Clean Room Contract Manufacturing for the FDA Medical Device & Life Sciences Industries
Genesis is an FDA-registered contract manufacturing organization dedicated to fulfilling the plastics welding needs of the highly regulated medical device industry. Our ISO Class 7 clean room (Class 10,000 equivalent) is isolated from the adjacent production area by air-lock doors and a positive pressure system designed to prevent entry of airborne particulates. We follow strict adherence to FDA and regulatory compliance standards to ensure only the highest quality in our medical device contract manufacturing.
In addition, our gown room is certified as an ISO Class 8 Clean Zone (per the requirements of ISO Standards 14644-1:1999 and 14644-2:2000). Both our gown room and clean room are in compliance as controlled environments and are periodically tested for HEPA leaks, velocities, air volume changes and particle count.