• Medical Device manufacturers operating under ISO 13485 quality management systems must comply with 21 cfr 820 QSR and face higher regulatory expectations and cost pressures associated with contamination(fm) related nonconforming product. Foreign Materials (FM) are a significant cause of in-process and final acceptance rejects, rework and CAPA’s.
• To help medical device manufacturers improve productivity and quality, Foamtec offers an innovative (FM) identification service that allows quality departments to carry our root cause analysis so that contamination related CAPA’s can be carried out according to 21 CFR Part 820.100 guidance.
• Foamtec's ISO Class 7 qualified cleanroom foam wipers, swabs and PharmaMOP® GO are production proven to dramatically reduce FM contamination on devices and critical work surfaces greatly reducing the rate of nonconforming product and rework.
Reduce inspection, rework and scrap rates by reducing large fiber contamination at the work station.
Develop root cause solutions for FM contamination.
Fiber Free Swabs, made in a wide variety of shapes, sizes and materials are ideal for cleaning Medical Devices.
Sahara+ PharmaMOP® is designed to remove FM and bioburdens from medical device cleanrooms.
In order to control contamination risks, medical device facilities perform thorough and extensive cleaning SOP's on floors, walls, and ceilings.