Presented By:
Tony Harrison

Speaker 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.

Webinar:
Testing Vaccines final dose form to USP 787 Subvisible Particulate Matter

Webinar Abstract:
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.

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