Introduction to IBC Washers. Cleaning and Hygienic Processing Solutions Since 1961

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1 Introduction to IBC Washers Cleaning and Hygienic Processing Solutions Since 1961

2 Introduction to Suncombe Since years + of Engineering Excellence Pioneers of Hygienic Processing, Washing and Cleaning Located in London, United Kingdom Worldwide network of sales and service agents UK Design and Manufacture to CE, cgmp, ASME BPE, EHEDG, GAMP, ATEX In-house personnel for all disciplines Motivated, dedicated and experienced Long Term Workforce Single point of contact for all aspects of a Project Validated Production including full documentation and testing Research and development for special requirements

3 Introduction to Washing The definition of washing is to clean with water and, typically, soap or detergent and clean as free from dirt, marks, or stains. The definition of cleaning is to expunge all residue of prior materials or more informally the removal of contaminants.

4 What is Contamination? Contamination is the presence of particles, chemicals, and other undesirable substances. It can take on many different forms, each of which may requires a specific cleaning mechanism for effective removal. In addition to considering the actual contamination we also need to consider the size, shape, thickness, adherence, positioning and many other factors, which may also have an effect on the selection of cleaning mechanism.

5 Result of Washing Washing results in the equipment being chemically clean. This is defined as "the removal of all residues of soil and all washing agents so that contact with the cleaned surface does not result in physical contamination". If the equipment being cleaned needs to be microbiologically clean then an additional process can be carried out. This process is called SIP.

6 How Washing Works The science of washing is based on applying the required amount of energy to the equipment to ensure that it is cleaned. The energy is primarily provided by the solution temperature (thermal energy), the use of detergent or solvent (chemical energy) and the application of kinetic energy for a defined time period.

7 Washing Energy Sources Time Mechanical Temperature Chemical

8 Temperature Effect on cleaning operation: Soil Proteins Fats Sugars Salts Effect medium good good good Note : Generally a 10 C temperature increase will improve cleaning efficiency by 50% (above 30 C)

9 Chemical (Detergent) Effect on cleaning operation: Soil Water Alkali Acid Proteins poor good medium Fats poor good medium Sugars good Salts medium medium good Note : required concentrations depend on soil level, processes used, working time, temperature,.

10 Water Quality of Water used for aqueous cleaning is critical for performance: Chemical properties (ph, hardness, etc.) Biological properties (bioburden, endotoxins)

Mechanical Effect on cleaning operation: Most

type of washer selected, and can include flow

11 Mechanical Effect on cleaning operation: Most washing processes require mechanical energy in addition to the other energy sources. The mechanical energy is determined by the type of washer selected, and can include flow and pressure of spray, agitation, turbulation and cavitation.

12 Time (Duration) The duration of each washing step is to be optimised according to the main following parameters : Type of Equipment Type of Wash Carried Out Cleaning solution temperature Chemical concentration Mechanical Energy Process

13 Introduction to Suncombe IBC Washing Suncombe manufacture a number of different systems to wash Intermediate Bulk Containers (IBCs). The following slides provide some details of our equipment.

14 IBCWashBooth Validated Internal and External Spray Cleaning and Drying, Full Containment, Single Door or Pass Through, Floor or Pit Mounted, Cone or Split Valve Operation

15 IBCWashBooth Loading Pit Mounted Internal Floor Forklift Loaded Pit Mounted version for floor level loading or loading with pallet truck/forklift

16 IBCWashBooth Doors Single Door Two door pass-through Inflatable Door Seals for full containment Single Door or Two Door Pass-through Versions

17 IBCWashBooth IBC Connections Bottom Split Butterfly Valve Top Split Butterfly Valve All different outlets catered for including split butterfly valves

18 IBCWashBooth External Spray External IBC Spray External Parts Spray External sprays specifically designed and 3D modelled to suit IBC and Equipment for validated Cleaning and Drying

19 IBCWashBooth Internal Spray Internal IBC Spray Computer Simulation Rotary spray jet device with rotation sensor option, 3D modelled to suit IBC for validated Cleaning and Drying

20 IBCWashBooth Internal Spray Fitting Manually Fitted Automatically Lowered and Raised Internal spray device manually or automatically fitted and removed

21 IBCWashBooth Parts Washing Parts Modelled and loaded for Washing Typical Trolleys Customised trolleys can be used in the IBCWashBooth for Equipment and Parts Washing

22 IBCWashBooth Pit Mounted

23 IBCWashBooth Pit Mounted 2

24 IBCWashBooth Floor Mounted 1

25 IBCWashBooth Floor Mounted 2

26 DuoWasher multiple IBC WashBooth DuoWasher are front loading or pass-through washers for washing 1, 2 or 3 IBCs simultaneously

27 Manufacturing 316L Stainless Steel, Duplex Stainless and Hastelloy materials. Stainless fully welded supports and framework Enclosed head orbital Welding Equipment Crevice free sanitary construction

Sanitary Standard Materials: Wetted parts 316 stainless steel, non wetted parts 304 stainless steel Finishes: wetted parts surface descaled and bead removed, non wetted parts satin polished Pipework

scaled bore, bead removed internally, polish 150 grit O.D. Pipework Standard: Configured to Good Manufacturing and Engineering Practices (cgmp). Designed to hygienic specifications. Free draining.

