Clarifying Pharmacopeial Requirements for Pharmaceutical Waters and Process Analytics

An Online Event Hosted by American Pharmaceutical Review

Total Organic Carbon measurement is a required test for pharma water and is regulated by USP and other pharmacopeia. Information can be misleading when it comes to what is required, and what meets regulatory compliance.  The importance of what is fact and what is incorrect has an impact on what methods are used to monitor TOC- differentiating from what is needed for validation requirements and providing better process control, risk mitigation, and more accurate proactive monitoring in manufacturing.  This discussion will directly dispel myths and false claims about compliance in pharmaceutical waters with specific focus on TOC and conductivity.

  •  Answers to common questions to distinguish actual pharmacopeial requirements for pharmaceutical waters vs what has become widely accepted in the industry for  TOC and conductivity
  •  Status of harmonization of pharma waters, test changes for sterile waters and more
  • The impact real-time release testing of pharma waters for TOC on risk mitigation and process control.
  • Details of a TOC system designed to meet regulatory requirements.

Your Event Presenters :

Jim Cannon – Head of OEM & Markets, Mettler Toledo Thornton

After receiving a B.S. in Biology, he continued with graduate degrees in Microbiology and Biophysics, and an MBA in Marketing and International Management. Cannon 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 electrodeionisation modules.

Cannon 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 has also involved in the development and the commercialization of alternative online microbial detection technology. He is also serving as technical advisor to several Pharmacopeia organizations and active in ISPE and PDA groups

Anthony Bevilacqua Ph.D. - Principal Scientist R&D, Mettler Toledo Thornton

Dr. Anthony Bevilacqua is a Professional Scientist at Mettler-Toledo Thornton.  He 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, the impact of CO2 on pure water, use of ultrapure water (UPW) as a conductivity solution standard, development of digital sensors, and the expansion of real-time analytical parameters (conductivity, TOC, microbial detection, ozone, sodium, and silica) for measurement and control of high purity water systems, including pharmaceutical water systems.

Anthony was the conductivity consultant to the USP during the implementation period for the á645ñ Water Conductivity and á643ñ Total Organic Carbon USP chapters in the mid-1990’s, and he developed the theory, methods, and practices used for conductivity testing for Purified Water and WFI.  Anthony was Chair of the USP Pharmaceutical Water Expert Committee from 2000-2005 and 2005-2010.  In addition, Anthony’s role continued in the 2010-2020 USP Chemical Analysis Expert Committee (CA EC), and he is currently serving on the current CA EC for 2020-2025.  For the last 20+ years, he has been working with EP, JP and other Pharmacopeias for international harmonization of pharmaceutical water quality standards and analytical test methods.