Typical Clientele. Products

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2 Message From Chairman Our company was created over 50 years ago specifically to supply a high quality range of process cleaning and sanitary processing equipment. To continually achieve our goals, we use the most up-to-date facilities and employ the best-qualified and experienced staff. Our Design PFD, P&ID, Schematics and Circuit Diagrams in ACAD Autodesk Inventor 3D Modelling is employed throughout the design process Suncombe Commitment Our commitment is to Design and Build in-house. This commitment has produced a work force made up of highly motivated and experienced personnel who have all proved their dedication to the industry. Guarantee Suncombe Limited guarantees that all of the systems we supply would operate in accordance with your stated requirements and our design solutions included in our proposals. Total Responsibility Our business philosophy is to carry out all aspect of a project with long term employed permanent staff. This allows us to take total control of all projects and guarantee the quality of all aspects of the project. We feel that this is critical in regard to Software, Instrumentation, Fabrication and Electrical works. This policy also allows us to give full support for all aspects for the lifetime of the equipment. We currently still support and maintain our equipment from 1961, the time of our company formation. Quality Statement We define our approach to quality as meeting or exceeding our customer s requirements for products and services. Our criteria include Satisfaction of Customers requirements, Zero Defects, On-Time delivery and Continued Product Support. All company functions are executed in accordance with our quality assurance system. We have a company-wide commitment to quality, which is integral to our business culture. Quality will remain our top priority and we will strive to provide quality in all aspects of our products and services. 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 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. Typical Clientele Our Sectors Pharmaceutical, Biotechnology, Research, Cosmetics, Toiletries, Healthcare, Medical, Food, Beverage and other hygienic and critical Processing Industries Products EDS - Effluent Decontamination Schemes IBC Wash Booths Mobile Cleaning In Place Systems Validation Lifecycle Our products follow the GAMP Validation Life Cycle with documentary evidence of procedures and processes during design, development, preconstruction, construction and commissioning. Company Policies Customer Care The Suncombe Customer Care department s obligation is to provide total customer support. This support starts at the proposal stage, continues throughout the contract and thereafter. A personal customer care agent will be assigned to you at quotation stage and will support you throughout. Static Cleaning In Place Systems Tanks, Vessels and Mixers Processing Skids and Schemes 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 Proto- cols. 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. Parts Washers Automation and Control Systems Bespoke Designed Systems and Skids Our Business years of Engineering Excellence Pioneers of Hygienic Processing, Effluent Treatment, Washing, Cleaning & Sterilising Worldwide network of sales and service agents UK Design and Manufacture to CE, cgmp, ASME BPE, 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 Copyright Suncombe

3 About Us Suncombe Ltd supply Cleaning and hygienic processing technology for the BioPharma, Medical, Food and other critical hygiene industries. From CIP to PartsWashers, we are uniquely capable of offering you a complete washing and processing solution. Typical Installation Features 316L Stainless steel radius-corners, sloping design, crevice-free Washing Chamber Floor mounted or pit mounted booth with adjustable levelling Formed in 1961, we have a tremendous amount IBC located by forklift or pedestrian of experience in-house and provide a high level of technical and engineering expertise. Our completed projects range from stand-alone systems to complete processing solutions. Our products are built to a high quality and encompass all rele- stacker truck Insulated Construction Standard and Special Chamber Sizes including DuoBooth twin IBC washing vant legislation, guidelines, testing, documentation, quality assurance and traceability requirements. IBCWashBooth and DuoBooth 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. The Suncombe DuoBooth is used on high throughput systems, where two IBCs are cleaned simultaneously in a single booth. Description Built to hygienic and sanitary standards and complying with ASME BPE, GAMP, ISPE and 21CFR11, the IBCWashBooth is available as a single door or pass through version, supplied worldwide to the Biotech, Pharmaceutical, Medical, Healthcare, Personal Care and other critical processing industries. Including internal and external IBC cleaning and drying, they incorporate technologies to provide repeatable patterns to ensure total coverage of all surfaces. The BoothWasher provides liquid heating, chemical dosing, air drying, valving, pumps, instrumentation and an in-built control system. Air Extraction (Drying & Cooling) Height adjustable sprayball Air Inlet (Drying & Cooling) Inflatable Door Seal Internal Spray Nozzle External Spray Bars cabinets. One to four chemical dosing systems Automatic locking hinged door with window and internal light Inflatable door seal for full containment Variants for cone and butterfly valve operation Special trolleys for drum and hose cleaning In-built CIP System for validated washing can be remote mounted Hygienic Pneumatically Operated Valves and instruments Hygienic Stainless Steel Pumps Stainless Steel covers Local or remote mounted HEPA filtered air drying and cooling Specification Operating Temperature: Ambient to 95 C (120 C Turbo Drying Cycle) Voltage: Vac (special voltages on request) Automation: Siemens or Allen Bradle ControlSuite Levels 2000 to 4000 Reporting: Printed records optional 21CFR11 records and batch reports.

