Testing in-process water and final end-product for endotoxins under USP <85> in the parenteral, medical device, dialysis, radiopharmaceutical, and compounding industries is critical. Errors or inefficiency in the manual testing steps to reach final result can create data integrity challenges and overall effect patient safety.
Lonza’s Subject Matter Expert Allen Burgenson discusses the current challenges and how automated endotoxin testing can help to overcome them.
Learn how automating the liquid handling aspect of the endotoxin test helps you save time and reduce manual pipetting errors and retests. Discover how the process is further optimized by linking automation with WinKQCLTM Endotoxin Detection and Analysis Software, improving compliance with data integrity regulations.
Topics discussed:
- Challenges caused by manual steps when performing the endotoxins test
- Potential data integrity gaps in current procedures
- What is endotoxin assay automation?
- Ease of automation integration and process workflow
- Global need for automation and the move towards Industry 4.0 and the FDA’s PAT Initiative
- Case Study: Automated vs. manual endotoxin testing
Webinar Speaker:
- Allen Burgenson, Global Subject Matter Expert, Testing Solutions
Lonza Bioscience Solutions
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