Safety of packaging machines Part 3: Form, fill and seal machines; fill and seal machines

Transcription

1 CEN/TC 146 Date: pren : 2017 CEN/TC 146 Secretariat: UNI Safety of packaging machines Part 3: Form, fill and seal machines; fill and seal machines Sicherheit von Verpackungsmaschinen Teil 3: Form-, Füll- und Verschließmaschinen Sécurité des Machines d'emballage Partie 3 : Machines d'emballage à former, remplir et sceller ICS: Descriptors: Document type: European Standard Document subtype: Document stage: CEN Enquiry Document language: E C:\Users\Martin\Documents\Standards\WG 2\EN 415-3\EN_415-3_(E) August 2017.doc STD Version 2.5a

2 Contents 1 Scope Normative references Terms and definitions Definition of terms Definitions of machines covered by this standard Form, fill and seal machines Fill and seal machines Filling machines Definition of machines which have similar hazards to those machines covered by this standard Hazards Hazards which occur on all machines in the scope of this standard Hazards on a flow wrapping machine Hazards on a vertical form, fill and seal machine Hazards on typical horizontal sachet form, fill and seal machines Hazards on a thermoform, fill and seal machine Hazards on a tubular bag form, fill and seal machine Hazards on a mandrel form, fill and seal machine Hazards on a pre-made bag erect, fill and seal machine Hazards on a cup or tub fill and seal machine Hazards on a sack fill and seal machine Hazards on an in-line sack fill and seal machine Hazards on a typical rotary sack fill and seal machine Hazards on an auger filler Hazards on a volumetric cup filler Hazards on a nett weigher Hazards on a multi-head weigher Safety requirements General requirements Requirements to minimize mechanical risks Electrical equipment Thermal hazards Noise reduction Vibrating mechanisms Radiation Products and substances used on machines which pose a risk Ergonomic design Hygienic design requirements Safety requirements for a flow-wrapping machine General Product Feed Film reel unwind mechanism Longitudinal sealing mechanism Transverse sealing and cutting mechanisms Discharge mechanism Integrity of safety related control systems Safety requirements for a vertical form, fill and seal machine General Product feeding devices...63 Page 2

3 5.3.3 Packing material reel unwind mechanism Longitudinal sealing mechanism Packaging material transport mechanism Transverse sealing and associated mechanisms Cutting and perforating mechanisms Product discharge opening Discharge conveyor Discharge into bins Provision for changing the forming tube Integrity of safety related control systems Safety requirements for a horizontal sachet form, fill and seal machine General Film reel unwind mechanism Vertical seal mechanism Transport mechanism Product feeding devices Product settling mechanism Top sealing mechanism Cutting mechanism Discharge chute or conveyor Integrity of safety related control systems Safety requirements for a thermoform, fill and seal machine General Lower web reel unwind mechanism Transport mechanism Heating chamber Forming die Packaging material apertures Automatic product feeding devices Upper film reel unwind mechanism Sealing die Cutting devices Scrap reel Discharge mechanism Pad or leaflet inserters Integrity of safety related control systems Safety requirements for a tubular bag form, fill and seal machine General Film reel unwind mechanism Transverse or corner sealing and cutting mechanism Openings in guards Cutting and perforating mechanisms Film draw and compensator Cooling mechanism Filling station Bag opening mechanism Product settling mechanism Bag sealing mechanism Discharge conveyor Conveyor height adjustment Bag transport mechanism Integrity of safety related control systems Safety requirements for a mandrel form, fill and seal machine Packaging material reel unwind mechanism Cutting mechanism Sealing mechanisms Carton blank magazine Mandrel former Compression mechanism

4 5.7.7 Transfer mechanisms Transport section Product feed Product settling devices Sterilization section Auxiliary media injection Package closing mechanism Vacuum sealing mechanism Discharge or compression conveyor Pak reject mechanism Integrity of safety related control systems Safety requirements for a pre-made bag, erect, fill and close machine General Bag magazine Bag erecting mechanism Transport mechanism Product feed Product settling devices Bag closing mechanism Discharge or compression conveyor Integrity of safety related control systems Safety requirements for a cup or tub fill and seal machine General Cup magazine Cup dispensing mechanism Transport mechanism Product feed devices Manual product loading Foil and lid magazines Reel unwind mechanisms Foil sealing mechanisms Scrap reels Lid placing mechanism Discharge mechanism and conveyor Integrity of safety related control systems Safety requirements for a sack fill and seal machine Safety requirements for an in-line sack fill and seal machine Safety requirements for a rotary sack fill and seal machine Safety requirements for an auger filler General Auger, stirrers and hopper Screw feeder Auger discharge and cut off devices Power supplies Ergonomic design requirements High level access Dusty products Integrity of safety related control systems Safety requirements for a volumetric cup filler General Hopper Cup plates Discharge hopper Ergonomic design requirements High level access Dusty products Integrity of safety related control systems Safety requirements for a nett weigher General

5 Product feed Vibratory feeders Weigh hopper High level access Integrity of safety related control systems Safety requirements for a multi-head weigher General Feed conveyor Vibratory conveyor, dispersion feeder and radial feeders Pool and weigh hoppers Timing hopper Cleaning weigher components High level access Dusty products Noise reduction Integrity of safety related control systems Verification of safety requirements General Visual inspections with the machine stopped Mechanical parts Pneumatic systems Hydraulic systems Electrical systems Guards Design requirements Marking and warning signs Measurements with the machine stopped Guards Electrical testing Visual inspections with the machine running Guards Safety related functions Dissipation of stored energy Measurements or tests with the machine running Electrical testing Measurement of noise emission Temperature Verification procedures Information General Marking Warning of residual risks Instructions General All the machines in the scope of this standard Machines for use with food, cosmetics or pharmaceuticals Specific requirements Annex A (normative) Noise test code A1 General A.2 Flow-wrapping machine A.3 Vertical form, fill and machine A.4 Horizontal sachet form, fill and seal machine A.5 Thermoform, fill and seal machine Sound pressure measurement A.6 Tubular bag form, fill and seal machine A.7 Mandrel form fill and seal machine A.8 Pre-made bag, erect, fill and seal machine A.9 Cup or tub fill and seal machine A.10 Sack fill and seal machine

6 A.11 Auger filler A.12 Volumetric cup filler A.13 Nett weigher A.14 Multi-head weigher Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 2006/42/EC

7 Foreword This document (pren 415-3:2017) has been prepared by Technical Committee CEN/TC 146 Packaging machines Safety, the secretariat of which is held by UNI. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by June 2018, and conflicting national standards shall be withdrawn at the latest by December This European Standard 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). See informative Annex ZA, which is an integral part of this standard, for the relationship with EU Directive(s),,. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France (incl. Guadeloupe, Martinique, Reunion & French-Guiana), Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Other parts of this standard include: EN 415 Safety of packaging machines; Part 1: Terminology and classification of packaging machines and associated equipment; Part 2: Pre-formed rigid container packaging machines. Part 4: Palletizers and depalletizers. Part 5: Wrapping machines. Part 6: Pallet wrapping machines. Part 7: Group and secondary packaging machines. Part 8: Strapping machines. Part 9: Noise measurement methods for packaging machines, packaging lines and auxiliary equipment Grade 2 and 3 accuracy Part 10: General requirements 7

8 Introduction Form, fill and seal machines and fill and seal machines are used extensively in Europe, in an increasingly wide range of industries. They contain many hazards and have the potential to cause serious injury. The extent to which hazards are covered is indicated in the scope and clause 4 of this standard. 1 Scope This European Standard establishes safety requirements for the main types of form, fill and seal machines, fill and seal machines and auger fillers, volumetric cup fillers, nett weighers and multi-head weighers which are frequently fitted to these machines. Form fill and seal machines Flow wrapping machine Vertical form, fill and seal machine Horizontal sachet form, fill and seal machine Thermoform, fill and seal machine Tubular bag form, fill and seal machine Mandrel form, fill and seal machine Fill and seal machines Pre-made bag, erect, fill and seal machine Cup or tub fill and seal machine Sack fill and seal machine Filling machines commonly fitted to form, fill and seal machines and fill and seal machines: Auger filler Volumetric cup filler Nett weigher Multi-head weigher. Other types of form, fill and seal machine which are described in clause 3.3 have similar hazards to these machines and clause 4 indicates which clauses of this standard are applicable to these machines. This standard covers the safety requirements for machine design, construction and all phases of life of the machines including installation, commissioning, operation, adjustment, maintenance and cleaning. This part of EN 415 applies to machines manufactured after the date of issue of this standard. 8

9 Exclusions This standard does not apply to: Blow mould fill and seal machines Bulk container fill and seal machines Cartoning machines Food depositors, including volumetric piston depositors Thermoforming machines This standard does consider hazards due to dust from the products being packed in these machines and modified atmosphere gases, but does not consider other hazards caused by the product being packed. 2 Normative references These documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. EN 349:1993+A1:2008, Safety of machinery Minimum gaps to avoid crushing of parts of the human body EN 415-1:2014, Safety of packaging machines Part 1: Terminology and classification of packaging machines and associated equipment EN 415-9:2009, Safety of packaging machines Part 9: Noise measurement methods for packaging machines, packaging lines and auxiliary equipment Grade 2 and 3 accuracy EN :2014, Safety of packaging machines Part 10: General requirements EN 574:1996+A1:2008 Safety of machinery. Two-hand control devices. Functional aspects. Principles for design EN 614-1:2006+A1:2009 Safety of machinery. Ergonomic design principles. Terminology and general principles EN 614-2:2000+A1:2008, Safety of machinery Ergonomic design principles Part 2: Interactions between the design of machinery and work tasks EN 618:2002+A1:2010 Continuous handling equipment and systems Safety and EMC requirements for equipment for mechanical handling of bulk materials except fixed belt conveyors EN 620:2002+A1:2010 Continuous handling equipment and systems Safety and EMC requirements for fixed belt conveyors for bulk materials EN : 2003+A1:2008. Safety of machinery. Human physical performance. Manual handling of machinery and component parts of machinery EN : 2002+A1:2008. Safety of machinery. Human physical performance. Recommended force limits for machinery operation EN :2005+A1:2008. Safety of machinery. Human physical performance. Evaluation of working postures and movements in relation to machinery 9

10 EN :2007. Safety of machinery. Human physical performance. Risk assessment for repetitive handling at high frequency EN :2005+A1:2009, Food processing machinery Basic concepts Part 2: Hygiene requirements EN ISO 4413:2010, Hydraulic fluid power General rules and safety requirements for systems and their components (ISO 4413:2010) EN ISO 4414:2010, Pneumatic fluid power General rules and safety requirements for systems and their components (ISO 4414:2010) EN ISO 7010:2012+A5:2015, Graphical symbols Safety colours and safety signs- Registered safety signs EN :2011 Explosive atmospheres. Explosion prevention and protection. Basic concepts and methodology EN ISO 12100:2010, Safety of machinery General principles for design Risk assessment and risk reduction (ISO 12100:2010) EN ISO :2008, Ergonomics of the thermal environment Methods for the assessment of human responses to contact with surfaces Part 1: Hot surfaces EN ISO :2015, Safety of machinery Safety-related parts of control systems Part 1: General principles for design (ISO :2006) EN ISO 13855:2010, Safety of machinery Positioning of safeguards with respect to the approach speeds of parts of the human body (ISO 13855:2010) EN ISO 13857:2008, Safety of machinery Safety distances to prevent hazard zones being reached by upper and lower limbs (ISO 13857:2008) EN ISO 14119:2013, Safety of machinery. Interlocking devices associated with guards. Principles for design and selection EN ISO 14120: 2015, Safety of machinery Guards General requirements for the design and construction of fixed and movable guards EN ISO :2016, Safety of machinery Permanent means of access to machinery Part 1: Choice of fixed means and general requirements of access EN ISO :2016, Safety of machinery Permanent means of access to machinery Part 2: Working platforms and walkways EN ISO :2016, Safety of machinery Permanent means of access to machinery Part 3: Stairs, stepladders and guard-rails EN ISO :2016 Safety of machinery Permanent means of access to machinery Part 4: Fixed ladders EN ISO :2015, Safety of machinery Reduction of risks to health from hazardous substances emitted by machinery Part 1: Principles and specifications for machinery manufacturers EN 15180:2014, Food processing machines Food depositors Safety and hygiene requirements EN :2014. Explosive atmospheres. Electrical installations design, selection and erection EN :2006+A1:2009, Safety of machinery. Electrical equipment of machines. General requirements 10

11 EN :2013, Safety of machinery. Electrical equipment of machines. Particular safety and EMC requirements for sewing machines, units and systems EN :2014, Safety of laser products. Equipment classification and requirements EN :2013, Safety of machinery. Electro-sensitive protective equipment. General requirements and tests EN :2013 Safety of machinery. Electro-sensitive protective equipment. Particular requirements for equipment using active opto-electronic protective devices (AOPDs) ISO :2011 Graphical symbols Safety colours and safety signs Part 1: Design principles for safety signs and safety markings ISO :2004 (R08) ED 1 Graphical symbols Safety colours and safety signs Part 2: Design principles for product safety labels ISO :2012 Graphical symbols Safety colours and safety signs Part 3: Design principles for graphical symbols for use in safety signs 3 Terms and definitions For the purposes of this document, the terms and definitions given in EN ISO 12100:2010, EN 415-1:2014 and the following apply. 3.1 Definition of terms bag Flat or gusseted flexible container longitudinally seamed and closed at one or both ends made from paper, plastic film, foil, laminate etc. NOTE: Bags produced on form, fill and seal machines will typically have a seal at both ends and a longitudinal seal running down the centre of the rear face of the bag cold adhesive adhesive that is liquid at room temperature EXAMPLE PVA adhesive cup; tub thin walled tapered container deformable material material which can be formed by the application of pressure alone film reel; packaging material reel continuous sheet of paper, carton board, plastics film, metal foil or flexible laminate wound on a cylindrical core 11

12 3.1.6 film web continuous sheet of paper, plastics film, metal foil or laminate hot melt adhesive adhesive that is solid at room temperature and which is melted and applied at elevated temperature longitudinal seal seal made on a package in line with the direction of material travel in the machine pack; package assembly of product and packaging materials produced by a packaging machine pre-made bag pre-formed flat or gusseted flexible container longitudinally seamed and closed at one end made from paper, plastic film, foil, laminate or a woven material pre-made sack pre-formed flat or gusseted sack longitudinally seamed and closed at one or both ends made from paper, plastic film, laminate, or a woven material product substance, article pack or package that is handled in the packaging machine PVA adhesive water dispersible emulsion adhesive made from polyvinyl acetate sachet flat package which when formed from two webs of flexible material is sealed on four sides and when formed from one web is sealed on three or four sides transverse seal seal made on a package at right angles to the direction of material travel in the machine change parts machine parts designed to handle a specific product, packaging material or pack size that need to be changed when the machine is set up to handle a different product, packaging material or pack size magazine mechanical assembly designed to hold stacks of cartons, carton blanks, pre-made bags, pre-made sacks, leaflets, labels, lids or stackable containers mandrel mechanical assembly around which a flexible package or carton is formed 12

13 modified atmosphere atmosphere where the normal atmosphere within a package is completely or partially replaced by one or more selected gases NOTE: Usually the objective is to extend shelf or storage life of the packaged products packaging material material used to make a package EXAMPLE Corrugated board, carton board, stretch film, paper, polypropylene packaging material transport mechanism mechanical assembly which transports packaging material through the packaging machine suction cup cup made of an elastic material to which a vacuum can be applied to lift a product reclosing feature applicator mechanism which applies a zip or self-adhesive packaging component to a package on a packaging machine sack discharge mechanism equipment that takes filled sacks away from the machine sack placer mechanism which places an empty pre-made sack onto a filling nozzle sack transfer mechanism mechanism which takes empty sacks from a sack magazine and transfers them to a sack placer manually adjustable guard adjustable guard where the adjustment is made manually and the adjustment remains fixed during a particular operation NOTE: A manually adjustable guard does not comply with this definition unless it has been dimensioned and positioned using relevant tables of EN ISO change part guard fixed or interlocking guard which has made to suit one product or pack size and must be changed every time the product or pack size is changed NOTE: A change part guard does not comply with this definition unless it has been dimensioned and positioned using relevant tables of EN ISO

14 fixed guard guard affixed in such a manner (for example, by screws, nuts, and welding) that it can only be opened or removed by the use of tools or by destruction of the means by which the guard is affixed NOTE: A fixed guard does not comply with this definition unless it has been dimensioned and positioned using relevant tables of EN ISO interlocking guard guard associated with an interlocking device so that, together with the control system of the machine, the following functions are performed: the hazardous machine functions covered by the guard cannot operate until the guard is closed; if the guard is opened while hazardous machine functions are operating, a stop command is given; when the guard is closed, the hazardous machine functions covered by the guard can operate (the closure of the guard does not, by itself, start the hazardous machine functions) Note 1: An interlocking guard does not comply with this definition unless it has been dimensioned and positioned using relevant tables of EN ISO Note 2: An interlocking guard does not comply with this definition unless the interlocking device complies with EN ISO 14119: automatically adjustable guard movable guard attached to a moveable machine element (e.g. moving side of a pre-made bag magazine) and a fixed machine element (e.g. machine frame) which moves automatically when the moveable element is adjusted NOTE: An automatically adjustable guard does not comply with this definition unless it has been dimensioned and positioned using relevant tables of EN ISO trip guard interlocking guard which is designed to move easily when touched by someone and which stops the machine before a danger zone can be reached tubular bag flexible container closed at both ends and made from a flat film tube 3.2 Definitions of machines covered by this standard Form, fill and seal machines flow-wrapping machine horizontally operating form, fill and seal machine with material reel mounted above the operating level, the product loaded horizontally and a longitudinal seal formed below the pack 14

