Certified Medical Cleanroom

Medical manufacturers have a responsibility to create life-changing applications — and AR Medical is committed to supporting those advancements.

From elastomeric parts and seals to micro miniature and custom solutions, we use our Class 10,000 ISO-07 cleanroom to develop innovative medical solutions that can withstand exposure to a demanding range of chemical and temperature environments. Within this certified medical cleanroom, we have complete processing, four injection molding machines, two post-cure ovens and a fully-automated ultrasonic parts cleaning system.

Our Certification of Compliance, performed by R. Kraft, Inc., reflects the following standards:

  • The air handling system that supplies the certified medical cleanroom area has recently been certified to ISO 14644-2 2000.09.15 (testing and monitoring), which corresponds to FS 209E Class 10,000
  • Air systems for the following areas have met ISO 14644-1 1999.05.10 guidelines to qualify for the following cleanliness classifications:
    • Main Cleanroom - ISO Class 7 (10000) in an "as-built" mode of operation at .5 microns
    • Inspection (Gown) Room - ISO Class 7 (10,000) in an "as-built" mode of operation at .5 microns

For more information on our ISO Class 7 (10000) certified medical cleanroom capabilities contact AR Medical today.

Medical Seals Quality

Our goal is to maximize our ability to provide quality products and services that meet or exceed our customers' requirements.

Quality Policy