Agenda • Introduction to Suncombe • Product Overview � Cleaning In Place (CIP) and SIP � BioWaste Decontamination � Washers � IBCWashBooth Introduction � Skids, Filter Skids and Modules � Tanks, Vessels and Mixers � Containerised Systems • Client Studies
Introduction to Suncombe • Incorporated in 1961 in London, UK • Engineering Excellence • Worldwide service and sales network • BioPharma Clientele and Research Laboratories
Custom as Standard • Suncombe equipment is individually designed for every project. • Manufactured in the United Kingdom with great attention to detail. • Our production site is purposely split into small teams, who work solely on just one product. • Our equipment is carefully assembled by hand, using qualified and experienced British engineers.
Suncombe’s Advantages • Robust, Reliable and Innovative Designs • Quality, Flexibility and Communication • All design, manufacturing and automation carried out by Suncombe personnel • Workforce of experienced engineers • Teamwork with our Clients
Suncombe’s Service • Collaboration and Teamwork • Enthusiastic, experienced workforce of motivated dedicated engineers, many with length of service of 10, 20 , 30 or more years • Fully validatable equipment with traceability and documentation • Client approvals throughout project • Factory Acceptance Tests
Suncombe’s Manufacturing • UK Design and Manufacture • CE marked equipment to European Standards • Encompassing International Biopharma guidelines, cGMP, ASME BPE, FDA, GAMP • Manufacturing expertise
Suncombe’s Facilities • Freehold owned manufacturing facility in London, United Kingdom. • 40 core long term permanent UK staff, with length of service of up to 40 years. • Financially stable, independent private company with same ownership since 1961. • Typical projects from €75,000 to €4,000,000
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 M oney 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
Our Products CIP - Cleaning In Place S ystems – Static and M obile, WIP Wash in Place and SIP Sterilise In Place S ystems Effluent and BioWaste Treatment Plants Washers – low pressure, high pressure, spray, turbulation, ultrasonic IBC Washers and IBC Liquid Handling M embrane Filter M odules and Skids Processing M odules and Skids including custom ASM E BPE skids, Purified Water & WFI Storage and Distribution, Solution Preparation and holding, Sterile processing, M ixing, Compounding, Heat Transfer and Chemical Dosing Sanitary and Sterile T anks, Vessels and M ixers
Our Design Drawing PFD, P&ID, Schematics and Circuit Diagrams in ACAD
Our Design 3D M odelling Autodesk Inventor 3D M odelling is employed throughout the design process
Our Certification Certification CE M ark – 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, ASM E VIII and EN 13445, with facilities for other codes. Self certification and third party certification are used, together with NDT T esting to code.
Our Risk Assessment In the development of all of our projects our aim is to eliminate hazards from the design. We carry out the consideration of hazard and risk in an integrated manner throughout the design process. As part of every proposal have carry out internal risk assessments which use leverage from risk assessments from recent CL2, CL3 andCL4 projects that we have carried out. The results from these risk assessments is used to qualify our proposals. Formal risk assessments and design reviews would be carried out as part of and throughout the detail design and construction of the system.
Our Risk Assesment Formal risk assessments (HAZOP , FM EA) and design reviews would be carried out as part of and throughout the detail design and construction of the system.
Our Hygiene Standards Equipment Standard 316L Stainless Steel, Duplex Stainless and Hastelloy materials Surface RA 0.5um or better ASM E BPE standard Pipework, fully annealed, chemistry to AS TM A-269, manufactured to AS TM A- 270, and 3A Standard. Sanitary designed to ensure no deadlegs or product retention areas complying with ASM E Bioprocessing Equipment guidelines.
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 15609 (formerly EN 288 Part 2), tested to EN ISO 15614 Part 1 (formerly EN 288 Part 3). Welding profiles and maps will be compiled for all welds. 100% Boroscopic Inspection of all welds
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.
