During a site compliance visit, an EMA team observed that our client’s central facility was storing, dispensing, and dispersing a potent API globally which was averse to their expectations. Without supporting data showing potent compound isolation, this was an unacceptable procedure.
The client’s Quality Laboratory in partnership with their Occupational Health colleagues developed a sampling and analysis protocol. With the introduction of FabOhio. Inc’s glovebag system the new protocol was to exceed normal validation criteria for containment and mitigation of cross contamination in a shared facility handling the potent compound, as well as improved the occupational exposure limit (OEL).
An extended series of sampling on personnel, in and around the dispensing suite, as well as associated warehouse access was conducted. Excluding the known addition spike samples incorporated for confirmation of method integrity, not a single sample was observed at, or above, the detection limit of 0.04 ng (40 picograms) which translates to 0.04 ng/cu.m. (40 pg/cu.m). The analytical level achieved during the EMA response was of the same magnitude as those used in validating installed performance of the best designed gloveboxes for the Nuclear Industry (American Glovebox Society publications) where they are measuring radiation.
THE CONTAINMENT PROCESS UNDER SCRUTINY WAS A FabOhio Inc. GLOVEBAG WHICH WAS DISCARDED DAILY, OVER THE COURSE OF 10 YEARS OF USAGE.
During the follow-up inspection the agency was provided with the entire set of protocol working documents and data which they took with them for examination at their Brussels Headquarters. After extreme scrutiny of the sampling program performance including all raw data the agency concluded that:
THE FabOhio Inc. GLOVEBAG IN THE HANDS OF TRAINED OPERATORS DOES DELIVER MATERIALS ISOLATION AT, OR BELOW, 0.04 NG/CU.M (40 PG/CU.M.) OEL AND CAN REASONABLY DELIVER SUCH EXPECTATIONS ON A DAILY BASIS.
This finding has also worked to the advantage of other flexible containment providers.
Shortly after the agency released their conclusion there was a distinct change in expectations about dedicated facilities. With time they have come to accept that third party and toll manufacturers showing competent dependence on this practice is a rational expectation.
FabOhio Inc. has undergone pharmaceutical company’s Quality Inspections on a routine basis. Our quality manufacturing and final inspection which exceeds the standards set out in the American Glovebox Society publication, are an accepted expectation.
Written by Brian Ward, PhD, CSci, CChem, FRSC