15 Figure 1 Diagram showing the principle of operation of a typical flow-wrapping machine vertical form, fill and seal machine machine which uses flexible packaging material to form a tube, which is then filled vertically with product and sealed in a sequence of operations whilst the packaging material is transported vertically downwards Figure 2 Diagram showing the principle of operation of a typical vertical form, fill and seal machine horizontal sachet form, fill and seal machine horizontally operating form, fill and seal machine in which packs are formed, sealed on 2 or 3 sides, filled vertically with product and sealed on the remaining side whilst the film web is moved horizontally with the pack vertical 15

16 Figure 3 Diagram showing the principle of operation of a typical horizontal sachet form, fill and seal machine thermoform, fill and seal machine machine in which a web of thermoformable material is heated and formed with pressure and/or vacuum, before being filled vertically with product, sealed with a top film or magazine fed lid and finally cut to produce individual packs NOTE: Machines can produce one or more lanes of packs and may incorporate equipment to evacuate packages before they are sealed. Figure 4 Diagram showing the principle of operation of a typical thermoform, fill and seal machine tubular bag form, fill and seal machine machine which forms a bag or sack from a reel of lay flat tubular flexible packaging film, before it is filled with product and sealed 16

17 Figure 5 Diagram showing the principle of operation of a typical tubular bag form, fill and seal machine mandrel form, fill and seal machine machine which forms packs from a reel of flexible material or carton blanks, on one or more mandrels, before filling the packs with product and sealing their tops within the machine Figure 6 - Diagram showing the principle of operation of a typical mandrel form, fill and seal machine Fill and seal machines pre-made bag fill and seal machine machine in which a pre-made bag is taken from a magazine, opened, filled with product and then sealed 17

18 Figure 7 Diagram showing the principle of operation of a typical pre-made bag fill and seal machine sack fill and seal machine machine in which a pre-made sack is taken from a magazine, before being opened, filled with product and sealed NOTE: The sacks may be filled in-line or on a rotary carousel Figure 8 Diagram showing the principle of operation of a typical in-line sack fill and seal machine cup or tub fill and seal machine machine in which a pre-made cup or tub is taken from a magazine, filled and then closed with a heat sealed foil or a press-on lid Figure 9 Diagram showing the principle of operation of a typical cup/tub fill and seal machine Filling machines auger filling machine filling machine which measures out a product, usually a powder, using an auger which rotates for a predetermined number of revolutions 18

19 volumetric cup filling machine filling machine which measures out a product, usually free-flowing solids or powder, in a cup of predetermined volume nett weigher filling machine which measures out a predetermined mass of product, usually free-flowing solids, before dispensing it as a fill multi-head weigher; selective combination weigher nett weighing machine with multiple weighing units, which computes an appropriate combination of loads to achieve the predetermined mass and discharges them together as a fill 3.3 Definition of machines which have similar hazards to those machines covered by this standard The following machines have similar hazards to those on the machines covered by this standard lower reel flow-wrapping machine horizontally operating form, fill and seal machine, with film reel mounted below the operating level, the product placed on to the film web and a longitudinal seal formed above the pack Figure 10 Diagram showing the method of operation of a typical lower reel flow-wrapping machine stick packing machine vertical form, fill and seal machine which produces small cross-section stick shaped packs NOTE: Machines typically produce several lanes of packages at the same time edge sealing machine horizontally operating form, fill and seal machine in which product is placed on a horizontal web of film before being sealed on 3 or 4 sides to an upper web of film NOTE: Machines can have one or two reels of film and can produce one or more lanes of packs. 19

20 Figure 11 Diagram showing the method of operation of a typical edge sealing machine vertical sachet form, fill and seal machine vertically operating form, fill and seal machine which uses one or two webs of film which are formed vertically, filled with product and sealed to produce a 3 or 4 side sealed sachet NOTE: Machines can have one or two reels of film and can produce one or more lanes of packs. Figure 12 Diagram showing the method of operation of a typical Vertical sachet form, fill and seal machine strip packing machine vertically operating sachet form, fill and seal machine which produces strips of individually sealed packs joined together in predetermined lengths vertical form, fill and seal machine for cartonboard vertically operating form fill and seal machine which uses a cartonboard laminate, which is formed, filled with product and sealed to produce a pack resembling a carton usually filled with a liquid 20

21 Figure 13 Diagram showing the method of operation of a typical vertical form, fill and seal machine for cartonboard deep draw machine machine in which a web of deformable material is formed under pressure in a die press, before being filled vertically with product, sealed with a top film or magazine fed lid, and finally cut to produce individual packs NOTE: Machines can produce one or more lanes of packs. Figure 14 Diagram showing the method of operation of a typical deep draw machine count filling machine filling machine which measures out solids according to a predetermined count 4 Hazards 4.1 Hazards which occur on all machines in the scope of this standard The hazards described in tables 1, 2 and 3 can be present on all the machines in the scope of this standard. The fourth column in each table refers to the applicable safety requirements for each hazard. NOTE Additional hazards and hazardous situations which are specific to a certain type of machine are provided in clauses 4.2 to A risk assessment shall be carried out to identify any further hazards that may be present. Table 1 Hazards found on all machines in the scope of this standard Hazard Harm Examples of hazardous situations Safety Mechanical hazards from moving parts Mechanical hazards caused by guards Crushing, cutting, drawing-in, entanglement and shearing Crushing, cutting, and shearing Requirement Details in clauses 4.2 to to 5.14 Guards trap operator s hands or arms Impact Operator walks into an open guard

22 Hazard Harm Examples of hazardous situations Safety Requirement Slip, trip and fall Impact and falling Operators slip on spilled product, lubricants or discarded film on the floor around the machine Electrical Electric shock Direct contact with electrical conductors Electric shock Indirect contact e.g. due to breakdown of insulation or ingress of water when cleaning Ergonomic Musculo-skeletal Loading packaging materials disorders Loading or unloading products Lifting machine parts during size changing or maintenance Fire Burning Packing a product which is flammable or using a flammable packaging material Noise Hearing loss, tinnitus and other harms due to interference with speech communication Elevated noise levels e.g. from vibrating mechanisms The noise output of machines in the scope of this standard may vary depending on the product being packed Table 2 - Hazards which may be present on all the machines in the scope of this standard Hazard Harm Examples of hazardous Safety situations Requirement Electrostatic Electric shock Electrostatic charges build up on phenomena metal components and discharge as a spark Thermal Burns Operational tasks on heat sealing mechanisms Vibration Loss of feeling in hands Touching vibrating mechanisms Radiation Hazardous substances - products Hazardous substances - Sterilizing agents - EXAMPLE: peracetic acid or hydrogen peroxide Hearing loss Burns and other health damaging effects Various health damaging effects Chemical burn, hazards to respiratory system and lungs Oxidizing Exothermic spontaneous decomposition due to pollution When the sound pressure level exceeds 80dB(A). Operational tasks and maintenance Operation and trouble shooting Process intervention, cleaning, maintenance, staying in the vicinity, malfunction, leakage, contact, inhalation Modified atmosphere packaging carbon dioxide Modified atmosphere packaging nitrogen Asphyxiation Asphyxiation Release of gas reduces the oxygen levels in the air around the machine or inside machine parts and has health damaging effects Release of gas reduces the oxygen levels in the air around the machine or inside machine parts Modified atmosphere Fire or explosion Contact of some products with

23 Hazard Harm Examples of hazardous situations packaging oxygen oxygen concentrations higher than 21% for example: - fat in products - lubricants, e.g. in the vacuum pump - materials of the machine Combustion products of packaging materials increase the risk of fires or explosions Dusty products Various health Operators inhale or come into damaging effects for contract with product particles example asthma Burns and impact from A spark causes a dusty Inadequate hygienic design flying debris Various health damaging effects including food poisoning atmosphere to explode The food, cosmetic or pharmaceutical product being packed in the machine is contaminated by the machine Safety Requirement Table 3 - Hazards related to work tasks which occur on all the machines in the scope of this standard Work Task Examples of hazardous situations Harm Safety Requirement Transport Machine drops or falls over during Crushing 7.4 transport Assembly installation Machine or machine assemblies drop Crushing impact 7.4 or fall over during assembly Moving mechanisms Machine is started while someone is All hazards while guards are open wholly or partly inside a danger zone Setting Size parts drop or move unexpectedly Crushing impact Size changing Lifting heavy parts Musculo-skeletal disorders Programming Programming error causes a hazard All mechanical 7.4 hazards Touching live conductors in the Electric shock electrical enclosure Operation Operator removes a guard to gain All hazards 7.4 access to the machine but does not replace it Safety related parts of the control system fail to danger causing the machine to start unexpectedly All mechanical hazards Inadequate ventilation in area where Heat exhaustion 7.4 machine is located Fault finding Guards are removed or defeated to All hazards

24 Work Task Examples of hazardous situations Harm Safety Requirement allow access while the machine is running Cleaning Machine run with guards removed All hazards 7.4 during cleaning Guards removed for cleaning but not replaced All hazards Maintenance Dismantling Electrical enclosures fill with water Electric shock Isolation of energy supplies and stored Range of mechanical 7.4 energy dissipation causes parts to hazards move unexpectedly Dismantling/removal of parts, components, devices of the machine Parts move unexpectedly under gravity Necessary to enter danger zones to lubricate components Machine or machine assemblies drop or fall over Crushing Impact Shearing Crushing Impact Shearing Falling Slipping Range of mechanical hazards Hazards on a flow wrapping machine Figure 15 shows the hazard zones on a typical flow-wrapping machine and table 4 describes these hazards and indicates which part of clause 5 of this standard provides the appropriate safety requirement. Table 5 shows the hazards on the optional equipment that is typically integrated with a flow-wrapping machine. The hazards on a lower reel flow-wrapping machine (3.3.1) and an edge sealing machine (3.3.3) are similar to those of a flow-wrapping machine. Figure 15 - Hazard zones on a typical flow wrapping machine 24

25 Table 4 - Hazards on a typical flow-wrapping machine Zone Source of hazard Hazards Hazardous situations Safety requirement 1 Infeed chain Drawing-in Shearing Accessing chain and sprockets while running Musculo-skeletal injuries Loading products by hand risk affected by - height of conveyor - mass of products - frequency of movement - operator posture 2 Product pushers attached Drawing-in, impact and Loading products by hand to the infeed chain shearing especially near the folding box 3 Film reel unwind mechanism Cleaning while running Drawing-in and shearing Access while running Musculo-skeletal injuries Lifting and loading reels Electrostatic shock Touching film rollers Slipping and falling from a height Working at height to load or thread film 4 Folding box Drawing-in Loading products by hand Cleaning while running 5 Longitudinal sealing Crushing and drawing-in mechanism 6 Transverse sealing and cutting mechanism 7 Flat belt discharge conveyor 9 Drive mechanisms Crushing Drawing-in Shearing Threading a new reel of film Accessing while running Unexpected start-up Burning Cleaning broken products Threading film Crushing, cutting and Accessing while running drawing-in Burning Cleaning jaws Threading film Drawing-in Accessing while running Accessing for maintenance while running Table 5 - Hazards on optional equipment which is typically integrated with a flow-wrapping machine Typically added to zone Source of hazard Hazards Hazardous situations Safety requirement 1 Flat belt infeed conveyors Drawing-in at rollers and between the moving belt and fixed parts Drawing-in between the discharge of one belt conveyor and the infeed of another conveyor Loading products by hand especially near the folding box Cleaning while running Handling products near belt transfers Cleaning while running Musculo-skeletal injuries Loading products by hand risk affected by - height of conveyor

26 Typically added to zone Source of hazard Hazards Hazardous situations Safety requirement 1 Automatic product dispensing devices for example side loading pushers or pick and place devices 3 Automatic reel splicing mechanism 3 Powered unwind mechanism 3 Reclosing feature applicator Crushing Shearing - mass of products - frequency of movement - operator posture Loading products Accessing while running Crushing Access while running Cutting Setting up new reel Drawing-in Accessing while running Drawing-in Accessing while running Burning 3 Thermal coder Crushing and drawing-in Burning 3 Laser coder Burning Laser radiation 8 Hand-wheel Entanglement, impact or 9 shearing Accessing while threading material Accessing while running Direct or indirect contact with laser beam If the wheel rotates while the machine is running Musculo-skeletal injuries Excessive effort turning hand-wheel Hazards on a vertical form, fill and seal machine Figure 16 shows the hazard zones on a typical vertical form fill and seal machine and table 6 describes these hazards and indicates which parts of clause 5 of this standard provides the appropriate safety requirement. Table 7 shows the hazards on the optional equipment that is typically integrated with a vertical form fill and seal machine. This clause also applies to the following machines: - stick packing machine (3.3.2); - vertical sachet form, fill and seal machine (3.3.4); - strip packing machine (3.3.5); - vertical form, fill and seal machine for cartons (3.3.6). 26

27 Figure 16 - Hazard zones on a typical vertical form, fill and seal machine Table 6 -Hazards on a typical vertical form, fill and seal machine Zone Source of hazard Hazards Hazardous situations Safety requirement 1 Filling machine See clauses or EN for food depositors 2 Forming tube Musculo-skeletal injuries Changing the forming Falling tube Film spreader fingers Stabbing If the spreader fingers are fitted to forming tube sharp or become sharp due to wear 3 Packaging material reel Drawing-in and shearing Accessing while running unwind mechanism Musculo-skeletal injuries Loading packaging material reels Slipping Packaging material left on the floor Falling from height Working at height to load or thread film 4 Longitudinal sealing Crushing Threading new reel of film mechanism Drawing-in Accessing while running Burning Cleaning jaws Threading film 5 Transverse sealing and Crushing and cutting Accessing while running cutting mechanism Burning Threading film Cleaning jaws Cutting knife Cutting Maintenance Threading film 6 Packaging material Drawing-in, impact and Accessing while running transport mechanism Shearing 7 Discharge conveyor Drawing-in Accessing while running

28 Zone Source of hazard Hazards Hazardous situations Safety requirement 8 Drive mechanisms Crushing, drawing-in and Shearing Accessing while running e.g. for maintenance Table 7 - Hazards on optional equipment which is typically integrated with a vertical form, fill and seal machine Typically added to zone Source of hazard Hazards Hazardous situations Safety requirement 2 Modified atmosphere Asphyxiation Working in or near the equipment machine 3 Automatic reel splicing Crushing and cutting Access while running mechanism Setting up new reel 3 Powered unwind Drawing-in Accessing while running mechanism 3 Reclosing feature Drawing-in Accessing while running applicator Burning Threading material Thermal coder Crushing, drawing-in and Accessing while running burning 3 Laser coder Laser radiation Direct or indirect contact with laser beam 5 Gussetting or top closing Crushing, drawing-in and Accessing while running mechanism burning 5 Perforating mechanism Stabbing Accessing transverse seal jaw area 5 Reciprocating packaging material transport mechanism Crushing Access while running Hazards on typical horizontal sachet form, fill and seal machines Figure 17 shows the hazard zones on a typical horizontal sachet form fill and seal machine and table 8 describes these hazards and indicates which parts of clause 5 of this standard provides the appropriate safety requirement. Table 9 shows the hazards on the optional equipment that is typically integrated with a horizontal sachet form fill and seal machine. Figure 17 shows a linear transport system but the hazards are the same on machines where the transport system is rotary or partly rotary. 28

29 Figure 17 - Hazard zones on a typical horizontal sachet form, fill and seal machine Table 8 - Hazards on a typical horizontal sachet form, fill and seal machine Zone Source of hazard Hazards Hazardous situations Safety requirement 1 Film reel unwind Drawing-in, entanglement Access while running mechanism and shearing Musculo-skeletal injuries Loading reels Slipping or falling Loading or threading film Electrostatic discharge Touching film rollers Vertical sealing Crushing Accessing while running mechanism Burning Touching hot surfaces 3 Transport mechanism Impact and shearing Accessing while running Filling machine See clauses or EN for food depositors 5 Top sealing mechanism Crushing and drawing-in Accessing while running Burning Cleaning jaws Hot melt glue Threading film 6 Cutting mechanism Cutting Threading film Maintenance 7 Discharge mechanism Impact and shearing Reaching in to package Drive mechanisms Crushing, drawing-in and shearing discharge opening Accessing while running Table 9 - Hazards on optional equipment which is typically integrated with a horizontal sachet form, fill and seal machine Typically added to Zone Source of hazard Hazards Hazardous situations Safety requirement 1 Automatic reel splicing Crushing and cutting Access while running

