Standard Services
Our Certificate of Conformance is a signed document attesting to the final quality inspection by FabOhio. Our inspection protocol has evolved through routine site visits, feedback, and approval from major Pharmaceutical Industry Quality Teams, their engineering professionals, and Federal Agencies.
Standard inspection services include in-house inflation testing of all polyurethane enclosures. Flexible panels and non-enclosure products will receive visual and seam test inspections. Originally, guidance provided by the American Glovebox Society (current document AGS-0002-1998, available from The American Glovebox Society (AGS) at gloveboxsociety.org) was used for pre-shipment inspections. To ensure product integrity for flexible isolators which can be used across a range of positive and negative internal pressures, FabOhio Inc. developed the inflation inspection process performed by a trained technician in response to performance requirements of our clients.
Our raw materials are lot verified and traceable to the source. Our polyurethane films have been tested for stability for both liquid and vapor stability with numerous solvents. Our films meet EMA and FDA performance criteria.
Premium Services
Specialized projects that may need decontamination services can be corrdinated by FabOhio and external partners to meet your requirements.
Clean Environment Isolators:
Flexible film is made by the “Blow Film” process, consequently it is exposed to room air. Our technicians exercise great care during all handling procedures (storage, tempering, pattern cutting, fabrication, testing, and finally shipping). As tested by our pharmaceutical partners using a CLiMet series 500 particle counter, an as delivered isolator will meet Clean Room Classification Level 6. FabOhio Inc. developed ability to deliver Clean Room Level 2 and better performance using time honored internal surface cleaning with certified alcohol wipes, clean environment isolators are shipped in additional layers of polyurethane film overpack to meet customer needs when specified on the purchase order.
Sterile Environment Isolators:
Clean environment isolators can be delivered to our e-Beam vendor in triple overpacks when specified. A Certified Scientist inoculated the flexible isolators with a statically significant battery of 12 standard organisms. After treating at 1x and 10x dose levels, both treatments resulted in no viable organisms, displaying a >1,000,000 kill factor.
Please Contact Us for more details.
Written by Brian Ward, PhD, CSci, CChem, FRSC