Medical Component Cleanroom Production UK

Medical Component Cleanroom Production UK

Medical components need consistent, documented production, not just a controlled environment on paper. Andel Plastics manufactures medical components within our Class 7 cleanroom in Birmingham, a facility running since 2015 that was developed specifically around the needs of medical and veterinary manufacturers. Our injection moulding machines span 30 to 300 tonnes, giving us the flexibility to produce small precision components as well as larger technical parts, with assembly and sterile packaging carried out in the same controlled space. We work to ISO9001 standards and follow ISO13485 procedures throughout the cleanroom, with recertification currently underway, so customers receive documented process evidence rather than a general assurance of quality. Backing the moulding operation is an in house toolroom, meaning tooling design, trials, and repairs happen on site without adding another supplier into the chain. For manufacturers supplying medical components into regulated supply chains, this combination of contamination control, documented compliance, and in house tooling is built to meet exactly that level of scrutiny.