30 Typically added to Zone Source of hazard Hazards Hazardous situations Safety requirement mechanism Setting up new reel 1 Powered unwind Drawing-in Accessing while running mechanism 1 Reclosing feature Drawing-in Accessing while running applicator Burning Threading material Thermal coder Crushing, drawing-in and Accessing while running Burning 1 Laser coder Laser radiation Direct or indirect contact with laser beam 4 Product settling Vibration Touching mechanisms mechanism while running 6 Modified atmosphere Asphyxiation Oxygen levels in equipment atmosphere reduced by release of gas 6 Hand-wheel Entanglement, impact and shearing If the wheel rotates while the machine is running Flat belt discharge conveyor Musculo-skeletal Turning handwheel Drawing-in Accessing while running Hazards on a thermoform, fill and seal machine Figure 18 shows the hazard zones on a typical thermoform fill and seal machine and table 10 describes these hazards and indicates which parts of clause 5 of this standard provides the appropriate safety requirement. Table 11 shows the hazards on the optional equipment that is typically integrated with a thermoform fill and seal machine. Figure 18 shows a linear transport system but the hazards are the same on machines where the transport system is rotary or partly rotary. This clause also applies to a deep draw machine (3.3.7). Figure 18 - Hazard zones on a typical thermoform, fill and seal machine 30

31 Table 10 - Hazards on a typical thermoform, fill and seal machine Zone Source of hazard Hazards Hazardous situations Safety requirement 1 Bottom film reel unwind Drawing-in and shearing Accessing while running mechanism Musculo-skeletal injuries Loading reels Slipping or falling Loading or threading film Transport mechanism Crushing and drawing-in Accessing while running Heating or pre-heating Crushing Accessing while running chamber Burning Threading film Forming die Crushing Reaching into forming Shearing area to pull lower web 5 Product loading area Musculo-skeletal injuries Loading products by hand 6 Top film reel unwind Drawing-in and shearing Accessing while running mechanism Musculo-skeletal injuries Loading reels Slipping or falling Loading or threading film Sealing die Crushing and drawing-in Accessing while running Burning Cleaning jaws and threading film 8 Cutting mechanisms Cutting Threading film Maintenance 9 Scrap reels Drawing-in Accessing while running Flat belt discharge Drawing-in Accessing while running conveyor 11 Drive mechanisms Crushing, drawing-in and shearing Accessing while running Table 11 - Hazards on optional equipment which is typically integrated with a thermoform, fill and seal machine Typically added to Zone Source of hazard Hazards Hazardous situations Safety requirement 1 Automatic splicing mechanism 1 Powered unwind mechanism 5 Automatic loading equipment for example pick and place or depositor Crushing Accessing while running Setting up new reel Drawing-in Accessing while running Crushing and impact Accessing while running Pad or leaflet inserter Crushing Accessing while running Musculo-skeletal injuries Loading pads or leaflets Thermal coder Crushing Drawing-in Burning Accessing while running Impact When coder moves sideways 6 Laser coder Laser radiation Direct or indirect contact with laser beam Impact When coder moves sideways 6 Self-adhesive labelling Drawing-in Accessing while running machine Impact When labeller moves sideways 7 Modified atmosphere Asphyxiation Oxygen levels in

32 Typically added to Zone Source of hazard Hazards Hazardous situations Safety requirement equipment atmosphere reduced by release of gas 4.6 Hazards on a tubular bag form, fill and seal machine Figure 19 shows the hazard zones on a typical tubular bag form, fill and seal machine and table 12 describes these hazards and indicates which parts of clause 5 of this standard provide the appropriate safety requirement. Table 13 describes hazards on the equipment typically integrated with a tubular bag form, fill and seal machine. Figure 19 - Hazard zones on a typical tubular bag form, fill and seal machine Table 12 - Hazards on a typical tubular bag form, fill and seal machine Zone Source of hazard Hazards Hazardous situations Safety requirement 1 Film reel unwind Drawing-in and shearing Accessing while running mechanism Musculo-skeletal injuries Loading film reels Slipping and falling from Working at height to load height or thread film 2 Drive Crushing, drawing-in and Accessing while running mechanism shearing e.g. for maintenance 3 Transverse or corner Crushing, drawing-in and Accessing while running sealing and cutting mechanism cutting Threading film Burning Cleaning jaws Cutting knife Cutting Touching knife e.g during maintenance 4 Film draw and Drawing-in and shearing Accessing while running compensator 5 Cooling mechanisms for sealing Crushing and shearing Accessing while running

33 Zone Source of hazard Hazards Hazardous situations Safety requirement 6 Product feeding mechanism See clauses or EN for food depositors 7 Filling mechanism Crushing and shearing Accessing while running Dust at filling station Various health damaging Contact with dust effects 8 Bag opening Crushing and shearing Accessing while running mechanism 9 Product settling Vibration Touching vibrating parts mechanism Crushing and shearing Accessing while running Bag sealing mechanism Burning Cleaning jaws Conveyor Drawing-in Accessing while running Conveyor height Crushing and shearing Adjusting conveyor height adjustment 12 Bag transport mechanism Impact, crushing and shearing Accessing while running Table 13 - Hazards on equipment which is typically integrated with a tubular bag form, fill and seal machine Typically added to Zone Source of hazard Hazards Hazardous situations Safety requirement 1 Automatic reel splicing Crushing and cutting Access while running mechanism Setting up new reel 1 Power unwind Drawing-in Accessing while running mechanism 1 or 4 Thermal coder Crushing, drawing-in Accessing while running Burning 1 or 4 Laser coder Laser Direct or indirect radiation contact with laser beam 1 or 2 Gussetting mechanism Crushing and drawing-in Accessing while running Perforating mechanism Stabbing Accessing while running Hazards on a mandrel form, fill and seal machine Figure 20 shows the hazard zones on a typical mandrel form, fill and seal machine which may incorporate a film reel unwind assembly or carton blank magazine or both assemblies. Table 14 describes these hazards and indicates which parts of clause 5 of this standard provide the appropriate safety requirement. Table 15 describes hazards on the equipment typically integrated with a mandrel form, fill and seal machine. 33

34 Figure 20 - Hazard zones on the range of mandrel form, fill and seal machines Table 14 Hazards on the range of mandrel form, fill and seal machines Zone Source of hazard Hazards Hazardous situations Safety requirement 1 Packaging material reel Drawing-in and Accessing while running unwind mechanism shearing Musculo-skeletal Loading packaging injuries material reels Slipping Packaging material left on the floor 2 Cutting mechanism Cutting Accessing while running Cutting Threading packaging material Heat sealing mechanisms Burning Touching hot surfaces Crushing, shearing Accessing while running Carton blank magazine Drawing-in Loading blanks into magazine Musculo-skeletal disorders Loading blanks into magazine Carton blank transfer mechanism Crushing, shearing Accessing while running Mandrel former Crushing, shearing, drawing-in Accessing while running

35 Zone Source of hazard Hazards Hazardous situations Safety requirement 7 Compression mechanism Crushing, shearing Accessing while running Transfer mechanism Crushing, shearing, drawing-in 9 Transport mechanism Crushing, shearing, drawing-in Accessing while running Accessing while running Product feed See clauses or EN for food depositors 11 Package closing mechanism Crushing, shearing Accessing while running Discharge conveyor Crushing, shearing, drawing-in 13 Drive mechanisms Crushing, drawing-in and shearing Accessing while running Accessing while running Table 15 - Hazards on optional equipment which is typically integrated with a mandrel form, fill and seal machine Zone Source of hazard Hazards Hazardous situations Safety 4 Automatic carton stack feeding mechanism Crushing, drawing-in shearing, requirement Accessing while running Sterilization section Burning Touching hot surfaces Respiratory Injury Hazardous gas levels in atmosphere Sterilizing agents Chemical burn Crushing Accessing the sterilization media distributor while running Vibration settling devices Hand or arm vibration Accessing while running Vacuum sealing mechanism Crushing Accessing while running Pack reject mechanism Crushing, shearing, drawing-in Accessing while running Hand-wheel Entanglement, impact, crushing, shearing, Wheel rotates while machine running musculo-skeletal injuries Excessive effort turning

36 4.8 Hazards on a pre-made bag erect, fill and seal machine Figure 21 shows the hazard zones on a typical pre-made bag erect, fill and seal machine and table 16 describes these hazards and indicates which parts of clause 5 of this standard provides the appropriate safety requirement. Table 17 shows the hazards on the optional equipment that is typically integrated with a premade bag erect, fill and seal machine. Figure 21 shows a rotary transport system but the hazards are the same on machines where the transport system is linear or partly linear. Figure 21 - Hazard zones on a typical pre-made bag erect, fill and seal machine Table 16 - Hazards on a typical pre-made bag erect, fill and seal machine Zone Source of hazard Hazards Hazardous situations Safety requirement 1 Bag magazine Drawing-in Loading bags into magazine Cutting Handling bags Manual handling Handling bags Bag dispensing and Crushing Reaching through opening mechanism Shearing magazine to the mechanism 3 Bag transport mechanism Crushing and shearing Accessing while running Filling machine See clauses or EN for food depositors 5 Product settling Vibration Touching vibrating mechanism mechanism 6 Bag closing or sealing Crushing and drawing-in Accessing while running mechanism Burning Touching hot surfaces Flat belt discharge Drawing-in Accessing while running conveyor 8 Drive mechanisms Crushing, drawing-in and shearing Accessing while running

37 Table 17 - Hazards on optional equipment which is typically integrated with a pre-made bag erect, fill and seal machine Typically added to Zone Source of hazard Hazards Hazardous situations Safety requirement 5 Modified atmosphere equipment Asphyxiation Oxygen levels in atmosphere reduced by release of gas Filling glue and trouble shooting Accessing while running Hot melt glue sealing equipment Burning and scalding 6 Thermal coder Crushing, drawing-in and burning 6 Laser coder Laser radiation Direct or indirect contact with laser beam 8 Hand-wheel Entanglement, impact If the wheel rotates while and shearing the machine is running Musculo-skeletal injuries Excessive effort turning hand-wheel Hazards on a cup or tub fill and seal machine Figure 22 shows the hazard zones on a typical cup or tub fill and seal machine equipped with a film reel unwind mechanism and figure 23 shows the hazard zones on a typical cup or tub fill and seal machine equipped for pre-cut foils and lids. Table 18 describes these hazards and indicates which parts of clause 5 of this standard provides the appropriate safety requirement. Table 19 shows the hazards on the optional equipment that is typically integrated with a cup or tub fill and seal machine. Figures 22 and 23 show linear transport systems but the hazards are the same on machines where the transport system is rotary or partly rotary. Figure 22 - Hazard zones on a typical cup or tub fill and seal machine with reel fed top foil 37

38 Figure 23 - Hazard zones on a typical cup or tub fill and seal machine for pre-cut top foils Table 18 - Hazards on a typical cup or tub fill and seal machine Zone Source of hazard Hazards Hazardous situations Safety requirement 1 Container magazine Crushing Shearing Reaching from magazine into the machine Crushing Cup support mechanism moves unexpectedly Musculo-skeletal Loading cups into injuries magazine 2 Container dispensing mechanism Crushing Shearing Reaching from magazine into the Container transport mechanism Drawing-in Shearing machine Reaching from magazine into the machine Filling machine See clauses or EN for food depositors 5 Top film reel unwind Drawing-in Access while running mechanism Shearing Musculo-skeletal Loading reels injuries Slipping and falling Loading or threading film 6 Sealing die Crushing and drawingin Accessing while running Burning Cleaning jaws Threading film 7 Scrap reel Drawing-in Accessing while running a Container discharge mechanism Crushing Shearing Reaching from magazine into the machine 8b Flat belt discharge Drawing-in Accessing while running conveyor Slat band discharge Drawing-in Accessing while running conveyor 9 Drive mechanisms Crushing and shearing Accessing while running

39 Table 19 - Hazards on optional equipment which is typically integrated with a cup or tub fill and seal machine Typically added to Zone Source of hazard Hazards Hazardous situations Safety requirement Rotary container magazine Drawing-in Shearing Loading containers during operation In-line container Drawing-in Loading containers magazine during operation 10a Foil magazine Crushing Shearing Reaching from magazine into the machine 10b Foil placing mechanism Crushing Shearing Reaching from magazine into the machine 11a Lid magazine Crushing Shearing Reaching from magazine into the machine 11b Lid placing mechanism Crushing Shearing Reaching from magazine into the machine 3 Modified atmosphere Asphyxiation Oxygen levels in equipment atmosphere reduced by release of gas Accessing while running Thermal coder Crushing and drawing-in Burning 9 Laser coder Laser radiation Direct or indirect contact with laser beam Hazards on a sack fill and seal machine Hazards on an in-line sack fill and seal machine Figure 24 shows the hazard zones of a typical in-line sack fill and seal machine and the equipment typically attached to or combined with an in-line sack fill and seal machine. Table 20 describes the hazards and indicates which parts of clause 5 of this standard provide the appropriate safety requirement. Table 21 describes hazards on the equipment typically attached to or combined with an in-line sack fill and seal machine. 39

40 Figure 24 - Hazard zones on a typical in-line pre-made sack fill and seal machine Table 20 - Hazards on a typical in-line sack fill and seal machine Zone Source of hazard Hazards Hazardous situations Safety requirement 1 Product feeding Crushing and shearing Accessing while running mechanism 2 Sack holding mechanism Crushing Accessing while running Sealing mechanism Impact, crushing and Accessing while running shearing Burning Touching hot surfaces Dust in filling nozzle area Various health damaging Contact with dusty effects products Burns and impact Spark ignites potentially explosive dust cloud 5 Holding and positioning Impact, crushing and Accessing while running mechanism shearing 6 Flow regulating Crushing and shearing Accessing while running mechanism 7 Conveying system Crushing, drawing-in and shearing Accessing while running Table 21 - Hazards on the equipment typically attached to or combined with an in-line sack fill and seal machine Zone Source of hazard Hazards Hazardous situations Safety requirement 8 Sack placer Impact Crushing Access while running Shearing 9 Sack discharge conveyor Drawing-in Accessing while running Falling Standing on the conveyor Hazards on a typical rotary sack fill and seal machine Figure 25 shows the hazard zones of a typical rotary sack fill and seal machine and the equipment typically attached to or combined with this type of machine. Table 22 describes the hazards and indicates which parts of clause 5 of this standard provide the appropriate safety requirement. Table 23 describes hazards on the equipment typically attached to or combined with an rotary sack fill and seal machine. 40

41 Figure 25 - Hazard zones on a typical rotary sack fill and seal machine Table 22 - Hazards on a typical rotary sack fill and seal machine Zone Source of hazard Hazards Hazardous situations Safety requirement 1 Carousel Crushing, entanglement, Accessing while running impact and shearing Sack holding mechanism Crushing Accessing while running Flow regulating Crushing and shearing Accessing while running mechanism Holding and positioning Impact, crushing and Accessing while running mechanism shearing Sealing mechanism Crushing and shearing Accessing while running Burning Touching hot surfaces Dust at filling nozzle area Various health damaging effects Contact with dusty products Table 23 - Hazards on equipment typically attached to or combined with a rotary sack fill and seal machine Zone Source of hazard Hazards Hazardous situations Safety requirement 2 Sack magazine Crushing, impact and Accessing while running shearing 3 Sack transfer Crushing, impact and Accessing while running mechanism shearing 4 Sack placer Crushing, impact and Accessing while running shearing 5 Sack discharge conveyor Drawing-in Accessing while running Falling Standing on the conveyor Hazards on an auger filler Figure 26 shows the hazard zones on a typical auger filler and table 24 describes these hazards and indicates which parts of clause 5 or 7 of this standard provides the appropriate safety requirement. 41

42 Figure 26 - Hazard zones on a typical auger filler Table 24 - Hazards on a typical auger filler Zone Source of hazard Hazards Hazardous situations Safety requirement 1 Screw feed conveyor Entanglement Shearing Reaching in to mechanism Hopper Inhalation of dust Operation cleaning Musculo-skeletal injuries Loading product manually Falling from height Loading product manually Auger screw Drawing-in Shearing Reaching in to mechanism Stirrers Entanglement Reaching in to mechanism 5 Cut-off device Crushing Reaching in to mechanism 6 Drive mechanism Drawing-in Operation cleaning maintenance Dusty products Various health damaging Contact with dusty effects products Whole machine Falling from a height Access during operation cleaning or maintenance Hazards on a volumetric cup filler Figure 27 shows the hazard zones on a typical volumetric cup filler and table 25 describes these hazards and indicates which parts of clause 5 or 7 of this standard provides the appropriate safety requirement. 42