Our Project Management Individual Project T eams are selected for every project, with a Project M anager or Project Director as a single point of contact and a single point of responsibility. M anaging Director Project Director Com m ercial PROJECT Autom ation Design M echanical Design Quality Director Project Accountant ENGINEERING Autom ation M echanical Purchasing Testing Designers Designers M anufacturing and Installation Software Authors Docum entation Autom ation M echanical Electrical Project Tim eline M anager Supervisor Supervisor
Automation • Automation systems developed on Siemens and Allen Bradley Platforms • Recipe controlled systems with 1, 6, 25 or 100 recipes • Developed in Functional Design Specification for Client Approval • Fault Diagnostics, Interfacing, Mimic Diagrams and Maintenance Mode • Fully configurable providing full controllability and repeatability • User log-in and control
Our Control Specification RED = DEACTIVATED All specifications are developed by GREEN = ACTIVATED START RINSE BLUE = INTERFACE SIGNAL IS CHEMICAL OPEN CHEMICAL VALVE [SV03] QUANTITY YES Suncombe personnel SET CHEMICAL REQUEST [OpXV3] > 0 WAIT FLOW TOTAL [ ∑ FT01] > OpXV3 NO IF WATER SELECTION [OpXV1]=0 THEN OPEN RO VALVE [SV02] OPEN CHEMICAL VALVE [SV03] IF WATER SELECTION [OpXV1]=1 ATHEN OPEN WFI VALVE [SV01] SET CHEMICAL CHECK FLAG RESET CHEMICAL REQUEST Functional Design Specification – IS RECIRC REQUIRED WAIT INTERMEDIATE LEVEL [LSI01] ON [OpXV1] IF TT01>OpXV5 FOR 5 SECONDS CLOSE STEAM VALVE [SV04] NO START IMMERSION HEATER SUBROUTINE IF TT01<OpXV5 individually compiled to confirm OPEN STEAM VALVE [SV04] CLOSE BLOCK VALVE [SV06] OPEN DRAIN VALVE [SV05] CLOSE WFI VALVE [SV01] CLOSE RO VALVE [SV02] IS PURE WATER all operational aspects of the WAIT LOW LEVEL [LSL01] ON YES WAIT 2 SECONDS CHECK REQUIRED [OpXV10] SET PURE WATER CHECK FLAG START DELIVERY PUMP [P01] AND SET DELIVERY TO INTERNAL RECIRC SPEED [VSD01] TO EngXV4 systems – in text and flowcharts OPEN TOP ROUTE VALVE [SV07] WAIT 2 SECONDS CLOSE BOTTOM ROUTE VALVE [SV09] Hardware Design Specification - WAIT TOP RINSE TIME [OpXV6] OPEN RACK ROUTE VALVE [SV08] compiled to confirm hardware WAIT 2 SECONDS CLOSE TOP ROUTE VALVE [SV07] architecture WAIT RACK RINSE TIME [OpXV8] NO OPEN BOTTOM ROUTE VALVE [SV09] WAIT 2 SECONDS Interface Specification - compiled CLOSE RACK ROUTE VALVE [SV08] WAIT RACK RINSE TIME [OpXV8] to confirm all interfaces including ADD ONE TO RINSE COUNTER hard wired, ethernet, profibus etc. IS RINSE COUNTER > OpXV9 YES OPEN DRAIN VALVE [SV12] RESET RINSE COUNTER CLOSE HW DI VALVE [SV01] Software Design Specification - CLOSE CW CITY VALVE [SV02] CLOSE HW CITY VALVE [SV06] CLOSE BOTTOM SPRAY ROUTE [SV10] OPEN PIPEWORK DRAIN VALVE [SV13] compiled to confirm software WAIT LSH01 OFF FOR DRAIN TIME [OpXV10] CLOSE DRAIN VALVE [SV12] modules and logic included FINISH RINSE
Our Programming All PLC programming, HM I development and SCADA configuration are carried out by qualified, experienced Suncombe personnel Programming encompasses international standard IEC 61131 for programmable logic controllers, GAM P guidelines, TickIT and IEC methodology. Compiled on current Siemens and Rockwell development platforms. T esting in development, module testing, client source code review, change control and extensive operational testing.
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