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

Three technologies, “Batch”, “Continuous” and “Micro”

Batch BioWaste Treatment Systems

BioWasteBatch™ - For any volume from CL1 to CL4

Continuous BioWaste Treatment Systems

BioWasteFlow™ - For volumes 500 litres per day + from CL1 to CL3

Small Scale BioWaste Treatment Systems

BioWasteMicro™ - For volumes from 30 to 500 litres per day + from CL1 to CL3

BioWaste Treatment Systems

Batch BioWaste Treatment Systems

Suncombe Bio-Waste Inactivation Systems are used to collect, contain and treat levels 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

BioWasteBatch™ Batch Treatment

ETP+Plus™ BioWaste Batch Treatment

This methodology cools and/or heats the effluent by recirculation rather than using a jacket.

The advantage is that there is no mixer in the vessel and some of the instruments can be installed on the loop.

In the event of pump or instrument failure the loop can be isolated and decontaminated, repaired and put back into service without vessel entry.

Alternative Methodology Batch Treatment

Suncombe Bio-Waste Inactivation Systems are used to collect, contain and treat levels 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

BioWasteFlow™ Continuous Treatment

Continuous BioWaste Treatment Systems

Suncombe Micro Bio-Waste Inactivation Systems are used to collect, contain and treat levels 1 to 3 biological critical waste solutions

Micro system kills/inactivates /treats effluent from 10 litres to 500 litres per day using thermal treatment

Total containment assured at all times

Electrical supply only, no steam or hot water required

Safe system maintenance

BioWasteMicro™ Low Volume

Treatment Low Volume BioWaste Treatment Systems

The BioWasteSink™ effluent treatment system are units of laboratory furniture .

They are pre-designed 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.

BioWasteSink™ Low Volume Treatment

Low Volume 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: mail@suncombe.com Web: www.suncombe.com