43 Figure 27 - Hazard zones on a typical volumetric cup filler Table 25 - Hazards on a typical volumetric cup filler Zone Source of hazard Hazards Hazardous situations Safety requirement 1 Hopper Inhalation of dust Operation cleaning Musculo-skeletal injuries Loading product manually Falling from height Loading product manually Cup plates Shearing Crushing 2 Hinged cup bases Crushing Shearing 2 Rotary brush Drawing-in Entanglement Reaching into the assembly Reaching into the assembly Reaching into the assembly Drive mechanism Drawing-in Reaching into the assembly 5 Discharge hopper Shearing Operating machine when hopper is removed Dust Various health damaging Contact with dusty effects products Whole machine Falling from a height Access during operation cleaning or maintenance Hazards on a nett weigher Figure 28 shows the hazard zones on a typical nett weigher and table 26 describes these hazards and indicates which parts of clause 5 or 7 of this standard provides the appropriate safety requirement. The hazards on a count filling machine (3.3.8) are similar to those on a nett weigher. 43

44 Figure 28 - Hazard zones on a typical nett weigher Table 26 - Hazards on a typical nett weighing machine Zone Source of hazard Hazards Hazardous situations Safety requirement 1 Bulk product feed Vibration Touching mechanism mechanism vibratory trough Product control flaps Crushing and shearing Accessing while running Bulk product feed Drawing-in Accessing while running mechanism - Belt conveyor (flat or trough) 1 Bulk product feed Drawing-in Accessing while running mechanism - screw conveyor 2 Weigh hopper Crushing, impact and Accessing while running shearing 3 Discharge Impact Falling products chute 1, 2 & 3 Dust Various health damaging Contact with dusty effects products 1, 2 & 3 Whole machine Slipping Falling from a height Access during operation or cleaning Hazards on a multi-head weigher Figure 29 shows the hazard zones on a typical multi-head weigher. Table 27 describes these hazards and indicates which parts of clause 5 or 7 of this standard provides the appropriate safety requirement. 44

45 Figure 29 - Hazard zones on a typical multi-head weigher Table 27 - Hazards on a typical multi-head weigher Zone Source of hazard Hazards Hazardous situations Safety requirement 1 Bulk product feed Noise Operation mechanism vibratory trough 1 Bulk product feed Drawing-in Operation cleaning mechanism - Belt conveyor (flat or trough) 2 Vibratory dispersion Noise Operation feeder Musculo-skeletal injuries Loading product manually Falling from height Loading product manually 3 Vibrating radial feeders Noise Operation Pool hoppers Crushing Shearing Reaching into hopper or mechanism e.g. to remove jammed Weigh hoppers Crushing Shearing products Reaching into hopper or mechanism e.g. to remove jammed products Discharge chute Impact Falling products Timing hopper Crushing Shearing 8 Support platform Slipping Falling from a height Dust Various health damaging effects Reaching into hopper or mechanism e.g. to remove jammed products Access during operation or cleaning Contact with dusty products Whole machine Noise Running with noisy products

46 5 Safety requirements 5.1 General requirements All the machines in the scope of this standard shall comply with the safety requirements and protective or risk reduction measures in clause 5.1 and the relevant machine specific clauses 5.2 to 5.14 where the equivalent hazard exists. Where a machine has hazards, which are not on a typical machine and so are not described in clause 4, the machine shall be designed according to EN : Requirements to minimize mechanical risks Inherently safe design Inherently safe design measures shall be applied as far as possible to eliminate or reduce risks, and shall comply with the requirements of clause of EN :2014. Clauses 5.2 to 5.14 identify some of the mechanisms where inherently safe design measures can typically be applied, for example by limiting the forces applied by the mechanisms. With the exception of cutting mechanisms accessible parts of the machine shall have no sharp edges, no sharp angles and no rough surfaces likely to cause injury Design of guards Guards shall comply with subclauses , and of EN :2014. Where the smallest dimension of a rectangular opening or diameter of a circular opening in a guard is less than or equal to 120 mm the safety distances in tables 3, 4 and 6 of EN ISO shall apply. Where the opening is larger than 120 mm, the safety distances shown in clause of EN : 2014 shall apply. 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. The design of guards and interlocking devices shall avoid the risk of people being trapped inside the machine Pneumatic and hydraulic 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 : 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. For example compressed air can be filtered but not lubricated and compressed air exhausts can be directed away from the product. 46

47 The machine shall be equipped with an isolation device for each supply for fluid power. These isolation devices shall not be located in a danger zone and shall be readily accessible, clearly labelled, and have features to allow them to be locked in the off position. The machine shall have the facility to release stored pneumatic and hydraulic energy in a safe manner. Pneumatic isolation valves shall comply with clause of EN ISO 4414:2010 and hydraulic isolation valves shall comply with clause of EN ISO 4413: Size or product changing Design of guards The design of the machine and its guards shall ensure that danger zones on the machine are safeguarded without the need for adjustment of safeguards, for all the product and pack sizes for which the machine has been specified. Where this is not possible adjustable guards or change part guards shall be used. Adjustable guards shall be either: a) adjusted in a positive mode by adjusting the functional parts either manually or under power, or b) fitted with interlocking devices which ensure that the machine cannot be started or operated unless the guards are adjusted correctly. Change part guards shall be either: a) connected to the functional parts so that the machine cannot function without the appropriate guarding being fitted, or b) fitted with interlocking devices so that the machine cannot be started or operated without the required guard in place. Where the design of guards causes shadows that prevent a good view of the process inside the machine, the manufacturer shall provide internal lighting Size or product changing under power Where parts of the machine are adjusted under power, the risks presented by these powered movements shall be eliminated using the following hierarchy of measures: a) ensuring that the movements are not hazardous by following the safety by design principles described in clause of EN : 2014, or; b) if a) is not possible by ensuring that movements can only take place when the machine s interlocking movable guards are closed or; c) where it is not possible to fulfil the requirements of a) or b), the movement can only take place using a hold-to-run control device complying with clause of EN : Drive mechanisms Drive mechanisms shall be enclosed with fixed or interlocking guards Hand-wheels Where handles or hand-wheels are provided to operate mechanisms manually, they should be disconnected when the machine runs automatically. If the hand-wheel is designed to rotate under power during automatic operation it shall comply with clause of EN :

48 Measures to minimize slip, trip and fall risks The measures described in clause of EN :2014 shall apply Tasks requiring guards to be open while mechanisms are moved under power The design of the machine shall avoid the need to carry out any task where it is necessary to move machine mechanisms while a guard is open. If mechanisms need to be moved in manual mode, this shall only be possible with all the interlocking guards in the closed position. Where for technical reasons this is not practicable, movement of the machine parts shall only be possible if all of the requirements of clause of EN have been satisfied Electrical equipment General requirements Electrical equipment fitted to machines in the scope of this standard shall comply with EN and clauses 5.3, 5.5 and 5.6 of EN Electrostatic phenomena On machines where hazards may arise from the generation of static electricity, the manufacturer shall provide sufficient earth bonding or static elimination equipment to ensure that hazardous levels of static electricity do not occur. This equipment shall ensure that electrostatic discharge shall lead neither to any injury nor to the ignition of potentially explosive atmospheres or combustible substances. High voltage static elimination devices shall be protected using interlocking guards and the control system shall ensure that the static elimination device is turned off when the interlocking guard is open Thermal hazards The external temperature of exposed parts of the machine, like guards, control panels and electric motors, shall not exceed the burn threshold temperatures stated in clause 4.2 of EN ISO :2008, which take into account the contact material and the foreseen contact time. Where the machine includes parts, like heating mechanisms with a foreseeable temperature greater than the burn thresholds described in EN ISO , the manufacturer shall minimize the risk of accidental contact, for instance by fitting insulation or guards to prevent unintentional contact and by fitting the warning hot surface pictogram specified in 7.3 on the outside of the machine or adjacent to the hot parts (see Figure 62). If having taken these measures, there is still a residual risk of touching hot surfaces this shall be stated in the instructions together with the measures which can be taken to avoid burn injuries, like wearing gloves or other personal protection equipment Noise reduction Machines in the scope of this standard shall be designed to minimize noise at its source using state of the art noise reduction technology. Noise shall be reduced by the methods stated in this standard. Where these measures are not applicable or insufficient, additional measures stated in EN ISO shall be applied to reduce noise at source. The criterion for assessing the efficiency of noise reduction measures is the actual noise emission values of the machine and not the nature of the reduction measure itself. 48

49 The method of noise measurement and wording of the noise declaration shall comply with EN The microphones for noise measurement shall be placed in the positions indicated in Annex A of this standard. The running conditions of the machine shall comply with those stated in Annex A of this standard Vibrating mechanisms Machines fitted with vibrating mechanisms shall be designed so that harmful levels of vibration are not transmitted to other parts of the machine or the surface on which the machine is fixed. The vibrating mechanisms shall be designed so it is not necessary for operators to touch or hold the parts while they are vibrating Radiation Where machines incorporate radiation sources the manufacturer shall comply with the requirements of clause 5.9 of EN : Where ultra-violet (UV) light is used to sterilise packaging materials or components, the machine shall be designed so, that no hazardous amounts of UV-light are emitted from the machine. Where the UV light causes thermal hazards, clause shall apply Products and substances used on machines which pose a risk Hazardous products Where the machine has been specified to pack a hazardous product, the manufacturer shall comply with the requirements of clause 5.10 of EN : Dusty products Where the machine is specified to pack a dusty product, the manufacturer shall supply local exhaust ventilation equipment with the machine which prevents hazardous levels of dust developing outside guarded areas. The local exhaust ventilation equipment shall comply with EN ISO : Potentially explosive dusty products Where the machine is specified to pack potentially explosive dusty products, the manufacturer shall comply with the requirements of EN and electrical equipment shall comply with EN Modified atmosphere packaging General Where machines are fitted with modified atmosphere packing equipment, all vessels, pipes and fittings shall be designed to safely contain the modifying gas. The gas supply shall be fitted with an isolation valve which can be locked in the off position and with a means to extract gas from the machine safely. Where a space inside the machine contains a hazardous modified atmosphere and the opening of a guard exposes the operator to this hazardous atmosphere, this guard shall be interlocked with a guard locking device and controlled so that this guard cannot be opened until the atmosphere inside the machine is safe to breathe. This guard door shall be released either by a sensor that can determine that the atmosphere is safe to breathe or after a time delay which is sufficient for the harmful substances to be extracted by the local exhaust ventilation system. Where gases like nitrogen are used to reduce oxygen levels in packages, the design of the machine and the gas control system shall ensure that oxygen levels within 1 m of the machine do not fall below 19%. 49

50 Gases harmful to health Where gases harmful to health are used, the design of the machine and the gas control system shall ensure that dangerous levels of the gas do not build up around the machine and that guard locking devices prevent exposure to dangerous concentrations of the gas inside parts of the machine accessible by operators. The concentration of the modifying gas shall be measured at 500 mm from possible gas emission points like the gas chamber. Note: For carbon dioxide (CO2), the concentration should not exceed 0,5 vol.% (5000 ml/m³ or 9000 mg/m³) and for carbon monoxide (CO), the concentration should not exceed 0,003 vol. % (30 ml/m³ or. 35 mg/m³). To prevent the emission of hazardous amounts of harmful gases, the manufacturer shall: a) Fit a solenoid valve to shut off the supply of the modifying gas automatically when the machine stops. This valve will be open during normal operation but shall not be the same valve that controls the gas flow; b) Fit a pressure reducer and a safety relief valve at the interface with the gas supply; c) Fit a manual supply disconnection device at the interface to the gas supply; d) Provide extraction equipment to remove or disperse dangerous levels of the modifying gas; e) Where the installation incorporates flexible hoses, fit a solenoid valve upstream of each flexible hose which can shut off the supply of the modifying gas automatically if a hose ruptures or the gas flow exceeds normal limits; f) Ensure the design of connections for different gases are different so it is not possible to mix them up; g) Fit signs next to the gas supply and to the connection to the machine to indicate the kind of gas to be used. On machines where mixtures of gases can be selected, instrumentation shall be provided which displays the concentration of the different gases which are being delivered to the machine. The instructions shall detail: - The gases that can be used with the machine; - The maximum pressure of the gas supply; - The safe procedure for connecting the gas supply; - The specifications of the pressure reducer and a safety relief valve to ensure safe operation; - The specification for the extraction system needed to remove the modifying gas to a safe area; - All necessary information on the requirements for the exhaust ducting or system that shall be connected to the machine; - The possible need of room ventilation and the required air exchange rate to prevent hazardous concentrations of harmful gases building up or to prevent oxygen levels being depleted; - That the machine shall not be operated with the modifying gas if the film is damaged or not present; Oxygen Where the modifying gas is oxygen, this clause also applies. All components which can encounter oxygen, such as pumps, hoses, pipes, fittings, instruments, seals or containers, shall be suitable for the use with oxygen. Devices shall be fitted to detect any leakage of oxygen that may occur during operation and to automatically shut off the oxygen supply if a leak is detected. The design or the control system shall prevent the generation of inflammable concentrations of gas and ensure that the temperature of heat sealing mechanisms do not exceed 200 C. Where the sealing temperature is greater than 200 C, the instructions shall state that the ignition temperature of the film shall be at least 50 K below this ignition temperature of the gas mixture and how this is to achieved. 50

51 The design shall ensure that oxygen does not come into contact with fat or oil. Where there is a risk of contact with fat or oil the manufacturer shall ensure that: 1. No lubricants or sealants are used which could self-ignite in contact with oxygen; 2. The flow rate of oxygen is restricted to 25 m/s; 3. Where a vacuum system is used to remove ambient atmospheres, the control system ensures that either a) the vacuum pump is designed so it can operate safely in high concentrations of oxygen or if this is not reasonably practicable; b) the concentration of oxygen passing through the vacuum pump is controlled so it does not exceed 21%. NOTE: One method of achieving this is by designing the control system so that the vacuum valve is closed before the gas mixture can enter the vacuum chamber and before the vacuum valve opens again no gas mixture remains in the chamber. The instructions shall state: - The lubricants which can be used; - The parts that fat or oil shall be cleaned from before the equipment is used; - Cleaning instructions to remove any debris from parts which can come into contact with oxygen; - The measures to be taken to avoid hazards caused by oxygen concentrations higher than 21% when emptying the system and ensuring that no ignition sources such as hot surfaces, electrostatic or electrical ignition sparks are present during emptying; - The need for regular inspections of seals to prevent hazardous oxygen concentrations; - The need for oxygen measurements during commissioning and the frequency of routine measurements around the machine to ensure that the oxygen concentration does not exceed 22% and the specification of the necessary measurement equipment Substances used to sterilise packaging materials and components Machines using hazardous substances (for example hydrogen peroxide) to sterilise or disinfect packaging materials and components shall be designed so that all foreseen interventions inside the machine 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 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 near the machine, such as: 51

52 - fitting extraction systems at, for example, discharge tunnels; NOTE: 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 is 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 Ergonomic design Loading points for packaging materials The requirements of clause of EN shall apply Product loading or unloading points On machines where products are fed or unloaded manually, the design of the hand loading or unloading area shall follow the ergonomic design principles indicated in EN , EN and EN to minimize the risk of muscular or skeletal injuries. NOTE Information on the risk assessment for repetitive handling at high frequency is given in EN : Hand-wheels Where a hand-wheel is used to move a mechanism by hand, the force that must be applied to the circumference of the hand-wheel to move the mechanism shall not exceed 20 N if one hand is used and 30 N if two hands are used Change parts 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 are 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, Mref may be taken as 40 kg. If two people are required to lift or fit change parts, this shall be stated clearly in the instruction manual. c) 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; d) Change parts with a mass greater than 25 kg shall be listed in the instruction manual. 52

53 5.1.9 Hygienic design requirements Where machines are designed or specified to pack foodstuffs, cosmetics, pharmaceuticals or other products where hygiene is an issue, the manufacturer shall: a) identify the level of hygienic design appropriate for the product. When the machine manufacturer is unable to find this information, he shall define the limitation of use for the machine and clearly state this in the instructions, for example This machine has been designed to pack foodstuffs with the following characteristics ; b) comply with the requirements of EN including: 1) use of contact materials complying with clause 5.2 of EN :2005+A1:2009, which are appropriate for the product, the contact time, the temperature, chemical reactions, physical characteristics (such as abrasion) and the cleaning method and cleaning substances; 2) design food and splash areas (as defined in clauses and of EN :2005+A1:2009) so they are free from crevices and ledges; 3) designing food and splash areas so that they can be easily cleaned and inspected for cleanliness; 4) prevent lubricating oils from coming into contact with the product, for example by fitting filters to compressed air exhausts; c) describe appropriate and safe cleaning procedures in the instructions including information on the cleaning or disinfection agents that shall be used; d) design the machine so that fallen packs or spilled products or substances can be easily detected and removed from the machine; e) where parts of the machine must be dismounted for cleaning, design the machine and the parts so that they can be easily removed and mounted as describe in clause Safety requirements for a flow-wrapping machine General The hazards described in 4.2 shall be eliminated or safeguarded by the following measures and those described in 5.1. These safety requirements also apply to a lower reel flow-wrapping machine (3.3.1) and an edge sealing machine (3.3.3) where the equivalent hazard exists. 53

