Controlling Impurities in Pharma Waters

Insights and Strategies for Maintaining High Water Quality

Event Program

• Common misconceptions about impurities in pharmaceutical waters
• Differences between chemical and microbial properties in WFI and PW
• Recommended approaches for measuring different impurities
• Insights on maintaining a healthy water loop

Enhancing Quality and Safety in Pharmaceutical Manufacturing

Without proper impurity control, pharmaceutical manufacturers risk compromising the safety and efficacy of their products. Microbial and organic impurities can enter water systems at various points in the manufacturing process and impact quality and safety.

Misunderstandings surrounding controlling impurities in pharma waters can lead to improper measurement and treatment approaches.

It is a common belief that chemical and microbiological properties in Water for Injection (WFI) and Purified Water (PW) are the same in pharmaceutical water systems. However, this is far from the truth. These properties react differently and are distributed unevenly in storage and distribution loops, which can have different effects on the health of the water system.

In this live roundtable discussion, we will dispel the most common myths about microbes and organics and controlling impurities in pharma waters. We will discuss the differences between chemical and microbiological properties in WFI and PW and recommend measurement approaches for each impurity. Additionally, we will cover how to maintain a healthy water loop to ensure high quality and safety in pharmaceutical manufacturing.

Presenter: Maura Rury (Senior Product Manager, METTLER TOLEDO Thornton)

Maura manages METTLER TOLEDO's Total Organic Carbon (TOC) product line, along with related services and training. Her prior roles include marketing, product management, and technical applications at LGC and Thermo Fisher Scientific. She received her Ph.D. in Analytical Chemistry from the University of Massachusetts, Amherst.

Presenter: Anthony C. Bevilacqua (Principal Scientist, METTLER TOLEDO Thornton)

Anthony Bevilacqua earned a doctorate in Analytical/Physical Chemistry from Tufts University. Since 1994, he has led several areas of Research and Product Development that include: impact of CO2 on pure water, ultrapure water as a conductivity solution standard, development of digital sensors, and expansion of real-time analytical parameters (conductivity, TOC, microbial detection, ozone, sodium, and silica) for measurement/control of high purity water systems, including pharmaceutical water systems. Anthony was Chair of the inaugural USP Pharmaceutical Water Expert Committee from 2000-2005, and re-elected from 2005-2010. Anthony’s role continued in the 2010-2015 and 2015-2020 cycles for the USP Chemical Analysis Expert Committee, and he is currently serving on the current committee for 2020-2025.

Presenter: Areen Kalantari (Global Segment Manager, Pharma & Life Sciences, METTLER TOLEDO Thornton)

Areen Kalantari holds a B.S. in Biological/Chemical Engineering and a Master of Business Administration (MBA) in International Business. He has experience in both biotechnology applications and pharmaceutical waters. Areen is a voting member of the American Society of Mechanical Engineers – Bioprocess Equipment (ASME-BPE) standards committee. He contributes to the Process Instrumentation subgroup to help implement standards for the bioprocessing and pharmaceutical industries, focusing on conductivity, pH, TOC, and other process technologies.