Table Of Contents. Suncombe Equipment. Static CIP Skids PartsWashers Mobile CIP skids IBC Wash Booths

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2 Table Of Contents 1. About Us 2. Introduction to Cleaning In Place (CIP) 3. Cleaning In Place (CIP) Systems 4. Introduction to Washers 5. PartsWashers 6. IBCWashers 7. Introduction to BioWaste Effluent Treatment 8. BioWaste Effluent Treatment Systems 9. Processing Skids and Modules 10. Storage, Mixing and Preparation Tanks and Vessels 11. IBC, Sanitary Drums and LiquiVessels 12. Automation and Integration Suncombe Equipment Static CIP Skids PartsWashers Mobile CIP skids IBC Wash Booths Tanks, Vessels and Mixers Bio-Waste Inactivation Skids BioPharma Processing Skids Solution Preparation Systems

3 ABOUT US Introduction Suncombe, formed in 1961, design and manufactures high quality cleaning and critical processing systems for the Processing Industries. Our expertise includes Cleaning In Place and Sterilising, Washers, BioWaste Effluent Treatment, Liquid Processing, Tanks and Vessels, Filter Skids, Processing Skids/Modules and bespoke processing solutions and projects for the BioPharma, Personal Care, Food and Beverage, Medical, Research and other critical processing Industries. Our Manufacturing Our Validation Our Business Engineering Excellence Pioneers of Hygienic Processing 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 and experienced Term Staff Single point of contact for all Projects Our Clientele Our Design Our Markets Equipment supplied worldwide through a network of agents and service companies.

4 INTRODUCTION TO CLEANING IN PLACE (CIP) CIP or in its full form, Cleaning In Place, is defined as techniques to clean process equipment without dismantling and with minimal operator involvement. Suncombe and CIP Suncombe pioneered the technology of CIP in the 1950's. Suncombe CIP Systems have been supplied for over 50 years and are used throughout the world in many different industries and sectors. First System installed in ,000s of System used throughout the world. 50+ years of design experience. Developed with major clientele to meet their requirements. Suitable for full validation. Time Kinetic CIP - Using Energy for Cleaning Cleaning uses a combination of thermal, chemical and kinetic energy applied for a set time. CIP allows higher thermal, chemical energies to be used for set times, thereby providing guaranteed repeatable cleaning. Benefits of CIP CIP provides many benefits over other methods of cleaning, including: Static CIP Automated, repeatable, reliable and validatable Improved Health and Safety No/minimal equipment dismantling required Often improves cleaning times and reduces labour costs More effective using higher temperatures, stronger chemicals Permanently installed unit with pipework and CIP routing used to transfer CIP fluids to the equipment being cleaned. Temperature Chemical Mobile CIP Plug and Play CIP system that is moved to point of use and connected via flexibles.

5 CLEANING IN PLACE (CIP) SYSTEMS PureCIP The PureCIP is a Total Loss Cleaning In Place system supplied worldwide to the Biotech, Pharmaceutical, Medical, Healthcare, Personal Care and other critical processing industries. Complying with ASME BPE, GAMP, ISPE and 21CFR11. Built to hygienic and sanitary standards the PureCIP incorporates a number of CIP buffer vessels for storing, batching and delivering CIP fluids. It also includes heating facilities, detergent dosing facilities, valving, pumps, instrumentation and an in-built control system. CIP+Plus The original Suncombe CIP+Plus systems were introduced in Since this time they have been continuously developed to provide a technologically advanced and robust, reliable means of supplying repeatable, validateable, controllable CIP cleaning. Used throughout the world in the Dairy, Food, Beverage, Cosmetics, Personal Care and other Industries, the CIP+Plus is available as a full or partial recovery system, which allow the recovery and reuse of the detergents used for CIP saving utilities and energy and subsequently costs. MobileCIP The MobileCIP is a Total Loss Cleaning In Place system supplied worldwide to the BioPharma, Healthcare, Cosmetics, Personal Care, Food, Dairy, Beverage and other Processing Industries. Designed and developed to be mobile to allow the entire system to be moved to its point of use. Manual or automatically operated, the systems can be used for cleaning processing equipment including Tanks, Vessels, Vats, Fermenters, Mixers, Processors, Pipework, Valves, Isolators, Mills, Coaters, Filters, Pumps, Dryers and Fillers.

