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.