APR 28, 2021 11:00 AM PDT

Changes to USP <643> Total Organic Carbon for Pharmaceutical Grade Waters

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:  April 28, 2021

    TIME:  11:00am PDT

     

    A revised version of the USP chapter on Total Organic Carbon (TOC) USP<643> was published recently and will become official on 1st May 2021. This paper gives an overview of this new USP chapter and discusses the reasoning behind the difference in the System Suitability Test materials called for in USP<643> and those in the Japanese JP16.

     

    Learning Objectives:

    • Learn about the revised USP chapter on Total Organic Carbon (TOC) USP<643> which will become official on 1st May 2021
    • Learn about the System Suitability Test in USP<643>
    • Learn the reason why Japanese Pharmacopoeia calls for different System Suitability Testing materials to USP

     

     

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