Sterility testing is widely used in both the medical device and pharmaceutical industries. The pharmacopeia test is the official procedure for testing the sterility of pharmaceutical products.
Despite its importance and its widespread use, many people are not aware of the limitations of the sterility test and are unsure how to proceed when a failure investigation occurs.
Questions to help with this process, like -- "Can the test be invalidated? Is the product rejected? What needs to be investigated? How is root cause established? What need to be done before production can resume?"-- will be answered in this webinar.
Learning Objectives:
- What the sterility test can and cannot demonstrate
- The causes of sterility test failures
- The actions required on being notified of a failure, including deviation management and quarantine
- Best practices for laboratory test investigations
- Best practices for processing investigations
- Best practices for aseptic processing investigations
- Developing a remediation plan including the necessity for media simulation trials
Why Should You Attend:
To gain an insight into the best practices for sterility test failure investigations, from a speaker who has presented sterility test failure investigation reports to both FDA and European Medicines Agency inspectors.
Topics
- History of the sterility test
- Statistical limitations of the sterility test
- Actions required by management on being notified of a sterility test failure
- The importance of genotypic microbial investigation
- Points to consider for investigating testing, such as cleanroom or isolator operational parameters
- Reviewing major contamination incidences in process areas that could lead to a sterility failure, from raw materials to wet equipment
- Detailed forensics for aseptic process investigations, such as reviewing people, processes and equipment
- How to do put an investigation report together
- How to test out CAPA through media fills
- What to do if the investigation is inconclusive
Instructor
Dr. Tim Sandle has over twenty-five years experience of microbiological research and biopharmaceutical processing. He is Head of Microbiology at Bio Products Laboratory (U.K.) and a visiting tutor with The University of Manchester School of Pharmacy.
Dr. Sandle serves on several national and international committees relating to pharmaceutical microbiology and cleanroom contamination control. He is a committee member of the Pharmaceutical Microbiology Interest Group (Pharmig); and is a member of several editorials boards for scientific journals.
Dr. Sandle has written over three hundred book chapters, peer reviewed papers and technical articles relating to microbiology. Dr. Sandle's current research interests are cleanroom fungi; microbiology of water; disinfectants; and rapid microbiological methods.
In addition, Dr. Sandle serves on several national and international committees relating to pharmaceutical microbiology and cleanroom contamination control (including the ISO cleanroom standards). He is a committee member of the Pharmaceutical Microbiology Interest Group (Pharmig); serves on the National Blood Service advisory cleaning and disinfection committee; and is a member of eleven editorials boards for scientific journals.
Dr. Sandle has acted as a consultant, expert witness and technical advisor to sterile and non-sterile manufacturing facilities, microbiology laboratories, the medical device industry and hospitals. Dr. Sandle has also undertaken several technical writing and review projects.