Improving the Integrity of Pharmaceutical Sterility Testing: A New Robotic Approach

摘要

Concern over the occurence of false positives within the sterility testing process has been and will continue to be of grave concern to pharmaceutical manufacturers. To date, very few truly effective solutions to this problem have been offered, while the FDA becomes ever more stringent over false positive results and second phase testing.A new robotic system for sterility test applications is described, which completely isolates the actual test area from human operators, and thus reduces substantially any possibility for false positives. The configuration utilizes the USP-preferred membrane filtration method, and uses the Millipore Steritest filtration chambers as its “output” for incubation. The system allows a technician to simply place product to be tested in an input station, mount the Steritest cannisters in designated sockets, then remove the empty containers and filled cannisters post-processing and incubate. This new method allows for the testing of a variety of different sample containers, including a range of vial sizes, ampoules, and pre-filled syringes.The test methodology will be described in detail, including an in-depth look at the actual application procedure and a discussion of major system components and overall system configuration.