Company Overview. Experienced personnel for all disciplines. Single point of contact for all aspects of a Project

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2 Specialists in CIP, Effluent Treatment, Hygienic Processing, Washing, Cleaning & Sterilising Engineering Excellence Since 1961 Custom built equipment based around proven technologies GMP design, robust, reliable, high quality Worldwide supply through a network of excellent sales and service agents UK Design and Manufacture to CE, cgmp, ASME BPE, EHEDG, GAMP, ATEX Experienced personnel for all disciplines Single point of contact for all aspects of a Project Company Overview

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4 Our Values We act with integrity and show respect We are passionate about our business and our products We aim for Engineering Excellence We offer Value for Money We pride ourselves on Innovative Design We offer Quality in everything that we do We use robust Health and Safety guidelines We strive to continuously increase our Knowledge We promote environmentally responsible practices We continuously Research and Develop new Innovations

5 Our Products Effluent and BioWaste Treatment Plants CIP - Cleaning In Place Systems Static and Mobile, WIP Wash in Place and SIP Sterilise In Place Systems Washers low pressure, high pressure, spray, turbulation, ultrasonic IBC Washers and IBC Liquid Handling Membrane Filter Modules and Skids Processing Modules and Skids including Buffer, Media Solution Preparation and holding, Sterile processing, Mixing, Compounding, Heat Transfer and Chemical Dosing Sanitary and Sterile Tanks, Vessels and Mixers

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

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

8 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.

9 Our Risk Assesment 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.

10 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.

11 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

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

13 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

14 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

15 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.

16 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.

17 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.

18 Our Documetation 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.

19 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.

20 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

21 Suncombe Worldwide Worldwide Network of Technical Sales Agents and Distributors

22 Product Portfolio The following slides provide details of some of our ranges of standard, customised and bespoke hygienic, sanitary and sterile processing equipment for Cleaning, Washing and Processing.

23 Static CIP Cleaning In Place Systems First System installed in ,000 s of System used throughout the world 50 years of design experience Developed with major Biopharma clientele to meet their requirements Suitable for full validation Cleaning Equipment

24 Mobile CIP Cleaning In Place Systems Systems supplied for over 30 years Used for smaller CIP duties or when CIP needs to be moved to Point of Use 50 years of design experience Developed with major Biopharma clientele to meet their requirements Suitable for full validation Cleaning Equipment

25 SIP Sterilise In Place Systems Sterilising Equipment Stand alone or combined with CIP systems Static or mobile versions available Designed to ASME BPE for BioPharma SIP 50 years of design experience Developed with major Biopharma clientele to meet their requirements Suitable for full validation

26 Washing Equipment PartsWashers Systems supplied for over 30 years Used for cleaning and drying parts, components, drums, change parts Cleaning technologies including spray cleaning, immersion cleaning, turbulation, cavitation, UltraSonic cleaning

27 Washing Equipment Wash Booths Systems supplied throughout the world for washing IBCs, drums, change parts, sieves, trolleys Used for internal and external washing and drying Single door or pass through Cabinets with automatic spray device insertion Cone and Butterfly Valve opening and cleaning Full containment versions for APIs and toxic residues. Custom trolleys and racks for holding parts

28 BioWaste Treatment Systems Three technologies, Batch, Continuous and Micro Batch BioWaste Treatment Systems BioWasteBatch - For any volume from CL1 to CL4 Continuous BioWaste Treatment Systems BioWasteFlow - For volumes 500 litres per day + from CL1 to CL3 Small Scale BioWaste Treatment Systems BioWasteMicro - For volumes from 30 to 500 litres per day + from CL1 to CL3

29 BioWasteBatch Batch Treatment Batch BioWaste Treatment Systems Suncombe Bio-Waste Inactivation Systems are used to collect, contain and treat levels 1 to 4 biological critical waste solutions Batch system effectively kills/inactivates/treats the effluent and total containment is assured at all times Mechanisms for Positive release of treated waste Totally CIP able and steam sterilisable and safe system maintenance

30 ETP+Plus BioWaste Batch Treatment Alternative Methodology Batch Treatment This methodology cools and/or heats the effluent by recirculation rather than using a jacket. The advantage is that there is no mixer in the vessel and some of the instruments can be installed on the loop. In the event of pump or instrument failure the loop can be isolated and decontaminated, repaired and put back into service without vessel entry.

