Webinar on pharma water system control

活动概述

Pharmacopeia requirements for PW and WFI
Specific tests for TOC, conductivity, and microbial contamination
Where process control should be maintained
Differences between process control and quality control testing

Process control, risk mitigation, and streamlining testing

Global pharmacopeias require that Purified Water (PW) and Water for Injection (WFI) produced by pharmaceutical water systems is tested to a strict specification. The design and construction of a pharmaceutical water system may require monitoring at many points, depending on what you are testing for. Understanding when to monitor at the point of use (POU) vs. monitoring on-line is critical for controlling quality and your process.

The goal of on-line analytical measurements is to achieve total process control, mitigate risk, and streamline water system testing while meeting both United States Pharmacopeia (USP) and other global pharmacopeia requirements, but also FDA process analytical technology (PAT) initiatives.

In this webinar, we will cover the pharmacopeia requirements for PW and WFI, as well as specific tests for total organic carbon (TOC), conductivity, and microbial testing. The differences between chemical and microbial impurities in a pharmaceutical water system, and where process control should be maintained, will also be discussed. We will also cover the differences between process control and quality control testing and how pharmaceutical water system users can utilize their process control instrumentation for determining quality control release based on the science behind chemical impurities.

Speakers

Areen Kalantari

Global Segment Manager – Pharma & Life Sciences

Areen Kalantari holds a B.S. in Chemical Engineering and has 10 years of experience in biotechnology applications and pharmaceutical waters. In his current role as an Industry Manager, he is responsible for the pharmaceutical and life science industries for METTLER TOLEDO Thornton. He supports with pharmacopeia regulation training sessions in relation to WFI and PW, technical papers, and water system design and analytics. Areen is a voting member for the American Institute 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 with focus on conductivity, pH, TOC, and various other process technologies.

Learn More