4 Design Options Wash all types and sizes of IBC s, Cone Valve, Butterfly Valve & others. Number of doors & hinge orientation to suit facility layout and IBC move- Wash Booth Loading The Wash Booths can be mounted in a floor pit for floor level loading, loaded using lifter trucks or conveyor loaded. Automation ControlSuite# Automatic control system with 100 fully configurable recipes, time changeable recipes, I/O faceplates, Mimic diagrams, Hard wired interfaces, Printer, Repeatable automatic cycles, User control with passwords, In built troubleshooting and diagnostic ability. ment. Mimic Systems integrated neatly into GMP Pit Mounted Unit> facility with support services located in technical spaces. Alternative IBC loading methods conveyors, AGV or other. Automatic actuation/opening systems for IBC inlet lids & outlet valves Buffer water storage tanks. Recipe Setup Re-circulation of wash water Multiple detergent/sanitiser additions International design guidelines cgmp, PED, ASME BPE, CE, GAMP, External Cleaning External cleaning is by provided by Suncombe exclusive Splurge Bars, providing repeatable results at low flow and low energy usage. ISPE, FDA, 21CFR11, ATEX & EHEDG. Data logging retention of cycle records. Communication with other systems such as DCS. Validation package with supporting Component Trolleys The Washers can also be used to wash and clean other equipment. Custom designed trolleys and racks are available, with 3D models, to clean any equipment required in a repeatable, validateable method. <Splurge External Sprays ControlSuite# Automatic control system with 100 fully configurable recipes, variable changeable recipes, I/O faceplates, Mimic diagrams, profibus, Ethernet and hard wired interafces, Printer, Datalogger, Repeatable automatic cycles, User control with passwords, In built troubleshooting and diagnostic ability. Mimic documentation. Simple relay logic controls Control Systems Control systems available in a number of different versions, from the basic single recipe ControlSuite1000 to complex 21CFR11 compliant SCADA based ControlSuite4000. All versions are designed to provide the optimum control for ideal processing. The ControlSuite3000 is the most common version used on the IBCWashers. Loaded and Unloaded Component Trolley> IBC Washer Accessories The IBC Washers can be fitted with many accessories including: Cone Valve Actuation Split Butterfly Valve Actuation Automatic Lid Removal Automatic Doors Targeted Spray Areas Loading Conveyors and Cartridges Automatic Loading and Unloading Systems Bar Code Identification Recipe Setup

5 Lean Technology Adopting LEAN principles, all Suncombe products are developed to ensure they minimise utilities and time, whilst ensuring the safety of the operators and the efficiency of the cleaning. Utilising innovative fluid handling techniques, they incorporate a combination of traditional and new technologies to provide an environmentally friendly, low water and energy usage washing facility that is safe and ergonomic for the operators.. Support The Suncombe Technical Support and Customer Care departments obligation is to provide total customer support. This support starts at the proposal stage, continues throughout the contract and thereafter. A personal customer care agent will be assigned to you at quotation stage and will support you throughout. The department currently supports all of our clients over the last 50 years. Support includes advise and surveys, installation and commissioning, User training, call-out repairs and service contracts for preventative maintenance. IBCWashBooth Layout Dimensions Front View Part # Dimensions mm Side View Validation/ Documentation The lifecycle approach is adopted (DQ, FDS, HDS, SDS, FAT, SAT, IQ & OQ) with validation being key to every stage of the development process, including Factory Acceptance Testing (FAT), SAT and Qualification. A B C IBCWashBooth ,000 2,000 1,250 IBCWashBooth ,300 2,300 1,500 IBCWashBooth ,800 2,600 1,800 IBCWashBooth ,200 3,000 2,200 DuoBooth 2000 for cleaning 2 IBCs simultaneously 2,800 2,600 4,000 Top View Typical Wash Cycle Times DuoBooth Layout

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