agenda - suncombe.eu company... · custom as standard • suncombe equipment is individually...

Agenda

• Introduction to Suncombe • Product Overview

Ø Cleaning In Place (CIP) and SIP Ø BioWaste Decontamination Ø Washers Ø IBCWashBooth Introduction Ø Skids, Filter Skids and Modules Ø Tanks, Vessels and Mixers Ø Containerised Systems

• Client Studies

Introduction to Suncombe

• Incorporated in 1961 in London, UK

• Engineering Excellence

• Worldwide service and sales network

• BioPharma Clientele and Research Laboratories

Custom as Standard

• Suncombe equipment is individually designed for every project.

• Manufactured in the United Kingdom with great attention to detail.

• Our production site is purposely split into small teams, who work solely on just one product.

• Our equipment is carefully assembled by hand, using qualified and experienced British engineers.

Suncombe’s Advantages

• Robust, Reliable and Innovative Designs

• Quality, Flexibility and Communication

• All design, manufacturing and automation

carried out by Suncombe personnel

• Workforce of experienced engineers

• Teamwork with our Clients

Suncombe’s Service

• Collaboration and Teamwork

• Enthusiastic, experienced workforce of motivated dedicated engineers, many with length of service of 10, 20 , 30 or more years

• Fully validatable equipment with traceability and documentation

• Client approvals throughout project

• Factory Acceptance Tests

Suncombe’s Manufacturing

• UK Design and Manufacture

• CE marked equipment to European

Standards

• Encompassing International Biopharma guidelines, cGMP, ASME BPE, FDA, GAMP

• Manufacturing expertise

Suncombe’s Facilities

• Freehold owned manufacturing facility in London, United Kingdom.

• 40 core long term permanent UK staff, with length of service of up to 40 years.

• Financially stable, independent private company with same ownership since 1961.

• Typical projects from €75,000 to €4,000,000

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

CIP - Cleaning In Place Systems – Static and Mobile, WIP Wash in

Place and SIP Sterilise In Place Systems

Effluent and BioWaste Treatment Plants

Washers – low pressure, high pressure, spray, turbulation, ultrasonic

IBC Washers and IBC Liquid Handling

Membrane Filter Modules and Skids

Processing Modules and Skids including custom ASME BPE skids,

Purified Water & WFI Storage and Distribution, 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 Assessment In the development of all of our projects our aim is to eliminate hazards from the design. We carry out the consideration of hazard and risk in an integrated manner throughout the design process. As part of every proposal have carry out internal risk assessments which use leverage from risk assessments from recent CL2, CL3 andCL4 projects that we have carried out. The results from these risk assessments is used to qualify our proposals. Formal risk assessments and design reviews would be carried out as part of and throughout the detail design and construction of the system.

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

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

M echan ica l D esign

D ocum entation

Q uality D irector

Testing

M anag ing D irector

A utom ation D esign P R O JE C T E N G IN E E R IN G

E lectrica lS uperv isor

P urchasing

A utom ationM anager

M echan ica l S uperv isor

A utom ation D esigners

S oftw are A uthors

P ro ject D irector

M anufacturing and Insta lla tion

P ro ject A ccountant

C om m ercia l

M echan ica lD esigners

P ro ject T im eline

Automation • Automation systems developed on Siemens

and Allen Bradley Platforms

• Recipe controlled systems with 1, 6, 25 or 100 recipes

• Developed in Functional Design Specification for Client Approval

• Fault Diagnostics, Interfacing, Mimic Diagrams and Maintenance Mode

• Fully configurable providing full controllability and repeatability

• User log-in and control

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 RINSE

RED = 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<OpXV5OPEN 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

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

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

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

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

Product Overview

• Pioneers of CIP in the 1950’s

• First System installed in 1961

• 1,000’s of System throughout the world

• Custom developed from proven designs

• Suitable for full validation

• Many different standard models available

Static Cleaning In Place - CIP

• Stand alone “plug and play” Mobile systems

• For CIP in separate areas

• Often used to save floorspace

• Ideal for Research and Development and Scale Up processes.