54 A - Infeed chain guard B - Infeed trip device C - Longitudinal seal guards D - Transverse seal mechanism infeed guard E - Transverse seal mechanism discharge guard F - Drive mechanism guard Figure 30 - Guarding requirements for a typical flow-wrapping machine Product Feed On machines which are to be fed by hand, the feeding area shall be designed to eliminate shearing, crushing and entanglement hazards, but at the same time shall allow access to the product pushing devices, using the methods described in , and Chains and drives The return chain run with its pushing devices and drive and tail sprockets of the chain infeed conveyor shall be safeguarded with fixed or interlocking guards. Any openings in the guards, for example to allow debris to fall out of the guarded area shall be dimensioned using tables 3, 4 or 6 of EN ISO If these guards need to be removed once a day or more frequently, they shall be fitted with interlocking devices complying with EN ISO and comply with the requirements for interlocking guards. Where cables make this area of the machine difficult to clean, mechanical trapped key interlocking devices complying with EN ISO type 2 can be used. The tail sprocket guard shall be designed to avoid shearing hazards for example by creating a tunnel guard. Where machines are equipped with product side guides which are adjustable without the need for tools, movement of these guides shall not expose any hazard Product pushing devices Product pushing devices shall be designed so that they do not present cutting, shearing or crushing hazards in the hand loading area and where they enter the folding box. The risk of impact between a pusher and the hand of an operator in the hand loading area can be considered negligible if the pusher has no sharp edges, there is no risk of entanglement or drawing-in and the speed of the conveyor is lower than 2 m/s. Other methods of eliminating hazards from pushing devices include the following: a) Pushing devices designed so that they come away from the chain in the event of a lateral force greater than 135 N being applied to them. The impact force shall not exceed 180N and the static pressure on the body surface shall not exceed 60 N/cm 2. NOTE: These limits assume that the pushing devices will be applying the force to hands or fingers. b) Pushing devices designed so that they can bend when a lateral force greater than 135 N is applied to them. The impact force shall not exceed 180 N and the static pressure on the body surface shall not exceed 60 N/cm 2. NOTE: These limits assume that the pushing devices will be applying the force to hands or fingers. c) Pushing device linkages designed so that the pushing devices are free to bend backwards as they enter the folding box; 54

55 d) A trip guard fitted with an interlocking device complying with EN ISO like the one in figure 31 which stops the infeed conveyor when someone s hand moves the trip guard. The trip guard shall comply with the requirements of clause of EN : 2014; e) Another safeguarding method which provides at least the same or a higher level of protection. Figure 31 Guards and trip device fitted in front of the folding box Flat belt infeed conveyor Where flat belt conveyors are used to feed products, the following requirements shall apply Danger zones at power transmission parts Power transmission parts shall be safeguarded with fixed or interlocking guards Drawing-in hazards at belt drive or support rollers The drawing-in hazards between drive or support rollers and the belt shall be safeguarded in one of the following ways: a) A combination of the conveyor body and the conveyor belt prevent access to these rollers as shown in figure 32; b) Fixed shaped blocks at each drawing-in point prevent access as shown in figure 33; c) A combination of the conveyor frame and a guard which can be removed for cleaning prevents access as shown in figure 34. Key 1 Drive roller 2 Tail roller 3 Conveyor belt 4 Side frame Figure 32 - Belt conveyor Example of using the side frame and belt to prevent access to danger zones 55

56 Key 1 Drive roller 2 Tail roller 3 Filling pieces 4 Conveyor belt Figure 33 - Belt conveyor Example of using filling pieces to prevent access to danger zones Key 1 Drive roller 2 Tail roller 3 Tension rollers 4 Conveyor belt 5 Guard Figure 34 - Belt conveyor Example of using a guard to prevent access to danger zones Drawing-in hazards between the moving belt and fixed parts The gap between the moving belt and fixed parts like guide rails shall either be less than 4 mm or more than 80 mm Drawing-in hazards between two belt conveyors Where there is a drawing-in hazard between one conveyor and another, for instance because the first conveyor can run faster than the second or the second conveyor can stop while the first continues to run, one of the following methods shall be used to eliminate the drawing-in hazard: a) A deadplate is fixed between the conveyors with gaps between the conveyor belts and the deadplate of no more than 4 mm as shown in figure 35; or b) A gap between the conveyors of no less than 80 mm, or c) A moveable deadplate or roller which is designed so it can pop out if someone s fingers or clothing are drawn into the gaps between the first conveyor belt and the deadplate or roller. The force required to release the deadplate or roller shall not exceed 135 N. NOTE: The pop-out roller or deadplate can be fitted with springs so it does not get lost and returns to its correct position. 56

57 Key 1 belt 2 deadplate 3 drive roller Figure 35 - Belt conveyor transfer Example of a fixed deadplate side view Drawing-in hazards between the moving belt and a deadplate Where a belt conveyor feeds products on to a deadplate, the drawing-in hazard between the belt and the deadplate shall be safeguarded in one of the following ways: a) A fixed deadplate with the gap between the conveyor belt and the deadplate of no more than 4 mm; or d) A moveable deadplate which is designed so it can pop out if someone s fingers or clothing are drawn into the gap between the belt and the deadplate. The force required to release the deadplate or roller shall not exceed 135 N. b) NOTE: The pop-out deadplate can be fitted with springs so it does not get lost and returns to its correct position Drawing-in and entanglement hazards underneath belt conveyors Where the clearance under a conveyor is higher than 600 mm but lower than 2100 mm one of the following measures shall be used to protect against drawing-in and entanglement hazards, especially of hair if someone passes under the conveyor: a) Fitting a fixed guard which prevents hair coming into contact with the moving belt or rollers, or b) Fitting barriers under the conveyor to prevent access under the conveyor and providing a permanent or mobile means of access to cross over the conveyor Cleaning the conveyor Where the conveyor belt requires frequent cleaning, the manufacturer shall design the belt conveyor so that the belt can be removed easily for cleaning and describe the method of cleaning in the instruction manual. 57

58 Automatic product feeding mechanisms Where automatic product feeding mechanisms are not safe by design as defined by clause of EN , they shall be enclosed with interlocking guards Film reel unwind mechanism General The film reel unwind mechanism shall be designed and positioned in accordance with Film reel unwind mechanisms shall either be made safe by design using the measures indicated in clause of EN : 2014 or they shall be enclosed with interlocking guards. Where the moving film edge presents a cutting hazard, the film path shall be enclosed with fixed or interlocking guards Tension roller assembly The shearing hazard between the tension roller assembly and the machine frame shall be eliminated either by ensuring that the moving assembly is at least 25 mm from the frame or by incorporating one of the devices shown in figure 36. Where the film braking or compensating mechanism cannot be made safe by design, it shall be enclosed in interlocking guards. A - Solid piece eliminates shearing hazard B - Plate attached to the machine frame eliminates hazard Figure 36 - Methods of safeguarding the tension roller assembly Coders Where a coding device is integrated with the film reel unwind mechanism, the power supplies for the coder (for example electricity and compressed air) shall be isolated when the machine s isolators are turned off. The coder shall be installed following the coder manufacturer s instructions. Thermal coders shall be guarded or insulated so touchable surfaces do not exceed the burn thresholds indicted in EN ISO :2006. Where there is a residual risk of burning a warning hot surface pictogram shall be fitted. Laser coders rated as class 3 or 4 shall be mounted in a class 1 safety enclosure that complies with EN For all classes of laser coder, a laser hazard warning pictogram (EN ISO 7010/W004) shall be fixed on the machine housing next to the coder or on the class 1 safety enclosure. Instructions for safe use, adjustment and maintenance of the laser coder shall be included in the instruction manual. 58

59 Where the coder is fitted in a hazardous area of the machine, the machine s hazardous functions shall be stopped and maintained in a stopped condition by a safety-related stop function, when the coder needs to be accessed, for example because of a malfunction or to refill printing ink Power unwind mechanism Drive mechanisms for power unwind devices shall be fitted with fixed guards. The in-running nips of the film driving rollers shall be safeguarded by one of the methods shown in figure 37 or the assembly shall be enclosed with interlocking guards. The clearance between the guard and roller (A in figure 37) shall be less than or equal to 4 mm. The safety distance (C in figure 37) shall be determined according to Table 28, depending on the film opening (B in Figure 37). The guard design shall ensure that it is not possible to access the rollers from the sides. Table 28 Safety distance (C) for different film openings (B) in Figure 37 Film opening (B) Safety distance (C) 0 mm < B 4 mm 2 mm 4 mm < B 6 m 10 mm B > 6 mm See table 4 of EN ISO 13857:2008 A Clearance between guard and roller ( 4 mm) B - Film opening C - Safety distance Figure 37 - Methods of safeguarding power unwind mechanism Automatic splicing mechanism Where the automatic splicing mechanism cannot be made safe by design using the methods described in clause of EN : 2014 or the mechanism incorporates a cutting device, the mechanism shall be enclosed with an interlocking guard. This interlocking guard shall be interlocked so that the splicer cannot operate when the splicer guard is open, but allows the main machine to continue to run. 59

60 The design of the guards shall ensure that danger zones on the main machine cannot be reached when the splicer s guard is open. NOTE: This can usually be achieved with fixed guards Static elimination equipment Where elimination equipment presents a hazard, it shall be protected with an interlocking guard and the control system shall ensure that the static elimination equipment is turned off when this interlocking guard is open Reclose feature mechanism Mechanisms for attaching a reclose feature to a package shall be enclosed with interlocking guards. The reclose feature reel unwind mechanism shall comply with Where heat is used to attach the reclose feature shall apply Longitudinal sealing mechanism The longitudinal sealing mechanism shall be safeguarded in one of the following ways: a) enclosing the mechanism with an interlocking guard fitted with a trip guard as described in (d) and shown as D in figure 31 or b) using a series of curved fixed guards in front of each set of rollers as shown in figure 38. The clearance between the curved fixed guards E and the drive rollers A shall be less than or equal to 4 mm. Where the film opening B is less than or equal to 4 mm, the safety distance to the danger zone C shall be at least 2mm. Where the film opening B is less than or equal to 6mm, the safety distance to the danger zone C shall be at least 10 mm. Where the film opening is greater than 6 mm the safety distance shall comply with table 4 of EN ISO A Clearance between guard and roller ( 4 mm) B - Film opening C - Safety distance 60

61 D Hinged plates E Curved fixed guards Figure 38 Curved guard longitudinal sealing mechanism guarding solution c) using interlocked flat plates as shown in figure 39. Where the film opening B is less than or equal to 4 mm, the safety distance to the danger zone C shall be at least 2mm. Where the film opening B is less than or equal to 6mm, the safety distance to the danger zone C shall be at least 10 mm. Where the film opening is greater than 6 mm the safety distance shall comply with table 4 of EN ISO Figure 39 - Flat guard longitudinal sealing mechanism guarding solution Where the longitudinal sealing mechanism is heated, the requirements of shall apply. When any of the interlocking guards described in (a), (b) or (c) are open the control system shall ensure that the mechanisms cannot move unexpectedly, however it is not necessary for the heating circuit to be disconnected Transverse sealing and cutting mechanisms The transverse sealing and cutting mechanisms shall be safeguarded with interlocking guards which prevent access to the mechanisms through both the infeed and discharge openings as illustrated by the guards marked as D and E in figure 30. Where the width or height of the product infeed or discharge opening in the guards is 20 mm or less the distance away from the nearest danger zone shall be at least 120 mm. Where the opening width or height is greater than 20 mm but less than 200 mm, the minimum distance away from the nearest danger zone shall be at least 850 mm. Where the opening width or height is greater than 200 mm the safety distance shall comply with clause of EN : Where the transverse sealing mechanism is pneumatically operated, it shall incorporate a brake mechanism or solenoid valve to ensure that the mechanism does not move unexpectedly when the guards are open or the compressed air supply is disconnected. Where the transverse sealing mechanism is heated, the requirements of shall apply. When the transverse sealing mechanism interlocking guard is open the control system shall ensure that the mechanisms cannot move unexpectedly, however it is not necessary for the heating circuit to be disconnected Discharge mechanism Where the discharge mechanism is a flat belt conveyor it shall comply with Other discharge mechanisms which are not safe by design shall be enclosed with interlocking guards. 61

62 5.2.7 Integrity of safety related control systems The safety related control systems of flow-wrapping machines shall as a minimum comply with the following performance levels of EN ISO :2015. Safety function Stopping the sealing and cutting mechanisms when the interlocking guard is opened Preventing unexpected startup of the sealing and cutting mechanisms when the interlocking guard is open Isolating and dissipating energy from the static eliminator when the interlocking guard is opened Stopping the chains and drives when the interlocking guard is opened Stopping the infeed conveyor when the trip guard is touched Stopping transmission parts when their interlocking guard is opened Stopping product feeding devices when their interlocking guard is opened Stopping the film reel unwind mechanism when the interlocking guard is opened Stopping the discharge mechanism when the interlocking guard is opened Stopping the tension roller assembly when its interlocking guard is opened Stopping the automatic splicing mechanism when its interlocking guard is opened Stopping all hazardous processes by the emergency stop circuit PLr d d c d d c c c c c c c 5.3 Safety requirements for a vertical form, fill and seal machine General The hazards described in 4.3 shall be safeguarded by the following methods and those described in 5.1. These requirements also apply to a stick packing machine (3.3.2), vertical sachet form, fill and seal machine (3.3.4), strip packing machine (3.3.5) and vertical form, fill and seal machine for cartonboard (3.3.6) where the equivalent hazards exists. A Drive mechanisms guard B Product feed mechanism guard C Interlocking guard D Tunnel guard Figure 40 - Guarding requirements for a typical vertical form fill and seal machine 62

63 5.3.2 Product feeding devices The safety requirements for four typical feeding devices are described in 5.11, 5.12, 5.13 and The product feeding device shall be guarded and interlocked with the vertical form fill and seal machine in such a way that it is not possible to reach danger zones inside the product feeding device from inside the guards of the machine or danger zones inside the machine from inside the guards of the feeding device Packing material reel unwind mechanism The requirements of clause also apply to a vertical form fill and seal machine Longitudinal sealing mechanism The longitudinal mechanism shall be guarded with interlocking guards similar to the one marked C in figure 40. Where the interlocking guard is open at the top, the dimensions for the guard shall be taken from table 2 of EN ISO and consider that operators could stand on the discharge conveyor or tunnel guard. Where the longitudinal sealing mechanism is heated, the requirements of shall apply. The longitudinal sealing mechanism shall not present a risk of burning when changing the packaging material. NOTE This can be achieved by making it possible to move the longitudinal sealing mechanism when changing the packaging material. When the longitudinal sealing mechanism interlocking guard is open the control system shall ensure that the mechanisms cannot move unexpectedly, however it is not necessary for the heating circuit to be disconnected Packaging material transport mechanism The packaging material transport mechanism shall be guarded with interlocking guards and a tunnel guard as illustrated by the guards marked C and D in figure 40. Where the interlocking guard is open at the top, the dimensions for the guard shall be taken from table 2 of EN ISO and consider that operators could stand on the discharge conveyor or the tunnel guard Transverse sealing and associated mechanisms The transverse sealing and associated mechanisms shall be guarded with interlocking guards and a tunnel guard as illustrated by those marked C and D in figure 40. Where the height of the discharge opening is 200 mm or less the safety distance from the discharge opening in the tunnel guard to the nearest danger zone on the transverse sealing or associated mechanism shall be at least 850 mm. Where the height of the opening is greater than 200mm the safety distances and safeguarding solutions shown in clause of EN shall apply. To prevent access by reaching with an arm under the interlocking guard, for example to remove empty packages from the sealing mechanism, the gap under the guard and the safety distance to the nearest danger zone shall comply with table 4 of EN ISO Where additional guards are fitted that restrict the movement of an arm or hand, the safety distances shown in tables 3 and 6 of EN ISO can be used. Where the transverse sealing mechanism is heated, the requirements of shall apply. The machine shall be provided with a facility to feed packaging material through the machine automatically or the design of the sealing mechanism shall allow packaging material to be threaded through the jaws while they are hot without a risk of burning. 63

64 When the transverse sealing mechanism interlocking guard is open the control system shall ensure that the mechanisms cannot move unexpectedly, however it is not necessary for the heating circuit to be disconnected Cutting and perforating mechanisms The design of the cutting and perforating mechanism shall minimise the risk of injury during a typical operator intervention to thread packaging material or clear a jam. This can be achieved by designing the cutting or perforating mechanism so it retracts into an enclosed area when the interlocking guard is opened. The machine shall be fitted with a facility to inhibit the cutting mechanism during set up or at the start of production to ensure that empty packages will be discharged without the need for operator intervention Product discharge opening Where the height of the discharge opening is 200 mm or less the safety distance from the discharge opening in the tunnel guard to the nearest danger zone on the transverse sealing or associated mechanism shall be at least 850 mm. Where the height of the opening is greater than 200 mm the safety distances and safeguarding solution shown in clause of EN shall apply Discharge conveyor Where the packs are taken away from the machine with a conveyor, the conveyor shall be interlocked with the machine so that when the interlocking guard of the machine is open the conveyor stops. Where the conveyor forms part of the guarding, it shall either be fixed in relationship to the machine, or interlocked so that the machine cannot operate unless the conveyor is in its correct position. Where the discharge conveyor is a flat belt conveyor it shall comply with Other types of conveyor shall comply with clause of EN Discharge into bins On machines where the product is discharged into bins without the use of a discharge conveyor, one of the following safeguarding solutions shall be used. a) the machine guards shall extend downwards round the bin far enough to prevent access to the transverse seal and associated mechanisms whether the bin is in place or not; b) The bin is detected with an interlocking device, conforming to EN ISO incorporated into the control system so that the machine can only operate when a bin is in its correct position. In this case, the combination of the bin and interlocking guards shall prevent access to the danger zones Provision for changing the forming tube The manufacturer shall design the forming tube so it can be installed and removed without a manual handling risk. Methods of achieving this include: a) Lightweight forming tubes; b) Mechanisms to support the forming tube during the installation and removal process; c) Trolleys to support the forming tube. The requirements of clause of EN shall also apply. Where it is likely that operators will stand on either the discharge conveyor or the tunnel guard to change the forming tube, the manufacturer shall either design the conveyor or the tunnel guard so they are safe to stand on or provide an alternative means of access and make it clear using the Do not stand here pictogram where 64

