Agenda Introduction to Suncombe Product Overview Cleaning In - - PowerPoint PPT Presentation

Agenda

• Introduction to Suncombe
• Product Overview
• Cleaning In Place (CIP) and SIP
• BioWaste Decontamination
• Washers
• IBCWashBooth Introduction
• Skids, Filter Skids and Modules
• Tanks, Vessels and Mixers
• 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 M oney 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 S ystems – Static and M obile, WIP Wash in Place and SIP Sterilise In Place S ystems Effluent and BioWaste Treatment Plants Washers – low pressure, high pressure, spray, turbulation, ultrasonic IBC Washers and IBC Liquid Handling M embrane Filter M odules and Skids Processing M odules and Skids including custom ASM E BPE skids, Purified Water & WFI Storage and Distribution, Solution Preparation and holding, Sterile processing, M ixing, Compounding, Heat Transfer and Chemical Dosing Sanitary and Sterile T anks, Vessels and M ixers

Our Products

Drawing PFD, P&ID, Schematics and Circuit Diagrams in ACAD

Our Design

3D M odelling Autodesk Inventor 3D M odelling is employed throughout the design process

Our Design

Certification CE M ark – 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, ASM E VIII and EN 13445, with facilities for other codes. Self certification and third party certification are used, together with NDT T esting 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

• f and throughout the detail design and construction of the system.

Our Risk Assesment

Formal risk assessments (HAZOP , FM EA) 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 ASM E BPE standard Pipework, fully annealed, chemistry to AS TM A-269, manufactured to AS TM A- 270, and 3A Standard. Sanitary designed to ensure no deadlegs or product retention areas complying with ASM E 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

• f corporate responsibility.

Quality - We have a companywide commitment to quality, which is integral to our business culture. Health and Safety – all work is carried

• ut in accordance with the relevant

statutory provisions and all measures taken to avoid risks to our employees

• r others who may be affected.

Environmental - Our policy is to wherever possible minimise the environmental impact of our

• perations.

Our Company Policies

Individual Project T eams are selected for every project, with a Project M anager or Project Director as a single point of contact and a single point

• f responsibility.

Our Project Management

M echanical Design Docum entation Quality Director Testing M anaging Director Autom ation Design PROJECT ENGINEERING Electrical Supervisor Purchasing Autom ation M anager M echanical Supervisor Autom ation Designers Software Authors Project Director M anufacturing and Installation Project Accountant Com m ercial M echanical Designers Project Tim 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

All PLC programming, HM I development and SCADA configuration are carried out by qualified, experienced Suncombe personnel Programming encompasses international standard IEC 61131 for programmable logic controllers, GAM P guidelines, TickIT and IEC methodology. Compiled on current Siemens and Rockwell development platforms. T esting in development, module testing, client source code review, change control and extensive

• perational 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

• ut 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 T est Protocols. Validation Lifecycle Our products follow the GAM P Validation Life Cycle with documentary evidence of procedures and processes during design, development, pre- construction, construction and commissioning .

Our Validation

A Factory Acceptance T est (F AT) Protocol is compiled for all systems and is client witnessed. The F AT incorporates full documentation checks, wet and dry system testing and is carried

• ut to ensure our clientele that
• ur systems are fully functional

prior to despatch. An F AT report accompanies the equipment and can be used as leverage for the site based Site Acceptance T esting (S AT). Suncombe personnel can carry

• ut 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 DataM anual Full validation documentation

• lifecycle. Datamanual including

Instruction, Operation and M aintenance 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.

• Suitable for full validation
• 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 ASM E 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
• f 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
• pening 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.

• Suitable for full validation

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

• Suitable for full validation

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

Client Study – Multi-national BioPharma

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

Client Study – Multi-national BioPharma

Ireland

• DrumWasher
• ATEX IBCWashBooth integrated

into washroom

• Stainless steel suite of rooms for

washbay

• MobileCIP for discharge Chutes
• ATEX ethanol immersion Tank

Client Study – Multi-national BioPharma

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

Client Study – Multi-national BioPharma

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