• Many different models available

Mobile Cleaning In Place - CIP

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

• Designed to inactivate levels 1 to 4 biowaste solutions

• Total containment is assured at all times

• Collection and positive release of treated waste

• Custom designed and suitable for validation and government approval

• Suncombe designs used on newest level 4 facilities

BioWaste Decontamination Systems

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

• Energy efficient technology for heat recovery

• pH neutralisation

• Positive release of treated waste

• Totally CIP’able and steam sterilisable and safe system maintenance

BioWaste Decontamination Systems

• 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

• Custom trolleys and racks for holding parts

IBCWashers

• Robust, reliable GMP Systems supplied for over 30 years

• Used for cleaning and drying drums, hoses, vessels, pallets, change parts etc.

• Washing technologies including spray cleaning, immersion cleaning, turbulation, cavitation, UltraSonic cleaning

GMP Washers

• Design, manufacture, installation, commissioning and qualification for processing and utility skid applications. Providing solutions to many processing challenges.


Skids, Superskids, Filter Skids and Modules

• Built to ASME BPE, GAMP and validatable for biopharma environments

• Custom designed and manufactured to suit our clients specific requirements

Skids, Superskids, Filter Skids and Modules

• Utility and Product Routing Panels

• Custom designed and built for your process

• Valves and instruments can be fitted on the rear of the panels to provide more involved process solutions.

Utility Transfer Panels

• Chemical Storage and Dosing systems are offered to provide safe chemical handling with external storage or internal storage systems.

• Suncombe pH Neutralisation. Available for different volume requirements, robust control systems and instrumentation ensure 100% pH neutralisation.

Ancillary Equipment

• Standard and custom built Atmospheric and Pressure vessels.

• 5 – 5,000 litre capacity • 316L Stainless Steel, Duplex

Stainless and Hastelloy materials.

• Ancillaries include mixers, load cells, automation, instruments


Tanks, Vessels & Mixers

• Suncombe equipment can be containerised for external locations and facility extensions

Containerised Systems

Client Studies

Client Study – Multi-national BioPharma

Belgium • MobileCIP for CIP of chromatography

Column in new vaccine facility. • Static CIP for cleaning mobile vessels

Ireland • Fully integrated and networked production

and mixing facility for tablet coating solutions

United Kingdom • High Pressure 100 barg Static CIP • DuoBooth– two position IBCWashBooth • IsolatorCIP for CIP of gloveboxes • Walk-in BoothWasher for Cleaning dis-

assembled Production parts • CIP for 6mm diameter R&D rig


China • Static CIP for Gloveboxes • Static CIP for Tablet Coater • Static CIP for Coating Suite • Static CIP for Mills

United Kingdom • SteriWasher for kegs with Split Butterfly

Valve • 6 x ATEX MobileCIP for Development

BioWaste Inactivation System


Ireland • DrumWasher

• ATEX IBCWashBooth integrated

into washroom

• Stainless steel suite of rooms for washbay

• MobileCIP for discharge Chutes

• ATEX ethanol immersion Tank


Ireland • BioWaste Collection Facility for new bio

facility • Utility Panels custom designed to provide

full production suite in service area with utility panel entry

United Kingdom • Multi-channel CIP for cleaning 50+ liquid

medicinals vessels • CIP design, development and routing

Client Study – Multi-national Biotech

Belgium • BioWaste Treatment System

including collection and treatment vessel, fully automatic control system, custom designed for external location

• Static CIP for cleaning

Client Study – Multi-national Pharma

Scotland • Purified Water Distribution Skid • Cleaning In Place System for all

equipment on site interfaced to site DCS

• ImmersionWasher for washing parts

• pH Neutralisation System

Jerusalem Israel • New ATEXCIP Cleaning In Place

System for ethanol, detergent and purified water cleaning


Ireland • 2 x IBCWashBooth for validated cleaning

and drying of IBCs after production • Static CIP for cleaning all equipment in API

facility

Singapore • PureCIP for new facility

United Kingdom • ATEXCIP for cleaning mills • Mobile drum washer for drum cleaning • Static CIP feeding to utility panel to provide

CIP utility • MobileCIP for R&D and development

Client Study – Institute of Animal Health • Biohazard Level 4 Effluent

Decontamination System

• 100% guarantee for decontamination

• Dual redundant collection vessels, individually steam sterilisable

• Dual redundant treatment vessels, series/parallel air filters for containment, SIL3 outlet loop

• Dual redundnant hot swap PLC control system with separate SIL3 Control System

• External Chemical storage Container and pipework into BioWaste Area

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

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