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>>>

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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+% 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.

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.

Webinar outline and time breakdown:

10:15 AM Log In Period
10:30 AM Introduction
10:40 AM Definitions,
Test Background, Methods of Sterility Testing, Media Used,
Articles and Number Required for Testing, Growth Promotion and I/E Testing,
11:30 AM Break
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
  • Validation
  • Auditors


Course Number: 217

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Client Testimonials:

"The live webinar was very useful to our team, the content was relevant and the instructor was very knowledgeable" QC Microbiology Supervisor, NJ

"We were very satisfied with the live presentation; we appreciated the speaker staying on to answer all of our questions" QA Director, MA

"Our group enjoyed the live presentation and found the experience much more engaging and worthwhile than any recorded webcasts" Sr Training Manager, CA

"This was my first live training, I found it easy to connect, participate and very useful" Laboratory Analyst, PA

"We had our entire department attend this training program and found it to be very useful, I am very satisfied with the speaker's ability to keep the audience engaged" QC Manager, NY

"Given how recent the content of the webinar was, our team members were very happy with the relevance of the training" VP Clinical Operations, CA

"Is my first time to attend training, I enjoy it very much" Sr Manager, Korea

"Our department found the level of interactivity between the audience and the instructor far beyond that of any other online training that we have attended before. Well done" Director Regulatory Affairs, ON

"Our interest group was spread out over three locations and we were able to participate simultaneously and interact very easily" Lead Compliance Manager, IL

"Well satisfied with the presentation. Our team found the speaker's level of knowledge and his ability to translate that knowledge to our processes very valuable" VP Quality Operations, NC

"We were impressed with the quality of the presentation, and despite our being located in Europe we were able to participate without a hitch" QC Manager, Ireland


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>>>