Suncombe Ltd, Jade House, Lockfield Avenue, Brimsdown, Enfield, Middlesex, EN37JY, United Kingdom

T +44(0)20-8443-3454 F +44(0)20-8443-3969 E info@suncombe.com W www.suncombe.com

Custom Biopharma Tanks, Vessels, Mixers

and Skid Systems

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. 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 pro-posals. 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 require-ments, 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.

Validation Lifecycle Our products follow the GAMP Validation Life Cycle with documentary evidence of procedures and processes during design, development, pre-construction, construction and commissioning.

Company Policies

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.

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.

Project Management Individual Project Teams are selected for every project, with a Project Man-ager or Project Director as a single point of contact and a single point of re-sponsibility. Our Business 1961 -2012 - 51 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

Our Design PFD, P&ID, Schematics and Circuit Diagrams in ACAD Autodesk Inventor 3D Modelling is employed throughout the design process

Typical Clientele Our Sectors Pharmaceutical, Biotechnology, Research, Cosmetics, Toiletries, Healthcare, Medical, Food, Beverage and other hygienic and critical Pro-cessing Industries Products

EDS - Effluent Decontamination Schemes IBC Wash Booths Mobile Cleaning In Place Systems

Static Cleaning In Place Systems Processing Skids and Schemes Tanks, Vessels and Mixers

Parts Washers Bespoke Designed Systems and Skids Automation and Control Systems

Copyright © Suncombe

Suncombe have been producing Custom Biopharma Tanks, Vessels, Mixers and Skid Systems for over 50 years and supplying them to the worldwide BioPharma and other critical processing sectors. Custom Design The vessels are high quality units, with each individual vessel being specifically designed by our engineers for your particular requirement. Manufacturing Location All Suncombe equipment is designed, developed, modeled, manufactured, finished, tested, documented and Factory Acceptance Tested in our manufacturing facility in the United Kingdom.  The equipment is available for inspection throughout production.  Tanks and Vessel Considerations A Tank is defined as a container for holding gases or liquids at atmospheric pressure. A vessel (or pressure vessel) is defined as a closed container designed to hold gases or liquids at a pressure different from the ambient pressure. Suncombe can supply both Atmospheric Tanks and Pressure Vessels, as required for the application. Pressure Vessels are typically designed to PD5500, ASME VIII or EN13445, although other standards are available. Materials of Construction Typical vessels are built from 316L Stainless Steel with optional materials including duplex and hastelloy with PTFE or similar FDA compliant elastomers. Sanitary Construction Suncombe vessels have a sanitary construction with full drainability. Internal and External Surface Finish Surface finishes are available for 2B (original material finish), satin finish or guaranteed surface finish typically following ASME BPE finishes SF1 to SF6, with surface roughness values from 0.76 to 0.38 µmra, with mirror finish and electropolishing available. Nozzles Nozzles can be fitted as required to the vessels typically with a combination of triclamp and NA-connect connections although other connections can be used as required. Spraydevices Permanent or removable spray devices can be fitted to the vessels for cleaning and flushing. Jackets Pressurised and non-pressurised heating and/or cooling jackets can be incorporate with or without integral heating abilities.

ATEX Suncombe vessels can be rated for safe area use or for use in ATEX areas.

Instrumentation Instrumentation can be incorporated into the vessels including level, pressure, temperature, conductivity, flowrate, pH, TOC etc. Mixers/Agitators/Homogenisers Mixers/Agitators/Homogenisers can be fitted into the vessels for low shear, and high shear mixing and powder incorporation — options are available for top, bottom or side mounted mixers with suitable sealing, magnetic mixers with no vessel intrusion or recirculation mixers.

Custom Biopharma Tanks, Vessels, MExamples

Process Pressure Vessels

Mobile Pressure Vessels

Mobile Mixing Vessels Mobile Mixing Vessel

Mixers and Skid Systems Vessel Geometries From a processing perspective the optimum height to diameter of a vessel is typically between L/D=1.0 and L/D=0.8. Our custom designed vessels are available with any L/D to suit client requirements. Cleaning In Place and Steaming In Place Suncombe vessels can be designed for cleaning in place and steaming in place. Automation The vessels are available with automation systems to suit the requirements, from simple junction boxes to full PLC/HMI controlled system with records, reports and audit capabilities. Vessel Skids Our designers can incorporate other processing equipment onto vessel skids, to provide a full processing system. These skids can incorporate processing components including pipework, pumps, valves, instruments, heater/coolers etc. Project Inclusions 

Project Management and experienced project team Equipment Design and development to GAMP lifecycle Autocad Drawings and 3D Models Material traceability with 3.1 Material certificates Orbital Welding with weld tables and weld maps Coded/certified welders, welding procedures, welding

machines 100% Boroscopic Inspection and CD Record Hydrostatic pressure testing and certification Functional Design Specification, schedules and calculations Control panels designed to EN60204 Instrument calibration and certification Generation of FAT protocol and pre-FAT Testing FAT testing Validation information and manuals, Instruction and Operational Manuals CE Marking and PED Certification

Mixing Vessel Skid

Mobile Vessel

Small Volume Mobile Vessel Skids

Static Storage Vessels