USP <71> Sterility Tests; Method, Limitations, Sampling Quantities and Volumes
: 11 Aug 2020
USP<71> Sterility Tests represents the "Gold Standard" for sterility testing. Together with both the European Pharmacopeia (EP 2.6.1 Sterility) and the Japanese Pharmacopeia (JP 4.06 Sterility Test), they represent a 90+% harmonized test method that is utilized to determine the sterility of a product.
A variety of issues with USP <71> make it a difficult test to understand, develop, and follow within one’s laboratory. Everything from growth promotion testing of the media to assuring no inhibition/enhancement (I/E) of the product tested requires the knowledge and assurance that the test is being completed as required. In addition, the number of units necessary for testing, the total volume required for the test, and assurance that the media is providing accurate results all become important aspects of assuring the test is performed properly and the final result meets those specifications. Finally, the correct interpretation of the results and the proper procedures to use should a failure occur require a thorough knowledge of USP <71>. Any failure of a Sterility Test will also cause one to potentially review all of the elements within the media fills or terminal sterilization validation that was involved in developing the process that would provide the final, sterile end product.
A failure of a Sterility Test (whether an accurate result or not), will result in an investigation to determine the “root cause” of the failure. Even if that “root cause” is determined, management will quite often determine, in the current regulatory environment, to scrap the product, rather than second guess the regulatory agencies that will periodically audit them. With sterility testing being an exacting procedure, and assurance of asepsis essential, it is important that personnel be properly trained and qualified.
The test for sterility is performed under aseptic conditions within an ISO Class 5 hood or within an ISO Class 5 Isolator. Precautions are required to assure that neither microorganisms from the individual testing or the environment contaminate the product being tested. The working condition of the area in which the test is performed should be monitored regularly by an appropriate sampling of the working area and by using appropriate aseptic methods to provide control. Each of these areas will be discussed in detail.
The objective of this live training webinar is to obtain an enhanced understanding of USP <71> Sterility Tests, its inherent method, limitations, sampling quantities, and volumes to assure that the test is being applied as appropriate per United States Pharmacopeia and how to interpret the final result, regardless of whether it represents a pass or a failure. Review of Case Studies/Warning Letters will also be reviewed to further explain this document.