ON DEMAND EDUCATION FROM INDUSTRY SUBJECT MATTER EXPERTS
Worst Case Assessment
Sterile Barrier Systems
This webinar presents various worst-case assessments for sterile barrier systems (SBS) and provides examples where reasons and possible solutions are provided. This video uses the ISO 11607 part one (Packaging System and Performance Testing and Usability Evaluation for Aseptic Presentation) and two (Validation of Packaging Processes) from the 2019 version. The video also elaborates on correct terminology and provides cases of “Worst-case configuration” of different divisions such as medical devices and sterile barrier systems.
In This Video You'll Learn About...
Regulations
Terminology
Worst-case assessments
Generating worst-case assessments
References
PRESENTED BY
ELON GOLDBAUM
Senior Director, Packaging Engineering