65 it is not safe to stand. Where the tunnel guard is used as a step it shall comply with EN ISO which requires handrails to be provided where a step has a height greater than or equal to 500 mm. Figure 41 - Tunnel guard designed to be stood on when changing the forming tube The manufacturer shall ensure that it is not possible to reach danger zones in the machine over guards when standing on the means of access described in this clause. Where guards are open at the top the safety distances in table 2 of EN ISO 13857: 2008 shall apply Integrity of safety related control systems The safety related control systems of vertical form, fill and machines shall as a minimum comply with the following performance levels of EN ISO :2015. Safety function Stopping sealing, perforating and cutting mechanisms when the interlocking guard is opened Preventing unexpected startup of sealing, perforating and cutting mechanisms when the interlocking guard is open Isolating and dissipating energy from the static eliminator when the interlocking guard is opened Stopping the sealing, perforating and cutting mechanisms when the discharge bin is not in place Stopping the sealing, perforating and cutting mechanisms when the discharge conveyor is not in place Stopping the packaging material transport mechanism when the interlocking guard is opened Stopping the discharge conveyor when the interlocking guard is opened Stopping all hazardous processes by the emergency stop circuit PLr d d c d d c c c 5.4 Safety requirements for a horizontal sachet form, fill and seal machine General The hazards described in 4.4 shall be safeguarded by the following methods and those described in 5.1. The drawing shows a linear transport system, but the safety requirements are the same on machines where the transport system is rotary or partly rotary. 65

66 A Reel unwind mechanism B Product feed device C Interlocked guards D Product discharge chute E - Drive mechanisms guard Figure 42 - Guarding requirements for a typical horizontal sachet form fill and seal machine Film reel unwind mechanism The requirements of clause also apply to a typical horizontal sachet form fill and seal machine Vertical seal mechanism The vertical seal mechanism shall be guarded with interlocking guards similar to those shown in figure 42. Where the closing medium is heat applies Transport mechanism The transport mechanism shall be guarded with interlocking guards as shown in figure Product feeding devices The safety requirements for typical feeding devices are described in 5.11, and 5.14 and EN 15180: Product settling mechanism The requirements of apply Top sealing mechanism The top seal mechanism shall be guarded with interlocking guards similar to those shown in figure

67 Where the closing medium is heat shall apply Cutting mechanism The cutting mechanism shall be enclosed with interlocking guards, interlocked so the cutting mechanism cannot operate when the guard is open. The blade of this device shall be designed either to withdraw into a recess or be fitted with a guard to prevent injury when the interlocking guard is open Discharge chute or conveyor Where the height of the discharge opening is 20 mm or less the opening shall be a t least 120 mm away from the nearest danger zone. Where the height of the opening is greater than 20 mm but less than 120 mm the distance from the discharge end of the opening to the nearest danger zone shall be 850 mm, which may require the use of a tunnel guard. Where the discharge mechanism is a flat belt conveyor it shall comply with Integrity of safety related control systems The safety related control systems of horizontal sachet form, fill and seal machines shall as a minimum comply with the following performance levels of EN ISO :2015. Safety function Stopping the sealing and cutting mechanisms when the interlocking guard is opened Isolating and dissipating energy from the static eliminator by the interlocking guard Stopping the transport mechanism When the interlocking guard is opened Stopping vibration devices when the interlocking guard is opened Stopping all hazardous processes by the emergency stop circuit PLr d d c c c 5.5 Safety requirements for a thermoform, fill and seal machine General The hazards described in 4.5 shall be safeguarded by the following methods and those described in 5.1. The drawing shows a linear transport system but the safety requirements are the same on machines where the transport system is rotary or partly rotary. These requirements also apply to a deep draw machine (3.3.7) where the equivalent hazard exists. A - Lower reel unwind mechanism B - Forming die guard C - Product loading area D - Upper reel unwind mechanism 67

68 E - Sealing die guard F - Cutting mechanism guard G - Scrap reels H - Product discharge conveyor J - Side guards Figure 43 - Guarding requirements for a typical thermoform fill and seal machine Lower web reel unwind mechanism The requirements of clause apply to the lower web reel unwind mechanism Transport mechanism Transport mechanisms shall be safeguarded as follows Counter rotating rollers The transport mechanisms of machines of this type shall be guarded with fixed or interlocking guards Chains and clamps Machines with chain and clamp transport mechanisms where products are manually fed shall be safeguarded with fixed guards which incorporate a slot for the lower film web no wider than 4 mm. Where this cannot be achieved the relationship between the slot width and the distance from the hazard shall comply with table 4 of EN ISO Where the machine is automatically fed, the mechanisms shall be guarded as in paragraph 1 or with interlocking guards that also guard the automatic feeding mechanisms Heating chamber The machine shall be designed in such a way that when the machine stops there is no risk of the film catching fire. The heating chamber and forming die shall be safeguarded with interlocking guards. In addition, the control system shall ensure that the heating chamber and forming die cannot move under gravity when the power supplies are disconnected. This may involve fitting a mechanical or pneumatic device which prevents the die from moving when power is removed. The safety distance through openings in these guards shall be in accordance with table 29. A warning hot surface pictogram shall be fitted to the heating chamber to warn of a residual burning hazard if this exists. The requirements of shall apply Forming die The forming die shall be guarded with interlocking guards Packaging material apertures The risk of impact from the moving parts of the packaging material transport mechanism in the loading area can be considered negligible if the moving parts are smooth without sharp edges and the speed is lover than 2 m/s. 68

69 The apertures for the packaging material shall be safeguarded using one of the methods described in , , , , or The methods described in , , , or shall only be used where the stopping time of the hazardous movement does not exceed 0,5 s. The objective of all the safeguarding solutions described is to ensure that the machine stops before a danger zone can be reached. The manufacturer shall check that the chosen safeguarding method achieves this objective using the methods described in EN ISO Where the opening is less than 20 mm the safety distances in table 4 of EN ISO shall apply. Where the opening is greater than 200 mm the safety distances in clause of EN : 2014 shall apply Fixed Guards Access to the forming and sealing dies shall be limited by fitting a false base in the product loading area. Where fixed guards are used to prevent access to danger zones, the safety distance through openings in the guards to the danger zones shall comply with dimension B in table 29. Type of Guard Table 29 - Safety distances for different types of guard Safety Distance A is > 20 to 30 A is > 30 to 40 A is > 40 to 60 A is > 60 to 120 A is > 120 to 200 Fixed guard B Trip guard C Trip guard with AOPD D ESPE E Linked guard F Automatic guard G Dimensions in millimetres Trip guard This comprises a moveable interlocking guard which can move easily if someone reaches into the opening. The maximum force to lift and activate the guard shall not exceed 50N. The interlocking device fitted to the guard shall comply with EN ISO 14119: 2014 and shall be interlocked in such a way that if the guard is lifted by 10 mm or less, the hazardous movements shall stop or reverse to a safe position. For this type of guard, safety distance C, in table 29 and figure 44 shall be used. The stopping time of the machine shall not exceed 0.5 s. The instructions shall warn the user that this type of guard can become ineffective if a heavy object is placed on top of the guard. 69

70 1 - Interlocked trip guard 2 Direction of access into danger zone 3 False base 4 Hazardous movement A Depth of opening C Safety distance Figure 44 - Trip guard Trip guard with AOPD device This comprises a moveable interlocking guard supplemented with an Active Opto-electronic Protective Device (AOPD). The AOPD shall comply with EN and the interlocking device fitted to the guard shall comply with EN ISO 14119: The control system shall ensure that if the guard is lifted 10 mm or the AOPD is activated the hazardous movements shall stop or if safe to do so reverse. The maximum force to lift and activate the guard shall not exceed 50N. The control circuit shall comply with PL d of EN ISO : For this type of guard, safety distance D, in table 29 and figure 45 shall be used. The AOPD shall be set at 20 mm from the trip guard. The stopping time of the machine shall not exceed 0.5 s. 70

71 1 - Interlocked trip guard 2 ESPE 3 - Direction of access into danger zone 4 - False base 5 Hazardous movement A Depth of opening D Safety distance X Horizontal ESPE offset distance Y Vertical ESPE offset distance Figure 45 - Trip guard with ESPE device ESPE trip device This comprises a moveable interlocking guard supplemented with electro-sensitive protective equipment (ESPE) which monitors the whole opening. The ESPE shall comply with EN type 4, the interlocking device shall comply with EN ISO 14119: The control system shall ensure that if the guard is lifted 10 mm or the ESPE is activated the hazardous movements shall stop or if safe to do so reverse. The maximum force to lift and activate the guard shall not exceed 50N. The control circuit shall comply with PL d of EN ISO : The distance E shown in table 29 and figure 46 shall be used. The stopping time of the machine shall not exceed 0.5 s. 1 Trip guard 2 - Direction of access into danger zone 3 - False base 4 - ESPE 5 - Hazardous movement A Depth of opening E Safety distance Figure 46 - ESPE trip device Linked automatic guard This comprises a guard which is attached to the moving part of the forming or sealing die mechanism which moves into place when the hazardous movements of the forming or sealing dies begin. The guard shall be interlocked with the machine to stop hazardous movements/or bring the die into a safe position, if there is an obstruction is detected. The control system shall ensure that if the guard is lifted 10 mm the hazardous movements shall stop or if safe to do so reverse. The maximum force to lift and activate the guard shall not exceed 50N. The control circuit shall comply with PL d of EN ISO :

72 Where the force of the guard exceeds those listed in clause of EN :2014, a pressure sensitive device, complying with EN shall be fitted to the guard, that will stop the hazardous movement if an obstruction is detected. The interlocking device shall comply with EN ISO 14119: 2014 and the control circuit shall comply with PL d of EN ISO : The distance between the vertical part of the linked automatic guard and fixed parts shall not exceed 4 mm in any position. For a linked automatic guard, the safety distance F, in table 29 and figure 47 shall be used. 1 - Interlocked trip guard 2 - Direction of access into danger zone 3 - False base 4 - Guard fixed to die 5 - Hazardous movement A Depth of opening F Safety distance Figure 47 - Linked automatic guard Automatic Guard The automatic guard is powered independently of other movements on the machine and moves into place after the transport cycle ends and before the forming and sealing cycles start. Dimension G applies when the automatic guard is completely closed. The control system shall ensure that the forming and sealing cycles cannot start until the automatic guard is completely closed and shall comply with PL d of EN ISO : Where the force of the automatic guard exceeds those forces listed in clause of EN :2014, a pressure sensitive device, complying with EN shall be fitted to the guard, that will stop the movement of the automatic guard if an obstruction is detected. For an automatic guard the safety distance G, in table 29 and figure 48 shall be used. 72

73 1 Direction of access into danger zone 2 - False base 3 Automatic guard 4 Hazardous movement A Depth of opening G Safety distance Figure 48 - Automatic guard Automatic product feeding devices Automatic product feeding devices shall be safeguarded with interlocking guards. Where the automatic feeding device is a belt conveyor it shall comply with Upper film reel unwind mechanism The requirements of clause shall apply to the upper web reel unwind mechanism. Where the coder moves across the film web to apply several codes, the coding assembly shall either be made safe by design as indicated in clause of EN or it shall be enclosed with interlocking guards Sealing die The sealing die shall be safeguarded with interlocking guards. Where the sealing die is heated clause applies Cutting devices Rotary and reciprocating cutting devices shall be safeguarded with interlocking guards similar to those shown in figure Scrap reel The drawing-in hazard on the scrap reel shall be reduced in one of the following ways: - Enclosing the scrap reel with an interlocking guard, or - Limiting the torque of the reel drive mechanism, so that the reel stops when a force of 60 N is applied to it. 73

74 Discharge mechanism Where the discharge mechanism is a flat belt conveyor it shall comply with Access to danger zones inside the machine from the discharge opening shall be prevented using a tunnel guard or interlocked trip guard which provides an 850 mm safety distance Pad or leaflet inserters The requirements for carton magazines in clause shall apply Integrity of safety related control systems The safety related control systems of thermoform, fill and seal machines shall as a minimum comply with the following performance levels of EN ISO :2015. Safety function Stopping forming, filling, sealing and cutting mechanisms when the interlocking guard is opened Stopping and/or reversing hazardous movements to a safe position when the trip guard is moved Stopping hazardous movements when the ESPE device is actuated Stopping the transport mechanisms when the interlocking guard is opened Stopping the discharge mechanism when the interlocked trip guard is moved Stopping the scrap reel when its interlocking guard is opened Stopping all hazardous processes by the emergency stop circuit PLr d d d c d c c 5.6 Safety requirements for a tubular bag form, fill and seal machine General The hazards described in 4.6 shall be safeguarded by the following methods and those described in 5.1. A Interlocking guard for product feeding mechanism B Film reel assembly C - Interlocking guard D Discharge conveyor 74

75 Figure 49 - Guarding requirements for a typical tubular bag form fill and seal machine Film reel unwind mechanism The requirements of clause apply to the film reel unwind mechanism. If the film reel loading mechanism is not guarded, it shall be provided with a hold to run control placed where there is a clear view of the danger zone. The design of the machine shall allow the film reel to be transported and loaded into the film reel unwind mechanism using standard lifting equipment such as a fork lift truck. If film reels can only be lifted using specially designed lifting equipment, the manufacturer shall supply this special lifting equipment with the machine Transverse or corner sealing and cutting mechanism This mechanism shall be guarded with a combination of fixed and interlocking guards as indicated by C in figure 49. Where the sealing mechanism is heated clause shall apply Openings in guards The safety distance from any openings in the guards shall be as follows: Smallest dimension of opening Safety distance 120 mm As indicated by tables 3, 4 or 6 of EN ISO mm 200 mm 850 mm 200 mm As indicated by clause of EN : Cutting and perforating mechanisms The requirements of clauses and of EN :2014 shall apply Film draw and compensator The requirements of clause of EN :2014 shall apply Cooling mechanism The requirements of clause of EN :2014 shall apply Filling station The filling station shall be guarded with a combination of fixed and interlocking guards as indicated by C in figure 49. Where the machine is specified to pack a hazardous or dusty product, clause of EN :2014 shall apply. Where the local exhaust ventilation system is not delivered with the machine, the manufacturer shall provide a detailed specification for the local exhaust ventilation system in the instructions which includes the details for the connection and the required airflow at the connection point Bag opening mechanism The bag opening mechanism shall be guarded with a combination of fixed and interlocking guards as indicated by C in figure

76 Product settling mechanism The product settling mechanism shall be guarded with a combination of fixed and interlocking guards as indicated by C in figure 49. The requirements of clause shall apply Bag sealing mechanism This mechanism shall be guarded with a combination of fixed and interlocking guards as indicated by C in figure 49. Where the bag sealing mechanism is heated clause shall apply Discharge conveyor The discharge conveyor shall comply with clause of EN Conveyor height adjustment The requirements of clause of EN :2014 shall apply. Where the conveyor adjustment mechanism is not guarded or safe by design, as defined by clause of EN :2014, it shall be fitted with a hold to run control device which shall be located where there is a clear view of the danger zone Bag transport mechanism On automatic machines, the bag transport mechanism shall be guarded by a combination of fixed and interlocking guards similar to those shown as C in figure 49. Where the height of the discharge opening is 200 mm or less the safety distance from the discharge opening to the nearest danger zone shall be at least 850 mm. Where the height of the opening is greater than 200mm the safety distances and safeguarding solution shown in clause of EN shall be used Integrity of safety related control systems The safety related control systems of tubular bag form, fill and seal machines shall as a minimum comply with the following performance levels of EN ISO :2015. Safety function Stopping the forming, opening, sealing, perforating and cutting mechanisms when the interlocking guard is opened Preventing unexpected start-up of the forming, opening, sealing, perforating and cutting mechanisms when the interlocking guard is open Stopping the filling device when the interlocking guard is opened Stopping the discharge conveyor, product settling device and bag transport mechanism when the interlocking guard is opened Enabling the film reel loading mechanism movement hold to run control Enabling the conveyor height adjustment hold to run control Stopping all hazardous processes by the emergency stop circuit PLr c d c c c c c 5.7 Safety requirements for a mandrel form, fill and seal machine General The hazards described in 4.7 shall be safeguarded by the following methods and those described in

