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
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
Our Values
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
Our Products
Drawing
PFD, P&ID, Schematics and Circuit Diagrams in ACAD
Our Design
3D Modelling
Autodesk Inventor 3D Modelling is employed throughout the design process
Our Design
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.
Our Certification
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.
Equipment Standard
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.
Our Hygiene Standards
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 Manufacturing
Our Components
PureKleen™ Parts Washer Example Equipment
Diaphragm Valves ASME BPE Pipework and Fittings
Hygienic Pumps BioPharma Instrumentation
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
All cables fitted with ferrules and individually numbered
All testing and commissioning, maintenance and servicing carried out by Suncombe personnel
Our Control Panels
All specifications are developed by Suncombe personnel
Functional Design Specification – individually compiled to confirm all operational aspects of the systems – in text and flowcharts
Hardware Design Specification - compiled to confirm hardware architecture
Interface Specification - compiled to confirm all interfaces including hard wired, ethernet, profibus etc.
Software Design Specification - compiled to confirm software modules and logic included
Our Control Specification
START RINSERED = DEACTIVATEDGREEN = ACTIVATEDBLUE = INTERFACE SIGNAL
IF WATER SELECTION [OpXV1]=0 THEN OPEN RO VALVE [SV02]IF WATER SELECTION [OpXV1]=1 ATHEN OPEN WFI VALVE [SV01]
WAIT TOP RINSE TIME [OpXV6]
WAIT LSH01 OFF FOR DRAIN TIME [OpXV10]
FINISH RINSE
CLOSE DRAIN VALVE [SV12]
OPEN RACK ROUTE VALVE [SV08]
WAIT 2 SECONDS
CLOSE TOP ROUTE VALVE [SV07]
WAIT RACK RINSE TIME [OpXV8]
IS RINSE COUNTER >
OpXV9
ADD ONE TO RINSE COUNTER
YES
OPEN TOP ROUTE VALVE [SV07]
WAIT 2 SECONDS
CLOSE BOTTOM ROUTE VALVE [SV09]
NO
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]
CLOSE BLOCK VALVE [SV06]OPEN DRAIN VALVE [SV05]
IS RECIRC REQUIRED
[OpXV1]
NO
OPEN BOTTOM ROUTE VALVE [SV09]
WAIT 2 SECONDS
CLOSE RACK ROUTE VALVE [SV08]
WAIT RACK RINSE TIME [OpXV8]
IS CHEMICAL QUANTITY
[OpXV3] > 0
NO
OPEN CHEMICAL VALVE [SV03]SET CHEMICAL REQUESTYES
WAIT FLOW TOTAL [∑FT01] > OpXV3
OPEN CHEMICAL VALVE [SV03]SET CHEMICAL CHECK FLAGRESET CHEMICAL REQUEST
WAIT INTERMEDIATE LEVEL [LSI01] ON
CLOSE WFI VALVE [SV01]CLOSE RO VALVE [SV02]
WAIT 2 SECONDS
START IMMERSION HEATER SUBROUTINE
IF TT01>OpXV5 FOR 5 SECONDS
CLOSE STEAM VALVE [SV04]
IF TT01<OpXV5
OPEN STEAM VALVE [SV04]
START DELIVERY PUMP [P01] AND SET DELIVERY TO INTERNAL RECIRC SPEED [VSD01] TO EngXV4
SET PURE WATER CHECK FLAG
IS PURE WATER
CHECK REQUIRED [OpXV10]
YESWAIT LOW LEVEL [LSL01] ON
All PLC programming, HMI development and SCADA configuration are carried out by qualified, experienced Suncombe personnel
Programming encompasses international standard IEC 61131 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.
Our Programming
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).
Suncombe personnel can carry out or assist in client Qualification activities.
Our Testing
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 .
Our Validation
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.
Our Documetation
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 Company Policies
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.
Our Project Management
Mechanical Design
Documentation
Quality Director
Testing
Managing Director
Automation DesignPROJECT
ENGINEERING
Electrical
Supervisor
Purchasing
Automation
Manager
Mechanical
Supervisor
Automation
Designers
Software Authors
Project Director
Manufacturing and
Installation
Project Accountant
Commercial
Mechanical
Designers
Project Timeline
Suncombe Worldwide
Worldwide Network of Technical Sales Agents and Distributors
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.
Product Portfolio
Static CIP Cleaning In Place Systems
First System installed in 1961
1,000’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
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
SIP Sterilise In Place Systems
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
Sterilising 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
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
Washing Equipment
BioWaste Batch Treatment Systems
Suncombe Bio-Waste Inactivation Systems are used to collect, contain and/or kill ACDP Bio Level 1 to 4 and SAPO Category 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
BioWaste Treatment Equipment
Suncombe Bio-Waste Inactivation Systems are used to collect, contain and/or kill ACDP Bio Level 1 to 3 and SAPO Category 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
BioWaste Treatment Equipment
Continuous BioWaste Treatment Systems
Suncombe Micro Bio-Waste Inactivation Systems are used to collect, contain and/or kill ACDP Bio Level 1 to 3 and SAPO Category 1 to 3 biological critical waste solutions
Micro system kills/inactivates /treats effluent from 10 litres per day using thermal treatment
Total containment assured at all times
Electrical supply only, no stema or hot water required
Safe system maintenance
BioWaste Treatment Equipment
Micro BioWaste Treatment Systems
Membrane Filtration Skids
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
Processing Equipment
Utility Transfer Panels
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.
Processing Equipment
Mobile Vessels
Standard and custom built Mobile Atmospheric and Pressure vessels.
5 – 500 litre capacity
316L Stainless Steel, Duplex Stainless and Hastelloy materials.
Ancillaries include mixers, load cells, automation, instruments
Suitable for full validation
Processing Equipment
Intermediate Bulk Containers IBCs, Drums and LiquiVessels
Processing Equipment
200 to 2,000 litre sanitary IBCs in 316 Stainless Steel and Alloy Materials
GMPDrum™s - 5 – 500 litre capacity sanitary drums
LiquiVessel™s - 10 – 500 litre capacity sanitary liquid vessels
LiquiVessel™ with Legs LiquiVessel™ with Hanging Brackets LiquiVessel™ in Drum Body
Static Vessels
Standard and custom built Static Atmospheric and Pressure vessels.
1 – 6,000 litre capacity produced in house, larger vessels sub-contracted to approved companies
316L Stainless Steel, Duplex Stainless and Hastelloy materials.
Ancillaries include mixers, load cells, automation, instruments
Suitable for full validation
Processing Equipment
Processing Skids
Design, manufacture, installation, commissioning and qualification for processing and utility skid applications. Providing solutions to many processing challenges.
Suitable for full validation
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
Processing Equipment
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.
Components and Spares
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
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
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
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
Automation
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
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
Automation
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
Thank you for your Attention
Suncombe Ltd , Jade House Lockfield Avenue Brimsdown Enfield Middlesex EN3 7JY United Kingdom
Tel +44(0) 208-443-3454 E-mail: [email protected] Web: www.suncombe.com