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2 Contents > Blister Packing > Pot & Bottle Filling > Peel Pouch Packing & Assembly > Cleanroom Facility > Medical Device Packing & Assembly > General Re-work & Hand Assembly > Design, Artwork & Digital Printing > Cartons & Leaflets > Research, Development & Manufacturing..18 > How to Find Us & Useful Contacts

3 A Unique Resource for the Pharmaceutical & Healthcare Sectors Chester Medical Solutions is firmly established as a valuable partner to ethical, generic and medical device brand owners, providing contract packing services to many of the industry's most prominent companies. We understand the unique requirements of pharma and healthcare. We pack product with care and attention to detail. Our ability to source most packaging materials in-house delivers increased control and speed of response, whilst enabling us to remain very competitive. Our purpose built contract packing site at Bromborough on the Wirral, is a state of the art GMP facility, fitted out to the highest standard with individual packing suites and a large ISO Class 7 cleanroom. We are fully accredited by the MHRA for packing solids, semi-solids and liquids, hand packing and medical-device assembly. Accreditations: > MHRA Licence > Veterinary Licence > ISO9001:2000 > Specials Licence > ISO Medical Devices > Soil Association Licence > Distribution Licence Our Services Include: > R & D and analytical support > Primary packing and assembly (pharma and medical device) > Secondary promotional packing and re-dressing > SRP packing > Packaging design and origination > Production of cartons, leaflets and blister packs > Late stage customisation > QP release > Storage and distribution We also hold a PS9000 accreditation for the production of cartons and leaflets. 3

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5 Blister Packing Using Noack 623 Blister Lines with in-line Hapa foil printers, image detection, automatic cartoning and banding, we pack a variety of solid dosage forms into thermo formed or cold form blisters. Dosage forms: > Tablets > Caplets > Capsules > Soft gel capsules > Liquids Blister materials: > PVC & PVDC > Triplex > Aclar > Cold form > Child resistant Our cold form line has colour camera detection and a tear check system. Packing environment is temperature and humidity controlled. 5

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7 Pot, Bottle & Sachet Filling Our tablet counting machines provide accurate dispensing of various size and shape tablets, caplets, capsules, soft gel capsules or powders. Complete with in-line capping, labelling, coding and cartoning, including the insertion of patient information leaflets. Products can be packed into glass or plastic bottles, containers with child-resistant / senior-friendly caps or a variety of flexible plastics foils and laminate sachets. Air handling systems and on-line dust extraction ensure an optimal packing environment. 7

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9 Peel Pouch Packing & Assembly Using Doyen technology 4 side seal packing machinery, we offer a variety of pouching and assembly solutions. Items we pack into peel pouches include: > Wound care dressings > Hospital ancillaries > Medical devices Dressings are packed in a large ISO Class 7 environment with the option of terminal sterilisation. 9

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11 Cleanroom Facility Our 1600 sq.ft. cleanroom facility offers an ISO Class 7 environment for either medical device or pharmaceutical production and assembly. Features include: > 1600 sq.ft. of floor space > Interlocking materials movement area > Integral change facility > Step over and hand sanitisation units > High pressure melamine laminate surface finish > Perfectly coplanar walls, doors and windows The air handling system supplies 20 air changes per hour through pre-bag and hepa filters and also controls temperature and humidity. The modular design incorporates a high pressure melamine laminate that is easily maintained to cleanroom standard. > Air handling system with temperature and humidity control > Modular construction for future expansion > Laminar flow cabinet to achieve ISO Class 6 environment 11

12 Medical Device Packing & Assembly We pack the following: > Burns & wound care dressings > Medical device kits > Tubing > Hospital kits > Diagnostic devices > Pregnancy test kits > Blister packing Primary packing can be carried out in our cleanroom or in one of our dedicated packing suites. The product can be packed into trays, pouches, bags or flow-wrap or as part of a KIT that is packed into a carton. Foam can also be die cut to hold ampoules and syringes. We also offer cellophane over-wrapping with tear tape option. If required we can validate and manage terminal sterilisation. 12

13 General Re-work & Hand Assembly We have the flexibility to re-dress and re-present product in a variety of formats, providing full batch traceability where required. Our fast and efficient service recognises the commercial pressures often present for re-work. Our In-house services include: > Re-work - removing/replacing cartons or leaflets with full batch integrity > Over-labelling including small vials > Shelf ready packing (SRP) > Clip strips > Collating various items into a KIT format > Over-wrapping > Promotional multi-packs > Kitting > Late stage customisation 13

14 Design, Artwork & Digital Printing Design and Origination Studio Equipped to the highest specification our design and origination studio is able to handle every element of your artwork requirements. Whether it be creating a distinctive new identity or preparing and outputting your supplied files through our CTP system, our team of designers and pre-press specialists are here to ensure your product is professionally presented to its intended audience. Our combination of technology and highly knowledgeable staff, means whatever your brief, we aim to engage, innovate and deliver on time, everytime, helping you achieve impressive results. 14

15 Digital Printing Our FSC and PEFC accredited in-house digital printing facility is ideal, not only for short run, fast turnaround jobs, but also for high quality registration samples and start up quantities. All artwork is output from a digital file, which means no plate origination charges, making this a truly fast, flexible and cost effective way to print. Our Digital Printing Service offers: > Océ digital leaflet presses > Xeikon 500D duplex digital press > Variable text and images > Full personalisation > Kitting > Late stage customisation > Cartons and leaflets - stock range from 60 gsm to 350 gsm (500 microns) > Full colour > Large format printing > No plate costs We also provide an in-house CAD sampling service for producing one-off pre-production carton samples, product sizing, material testing and digitally printed mock ups. The fact that we can handle all aspects of contract projects in-house, delivers significant cost benefits for our customers, without them sacrificing quality or service. David Patterson, Managing Director 15

