We also develop and manufacture some of the world's most successful devices for major global pharmaceutical and healthcare companies. Products include

Methodologies

Bespak is proud of its culture and its unrivalled record in delivering large pharmaceutical development programmes; both of which have been realised in our proprietary phase-gated product development process BPIP, together with a number of improvement tools and techniques including

The Bespak Product Introduction Process (BPIP)

BPIP is a bespoke planning tool tailored specifically for the manufacture of medical devices. Designed to deliver effective risk management, accurate planning, improved process control, increased productivity and reduced waste; BPIP is applied throughout the development and manufacturing cycle to make certain that progress over time is based on quantified risk and known cost to yield greater confidence. BPIP ensures that learning from previous projects is retained within Bespak's business to the benefit of all our customers.

Quality

Bespak has over time, invested substantially in the provision of robust regulatory and quality systems to ensure reliability in the development, manufacture and supply of our devices. These systems include a mature ISO 9000 accreditation and an FDA 21CFR820 compliant quality system, which have been audited by our pharmaceutical partners and US and European regulatory authorities.

We also offer a fully validated SAP system to control the supply chain, manufacturing and supply and all our sites operate to ISO13485, the MHRA standard for medical device manufacture.

Compliance

Robust regulatory and quality systems are the result of considerable long-term investment in appropriate facilities and knowledgeable, trained employees.

Bespak has demonstrable experience of selecting, refining and routine analysis of materials within devices that come directly into contact with the drug. We conduct our own extractables testing and offer test method development.

Facilities

Bespak has invested heavily in plant and equipment to offer flexible development, industrialisation and scaleable manufacturing solutions to a wide range of companies and an even wider range of projects. Our facilities are capable of delivering more than 1 billion plastic moulded components every year. Currently we manufacture over 450 million devices per year in facilities that are tailored to meet the regulatory and design requirements of each product. Our cleanrooms are temperature controlled and can operate to class 100,000 for moulding and assembly, with higher classifications achieved in localised environments if required. 100,000m² footprint (328,080ft²) for manufacturing in UK with 10,000m² (32,808ft²) dedicated to cleanroom manufacture. Our US facilities comprise more than 38,100m² (125,000 ft²) of floor space.

Our People

Bespak's flexible manufacturing approach and multi-skilled workforce enables us to work across several product lines. Normally, production operates 24 hours a day during the working week, but this can be flexed from a single shift pattern for low volume production to full 24/7 manufacturing to meet peaks.

Categories this company is listed under in the European Medical Manufacturing Suppliers Directory:

• Components/Parts/Original Equipment Manufacturers: Gaskets (42 companies)
• Components/Parts/Original Equipment Manufacturers: Parts, moulded (59 companies)
• Components/Parts/Original Equipment Manufacturers: Valves, check (50 companies)
• Design and Research and Development Services: Product design and development (403 companies)
• Design and Research and Development Services: Rapidprototyping (130 companies)
• Moulding and Extrusion: Moulding equipment: Precision-moulding (47 companies)
• Moulding and Extrusion: Moulding services: Clean-room moulding (141 companies)
• Moulding and Extrusion: Moulding services: Injection-moulding (228 companies)
• Moulding and Extrusion: Moulding services: Mould tool-making (107 companies)
• Moulding and Extrusion: Moulding services: Tool development (91 companies)