Meeting Pharmacopeia Regulations & Controlling the Risk of Contamination in Pharmaceutical Waters

This webinar will cover key analytical requirements and regulations to ensure pharmacopeia compliance of pharmaceutical waters. The speaker will also discuss methods for implementing real-time measurement to improve process control to achieve compliance with those regulatory requirements.

The panelist will start with a background of the US Pharmacopeia (USP) and the updated process for USP, including supplements and major revisions. He will also talk about the global panel of experts that make up the USP. This will lead into a discussion on how the USP is harmonized with other global pharmacopeias, including European Pharmacopeia (EP), Japanese Pharmacopeia (JP), Chinese Pharmacopeia (ChP) and Indian Pharmacopeia (IP). The speaker will then discuss trends in measurement as they relate to USP, including discussion of In-Line, At-Line and Off-Line measurement, and the shifts of key measurements from off-line to at-line. Such measurements that are shifting include total organic carbon (TOC) and microbiological contamination. Next, he will tie the harmonization of these different global pharmacopeias to different water types and measurement points, including source water and water for injection (WFI). The panelist will go into specific monographs that relate to in-line, at-line and off-line measurements.

Once he has covered the overview of harmonization and regulations, the speaker for this webinar will move into three specific analytics for pharmaceutical waters and the related measurement to help ensure pharmacopeia compliance of pharmaceutical waters. Those measurements are conductivity, microbial contamination, and TOC. For measuring conductivity, the speaker will discuss the benefits of in-line measurement of conductivity, the importance of temperature compensation <USP1644> and non-temperature compensated <USP 645> measurement, and how participants can achieve both efficiently. He will also discuss the importance of verification and calibration according to USP standards to ensure the compliance of water systems.

In TOC monitoring, the panelist will discuss the benefits of oxidation/conductivity methods for TOC monitoring to help ensure a compliant water system. In particular, he will discuss the ability of UV oxidation to provide a real-time, continuous measurement that is unique to this technology.

The speaker will then discuss the trend towards implementing online bioburden detection as a method of process control in parallel to plate counting. In shifting to online water bioburden analysis (OWBA), many pharmaceutical companies have questions about the regulatory perspective. The panelist will discuss the regulatory perspective on this topic, including providing an overview of how different workgroups in the industry are engaging on this topic. He will conclude with a summary of how effective analytics can help pharmaceutical companies meet global pharmacopeia requirements and ensure the most effective process control to meet their compliance needs.

Speaker

Jim Cannon, Head of OEM and Markets, Mettler-Toledo Thornton

Jim Cannon is Head of OEM and Markets at 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.

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