the product foreseen to be packed have been followed Marking and warning signs Check that the required markings and warning signs are fitted permanently and at the required position. 6.3 Measurements with the machine stopped Safeguards For every type of machine, check that the relationship between the size of any apertures in the safeguards and their distance from the nearest danger zones conform to the requirements detailed in this standard. 168

170 6.3.2 Electrical testing The tests as described in clause 18 of EN :2006 shall be performed on every machine before it is dispatched. Three tests shall be performed compulsory: a) verification that the electrical equipment complies with technical documentation; b) in case of protection against indirect contact by automatic disconnection, conditions for protection by automatic disconnection shall be verified according to 18.2 EN :2006 f) functional tests (see 18.6 EN : Visual inspections with the machine running Safeguards Check with the machine running that the safeguards conform to the safety requirements and that the interlocked guards and ESPE are working correctly Interlocking devices Check the operation of all emergency stop and interlocking devices. Check that following the operation of an emergency stop or interlocking device all hazardous movements cease within the required stopping time and that the machine does not restart without resetting the emergency stop device or the interlocking devices and without an intentional start command Dissipation of stored energy Check for each type of machine that stored energy e. g. from pneumatic systems or mechanisms that can move under gravity is either dissipated automatically before accessing danger zones or can be made safe by the use of a means provided for this purpose. 6.5 Measurements with the machine running Measurement and declaration of noise emission For every type of machine measure the noise emission values in the manner described in Annex A Temperature For every type of machine, with the machine fully warmed up, check that the external safeguard temperatures are not higher than the burn threshold limits for the foreseen contact times and materials. Identify all areas within the machine's safeguards which are greater than the burn thresholds so that they can be recorded in the instructions and the warning sign shown in 7.3. can be fitted. 169

171 6.6 Verification procedures Verification procedures for each safety requirement detailed in Clause 5 are shown in Table 36 Table 36 Verification procedures for safety requirements identified in Clause 5 Visual inspec tion Safety requirement Functional test Measurement Calculati on Safety require ment Visual inspecti on Function al Test Measure ment Calculati on General Requirements 7 Information for use 7.1 General The information shall comply with 6.4 of EN ISO 12100:2010 and the following. As well the information shall comply with the requirements for information that are stated in the machine specific clauses of this standard. 7.2 Marking 7.2 of EN :2014 applies. 7.3 Signals and warning signs 7.3 of EN :2014 and the following shall apply. Where required in Clause 5 the following pictograms shall be fitted to the machine permanently and in such a way that the related hazard is clearly identifiable. These warning pictograms shall comply with EN 170

172 ISO 7010: 2012, reproduced below. The shape and colour of these warning pictograms shall comply with ISO , ISO and ISO Table 37 Pictograms for use on machines in the scope of this standard Warning: Hot surface W017 - EN ISO 7010: 2012 Warning: Corrosive substance W023 - EN ISO 7010: 2012 Warning: Crushing of hands W024- EN ISO 7010: 2012 Warning: Sharp element W022 EN ISO 7010: 2012 Warning: Electricity W012 - EN ISO 7010: 2012 Warning: Laser beam W004 - EN ISO 7010: 2012 Warning: Optical radiation W027 - EN ISO 7010: 2012 Warning: Radioactive material or ionizing radiation W003 - EN ISO 7010: 2012 Warning: Magnetic field W006 - EN ISO 7010: 2012 Prohibition: No reaching in P015 - EN ISO 7010: 2012 Prohibition: No access for people with active implanted cardiac 171