Andy Tibbs, Boddingtons CEO, reflects on the success of the company’s investment in a Class 7 cleanroom.
When Lord Digby Jones opened the £4.6 million purpose-built factory building at Boddingtons some four years ago, room for expansion was already built in.
The Class 7 cleanroom was of modular construction and the existing footprint was doubled in size this year; testimony to the compelling power of its use in medical device and healthcare markets.
Suppliers to the medical world cannot hope to compete for international Class 1 and 2 medical device business without the manufacturing asset of a Class 7 cleanroom, minimum.
That is part of the reason why Boddingtons has also travelled the globe, servicing sales and marketing and promoting its Class 7 assets; exhibiting every year at Compamed in Dusseldorf, as well as at the major US shows and also at other specialist and international events.
The work on the new cleanroom this year effectively doubles the capacity at Boddingtons. At 225 sq metres in size the footprint of the expansion is just 10 sq metres short of the existing facility. It has the potential to house a further eight injection moulding production cells and additional assembly lines – in addition to the eight production cells currently in the adjacent facility.
The growth at Boddingtons in Class 7 cleanroom competences has led to increased business and lifted its medical manufacturing ambitions and competences, including winning the Industrial Design category of the Plastics Industry Awards for the fourth time last Autumn.
Boddingtons was required in this case to create 12 injection moulding tools for Bladderlight; some of these more than single cavity, thus requiring the creation of nearly 20 moulded parts.
A total of 38 parts for Bladderlight then needed to be assembled at Boddingtons. The assembly was complex, and it included needle handling for which specific health and safety training and provision needed to be provided.
Chris Philpott, Boddingtons' business development manager for the project said: “The basic inspiration that kept us all going through development was that this product will save lives through early detection and diagnosis of bladder cancer.”
Without the Class 7 cleanroom such ambitions would simply be wish fulfilment.
The costs, disciplines and protocols, audits and inspections for the Class 7 cleanroom operations are within reach of the company’s pre-existing abilities and commitment to integrate all medical-related administration - quality, regulation and approval – under one roof.
Boddingtons’ administrative service is complementary to cleanroom management. Some of it is expressed through the company’s operation of the Medical Device Single Audit Program (MDSAP). MDSAP promotes alignment of Quality Management Systems and Regulatory approaches, integrating ISO, BSI, FDA and other all under one roof.
The programme includes device marketing, authorisation and facility registration. The benefits include a single audit, optimising time and resource; improved predictability, a scheduled and routine audit programme with no additional requirements.
The Class 7 cleanroom capabilities have also helped Boddingtons to mobilise for manufacturing action in the middle of the current pandemic, as the company helped in designing, manufacturing and supplying components and devices in the fight against COVID-19. If it turned out that the medical product did not necessarily need the Class 7 qualification the client was still assured that it had the option of producing parts from that resource, if needed.
The Penlon emergency ventilator project – led by Maclaren and Airbus – was such a project: Boddingtons was called on to help design and mould the bellows plate of the equipment, a critical component now being produced at the rate of some 600 component mouldings per day. The UK project team specified all the features needed from the part, including materials specification and colour, a TPX polymer blend from Mitsui. Subsequent to the Penlon project, the Boddingtons Class 7 Cleanroom has also helped attract more day-to-day business such as tool transfer projects.
Other investments at Boddingtons – including the Mitutoyo Quick Vision Active CMM machine have assisted and complemented the ongoing development of the core Class 7 cleanroom competence.
Boddingtons is set to market all of these features at Med-Tech Innovation Expo June 29-30, 2021 at the NEC Birmingham.