28 Sanitary Standard Materials: Wetted parts 316 stainless steel, non wetted parts 304 stainless steel Finishes: wetted parts surface descaled and bead removed, non wetted parts satin polished Pipework Material: Welded 316 Stainless Steel tubing, fully annealed, chemistry to ASTM A-269, manufactured to ASTM A-270. Descaled bore, bead removed internally, polish 150 grit O.D. Pipework Standard: Configured to Good Manufacturing and Engineering Practices (cgmp). Designed to hygienic specifications. Free draining. Welding: Welding would be of T.I.G. (Tungsten Inert Gas) method; using an internal and external argon gas purge, using a computer controlled enclosed head orbital welding plant, carried out by technicians coded to EN 287, to Suncombe procedures coded to EN288. Weld finishing: Pipework welds, externally cleaned, fabrication welds cleaned and buffed Inspection: 100% visual, Hydrostatic Testing Material Documentation: 2.2 certificates of conformity, generic welder certificates, generic welding machine certificates, generic welding procedures, no weld logs or weld maps Process fittings Triclamp, Service fittings BSP or Flanged Process valves: Hygienic specification butterfly valves, 316 stainless steel, EPDM gaskets Service valves yellow metal gate type Documentation: Certificate of conformance, GA Drawing, P&ID, Electrical Drawings, Operation manual, Visual inspection report

ASME BPE Standard Materials: Wetted parts 316L stainless steel, non wetted parts 304 stainless steel Finishes: wetted parts surface RA 0.5um max, non wetted parts RA 0.

(Tungsten Inert Gas) method; using an internal and external argon gas purge, using a computer controlled enclosed head orbital welding plant, carried out by technicians coded to EN 287, to Suncombe

29 ASME BPE Standard Materials: Wetted parts 316L stainless steel, non wetted parts 304 stainless steel Finishes: wetted parts surface RA 0.5um max, non wetted parts RA 0.9um max Pipework Material: ASME BPE standard, Welded 316L Stainless Steel Bio-pharmaceutical specification tubing, fully annealed, chemistry to ASTM A-269, manufactured to ASTM A-270, and 3A Standard. Pipework Standard: Configured to Good Manufacturing and Engineering Practices (cgmp). Designed to ASME BPE specifications. Free draining. Welding: Welding would be of T.I.G. (Tungsten Inert Gas) method; using an internal and external argon gas purge, using a computer controlled enclosed head orbital welding plant, carried out by technicians coded to EN 287, to Suncombe procedures coded to EN288. Inspection: 100% visual external, 100% Dye-penetrant, 20% Boroscope Material Documentation: 3.1b material certificates linked to each part, weld maps, weld logs, welder certificates, welding machine certificates, welding procedures. Welding profiles and maps will be compiled for all welds. Process fittings Triclamp, Service fittings BSP or Flanged Process valves: Pharmaceutical specification diaphragm valves, 316 stainless steel, 0.5um max, internal finish, fully certified and documented, PTFE sandwich gaskets (FDA compliant material). Service valves yellow metal gate type Documentation: Full documentation package as per enquiry pack.

Batch Control Systems Designed to GAMP guidelines Electrical Designed

30 Automation Automation Excellence PLC Based Siemens or Allen Bradley Control Systems 4 15 HMI or Industrial PC Operator Interface Recipe or Batch Control Systems Designed to GAMP guidelines Electrical Designed in house Software development and authors in house Suitable for full validation

31 Automation Suite#1000 Manually operated and simple programmable logic Hard Coded fixed Recipes with variable time parameters Stand alone systems Built to GAMP guidelines Suitable for full validation

with option for printout, Interface support, no networking

32 Automation Suite#2000 PLC Based 20 Recipe mid-level Control Systems 10 Steps per recipe, 10 variables per step 6 Colour HMI with option for printout, Interface support, no networking Stand alone systems Built to GAMP guidelines Suitable for full validation

step 8 or 10 Colour HMI with printout Interface support,

33 Automation Suite#3000 PLC Based 100 Recipe advanced Control Systems 15 Steps per recipe, 15 variables per step 8 or 10 Colour HMI with printout Interface support, networking Built to GAMP guidelines Suitable for full validation

printout Interface support, networking 21CFR11 compliant Electronic records

34 Suite#3000 with 21CFR11 Reports PLC Based 100 Recipe advanced Control Systems 15 Steps per recipe, 15 variables per step 8 or 10 Colour HMI with printout Interface support, networking 21CFR11 compliant Electronic records and Batch Reports Built to GAMP guidelines Suitable for full validation Automation

