TOC fitness for purpose: How to ensure your TOC analyser is fit for compendial water & cleaning validation
ABOUT THIS WEBINAR
This webinar presents how to easily evaluate “fitness for purpose” of a TOC instrument for compendial water and cleaning validation applications based on USP <1058> and ICH Q2(R1). This is an important part of selecting the right laboratory equipment, especially to have confidence in the validity of your data when moving a current instrument into cleaning validation applications.
The talk focuses on a suggested study setup that can help you evaluate available instrument technology in just a few hours. This is accompanied by real life examples and test results of various TOC technologies.
Key learning points:
- How to easily evaluate “fitness for purpose” of a TOC instrument for compendial water and cleaning validation based on USP <1058> and ICH Q2(R1)
- How to categorize TOC instruments according to USP <1058> and what to perform during method validation
- Typical ranges for TOC analysis in different applications and how to demonstrate your process is under control
- Where to start with cleanability, feasibility and suitability studies.
Daniel Kellner-Steinmetz, EMEA Application Lead UPW/CV, SUEZ
Daniel Kellner-Steinmetz is the EMEA Applications Lead for SUEZ, focusing on Life Science UPW and Cleaning Validation applications. He has eight years of experience in the Quality, Manufacturing and Training areas of the pharmaceutical industry. Most recently he served as the Global Product Quality Lead for several commercial products at Shire (formerly Baxter) in Vienna. Daniel holds a Bachelor of Science in Biomedical Engineering.