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 surety 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. Record keeping conforms with stringent Government and ISO standards.
Specialized projects may require additional sterilization services. FabOhio has the capabilities and external partners to support your level of sterilization 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) to mitigate further contamination. 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.
Particle Free Low-Bioburden Isolators
The ultimate in flexible isolator manufacturing is one prepared for nano-particle containment, being a particle free enclosure which has been e-beamed and only accessible to the external environment through purgeable transfer sleeves (pass-throughs) fitted with nano-particle filtration. As new micro-organisms evolve and manufacturing procedures for nano-particles API’s develop this provides a simple, safe, economical, and disposable method of ensuring complete materials isolation both with, and devoid of air exchanges.
Please Contact Us for more details.
Written by Brian Ward, PhD, CSci, CChem, FRSC