Electronic record storage facilities and batch reporting compliant with

35 Automation Suite#4000 PLC Based 100 Recipe advanced Control Systems Industrial PC running WINCC SCADA, full interfacing and networking Electronic record storage facilities and batch reporting compliant with 21CFR11 Interface support, networking Built to GAMP guidelines Suitable for full validation

36 Our Design Drawing PFD, P&ID, Schematics and Circuit Diagrams in ACAD

37 Our Design 3D Modelling Autodesk Inventor 3D Modelling is employed throughout the design process

Our Certification Certification CE Mark we design and manufacture pressure vessels and assemble pressure equipment and CE mark in accordance with Pressure Equipment Directive

38 Our Certification Certification CE Mark we design and manufacture pressure vessels and assemble pressure equipment and CE mark in accordance with Pressure Equipment Directive 97/23/EC We primarily design to PD5500, ASME VIII and EN 13445, with facilities for other codes. Self certification and third party certification are used, together with NDT Testing to code.

39 Our Risk Assessment Formal risk assessments (HAZOP, FMEA) and design reviews would be carried out as part of and throughout the detail design and construction of the system.

Equipment Standard Our Hygiene Standards 316L

fully annealed, chemistry to ASTM A-269,

Sanitary designed to ensure no deadlegs or

40 Equipment Standard Our Hygiene Standards 316L Stainless Steel, Duplex Stainless and Hastelloy materials Surface RA 0.5um or better ASME BPE standard Pipework, fully annealed, chemistry to ASTM A-269, manufactured to ASTM A- 270, and 3A Standard. Sanitary designed to ensure no deadlegs or product retention areas complying with ASME Bioprocessing Equipment guidelines.

Our Manufacturing Welding Welding would be of T.I.G.

using a computer controlled enclosed head orbital welding plant, carried out

(formerly EN 288 Part 2), tested to EN ISO 15614 Part 1 (formerly EN 288

41 Our Manufacturing Welding Welding would be of T.I.G. (Tungsten Inert Gas) method; using an internal and external argon gas purge, using a computer controlled enclosed head orbital welding plant, carried out by technicians coded to EN 287, to Suncombe procedures to EN ISO (formerly EN 288 Part 2), tested to EN ISO Part 1 (formerly EN 288 Part 3). Welding profiles and maps will be compiled for all welds. 100% Boroscopic Inspection of all welds

42 Our Components Diaphragm Valves ASME BPE Pipework and Fittings Hygienic Pumps BioPharma Instrumentation PureKleen Parts Washer Example Equipment

EN60204 standards Our Control Panels All cables fitted with ferrules and individually

43 All design and manufacture carried out by Suncombe personnel 3D Control Panel Layout Design Individually developed Electrical Diagrams Stainless steel enclosures Wired to EN60204 standards Our Control Panels All cables fitted with ferrules and individually numbered All testing and commissioning, maintenance and servicing carried out by Suncombe personnel

44 Our Control Specification All specifications are developed by Suncombe personnel RED = DEACTIVATED GREEN = ACTIVATED BLUE = INTERFACE SIGNAL START RINSE IS CHEMICAL QUANTITY [OpXV3] > 0 NO YES OPEN CHEMICAL VALVE [SV03] SET CHEMICAL REQUEST WAIT FLOW TOTAL [ FT01] > OpXV3 Functional Design Specification individually compiled to confirm all operational aspects of the systems in text and flowcharts IF WATER SELECTION [OpXV1]=0 THEN OPEN RO VALVE [SV02] IF WATER SELECTION [OpXV1]=1 ATHEN OPEN WFI VALVE [SV01] IS RECIRC REQUIRED [OpXV1] NO CLOSE BLOCK VALVE [SV06] OPEN DRAIN VALVE [SV05] IS PURE WATER WAIT LOW LEVEL [LSL01] ON YES CHECK REQUIRED [OpXV10] SET PURE WATER CHECK FLAG OPEN TOP ROUTE VALVE [SV07] WAIT 2 SECONDS OPEN CHEMICAL VALVE [SV03] SET CHEMICAL CHECK FLAG RESET CHEMICAL REQUEST WAIT INTERMEDIATE LEVEL [LSI01] ON START IMMERSION HEATER SUBROUTINE CLOSE WFI VALVE [SV01] CLOSE RO VALVE [SV02] WAIT 2 SECONDS START DELIVERY PUMP [P01] AND SET DELIVERY TO INTERNAL RECIRC SPEED [VSD01] TO EngXV4 IF TT01>OpXV5 FOR 5 SECONDS CLOSE STEAM VALVE [SV04] IF TT01<OpXV5 OPEN STEAM VALVE [SV04] Hardware Design Specification - compiled to confirm hardware architecture NO CLOSE BOTTOM ROUTE VALVE [SV09] WAIT TOP RINSE TIME [OpXV6] OPEN RACK ROUTE VALVE [SV08] WAIT 2 SECONDS CLOSE TOP ROUTE VALVE [SV07] WAIT RACK RINSE TIME [OpXV8] OPEN BOTTOM ROUTE VALVE [SV09] Interface Specification - compiled to confirm all interfaces including hard wired, Ethernet, profibus etc. WAIT 2 SECONDS CLOSE RACK ROUTE VALVE [SV08] WAIT RACK RINSE TIME [OpXV8] ADD ONE TO RINSE COUNTER IS RINSE COUNTER > OpXV9 YES Software Design Specification - compiled to confirm software modules and logic included OPEN DRAIN VALVE [SV12] RESET RINSE COUNTER CLOSE HW DI VALVE [SV01] CLOSE CW CITY VALVE [SV02] CLOSE HW CITY VALVE [SV06] CLOSE BOTTOM SPRAY ROUTE [SV10] OPEN PIPEWORK DRAIN VALVE [SV13] WAIT LSH01 OFF FOR DRAIN TIME [OpXV10] CLOSE DRAIN VALVE [SV12] FINISH RINSE