16 Cartons & Leaflets Using a variety of printing processes including Lithographic, Screen, Letterpress and Digital, we have the capabilities to produce short, medium and long runs all with PS9000, FSC and PEFC accreditation. Carton Production: > UV lithographic printing - 5 colours in one pass > UV screen printing > Clinical trial blister wallets (including heat seal/ cold seal varnish) > Cutting & creasing > In-line gluing with pharmacode scanning > Security systems > Segregated production areas > Accurate reconciliation & vendor certification 16

17 Die Cutting Our Bobst Evoline SP106 Autoplaten gives improved die cutting accuracy and tolerances on our more demanding product lines such as blister cards. Leaflet Production: > Sheet fed lithographic printing > Printing mainly onto 50, 60 & 80gsm uncoated opaque paper > Supplied flat in brick style > Parallel folded or crossfolded and supplied in cassette trays Chester Medical Solutions hold a PS9000 accreditation for the production of cartons and leaflets. 17

18 Research, Development & Manufacturing Our sister company Quay Pharmaceuticals Limited, provides a comprehensive outsourcing service for the development and testing of pharmaceutical products, including the manufacture of clinical trial supplies. Quay Pharma holds a Manufacturing Authorisation from the MHRA for the manufacture and testing of investigational medicinal products (IMP's), as specified by the EU Clinical Trial Directive (2001/20/EC). They also hold a manufacturing licence for specials and are well equipped with both laboratory, processing and testing equipment, as well as pilot scale machinery up to 50Kg. With access to the most advanced analytical instrumental techniques, the company is able to undertake almost any analytical procedure. 18

19 Prof. Mike Rubinstein - CEO The company is headed by Professor Mike Rubinstein, who has over 30 years academic and industrial experience in Pharmaceutical Dosage Form Design, Development and Manufacture. Professor Rubinstein is both a Chemical Engineer and a Pharmacist with QP status and was previously Director of the School of Pharmacy and Chemistry at Liverpool John Moores University in the UK. Quay Pharma provide the following: > Formulation development and optimisation of dosage forms including the design of conventional and controlled release tablets and capsules > Clinical trial manufacture > Novel drug delivery, design and development > Analytical R & D development > ICH compliant stability testing > Analytical method development including validation and transfer > Process development, scale-up and optimisation > Drug syntheses > Solids characterisation > Compaction simulation > QA testing & analysis 19

20 Location Map & Contacts David Patterson Managing Director Tel: +44 (0) Ian McDougall New Projects Co-ordinator Tel: +44 (0) Tammy Williams Sales Director Tel: +44 (0) Elliott Johnson New Projects Co-ordinator Tel: +44 (0) How To Find Us FROM LIVERPOOL McDonalds WIRRAL RETAIL & LEISURE PARK Sue Thomas Production Planner Sandra Whittaker Customer Services Co-ordinator A41 Thursby Rd. Croft Ave. Caldbeck Road Bassendale Road Bassendale Road Tel: +44 (0) Tel: +44 (0) A41 Martindale Rd. Apex Court Hawkshead Rd. Bassendale Rd. Mike Mills Sales Manager Alan Clegg Quality Manager - Contract Packing A553 Wallasey J1 J2 Birkenhead A552 BROMBOROUGH FROM NORTH WALES CHESTER & M53 A41 Gateway House Old Hall Road Sign for Wirral International Business Park Tel: +44 (0) mmills@chestermedical.com Tel: +44 (0) aclegg@chestermedical.com DEESIDE FROM FLINT PARKWAY Site Map ZONE 2 A548 1st Avenue 1st Avenue River Dee DEESIDE INDUSTRIAL PARK UNIT 48 FROM LIVERPOOL & MANCHESTER M56 River Dee Drive C A550 A550 NORTH WALES Drive D FROM N. WALES FLINT & BUCKLEY J3 A41 M53 J4 A5137 BROMBOROUGH A494 A540 Neston A548 DEESIDE A550 Queensferry Hawarden A41 River Mersey LIVERPOOL AIRPORT J5 J6 J7 J8 J9 Ellesmere Port A550 M53 A41 J14 J10 A540 Chester J11 J15 M56 A41 J12 A51 M56 TO MANCHESTER & M6 J9 J13 Shaun Dutton QA Manager - Medical Devices Tel: +44 (0) sdutton@chestermedical.com Russ Dorman Studio Manager Tel: +44 (0) rdorman@ads-graphics.com Kirsty Rae Quality Manager - Cartons & Leaflets Tel: +44 (0) krae@ads-graphics.com General Enquiries Contract Packing: Tel: +44 (0) Cartons & Leaflets: Tel: +44 (0) A550

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22 Cert. No: Cert. No: 8345 Head Office & Contract Packing: 3-4 Apex Court Bassendale Road Bromborough Wirral CH62 3RE Tel: +44 (0) Fax: +44 (0) PEFC/ FM Carton & Leaflet Manufacturing: Unit 48 First Avenue Deeside Industrial Park Deeside Flintshire CH5 2NU Tel: +44 (0) Fax: +44 (0) Chester Medical Solutions is a trading style of ADS Graphics Ltd. Registration No England D /13