Contamination Control Solutions for Class III Medical Device Manufacturers

• The medical device industry simultaneously faces higher regulatory expectations and cost pressures associated with medical reimbursement programs. At many device manufacturers foreign materials (FM) are a significant cause of nonconforming product, 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.

 

All Compound Semiconductor Flat Panel Display(LCD) GMP Manufacturing Hard Disk Drive Medical Devices

Optics Ultra Fine Line Screen Printing Semiconductor Manufacturing Solar Cell Aseptic Processing