USP <71> Sterility Tests; Method, Limitations, Sampling Quantities and Volumes to Conform with USP
Live, Interactive Training Webinar
Available Live On-Demand
Instructor: Barry A.Friedman Ph.D. Biography>>>
Available Live On-Demand
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 to be 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 meet those specifications. Finally, 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 were 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 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.
-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.
Webinar outline and time breakdown:Time*
|10:15 AM||Log In Period|
|Test Background, Methods of Sterility Testing, Media Used,|
|Articles and Number Required for Testing, Growth Promotion and I/E Testing,|
|11:40 AM||Time Frame Related to Testing including Other Assays Historically Used,|
|Choosing the Appropriate Method, Training the Personnel,|
|Interpreting the Results of a Sterility Pass or Failure,|
|Review of Pertinent Case Studies/Warning Letters,|
|12:30 PM||Live Questions & Discussion|
*Please note all times are Eastern Time (New York Time)
This live training webinar includes the following for each registered attendee:
- A copy of the presentation slides
- A certificate of participation for attendee training records
Who should attend:
The following individuals or disciplines will benefit from attending this Webinar:
- Quality Assurance personnel
- Quality Control personnel
- Research & Development
- Regulatory Affairs Professionals
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Instructor: Barry A. Friedman Ph.D.
Barry A. Friedman, Ph.D., is a Senior Consultant in the Biotechnology, Regulatory Compliance and Aseptic Processing arena. Dr. Friedman is a frequent seminar speaker in the GMP areas of internal auditing, aseptic processing of sterile drug products, USP microbiology, validations and the requirements for the manufacture of Phase 1, 2 and 3 clinical trial materials. He has recently given presentations for the FDA, PDA, PTi. He is a member of AAMI, ASM, PDA and RAPS. He served as a Captain in the Medical Service Corps, U.S. Army and is the past President of the Capital Area Chapter, PDA... Full Bio>>>