Contract Manufacturing Services

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[email protected] www.steripackgroup.com Creating Solutions Together for your outsourcing needs SP-CM-insert-2012-07-rev00 Europe Asia USA tel: + 353 57 9331 888 tel: + 48 71 381 81 99 tel: + 60 3 316 73596 tel: + 1 863 648 2333

description

SteriPack offers complete turnkey manufacturing solutions to the medical industry worldwide.

Transcript of Contract Manufacturing Services

Page 1: Contract Manufacturing Services

[email protected]

Creating Solutions Togetherfor your outsourcing needs

SP-C

M-in

sert

-201

2-07

-rev

00

Europe Asia USA

tel: + 353 57 9331 888tel: + 48 71 381 81 99tel: + 60 3 316 73596tel: + 1 863 648 2333

Page 2: Contract Manufacturing Services

About SteriPackFounded in 1994, SteriPack is a leading provider of Contract Manufacturing and Contract Engineering Solutions for the medical and pharmaceutical industries worldwide. SteriPack’s global presence includes manufacturing facilities in Europe, Asia and USA ensuring an in-depth understanding of the country specific requirements and guarantees a solution tailored to the needs of the local markets.

Why outsource with SteriPack?SteriPack excels at providing customised solutions from initial design to full scale manufacturing ensuring that each stage of the project implementation meets ambitious deadlines and requirements in the medical device and pharmaceutical industries.

With years of experience we can design and deliver the best possible solution for your product while providing expert advice and technical assistance. Our vision is to build on our Customer relationships based on partnership and trust. We aim to go beyond supporting the Customer and become a virtual extension of your organisation.

ExperienceAccess to diversified knowledge and technologies gained from years of multi-disciplinary work

ResponsivenessTimely, accurate and reliable services

TrustworthinessA Partnership based on proven and successful product implementation

Passion and EnergyMatching your enthusiasm and energy for the success of your project

Global presence, local suppliesPresent in Europe, Asia and the USA, SteriPack stays close to the market ensuring quick lead times

and cost effective logistics

Complete Range of Contract Manufacturing Services:

- Product Design & Development and Process Validation- Manufacturing- Assembly- Packaging- Supply Chain Management- Sterilisation Management

Contract Manufacturing Capabilities

Include

Quality - ISO 13485 Certification- FDA Accreditation- cGMP Pharmaceutical Manufacturing License- ISO 7 (10,000) and ISO 8 (100,000) Cleanroom Operation- CE Marking and 510K - Country Specific Registrations (CAN/CSA, JPAL)- ISO 17025 Test Laboratory

Product Design & Developmentand Process Validation- Product Design (3D, 2D, FEM, dFMEA)- Materials Research & Selection- Prototyping (rapid and pre-series)- Packaging Design- Tool Building- Process Validation (DoE, IQ, OQ, PQ)- Quality & Regulatory Services (CE marking, 510K)

Supply Chain Management- Components and Raw Materials Sourcing- Qualification and Auditing of the Suppliers- Incoming Inspection- Stock Management- Supply Chain Optimisation- Vendor Management

Manufacturing- Moulding, Overmoulding , Insert Moulding- Heat Welding- Plasma Treatment and Coating- Component Cleaning and Disinfecting- Metal Processing- Thermoforming and Shaping- Coiling- Bonding- Printing- Automated Filling for Pharmaceutical Industry- Blister Packing for Pharmaceutical Industry

Assembly- Manual and Automated Assembly- Kit Packing

Packaging- Manual Pouching- 4-Side-Sealing Machine Packing- Rigid Blister Sealing- Form, Fill, Seal (FFS) Packing (soft, semi-rigid and rigid blister)- Labelling- Primary, Secondary and Tertiary Packaging

Sterilisation Management- Sterilisation Validation Management- Sterilisation Management (EO, Gamma, E-beam)

People behind CommitmentsWith the latest manufacturing technology and recognised can do attitude, we can confidently propose innovative ideas for a wide range of end user applications. Our trained, experienced and devoted team of experts stand behind every commitment we make.

Manufacturing Facilities- Ireland- Poland- Malaysia- USA

Turnkey Solutions from Design to Manufacturing