PHARMACEUTICAL STERILITY TESTING
Lot Release Sterility Testing
The Sterility Test specified in USP General Chapter <71> has been harmonized with the European and Japanese Pharmacopoeia. This test procedure determines if a Pharmacopeial article purporting to be sterile complies with the requirements of the test and is not by itself designed to insure that a batch of product is sterile. This can only be accomplished by validation of the sterilization process or of the aseptic processing procedures.
At Pacific BioLabs we conduct the membrane filtration test using the Millipore Steritest system and the direct inoculation method in an ISO Class 5 sterility suite. In both methods the samples are placed in Soybean Casein Digest Medium (SCDM) and Fluid Thioglycollate Medium (FTM) and incubated for 14 days. The samples are observed for evidence of microbial contamination daily.
The validation of the sterility test also known as Bacteriostasis and Fungistasis Test (B&F) must be conducted for each Pharmacopeial article. This test in necessary to demonstrate that the product is free of inhibiting factors eliminating the occurrence of false negative results. Six simulated sterility test samples are inoculated with less than 100 Colony Forming Units (CFU) of six specified microorganisms (3 in SCDM and 3 in FTM). The samples are observed for evidence of microbial growth daily and media turbidity must be observed within 5 days.
More information on microbiology and sterility testing can be found in the Learning Center section on Sterility Assurance Tests.