USP <71> Sterility Tests; Method, Limitations, Sampling Quantities and Volumes to Conform with United States Pharmacopeia

Live Webinar: USP <71> Sterility Tests; Method, Limitations, Sampling Quantities and Volumes to Conform with United States Pharmacopeia When: Wednesday Jul 28, 2021 - 01:00 PM Duration: 90 Minutes.

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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+% harmonised test method that is utilised to determine the sterility of a product. The objective of this 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.
Learning Benefits:
Methods of sterility testing.
Review of the appropriate media to use for sterility testing.
Determination of the quantity of each article for testing and why.
Review of number of items for each medium and why.
How to select the appropriate technique for testing.
Use of diluents with sterility testing.
Interpretation of the results – regardless of a pass or failure.
Review of pertinent Warning Letters.