77 A Reel unwind mechanism B Product feed device C Interlocked guards D Product discharge chute E - Drive mechanisms guard Figure 50 - Guarding requirements for a mandrel form fill and seal machine Packaging material reel unwind mechanism On machines fitted with a reel unwind mechanism, the requirements of clause shall apply Cutting mechanism On machines fitted with a cutting mechanism, the cutting mechanism shall be enclosed with interlocking guards, interlocked so the cutting mechanism cannot operate when the guard is open. The blade of this device shall be designed either to withdraw into a recess or be fitted with a guard to prevent injury when the interlocking guard is open Sealing mechanisms Where the closing medium is heat or hot melt adhesive, shall apply. Hot melt gluing systems shall comply with clause of EN Where a spray gluing system or hot melt gluing system is fitted, the guards shall be capable of containing any foreseeable glue over spray and the system shall comply with the requirements of clause 5.7 of EN : Carton blank magazine On machines fitted with a carton blank magazine that is loaded by hand, the following requirements shall apply: 77

78 a) Where the carton magazine is adjustable for different sizes of carton, the design shall ensure that it is not possible to reach around the stack of cartons to danger zones in the machine for every size of carton for which the machine has been specified; NOTE - It is preferable for the guards around the carton magazine to be self-adjusting guards, which are fixed to the size adjustment parts so that they are adjusted automatically when the size adjustment part is moved as shown in figure 51; b) Where change part guards or manually adjustable guards are used, interlocking devices complying with EN IS : 2014 shall be fitted to prevent the machine from running when these guards are not in place or not adjusted correctly; c) The carton magazine shall be fitted with a system of carton sensing devices, for instance electrosensitive protection devices complying with EN which stop the machine when a predetermined number of cartons are left in the carton magazine or if the cartons are removed from the magazine, exposing the carton transfer mechanism; d) The carton sensing system shall be designed to minimise the risk of being deliberately defeated. Methods of minimizing the risk of deliberate defeat include: a. sensors mounted on both sides of the magazine or above and on one side of the magazine; b. monitoring a pre-determined sequence of signals; c. sensors looking for an object at a pre-determined distance from the sensor Where the carton blank magazine is fitted with an automatic carton loading mechanism, this mechanism shall be guarded with interlocking guards. A Self-adjusting guard B Carton sensor C Carton magazine Figure 51 - Carton magazine 78

79 5.7.6 Mandrel former This mechanism shall be safeguarded with fixed or interlocking guards Compression mechanism This mechanism shall be safeguarded with fixed or interlocking guards Transfer mechanisms These mechanisms shall be safeguarded with fixed or interlocking guards Transport section This mechanism shall be safeguarded with fixed or interlocking guards Product feed The safety requirements for typical feeding mechanisms are indicated in 5.11, 5.12, 5.13 and 5.4. The product feed device and the connection to the machine shall be designed so that it is not possible to reach hazard zones in the machine from the product feed device and vice versa. Where these hazard zones could be reached through interlocking guards the interlocking shall stop both the machine and the product feed device. Movable elements like hoppers that will be opened once a week or more often shall be interlocked in the same way Product settling devices Where the device uses vibration to the settle the product, the requirements of clauses shall apply. This mechanism shall be guarded with interlocking guards, interlocked so that the vibration devices stop vibrating when the guards are opened Sterilization section This mechanism shall be safeguarded with fixed or interlocking guards and shall comply with relevant requirements of clause Auxiliary media injection This mechanism shall be safeguarded with fixed or interlocking guards Package closing mechanism The pack closing mechanism shall be guarded with interlocking guards. Where the closing medium is heat or hot melt adhesive, shall apply. Hot melt gluing systems shall comply with clause of EN Where a spray gluing system or hot melt gluing system, is fitted the guards shall be capable of containing any foreseeable glue over spray and the system shall comply with the requirements of clause 5.7 of EN : Vacuum sealing mechanism This mechanism shall be safeguarded with fixed or interlocking guards. 79

80 Discharge or compression conveyor Where the discharge conveyor is a flat belt conveyor it shall comply with Where the discharge conveyor applies compression to the packs it shall be fitted with interlocking guards and a tunnel guard which provides an 850mm safety distance from the discharge end of the tunnel guard to the nearest danger zone Pak reject mechanism Belt conveyors shall comply with and other types of conveyor shall comply with clause of EN : Integrity of safety related control systems The safety related control systems of mandrel form, fill and seal machines shall as a minimum comply with the following performance levels of EN ISO :2015. Safety function Stopping feeding, forming, filling, sealing and closing mechanisms when the interlocking guard is opened Stopping the film reel unwind mechanism when the interlocking guard is opened Stopping the carton blank magazine when the interlocking guard is opened Stopping the filling device when the interlocking guard is opened Stopping the transport mechanism when the interlocking guard is opened Stopping the discharge mechanism when the interlocking guard is opened PLr d d d c c c 5.8 Safety requirements for a pre-made bag, erect, fill and close machine General The hazards described in 4.8 shall be safeguarded by the following methods and those described in 5.1. The drawing shows a rotary transport system but the safety requirements are the same on machines where the transport system is linear or partly linear. 80

81 A Bag magazine B Interlocked guards C Product feed device D Tunnel guard and discharge conveyor E - Drive mechanisms guards Figure 52 - Guarding requirements for a typical pre-made bag fill and seal machine Bag magazine The bag magazine shall comply with clause Bag erecting mechanism This mechanism shall be guarded with interlocking guards similar to those shown in figure Transport mechanism This mechanism shall be guarded with interlocking guards similar to those shown in figure Product feed The safety requirements for typical feeding mechanisms are indicated in 5.11, 5.12, 5.13 and 5.14 and EN 15180: The product feed and the connection to the machine shall be designed so that it is not possible to reach hazard zones in the machine from the product feed and vice versa. Where these hazard zones could be reached through interlocking guards the interlocking shall stop both the machine and the product feed. Movable elements like hoppers that will be opened once a week or more often shall be interlocked in the same way Product settling devices This mechanism shall be guarded with interlocking guards similar to those shown in figure 52, interlocked so that the vibration devices stop vibrating when the guards are opened. The requirements of clause shall apply Bag closing mechanism The bag closing mechanism shall be guarded with interlocking guards similar to those shown in figure 52. Where a spray gluing system or hot melt gluing system, is fitted the guards shall be capable of containing any foreseeable glue over spray and the system shall comply with the requirements of clause 5.7 of EN : Where the closing medium is heat or hot melt adhesive, clause shall apply. Hot melt gluing systems shall comply with clause of EN Discharge or compression conveyor Where the discharge conveyor is a flat belt conveyor it shall comply with Where the discharge conveyor applies compression to the packs it shall be fitted with interlocking guards and a tunnel guard which provides an 850 mm safety distance from the discharge end of the tunnel guard to the nearest danger zone. 81

82 5.8.9 Integrity of safety related control systems The safety related control systems of bag erect, fill and seal machines shall as a minimum comply with the following performance levels of EN ISO :2015. Safety function Stopping the erecting, filling, transport, sealing and cutting mechanisms when the interlocking guard is opened Stopping the machine when the bag magazine interlocking guard is opened and/or electro-sensitive protection devices are actuated Stopping the vibration devices when the interlocking guard is opened Stopping all hazardous processes by the emergency stop circuit PLr d d c c 5.9 Safety requirements for a cup or tub fill and seal machine General The hazards described in 4.9 shall be safeguarded by the following methods and those described in 5.1. The drawing shows a linear transport system but the safety requirements are the same on machines where the transport system is rotary or partly rotary. A Cup magazine B Interlocking guards C - Product feed devices D Lid magazine E = Tunnel guard/discharge conveyor F Drive mechanism guards Figure 53 - Guarding requirements for a typical cup fill and seal machine Cup magazine Change part guards like the one in figure 55 shall be provided for each type of cup, dimensioned using table 4 of EN ISO so it is not possible to reach danger zones around the stacks of cups. 82

83 The magazine shall be fitted with an interlocking device, for example an electro-sensitive protection device complying with EN which stops the machine before the last few cups are removed from the magazine, exposing the cup dispensing and transport mechanisms. Where the machine incorporates automatic cup or tub stack loading mechanisms, these mechanisms shall be guarded with interlocking guards, or electro-sensitive protective equipment complying with EN during the cycle when the stack is moved. 1 Stack of cups 2 AOPDOR 3 Cup separation mechanism 1 Fixed or interlocking guard 2 Stack of cups 3 Cup separation mechanism Figure 54 Methods of safeguarding the cup magazine Cup dispensing mechanism Access to the hazardous movements of the cup or tray dispensing mechanism through the cup or tray magazine shall be prevented by one of the following methods: a) Enclosing the cup magazine in a combination of fixed and interlocked guards as shown in figure 54; b) Designing the cup or tray guides as tubes or funnels complying with as shown in figure 55. Where change part guards are used or to assist product changing guides must be removed, these parts shall be fitted with interlocking devices to prevent the machine from running when these parts are not in place. Where the dimensions of the guards do not comply with , a system of safety protection devices, for example a combination of electro-sensitive protection devices complying with EN capable of measuring distance to objects shall be used. These devices shall stop the machine when only a pre- 83

84 determined number of cups or trays is in the magazine or if the cups or trays are removed from the magazine, exposing the hazard zone. The cup sensing system shall be designed to minimise the risk of being deliberately defeated. Methods of minimizing the risk of deliberate defeat include: a. sensors mounted on both sides of the magazine or above and on one side of the magazine; b. monitoring a pre-determined sequence of signals; c. sensors looking for an object at a pre-determined distance from the sensor Transport mechanism This mechanism shall be guarded with interlocking guards like those shown in figure Product feed devices The safety requirements for volumetric piston depositors can be found in EN 15180: The safety requirements for other feeding mechanisms are indicated in 5.11, 5.12, 5.13 and Manual product loading Where the product is loaded by hand clause shall apply Foil and lid magazines The requirements of clause shall apply Reel unwind mechanisms Reel unwind mechanisms shall comply with clause Foil sealing mechanisms Foil sealing mechanisms shall comply with clause Scrap reels Scrap reels shall comply with clause Lid placing mechanism This mechanism shall be guarded with interlocking guards like those shown in figure Discharge mechanism and conveyor The discharge mechanism and conveyor shall be fitted with interlocking guards and a tunnel guard which provides an 850 mm safety distance from the discharge end of the tunnel guard to the nearest danger zone. Where the discharge conveyor is a flat belt conveyor is shall comply with Integrity of safety related control systems The safety related control systems of cup or tub fill and seal machines shall as a minimum comply with the following performance levels of EN ISO :2015. Safety function Stopping the dispensing, filling, sealing and transport mechanisms when the interlocking guard is opened PLr d 84

85 Stopping the cup, foil or lid magazine when the interlocking guard is opened and/or electro-sensitive protection devices are actuated Stopping all hazardous processes by the emergency stop circuit d c 5.10 Safety requirements for a sack fill and seal machine Safety requirements for an in-line sack fill and seal machine General The hazards described in shall be safeguarded by the following methods and those described in 5.1. A - Flow regulation mechanism guard B - Product conveying system guard C - Product feeding mechanism guard D - Interlocking guard E - Sack placer interlocking guard Figure 55 - Guarding requirements for a typical in-line sack fill and seal machine Product feed mechanism The safety requirements for typical product feeding mechanisms are indicated in 5.11, 5.12, 5.13 and The product feed and the connection to the machine shall be designed so that it is not possible to reach hazard zones in the machine from the product feed and vice versa. Where these hazard zones could be reached through interlocking guards the interlocking shall stop both the machine and the product feed. Movable elements like hoppers that will be opened once a week or more often shall be interlocked in the same way Sack holding mechanism On automatic machines, this mechanism shall be guarded with fixed and interlocking guards. On semi-automatic machines, at least one of the following measures shall be applied: a) Ensuring the gap between the holding mechanism and the filling nozzle is no greater than 5 mm; 85

86 b) Where the gap is greater than 5 mm, ensuring the static force applied by the mechanism is no greater than 135 N and the pressure applied is no greater than 60 N/cm²; c) Providing a two-hand control which complies with type III A of EN 574:1996+A1:2008. The control system shall ensure that movement is stopped or, if no hazard is generated, reversed, when one of the two hand control devices is released; d) Electro-sensitive protective equipment (ESPE) that complies with EN This ESPE shall be positioned and designed according to EN ISO Sealing mechanism On automatic machines, this mechanism shall be guarded with fixed and interlocking guards. On semi-automatic machines, at least one of the following measures shall be applied: a) Providing a two-hand control which complies with type III A of EN 574:1996+A1:2008. The control system shall ensure that movement is stopped or, if no hazard is generated, reversed, when one of the two hand control devices is released; b) Electro-sensitive protective equipment (ESPE) that complies with EN This ESPE shall be positioned and designed according to EN ISO Filling nozzle area The machine shall be fitted with a local exhaust ventilation system complying with clause Where the machine is specified to pack a hazardous or dusty product, clause of EN :2014 shall apply. Where the local exhaust ventilation system is not delivered with the machine, the manufacturer shall provide a detailed specification for the local exhaust ventilation system in the instructions which includes the details for the connection and the required airflow at the connection point. Where the machine is specified to pack a hazardous product or a product which has a temperature greater than 55 C, the filling nozzle shall be fitted with a sack sensor which ensures that filling cannot start if there is no sack on the filing nozzle Sack holding and positioning mechanism On automatic machines, this mechanism shall be guarded with interlocking guards. On semi-automatic machines, where the sack holding mechanism cannot be made safe by design as defined by Clause 5.2 of EN : 2014, at least one of the following measures shall be applied: a) Providing a two-hand control which complies with type III A of EN 574:1996+A1:2008. The control system shall ensure that movement is stopped or, if no hazard is generated, reversed, when one of the two hand control devices is released b) Electro-sensitive protective equipment (ESPE) that complies with EN ISO This ESPE shall be positioned and designed according to EN ISO Flow regulating mechanism The flow regulating mechanism shall be fitted with interlocking guards Conveying system The conveying system shall comply with clause of EN : Sack placer On automatic machines, this mechanism shall be guarded with fixed or interlocking guards. 86

87 The control system shall ensure that all hazardous movements of the sack placer are stopped before the inline sack fill and seal machine can be operated in manual mode Sack discharge conveyor The conveyor shall comply with Where the height of the discharge opening is 200 mm or less the safety distance from the discharge opening to the nearest danger zone shall be at least 850 mm. Where the height of the opening is greater than 200mm the safety distances and safeguarding solution shown in EN clause shall apply Integrity of safety related control systems The safety related control systems of an in-line sack fill and seal machine shall as a minimum comply with the following performance levels of EN ISO :2015. Safety function Stopping the product feeding mechanism and product feed when their interlocking guard is opened Enabling the sealing mechanism using the two-hand control device on semi-automatic machines Stopping the sealing mechanism when electro-sensitive protective equipment (ESPE) is actuated on semi-automatic machines Enabling of machine operation only if the extraction system is running where the product is hazardous Stopping sack holding, sealing, holding and positioning mechanisms when the interlocking guard is opened on an automatic machine and the disable function Enabling the sack holding and positioning mechanism using the two-hand control on semi-automatic machines Stopping the sack holding and positioning mechanism when electro-sensitive protective equipment (ESPE) on semi-automatic machines is actuated Stopping the flow regulating mechanism and product flow when the interlocking guard is opened Stopping the product conveying system when the interlocking guard of the product conveying system is opened Stopping the sack placer when the interlocking guard is opened Stopping the sack discharge conveyor when the interlocking guard on automatic machines is opened Stopping all hazardous processes by the emergency stop circuit PLr c d d c c c c c c c c c 87

88 Safety requirements for a rotary sack fill and seal machine General The hazards described in shall be safeguarded by the following methods and those described in Clause 5.1. A - Sack magazine guard B Sack transfer mechanism guard C - Sack placer interlocking guard D - Sack discharge guard E - Carousel guard F - Trip guard G Interlocked access door H Manual sack placing position Figure 56 - Guarding requirements for a typical rotary sack fill and seal machine Carousel On automatic machines, access to the carousel shall be prevented by a combination of fixed and interlocking guards like those marked "G" and "E" in figure 57. Where it is necessary to move around the carousel inside the guards, the minimum distance between these guards and parts of the carousel shall be 600 mm. Where there is insufficient space to allow this method of access, the carousel guard E shall comprise as series of interlocking guards so the carousel can be accessed from outside the guards. In the area for manual sack placing H, the distance between the guards and the carousel shall be at least 1000 mm. Access to areas where there is less than 1000 mm clearance shall be prevented by a trip guard like the one marked "F" in figure 57. The trip guard F shall be designed so that it can move easily both in the direction of rotation of the carousel and in the opposite direction if it is pushed by the operator. The trip guard F shall be interlocked and positioned following the requirements of EN ISO and clause of EN : 2014 to ensure that the carousel has stopped before the operator can reach a danger zone. 88