6 INTRODUCTION TO WASHERS The definition of washing is to clean with water and typically, soap or detergent and clean as free from dirt, marks, or stains. The result of washing is "the removal of all residues of soil and all washing agents so that contact with the cleaned surface does not result in physical contamination". Suncombe and Washers Suncombe washers have been supplied for over 50 years since the 1950's and encompass many different washing technologies to provide a full range of washing facilities. They are used throughout the world in many different industries and sectors. First System installed in ,000s of System used throughout the world. 50+ years of design experience. Developed with major clientele to meet their requirements. Suitable for full validation. Washing Technologies Immersion Immersion with Agitation Immersion with Turbulation Spray Cleaning Fogging Ultrasonic Cleaning Air Purging Drying and Cooling BoothWasher The BoothWasher is a multi-purpose washer in single door or pass through versions, that offers a contained, validateable unit to clean and dry any combination of components,

7 PARTSWASHERS PureKleen PureKleen range of PartsWashers are front loading or passthrough washer/disinfectors, supplied worldwide to the Biotech, Pharmaceutical, Medical, Healthcare, Personal Care and other critical processing industries. Built to hygienic and sanitary standards and complying with ASME BPE, GAMP, ISPE and 21CFR11, they are designed for the cleaning of critical components. SonoKleen Built to hygienic and sanitary standards and complying with ASME BPE, GAMP, ISPE and 21CFR11, the SonoKleen PartsWashers employ a combination of ultrasonic, immersion, turbulation, recirculation and spray cleaning to provide the ultimate clean. They provide an environmentally friendly, low water and energy usage washing facility for parts washing. ImmersionWasher Employing a combination of immersion, turbulation, recirculation and spray cleaning, the ImmersionWasher range of Parts Washers are top loading washer/disinfectors, which provide a cleaning solution for hoses, pipework, change parts, valves, fittings and other parts. Direct connections within the washers can be used for hoses and standard and bespoke baskets can be used for parts cleaning. They provide an environmentally friendly, low water and energy usage washing facility for washing.

8 IBCWASHERS IBCWashBooth The Suncombe IBCWashBooth is a high specification unit, using an innovative spray technique, that offers a contained, validatable unit to clean and dry Intermediate Bulk Containers (IBCs). Achieving excellent cleaning using high impact accurate spray targeting, they incorporate existing and new technologies to provide an environmentally friendly, low water and energy usage washing facility for IBC washing. IBCWashStation Supplied worldwide to the Food, Dairy, Beverage, Biotech, Pharmaceutical, Medical, Healthcare, Personal Care and other processing industries, the IBCWashStation provides internal IBC cleaning and drying, incorporating technologies to provide repeatable patterns to ensure total coverage of all internal surfaces. IBC Discharge Stations The IBC discharge station mounts a single or more IBCs which are connected to a transfer pump for IBC discharge. Instrumentation allows for discharge at controlled rates and sensing when the IBC is low. At this point the system can automatically switch to another IBC or come to a controlled stop. After discharge, if the cleaning option has been included, the IBC can be cleaned prior to removal and replacement.

