ISO13485 Cleanroom Assembly UK

ISO13485 Cleanroom Assembly UK

Cleanroom assembly aligned with ISO13485 procedures gives medical device manufacturers a documented, auditable process rather than an assumption of quality. Andel Plastics carries out assembly work within our Class 7 cleanroom in Birmingham, operational since 2015 and built specifically for medical and veterinary product manufacturers. We work to ISO9001 standards across the business and follow ISO13485 procedures throughout the cleanroom itself, with recertification currently in progress, giving customers a clear line of documented evidence behind every assembled component. Assembly happens in the same controlled environment as moulding on machines from 30 to 300 tonnes, so components never pass through uncontrolled conditions between production stages. An in house toolroom supports the moulding side of the operation, allowing tooling to be adjusted quickly as assembly requirements change during a project. Sterile packaging is available at the end of the process, meaning finished, assembled components can go straight from cleanroom production to dispatch.

For manufacturers who need assembly work that stands up to regulatory scrutiny, this documented, standards led process is exactly what our cleanroom offers.