Rapid Sterility Tests for Short Shelf-Life Products: A Risk-Based Approach

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USP experts share current perspectives on a risk-based approach to rapid sterility tests for short shelf-life products such as cell and gene therapies. Live: Wednesday, May 9, 2018 at 12 pm EDT | 11 am CDT | 9 am PDT / On Demand available after airing until May 9, 2019. Register free: http://www.biopharminternational.com/bp_w/rapid

Register Free: http://www.biopharminternational.com/bp_w/rapid

Current growth-based sterility tests typically require a 14-day incubation. However, for drug products with a short-shelf life or those that are prepared for immediate use-such as compounded sterile preparations, positron emission tomographic (PET) products, and cell and gene therapies due to the turn around time of the compendial tests, the results may not be completed before the drug must be administered.

Patient safety is best served through the completion of a test that detects microbial contamination prior to use. Suitable sterility tests should be risk-based so the stakeholder can select the preferred technology for its intended use, and balance competing user requirement specifications (URS) including time to result, specificity, limit of detection, sample size, and product attributes.

The webcast will review URS for:

  • Rapid sterility tests for short shelf-life products

  • A risk-based approach to select appropriate technologies that meet URS



Radhakrishna S. Tirumalai, Principal Scientific Liaison-General Chapters, USP


Date and Time:

Live: Wednesday, May 9, 2018 at 12 pm EDT | 11 am CDT | 9 am PDT

After the final airing of the webcast on May 9, 2018 it will be available on demand until May 9, 2019. 

Sponsor: USP  

Register Free:http://www.biopharminternational.com/bp_w/rapid