Our Class 7 Medical Clean Room Meets ISO and FDA Certified Requirements for Plastics Welding
Genesis’ medical clean room and gown room meet FDA and ISO 7 (class 10000) and 8 certified medical clean room requirements for plastics welding. As a plastics contract manufacturing company, we specialize in radio frequency (RF) plastics welding and plastic heat sealing of medical devices, supplies and equipment. We have experience with surgical instrument covers, cooling therapy products, medical device inflatable components, oxygen hoods, compression therapy and DVT sleeves, cooling caps, disposable warming blankets, fluid bladders and drainage bags.
Features and Benefits of Our Contract Manufacturing Medical Clean Room
- Certified FDA medical clean room
- Meets the requirements of a ISO standard 14644 medical clean zone for particle count testing
- Meets the requirements of a ISO 7 Class 10000 certified medical clean room [view our clean room certificate of compliance]
- Meets the requirements of a ISO 8 certified medical clean room (14644-1:1999 and 14644-2:2000) [view our gown room certificate of compliance]
- Designed for a variety of plastic heat sealing processes including impulse welding, sonic welding and RF welding of both polar materials and non-polar materials, within the clean room.
- Protected from airborne particulates by industrial-grade HEPA filters, air-lock doors and a positive pressure system
- Regularly tested for HEPA leaks, velocities, air volume changes and particle count
Genesis maintains a quality system that complies with the Quality System Regulation 21 CFR 820 and ISO 13485 2003 standards.