9 INTRODUCTION TO BIOWASTE EFFLUENT TREATMENT Suncombe BioWaste Effluent Treatment Systems decontaminate liquid hazardous infectious waste streams for research, production, laboratory and bio-containment environments. Suncombe and BioWaste We offer Continuous Flow BioWaste decontamination systems and Batch BioWaste decontamination systems. Our systems are available for both thermal and thermochemical inactivation. Thermal inactivation can be performed using steam, super heated water or an established licensed electrical heating technique which minimises time and space. BioWaste Levels Bio-waste can be classified by the relative danger to the surrounding environment as biological safety levels (BSL). There are four safety levels. These are level 1 through level 4. Higher numbers indicate a greater risk to the external environment. First System installed in 1990s 50+ years of design experience. Suitable for full validation. Treatment Excellence Using robust, proven design principles, the systems deal with Biowaste Level 1 to 4 and take into account two main areas of concern. Firstly the systems effectively sterilise or inactivate any harmful pathogens in the waste stream and secondly total containment must be assured at all times. Batch BioWaste Treatment Systems BioWasteBatch For any volume from CL1 to CL4 ETP+Plus For any volume from CL1 to CL3 Continuous BioWaste Treatment Systems BioWasteFlow For volumes 500 litres per day + from CL1 to CL3 Small Scale BioWaste Treatment Systems BioWasteMicro and BioWasteSink For volumes from 30 to 500 litres per day + from CL1 to CL3

10 BioWasteSink BIOWASTE EFFLUENT TREATMENT SYSTEMS litres per day BSL 1, 2 and 3 Waste The BioWasteSink effluent treatment system are units of laboratory furniture and placed against the service spine or a wall. They are predesigned 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. Up to 500 litres per day BSL 1, 2 and 3 Waste BioWasteFlow The BioWasteFlow effluent treatment system is a predesigned system which treats effluent continuously. It consists of a buffer tank which buffers the effluent, ensuring that there is a controlled supply to the continuous system regardless of flow peaks and toughs. Using SteriHeat our trademarked established licensed electrical heating technology, steam or super heated water, the effluent is passed through a heating zone, held at temperature and then passed back through 2 cooling zones. Only on confirmation of success of all of these steps is the effluent cleared for release. BioWasteMicro The BioWasteMicro effluent treatment system is a pre-designed system which treats low volumes of effluent using an innovative batch process allowing positive release of all of your waste. A buffer vessel is used to provide a continuous collection facility and a set volume batch treatment facility is used. Using SteriHeat our trademarked established licensed electrical heating technology, steam or super heated water, the effluent is inactivated in batch at variable f0 lethality settings. Up to 5,000 litres per hour BSL 1, 2 and 3 Waste

11 ETP+Plus BIOWASTE EFFLUENT TREATMENT SYSTEMS Up to 1,000 litres per hour BSL 1, 2 and 3 Waste The ETP+Plus system is a pre-designed system consisting of 2 vessels, which are used for both collection and treatment. With capacities to suit the waste volume, the systems are supplied with controls and interlocking functionality to ensure containment is always maintained and there is always a positive release prior to discharge of treated waste. Our Bio-Waste Effluent Treatment Systems are available for both thermal and thermochemical inactivation. Thermal inactivation can be performed using steam, super heated water or an established licensed electrical heating technique which minimises time and space. Any Capacity BSL 1, 2, 3 and 4 BioWasteBatch The BioWasteBatch effluent treatment systems are custom designed systems which provide any number of collection and treatment vessels. They are available in the traditional, heat and cool in the treatment vessels or our new hybrid technology that heats them in vessel and cools them on discharge. On higher level systems, Safety Integrity Assessments and facilities are carried out to ensure that their is no possibility of untreated waste being inadvertently discharged.

12 PROCESSING SKIDS AND MODULES Skid mounted, sanitary modular systems helps simplify the installation of complicated processes and are used throughout industry. Providing a controlled environment for manufacture, skid mounting allows in process inspection and Factory Acceptance testing prior to delivery. Advantages of Processing Skids/Modules Smart Project Management controlling all aspects of the Skid/Module with a single Project Manager/Director. All aspects of the project carried out with in-house staff including design, development, drawings, calculations, fabrication, finishing, piping, wiring, testing, automation, integration and testing. Skid/Module can be built and completed in parallel with the facility build of pre-built ready for a shutdown/ changeover period. Pre-validated system allows full documentation and testing protocols to be performed prior to shipment. Example Skids/Modules Solution Preparation Buffer and Media Preparation Final Formulation and Fill Process Utility Skids Temperature Control Systems Powder Incorporation Heating/Cooling Skids IBC Discharge Stations Neutralisation Skids SunFlo Utility Panels Transfer Panels & Flowplates

