Pharmacopeia Compliance

This series of three, on-demand webinars detail the pharmacopeia compliance requirements for on-line water quality measurements. 

Part 1: Conductivity 

• Regulations on pharmaceutical waters according to the harmonized pharmacopeias
• The impact of Annex 1 and importance of process control
• Calibration requirements for conductivity
• Test requirements for packaged waters

Part 2: TOC and Ozone

• Review of on-line TOC technology
• TOC instrument requirements
• System Suitability Test integral to the IQ/OQ/PQ and review of USP <1225>
• Use of ozone for sanitization and meeting pharmacopeia compliance for “no added substance”

Part 3: Rapid Microbial Testing

• Review of on-line alternative microbial technology
• Perspective of the pharmacopeias, regulators and industry stakeholders on alternative methods
• Industry case studies and the practical use of an on-line microbial contamination analyzer

About the Host

Hosting these sessions is Jim Cannon. Jim is the Head of OEM and Markets at METTLER TOLEDO Thornton and has over 35 years of experience in the management, design and development of ultrapure water (UPW) treatment and technology. This includes measuring differential conductivity and UV oxidation for the detection of TOC in UPW and the design of electrodeionization modules.

Jim is an expert in matters regarding pharmacopeia compliance. He is currently involved in the standards and regulatory organizations for the pharmaceutical market and the commercialization of alternative microbial technology.