Chris Philpott, commercial and technical manager at Boddingtons, explains the importance of choosing the right injection moulder and the story behind their Class 7 cleanroom.
To paraphrase an advert from a leading UK retailer: there’s injection moulding in manufacturing and then there’s medtech injection moulding.
Choosing the right injection moulder
For many clients in the medical sphere, it’s important to find a company that understands and can take primary legal responsibility for all regulatory matters of medical device manufacture, from concept design following design and development processes and procedures, process optimisation & validations, whilst maintaining conformity to international medical standards such as MHRA & FDA including device registrations and working to the Medical Device Regulations (MDR).
Boddingtons is a company that operates a facility in Southeast England for the production of injection-moulded components, medical devices and assemblies. All manufacturing is included within the scope of ISO 13485 MDSAP and ISO 14001 accreditations.
Why Class 7 cleanrooms are essential
A modular Class 7 cleanroom was established within the new Boddingtons factory straightaway, as the company believes that to succeed in medtech device manufacture, Class 7 cleanroom technology assets are essential and mandatory to make approved Class 1 and Class 2 medical devices. The controls, filtration and essentially the bio-burden must all be monitored regularly and maintained to de-risk products that especially come into patient contact.
The Boddingtons cleanroom facility has now doubled in size since the factory opening. Boddingtons commercial and technical manager, Chris Philpott notes that “the medical sector requires so much from its suppliers in terms of complete control, traceability, process stability and consistency and all following fully validated manufacturing processes within our Class 7 cleanroom was always the way to go, it is why we invested heavily to support the needs of our customers within the medtech sector.
Now that we are well along the curve of our Class 7 cleanroom expertise, we don’t hesitate to apply manufacturing lessons to other areas of our business; building additional cleanroom resource for specific new projects and applying cleanroom manufacturing disciplines across the whole of our facilities offering flexibility, capability and increased volume manufacturing.”
The importance of meeting cleanroom standards
The full operation of the Boddingtons Class 7 cleanroom means a failsafe and scrupulous approach to standards, now expressed in the pages of the operation and training manual at the company. No staff at Boddingtons are allowed access to the cleanroom without a minimum of two full days of training. There are no exceptions. Just one incident of non-conformance, not following the stringent procedures just to enter the room itself can close the cleanroom for a deep cleanse. Standards are of the highest level, control and discipline has been trained into every staff member to maintain these high levels.
These high standards need to accommodate and prevail for all new Class 7 cleanroom medtech projects in all circumstances: Any item, person or material entering the cleanroom environment is subject to its stringent protocols.
For example, when new injection moulding machines were introduced to the Boddingtons Class 7 cleanroom environment, the material feedstock from outside the facility needed to be expanded – but not so as to interfere with existing production and standards. A second materials link was accordingly created ensuring a dedicated material flow to the new moulding machines while enhancing material control and full traceability.
Philpott points out that “injection moulders should take note that – even after investment and capital outlay - Class 7 cleanroom benefits do not come without ongoing costs – in terms of energy, rigorous maintenance, deep cleaning and an audit process that could see customers or regulatory bodies arriving unannounced at any time – day or night. All of which requires us to properly resource and commit to our cleanroom moulding, not least in terms of our people where a culture of pride resides.”