13 STORAGE, MIXING & PREPARATION TANKS & VESSELS For over 50 years, Suncombe have been a leading manufacturer of hygienic and sterile Tanks, Vessels, Mixers and Processors. Manufactured in stainless steel, duplex and Hastelloy materials, they have been supplied to many major worldwide corporations in the Pharmaceutical, Biotech, Medical, Personal Care, Food, Dairy, Beverage and Process Sectors Scope of Supply We offer a range of standard solutions, as well as custom vessels and pride ourselves on our ability to understand and meet our customers particular needs by producing custom stainless steel vessels to match their precise requirements. Our pressure vessels are PED certified and conform to PD 5500, ASME VIII, EN13445 and other internationally recognised standards. With in-house control, instrumentation and process designers, we work with our clients to develop, manufacture, install and validate an entire system with spray devices, mixers, jackets, valves, instrumentation and control systems. Features Heating and Cooling Jackets Magnetic Mixers and Top Mount Mixers Powder Incorporation Mixing, blending, conditioning and transfer CIP, SIP and Neutralisation Media and Buffer Preparation Simple Relay logic automation to PLC/HMI and SCADA Control Systems with Batch recording to 21CFR11 and networking

14 IBCs, SANITARY DRUMS AND LIQUIVESSEL s Liquid IBCs Suncombe Liquid Intermediate Bulk Containers (IBCs) are a range of fully sanitary IBCs, available in capacities from 200 to 2,000 litre with the option of custom design and manufacture for your particular requirement. Standard configurations and custom designed, the Liquid Intermediate Bulk Containers (IBCs) are manufactured from 316 stainless steel and are available manufactured to two different standards; ASME BPE for Biopharma applications and Sanitary for food, dairy, brewery, personal care and other sanitary sectors. Sanitary Drums (GMPDrum s) Suncombe GMPDrum Liquid Storage and transport Containers are a range of fully sanitary liquid containers, developed for the specific requirements of the biopharmaceutical, personal care, healthcare, food science and beverage sectors. Available in capacities from 5 to 200 litres, with the option of custom design and manufacture for your particular requirement, they are manufactured to ASME BPE or food quality, EHEDG and other relevant guidelines and are designed for longevity, robustness and economy. LiquiVessel s Suncombe LiquiVessel Liquid Storage and transport Containers, available in capacities from 10 to 500 litres, are a range of fully sanitary liquid containers available in 316 Stainless steel, duplex or Hastelloy materials, developed for the specific requirements of the biopharmaceutical, personal care, healthcare, food science and beverage sectors. With standard vessel internals they are available with different external layouts. LiquiVessel with Legs LiquiVessel with Hanging Brackets LiquiVessel in Drum Body

15 AUTOMATION AND INTEGRATION With dedicated electrical, instrumentation, software and automation personnel, Suncombe engineers have tremendous experience in incorporating a broad range of control solutions to suit your specific control requirements. ControlSuite Automation Developed over the last 50+ years specifically for control of the Suncombe range of products, the ControlSuite range of packages are Automatic Control Systems which are renowned for their ease of use, reliability and longevity. Developed in co-ordination with clients operational staff, engineers and validation staff, they encompass all elements required to provide a controllable, repeatable automatic system. Suite#1000 Basic Control Automation Activities Automation Surveys and Evaluations Integration Conceptual Analysis CAD electrical and pneumatic schematic design Functional Specifications Hardware Specifications Wiring Schedules Software Specifications Software Programming HMI/Visualisation Development Equipment and Instrumentation Specifications Interfaces to Equipment, Factory Wide Control Systems Printouts, batch reporting, electronic storage Suite#2000 Mid level PLC and HMI Control Suite#3000 High level PLC and HMI Control Suite#4000 High level PLC and SCADA Control, electronic storage, optional 21CFR11 compliance, batch records

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