Barrier Isolators were created to exclude the principal source of microbial contamination from filling lines, i.e., human operators. In large part the use of barrier isolators has be highly successful. However, isolators are not ‘magic boxes’ and must be utilized in specific ways. This webinar will explain how to properly operate both sterility test isolators and production isolators, so that microbial contamination of sterility tests and lots of sterile product is avoided. Improper use of a sterility test isolator may result in false-positive test results. Failure to operate a production isolator properly may result in product contamination.
What you will learn about:
- The Regulatory view of Sterility Testing in Isolators
- How to properly investigate Sterility Test Positives
- Expected Isolator Environments
- Proper decontamination of Production & Sterility Testing Isolators
- Proper decontamination of Sterility Test Units and testing materials
- The best type of disinfectants to use
- Proper maintenance of Production & Sterility Testing Isolators
- Acceptable training frequencies for operators
Several case studies will be presented that illustrate real failures for sterility test isolators and production isolators. Advice will be given on how to avoid these sort of unfortunate scenarios.
Who should attend?
- Quality Assurance/Quality Control [especially Microbiologists]
- Technical Services/Validation
- Production
- Facility Engineers
