Contamination Control Solutions for Class III Medical Device Manufacturers
Foamtec International Contamination Control Division
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 FM Related Rejects and Rework
Reduce inspection, rework and scrap rates by reducing large fiber contamination at the work station.
Close FM Related CAPA's
Develop root cause solutions for FM contamination.
Fiber Free Swabs
Fiber Free Swabs, made in a wide variety of shapes, sizes and materials are ideal for cleaning Medical Devices.
Improved Contamination Control for Medical Device Cleanrooms
Sahara+ PharmaMOP® is designed to remove FM and bioburdens from medical device cleanrooms.
Control Bioburdens
In order to control contamination risks, medical device facilities perform thorough and extensive cleaning SOP’s on floors, walls, and ceilings.
About Foamtec WCC
Foamtec's mission is to enable contamination control professionals to improve particle control in clean rooms by solving surface contamination challenges. The Wilshire Contamination Control Division of Foamtec International supplies clean room mops, foam swabs, microfiber swabs, foam wipers, microfiber wipers, UltraSOLV® ScrubPADS to address clean room cleaning and the critical cleaning of process equipment.