ウェビナー：薬局方における製薬用水要件の明確化

主催：アメリカン製薬業界レビュー

全有機体炭素/全有機炭素測定は製薬用水に必須の試験、テストであり、USPなどの薬局方で規制されています。情報が必要で、何が薬局方の要件を満たすかについては、誤解を招く可能性があります

何が事実で何が間違っているかの重要性は、TOCを監視するために使用される方法に影響を与えます。検証要件に必要なものとの差別化を図り、より優れたプロセス制御、リスク軽減、プロアクティブな監視を提供します。

この考察は、医薬品水域における薬局方の要件に関する都市伝説を直接払拭し、特にTOCと導電率に焦点を当てています。

医薬品用水に対する薬局方の要件に関する質問にお答えします。
製薬用水の調和状況と滅菌水の試験、テスト要件の変更
製薬用水のリアルタイムリリーステストにおけるTOC要件への影響とリスクコントロール
その他

プレゼンター :

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.