Comprehensive Container Qualification and Control Strategies over the Product Lifecycle
Wednesday, December 7, 2022
10:00 - 11:30 AM
What will you learn?
Attendees can expect to leave the webinar with an understanding of:
What is “comprehensive qualification”? – A review of relevant compendial and non-compendial tests for regulatory success.
USP <1207> Container Closure Integrity concepts over the product lifecycle
Unique risks to package integrity posed by deep and ultra-cold storage.
Elastomer shrinkage upon reaching glass transition, causing leakage.
Dimensional impacts and evaluations.
A review of relevant container or package component tests and control strategies at each critical lifecycle stage to characterize and mitigate risk and ensure regulatory success.
Product / Package Development
Product / Package Validation
Manufacturing – Clinical and Commercial
Shelf-life Stability Studies
Container and package qualification requirements for regulated life science products have rapidly evolved over the last decade, and continue to do so. At the same time, there has been a proliferation of novel products requiring unique package systems or processes. Deep and ultra-cold storage of vaccines, cell and gene therapy products, are an example of this. At these extreme cold temperatures, elastomers reaching glass transition impose unique risk to package integrity relative to more traditional products stored at less aggressive temperatures. As with all pharma, biotech, and medical device products, a robust container qualification program is required to identify, characterize, and mitigate risks throughout the product lifecycle. Through this presentation, CS Analytical will review risks, qualification, and control strategies specifically for these unique systems. Topics will include a review of relevant compendial (USP / EP), and non-compendial tests and USP <1207> Container Closure Integrity through the product lifecycle – from development to stability.