DEC 14, 2020 10:00 AM PST

Testing Vaccines final dose form to USP<787> Subvisible Particulate Matter

Speaker
  • Senior Marketing Manager, Beckman Coulter
    Biography
      Tony held the Convenorship of the ISO Working Group revising ISO 14698-1 & -2 for microbial control in cleanrooms and was the UK subject matter expert to the ISO Working Group who issued the 2015 revised versions of the ISO 14644-1 & -2 documents for cleanroom classification at the heart of the aseptic manufacturing chapters of both the European GMP and the USA cGMP documents. Tony was joint editor on the ISPE Guide to Ozone Sanitization of Pharmaceutical Water Systems and was also chief editor of the PHSS Best Practice Guide for Cleanroom Monitoring. Tony is employed by Beckman Coulter Life Sciences as a Senior Manager.

    Abstract

    DATE:  December 14, 2020

    TIME:  10:00am PST

     

    USP chapter <787>, Subvisible Particulate Matter in Therapeutic Protein Injections, became official August 1, 2014 and provides specific guidance for testing the final dose form of protein-based formulations, such as vaccines. This regulation focuses specifically on protein formulations and, unlike USP<788>, allows the user to test a smaller number of finished product as well as take smaller test aliquots. This paper discusses the challenges that fully implementing USP<787> presents to liquid particle counters with inherently large tare volumes, poor sample-to-sample repeatability with such low sample volumes and inability to precisely deliver small volumes and how the HIAC 9703+ liquid particle counter from Beckman Coulter overcomes these challenges.

     

    Learning Objectives:

    • Vaccine testing to USP<787>: learn the challenges when using USP<787> for testing vaccines

    • Learn the difference between USP<788> and USP<787>

    • Learn why Light Obscuration is the preferred technology for measuring and counting particle contamination in both USP<787> and USP <788>

    • Learn how the HIAC 9703+ Light Obscuration analyser from Beckman Coulter is designed specifically to help you successfully apply USP<787> to vaccine testing

     

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    Testing Vaccines final dose form to USP<787> Subvisible Particulate Matter


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