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Hem Expert-bibliotek Clarifying Pharmacopeial Requirements
Utbildning

Clarifying Pharmacopeial Requirements

For Pharmaceutical Waters and Process Analytics

Hosted by American Pharmaceutical Review

Total Organic Carbon measurement is a required test for pharma water and is regulated by USP and other pharmacopeias. Information can be misleading when it comes to what is required and what meets pharmacopeial requirements. 

The importance of what is fact and what is incorrect has an impact on the methods used to monitor TOC; differentiating from what is needed for validation requirements and providing better process control, risk mitigation, and proactive monitoring.  

This discussion directly dispels myths and false claims about pharmacopeial requirements in pharmaceutical waters, with a specific focus on TOC and conductivity.

  • Get answers to questions regarding pharmacopeial requirements for pharmaceutical waters.
  • Status of harmonization of pharma waters and test changes for sterile waters.
  • The impact of real-time release testing of pharma waters for TOC on risk mitigation and process control.
  • ...plus more

Presenters :

Jim Cannon – Head of OEM & Markets, METTLER TOLEDO Thornton

After receiving a B.S. in Biology, Jim continued with graduate degrees in Microbiology and Biophysics, and an MBA in Marketing and International Management. Jim has over 35 years of experience in the management, design and development of ultrapure water treatment and technology. This includes measuring differential conductivity and UV oxidation for the detection of TOC in UPW and the design and commercialization of electrodeionization modules.

He is currently involved in the standards and regulatory organizations for the semiconductor, photovoltaic and pharmaceutical markets, including the facilities and liquids committee, Reclaim/Reuse/Recycle Task Force and the UPW Task Force. He is also serving as technical advisor to several pharmacopeia organizations and is active in ISPE and PDA groups.









Anthony Bevilacqua Ph.D. - Principal Scientist R&D, METTLER TOLEDO Thornton

Dr. Anthony Bevilacqua earned a doctorate in Analytical and Physical Chemistry from Tufts University. He has been at Thornton since 1994, leading the instrumentation development for Thornton in several areas of R&D, including improved high temperature conductivity measurements, use of ultrapure water (UPW) as a conductivity solution standard, and the expansion of real-time analytical parameters for measurement and control of high purity water systems.

Anthony was the conductivity consultant to the USP during the implementation period for the <645> Water Conductivity and <643> Total Organic Carbon USP chapters in the mid-1990’s. He is currently serving on the current Chemical Analysis Expert Committee (CA EC) for 2020-2025. For the last 20 plus years, he has been working with EP, JP and other pharmacopeias for international harmonization of pharmaceutical water quality standards and analytical test methods.