Don’t let difficult substances control your cleaning validation
TOC analysis is a widely adopted method for detecting residual product or cleaning agents on manufacturing equipment. Compared to specific methods such as HPLC, TOC can provide better process understanding and efficiency for cleaning validation (CV), verification and continuous monitoring.
Some products have complicated organic structures and/or are difficult to oxidise, such as proteins and high molecular weight compounds. For these challenging applications, it may be necessary to consider different TOC vial types and perform recovery studies to determine suitability. While some substances are difficult, it doesn’t always mean they can’t be recovered.
Watch this webinar on-demand to hear examples of best practices for performing TOC recovery studies for cleaning validation applications, including comparison of pre-acidified and non-acidified vials. Learn how to take control and detect difficult substances.
Register
Speakers
Daniel Kellner-Steinmetz, EMEA Application Lead UPW/CV, SUEZ
Daniel Kellner-Steinmetz is the EMEA Applications Specialist for SUEZ, focussing 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.
Key learning points
- Challenges of difficult-to-recover compounds in cleaning validation applications
- Examples of TOC recovery studies and best practices
- Comparison of acidified and non-acidified vials for recovery studies
- How to make dilutions, test and evaluate resultant data for recovery and linearity
- Other considerations using TOC for CV.
Related topics
Analytical techniques, Downstream, Environmental Monitoring, HPLC, Lab Automation, Manufacturing, Process Analytical Technologies (PAT), Production, Proteins, QA/QC, Technology, Total Organic Carbon (TOC)