31 BioWasteFlow Continuous Treatment Continuous BioWaste Treatment Systems Suncombe Bio-Waste Inactivation Systems are used to collect, contain and treat levels 1 to 3 biological critical waste solutions Continuously kills/inactivates /treats effluent using steam, hot water or electrical heating Total containment is assured at all times Totally CIP able and steam sterilisable Safe system maintenance

32 BioWasteMicro Low Volume Treatment Low Volume BioWaste Treatment Systems Suncombe Micro Bio-Waste Inactivation Systems are used to collect, contain and treat levels 1 to 3 biological critical waste solutions Micro system kills/inactivates /treats effluent from 10 litres to 500 litres per day using thermal treatment Total containment assured at all times Electrical supply only, no steam or hot water required Safe system maintenance

33 BioWasteSink Low Volume Treatment Low Volume BioWaste Treatment Systems The BioWasteSink effluent treatment system are units of laboratory furniture. They are pre-designed systems for use in biocontainment labs, to treat low volumes of effluent using an innovative batch process allowing positive release of all of your waste. The system is designed to fit into new or retrofit into existing laboratories. Designed to operate from a single 13 amp 230 Vac plug (European versions), the BioWasteSink, uses SteriHeat established licensed electrical heating technology to treat the effluent in batches at variable f0 lethality settings.

34 Membrane Filtration Skids Processing Equipment Direct and Tangential Flow Membrane Filter Systems For the concentration and separation of liquid streams Combinations of microfiltration, ultrafiltration, nanofiltration and reverse osmosis. Working with world renowned Filter manufacturers, we offer innovative static and mobile filter solutions

35 Utility Transfer Panels Processing Equipment Utility and Product Routing Panels Custom designed and built for your process Used for access from service areas to clean areas Offered as simple straight through panels Valves and instruments can also be fitted on the rear of the panels to provide more involved process solutions. Different orientations including mounting on legs, on columns, or through wall openings.

36 Mobile Vessels Standard and custom built Mobile Atmospheric and Pressure vessels litre capacity Processing Equipment 316L Stainless Steel, Duplex Stainless and Hastelloy materials. Ancillaries include mixers, load cells, automation, instruments Suitable for full validation

37 Processing Equipment Intermediate Bulk Containers IBCs, Drums and LiquiVessels 200 to 2,000 litre sanitary IBCs in 316 Stainless Steel and Alloy Materials GMPDrum s litre capacity sanitary drums LiquiVessel s litre capacity sanitary liquid vessels LiquiVessel with Legs LiquiVessel with Hanging Brackets LiquiVessel in Drum Body

38 Static Vessels Processing Equipment Standard and custom built Static Atmospheric and Pressure vessels. 1 6,000 litre capacity produced in house, larger vessels subcontracted to approved companies 316L Stainless Steel, Duplex Stainless and Hastelloy materials. Ancillaries include mixers, load cells, automation, instruments Suitable for full validation

39 Processing Skids Processing Equipment Design, manufacture, installation, commissioning and qualification for processing and utility skid applications. Providing solutions to many processing challenges. Suitable for full validation

40 Processing Equipment Solution/Media/Buffer Preparation Media, Buffer, Solution Preparation and Hold Modules are designed, built and tested off site to minimise construction and validation activities on site. Detailed design of mixing, powder incorporation, measuring, weighing, heat transfer, vacuum, pressure holding with full 21CFR11 compliant automation systems. Suitable for full validation

41 Components and Spares Our range of Components and Spares have been developed to compliment our equipment and for use by hygiene and sterile end users. Manufactured by or for Suncombe the equipment is all reliable, robust and economic, and is offered to improve your processing operation.

42 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

43 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

44 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

45 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

46 Suite#3 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

47 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

48 Finally.. We are suppliers to many major companies who have critical processing requirements With worldwide representation, we have thousands of our systems in operation throughout the world Our treatment and processing experience is your personnel and product security Our interest is in long term partnerships, and ongoing customer satisfaction

49 Thank you for your Attention Suncombe Ltd, Jade House Lockfield Avenue Brimsdown Enfield Middlesex EN3 7JY United Kingdom Tel +44(0) Web: