Best practice for sterility test failure investigations

July 04 , 2.00 pm IST


Dr. Tim Sandle

About the Webinar 

For every positive sterility test an investigation should be undertaken to consider if the result is valid. That is, does the failed test relate to the sterility of the product or is it due to a laboratory test error (such as environmental contamination during the test session)?

The webinar focuses on the likely occurrences of false positives and the areas for consideration including the sterility test environment, operator technique, consumables and reagents, and what might have caused a failure within the production environment, including issues relating to aseptic practice, sterilisation and barrier technology. The webinar includes reference to genotypic microbiological identification and current FDA recommendations in relation to the number of permitted repeat sterility tests.

The key points covered include:

The Sterility Test




Immediate actions in the event of a failure

Laboratory failure investigations

Process failure investigations

Outcomes and follow-up actions

About the Presenter 

Dr. Tim Sandle has over twenty-five years experience of microbiological research and biopharmaceutical processing. Dr. Sandle is a member of several editorials boards and he has written over six-hundred book chapters, peer reviewed papers and technical articles relating to microbiology. Dr. Sandle works for a pharmaceutical manufacturer in the UK, and is a visiting tutor at both the University of Manchester and UCL.