Medical Device Cleanroom Packaging

Medical Device Cleanroom Packaging

Medical device packaging carried out in a genuinely controlled environment removes one of the most common contamination risks in the supply chain. Andel Plastics provides cleanroom packaging for medical devices from our Class 7 facility in Birmingham, operational since 2015 and built specifically to support medical and veterinary manufacturers. Because packaging happens in the same environment as moulding and assembly, devices are never exposed to uncontrolled conditions before they are sealed for dispatch. We work to ISO9001 standards and follow ISO13485 procedures within the cleanroom, with recertification currently in progress, so customers have documented evidence of a compliant process rather than a general assurance. Our moulding machines range from 30 to 300 tonnes, and an in house toolroom supports production from tooling design through to repair, keeping the whole operation on site rather than split across suppliers. For manufacturers of medical devices who need packaging integrated into a documented, contamination controlled process rather than bolted on at the end, this is exactly what our cleanroom was designed to provide.