45 Our Programming All PLC programming, HMI development and SCADA configuration are carried out by qualified, experienced Suncombe personnel Programming encompasses international standard IEC for programmable logic controllers, GAMP guidelines, TickIT and IEC methodology. Compiled on current Siemens and Rockwell development platforms. Testing in development, module testing, client source code review, change control and extensive operational testing.

46 A Factory Acceptance Test (FAT) Protocol is compiled for all systems and is client witnessed. The FAT incorporates full documentation checks, wet and dry system testing and is carried out to ensure our clientele that our systems are fully functional prior to despatch. An FAT report accompanies the equipment and can be used as leverage for the site based Site Acceptance Testing (SAT). Our Testing Suncombe personnel can carry out or assist in client Qualification activities.

Validation Documentation Typical documents packages include Document Index, Quality Plan, GANTT Programme, FDS, HDS, SDS, P&ID Drawings, GA Drawings, Equipment List, Instrument List, Circuit

47 Validation Documentation Typical documents packages include Document Index, Quality Plan, GANTT Programme, FDS, HDS, SDS, P&ID Drawings, GA Drawings, Equipment List, Instrument List, Circuit Drawings, Software Code and Test Protocols. Validation Lifecycle Our Validation Our products follow the GAMP Validation Life Cycle with documentary evidence of procedures and processes during design, development, preconstruction, construction and commissioning.

48 Our Documentation Weld Validation Weld maps and tables linking every weld to its base materials (3.1b), the weld reference, the welder, the welder qualification and the welding machine. Documentation and DataManual Full validation documentation lifecycle. Datamanual including Instruction, Operation and Maintenance manuals, Design Drawings, Schedules and Specifications including all validation documentation.

Our Company Policies Corporate Responsibility - we set,

the relevant statutory provisions and all measures taken to

49 Our Company Policies Corporate Responsibility - we set, maintain and promote high standards of corporate responsibility. Quality - We have a companywide commitment to quality, which is integral to our business culture. Health and Safety all work is carried out in accordance with the relevant statutory provisions and all measures taken to avoid risks to our employees or others who may be affected. Environmental - Our policy is to wherever possible minimise the environmental impact of our operations.

50 Our Project Management Individual Project Teams are selected for every project, with a Project Manager or Project Director as a single point of contact and a single point of responsibility. Managing Director Project Director Commercial Automation Design Project Accountant Mechanical Design PROJECT ENGINEERING Quality Director Automation Designers Purchasing Mechanical Designers Testing Manufacturing and Installation Software Authors Documentation Project Timeline Automation Manager Mechanical Supervisor Electrical Supervisor

51 Suncombe Worldwide Worldwide Network of Technical Sales Agents and Distributors

52 Suncombe Products

53 Typical Clientele BioPharma/Medical/Chemical

54 Typical Clientele Personal Care

55 Typical Clientele Food and Beverage

56 Thank you for your attention For further information please contact: Suncombe Ltd Jade House Lockfield Avenue Brimsdown Enfield Middlesex EN3 7JY UK Tel +44(0) Fax +44(0) Web:

Pharmaceutical washing-systems

Pharmaceutical washing-systems For the Environmentally conscious > high performance and production capacity - 2 - for pharmaceutical industry The needs of the pharmaceutical field are focused to reach