89 It shall only be possible to select manual mode using a key or password. In addition to the emergency stop device on the control panel, a pull-cord operated emergency stop device shall be installed in the interior of the safeguarded area all around the machine Sack holding mechanism On automatic machines, this mechanism shall be guarded with interlocking guards. On machines where sacks are placed manually, the holding mechanism shall be safeguarded by a trip guard like the one marked "F" in figure Flow regulating mechanism On automatic machines, this mechanism shall be guarded with interlocking guards. On machines where sacks are placed manually, the flow regulating mechanism shall be safeguarded by a trip guard like the one marked "F" in figure Sack holding and positioning mechanism On machines where manual sack placing is foreseeable, the holding and positioning mechanism shall be safeguarded by a trip guard like the one marked "F" in figure Sealing mechanism On machines where manual sack placing is foreseeable, the sealing mechanism shall be safeguarded by a trip guard like the one marked "F" in figure Filling nozzle area Where the machine is specified to pack a hazardous or dusty product, clause of EN :2014 shall apply. Where the local exhaust ventilation system is not delivered with the machine, the manufacturer shall provide a detailed specification for a suitable local exhaust ventilation system in the instructions which includes details for the connection to the machine and the required airflow at the connection point. On automatic machines, this mechanism shall be guarded with interlocking guards. On machines where manual sack placing is foreseeable, the filling process shall only be started in the zone which is safeguarded by the trip guard marked "F" in figure Sack magazine The requirements of clause shall apply Sack transfer mechanism The sack transfer mechanism shall be safeguarded with fixed and interlocking guards Sack placing mechanism On automatic machines, the sack placing mechanism shall be safeguarded with an interlocking guard. The sack placing mechanism shall not operate when the machine is in manual mode. The sack placing mechanism shall only operate when the interlocked access door marked "G" in figure 57 is closed. 89

90 Sack discharge conveyor The discharge conveyor shall comply with clause of EN : Where the height of the discharge opening is 200 mm or less the safety distance from the discharge opening to the nearest danger zone shall be at least 850 mm. Where the height of the opening is greater than 200 mm the safety distances and safeguarding solutions shown in EN clause shall apply Integrity of safety related control systems The safety related control systems of a rotary sack fill and seal machine shall as a minimum comply with the following performance levels of EN ISO :2015. Safety function Stopping the carousel when the interlocking guard is opened on automatic machines Stopping the carousel when the trip guard is moved on machines where sacks are placed manually Stopping the sack holding, flow regulating, sealing, holding and positioning mechanisms when the interlocking guard is opened on automatic machines Stopping the sack holding, flow regulating, sealing, holding and positioning mechanisms when the trip guard is moved and the disable function on machines where sacks are placed manually Enabling machine operation only if the extraction system is running where the product is hazardous Stopping the sack holding, sealing, holding and positioning mechanisms on machines where sacks are placed manually with the positioning control in the manual sack placing position Selection of manual mode by key or code word Stopping the transfer mechanism when the interlocking guard is opened Stopping the sack placer when the interlocking guard is opened Stopping all hazardous processes by the emergency stop circuit PLr d d c c c c c c c c 90

91 5.11 Safety requirements for an auger filler General The hazards described in 4.11 shall be safeguarded by the following methods and those shown in 5.1. These requirements apply when an auger filler is fitted to one of the machines in the scope of this standard. A Product infeed point B Screw conveyor C Fixed guard D Hopper E Cut-off mechanism Figure 57 - Guarding requirements on an auger filler Auger, stirrers and hopper The hopper and top cover of the auger filler shall act as a guard for the auger and stirring mechanisms. Where the hopper can be removed from the top cover without the use of a tool it shall be fitted with an interlocking device which complies with EN ISO 14119, integrated with the control system so that the auger cannot run unless the hopper is fitted correctly Screw feeder The screw feeder shall be guarded with fixed guards. The socks that connect the screw feeder to the auger and the screw feeder to the product feed system shall be attached with fixings which can only be removed using a tool Auger discharge and cut off devices The control system of the auger shall be integrated with the form, fill and seal or fill and seal machine in such a way that the auger and cut-off devices cannot run when the interlocking guards of the form fill and seal or fill and seal machine or fill and seal machine are open. 91

92 Power supplies The power supplies for the auger shall be integrated with those of the form fill and seal or fill and seal machine so that the auger is isolated when the form fill and seal or fill and seal machine is isolated Ergonomic design requirements The hopper, auger, auger funnel and any other components which must be removed regularly for cleaning, shall be designed to avoid the risk of injury due to excessive effort. Where the mass of such components is greater than 25 kg, the manufacturer shall design the parts so that two operators can lift them or so that lifting equipment can be used to lift them into and out of position High level access If the filler is mounted in a position where it cannot be reached for cleaning or maintenance from the floor, one of the following shall be provided. a) A permanent means of access complying with EN ISO and EN ISO , or; b) A permanent platform around the filler which complies with EN ISO that can be accessed safely from mobile steps that comply with EN ISO Dusty products Where the product being packed produces a hazardous amount of dust, the machine shall be enclosed with interlocking guards and local exhaust ventilation (LEV) shall be provided. The interlocked guards shall be fitted with guard locking devices that will only release the doors when either a sensor indicates that the atmosphere inside the guards is safe to breathe or after a time delay long enough for the LEV system to remove the hazardous dust. Clause shall apply Integrity of safety related control systems The safety related control systems of the auger filler shall as a minimum comply with the following performance levels of EN ISO :2015. Safety function Stopping the auger and stirring mechanisms when the hopper is not fitted correctly Preventing unexpected startup of the auger and stirring mechanisms when the hopper is removed Enabling machine operation only if the extraction system is running where the product is hazardous Stop of all hazardous processes by emergency stop circuit PLr d d d c 92

93 5.12 Safety requirements for a volumetric cup filler General The hazards described in 4.12 shall be safeguarded by the following methods and the requirements in 5.1. These requirements apply when a volumetric cup filler is fitted to one of the machines in the scope of this standard. A Interlocking guard B Interlocking hopper guard C Infeed hopper E Drive mechanism guard D Discharge hopper Figure 58 - Guarding requirements on a volumetric cup filler Hopper Where the hopper is fed automatically, the connection between the feeding equipment and the hopper shall be fixed and any openings shall be dimensioned and positioned using appropriate tables of EN ISO so it is not possible to reach danger zones in the machine through the hopper. Where the hopper is fed from a mezzanine floor above the hopper, it is foreseeable that someone may put their feet into the hopper and so in that case table 7 of EN ISO shall be used to determine safety distances when designing fixed or interlocking guards. Where the hopper is fed manually, the hopper shall either be fitted with a fixed mesh or fixed bars dimensioned using table 4 of EN ISO 13857, or fitted with an interlocking guard as shown in by B in figure 59 or with ESPE complying with EN Cup plates The cup plates shall be enclosed with fixed or interlocking guards as shown as A in figure 59. To avoid an accident during cleaning, the cup filler shall either be equipped with an isolator, accessible from the cleaning area or the discharge hopper and other guards giving access to the shearing hazard, shall be interlocked with devices complying with EN ISO 14119: 2013 to prevent the machine operating when the hopper or guards are removed. 93

94 Discharge hopper The discharge hopper shall be designed to prevent access to danger zones in the cup filler when it is fitted in place on the form fill and seal or fill and seal machine and shall either be fixed with fixings which can only be undone with a tool or fitted with an interlocking device which complies with EN ISO 14119: Ergonomic design requirements The hopper, cups, cup plates and any other components which must be removed regularly for cleaning, shall be designed to avoid the risk of injury due to excessive effort. Where the mass of such components is greater than 25 kg, the manufacturer shall design the parts so that two operators can lift them or so that lifting equipment can be used to lift them into and out of position High level access If the cup filler is mounted in a position where it cannot be reached for cleaning or maintenance from the floor, clause shall apply Dusty products Where the product being packed produces a hazardous amount of dust, the cup filler shall be enclosed with interlocking guards and local exhaust ventilation shall be provided. Clause shall apply Integrity of safety related control systems The safety related control systems of a cup filling machine shall as a minimum comply with the following performance levels of EN ISO :2015. Safety function Stopping the feeding and cup plate mechanisms when the interlocking guard is opened Enabling machine operation only if the extraction system is running where the product is hazardous Stopping all hazardous processes by the emergency stop circuit PLr d d c 94

95 5.13 Safety requirements for a nett weigher General The hazards described in 4.13 shall be safeguarded by the following methods and those described in 5.1. These requirements also apply to a count filling machine (3.3.8) where the equivalent hazard exists. A Fixed or interlocking guard B - Product feed C Weigh hopper Figure 59 - Guarding requirements for a typical net weigher Product feed Where the feed conveyor is a flat belt conveyor it shall comply with Other types of feed conveyor shall comply with clause of EN :2014. The feed conveyor shall be equipped with its own isolator. The feed conveyor and it s isolator shall be accessible from floor level or by the means of access for the weigher as stated in without the need for an additional means of access Vibratory feeders The vibration tray linkages shall either be safe by design as defined by clause of EN , or designed in accordance with EN 349 to ensure that they do not present crushing hazards or they shall be enclosed with fixed or interlocking guards. The method of mounting of these mechanisms shall ensure that no hazardous vibration is transmitted to the supporting structures Weigh hopper Where the opening and closing mechanisms of the weigh hopper are not safe by design, as defined by clause of EN they shall be enclosed with a fixed or an interlocking guard. 95

96 High level access if the weigher is mounted in a position where it cannot be reached for cleaning or maintenance from the floor, clause shall apply. For nett weighers which are mounted on moveable packaging machines, the means of access may be a fixed ladder complying with EN ISO Integrity of safety related control systems The safety related control systems of a nett weigher shall as a minimum comply with the following performance levels of EN ISO :2015. Safety function Stopping the nett weigher when the interlocking guard is opened Preventing unexpected startup of the nett weigher when the interlocking guard is open Stopping all hazardous processes by the emergency stop circuit PLr c d c 96

97 5.14 Safety requirements for a multi-head weigher General The hazards described in 4.14 shall be safeguarded by the following methods and the requirements in 5.1. These requirements apply when a multi-head weigher is fitted to one of the machines in the scope of this standard. A Feed conveyor B Interlocking guard C Support platform D Hand-rails E Timing hopper guard Figure 60 - Guarding requirements on multi-head weigher Feed conveyor Where the feed conveyor is a flat belt conveyor it shall comply with clause Where the feed conveyor is a trough belt it shall comply with EN 620. Where the feed conveyor is some other kind of bulk feed conveyor it shall comply with EN 618. The feed conveyor shall be equipped with its own isolator which is accessible from the weigher support platform without the need for mobile steps Vibratory conveyor, dispersion feeder and radial feeders The vibration tray linkages shall either be designed in accordance with EN 349 to ensure that they do not present crushing hazards or enclosed with fixed guards. The method of mounting of these mechanisms shall ensure that no hazardous vibration is transmitted to the supporting structures. 97

98 Pool and weigh hoppers Where the opening and closing mechanisms of the pool and weigh hoppers are not safe by design, as defined by clause of EN they shall be enclosed with interlocking guards as shown by B in figure Timing hopper Where the opening and closing mechanisms of the timing hopper is not safe by design, as defined by clause of EN it shall be enclosed with an interlocking guard as shown by E in figure Cleaning weigher components Where the weigher components need to be dismantled and cleaned more than two times a week, provision for cleaning shall be provided on the same level as the multi-head weigher so it is not necessary to carry components up and down access stairs High level access The support platform shall comply with EN ISO and shall be provided with access stairs and handrails which comply with EN ISO Dusty products Where the product being weighed produces a hazardous amount of dust the feed conveyor and weigher shall be enclosed with interlocking guards and local exhaust ventilation shall be provided Noise reduction Where the sound pressure level of the weigher running with the specified product is potentially hazardous, the manufacturer shall: a) Reduce noise at source by reducing product falling heights, using servomotors to close flaps or changing contact materials or; b) Enclosing the weigher in an acoustic enclosure which reduces the sound pressure level outside the enclosure to a safe level Integrity of safety related control systems The safety related control systems of a multi-head weigher shall as a minimum comply with the following performance levels of EN ISO : Safety function Stopping the bulk feeder and multi-head weigher when the interlocking guard is opened Enabling machine operation only if the extraction system is running where the product is hazardous Stopping of all hazardous processes by the emergency stop circuit PLr d d c 98

99 6 Verification of safety requirements 6.1 General 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 ISO 4414 and are correctly installed Hydraulic systems Check that hydraulic components and piping conform to the safety requirements of EN ISO 4413 and are correctly installed Electrical systems Check that documentation complies with clause 17 of EN :2006, Guards Check that all guards are in place and securely fixed and that the guards and their dimensions are suitable for the hazards expected and their dimensions are according to the design. Check that all interlocking devices are fitted. Check that adjustable guards can be properly adjusted to the specified products and pack sizes Design requirements Check for each type of machine, that the design features stipulated in Clause 5 have been incorporated. Check for each type of machine, that the appropriate design requirements for the packaging materials intended to be used and the product intended 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 Guards For every type of machine, check that the dimensions of the guards comply with the relevant part of clause 5 and that the relationship between the size of any openings in the guards and their safety distance from the nearest hazard zone comply with the requirements Electrical testing Carry out the tests required by clause 18 EN :

100 6.4 Visual inspections with the machine running Guards Check with the machine running that the guards conform to the safety requirements and that the interlocking movable guards and ESPE are working correctly Safety related functions Check the operation of all safety related functions. Check that following the operation of an emergency stop or interlocking device all hazardous functions 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 For each type of machine check that stored energy is either dissipated automatically or a manual means of releasing this stored energy has been provided. 6.5 Measurements or tests with the machine running Electrical testing For each machine, carry out the functional tests stated in clause 18.6 of EN : Measurement of noise emission For each type of machine, measure the noise emission values as stated in EN Temperature For every type of machine, with the machine fully warmed up, identify all the areas of the machine where the temperature will be greater than the burn thresholds indicated in EN ISO Verification procedures Verification procedures for each safety requirement detailed in 5.1 are shown in Table 28. Verification procedures for form, fill and seal machines are in table 29. Verification procedures for fill and seal machines are in table 30. Verification procedures for filling machines are in table 31. Table 30 - Verification procedures for safety requirements in clause 5.1 Safety requirement Visual inspection Function test Measurement Calculation Safety requirement X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X Visual inspection Function test Measurement Calculation 100

101 Table 31 - Verification procedures for form, fill and seal machines Safety requirement Visual inspection Function test Measurement Calculation Safety requirement 5.2 Flow-wrapping machine 5.5 Thermoform fill and seal machine X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X 5.3 Vertical form, fill and seal machine X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X x X X X 5.6 Tubular bag form, fill and seal machine X X X X X X X X X X X X X X X X X X X X X X X X X X X X X x x x 5.4 Horizontal sachet form, fill and seal machine X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X Visual inspection Function test Measurement Calculation 101

102 Safety requirement Visual inspection Function test Measureme nt Calculation Safety requirement Visual inspection Function test Measureme nt Calculation X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X Table 32 - Verification procedures for fill and seal machines Safety requirement Visual inspection Function test Measurement Calculation Safety requirement Visual inspection 5.8 Pre-made bag fill and seal machine In-line sack fill and seal machine X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X 5.9 Cup or tub fill and seal machine X X X X X X X X Rotary sack fill and seal machine X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X Function test Measurement Calculation 102

103 Table 33 - Verification procedures for filling machines Safety requirement Visual inspection Function test Measurement Calculation Safety requirement Visual inspection 5.11 Auger filling machine 5.13 Nett weigher X X X X X X X X X X X X X X X X X X X X X X X X X X X X x X X X X X Function test Measurement Calculation 5.12 Cup filling machine 5.14 Multi-head weigher X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X 7 Information 7.1 General The information provided by the manufacturer with the machine shall comply with the following clauses and EN ISO 12100:2010, Marking All machinery in the scope of this standard shall be marked visibly legibly and indelibly with the following minimum information: a) the business name and full address of the manufacturer and, where applicable, his authorized representative; b) designation of the machinery; c) mandatory marks if appropriate, for example the CE marking; d) designation of series or type; e) serial number, if any; f) year of construction, that is the year in which the manufacturing process is completed; g) electrical markings as indicated in EN :2006, Clause 16; 103

104 h) rating information required for lifting equipment, if appropriate, e.g. carrying capacity, working load limit, centre of gravity, gross weight. 7.3 Warning of residual risks 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 ISO 7010: 2012, reproduced below. The shape and colour of these warning pictograms shall comply with ISO , ISO and ISO 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 No reaching in P015 - EN ISO 7010: Instructions Figure 61 - Pictograms for use on machines in the scope of this standard General The instructions shall contain all the information listed in clause of EN ISO 12100:2010, where the equivalent hazard exists. In addition, the instructions shall contain the information that is specific to the machines in the scope of this standard as stated in to All the machines in the scope of this standard The instructions shall contain the following information: a) an explanation of the markings on the machine as stipulated in 7.2; b) a description of the intended use for the machine; c) a description of the work stations likely to be occupied by operators; d) instructions on how to move the machine safely; e) instructions routine maintenance, inspection and testing; 104