Lyophilization is a complex, time intensive and often challenging process. It has become a common manufacturing practice for parenteral pharmaceuticals that are unstable in aqueous solution. The process itself poses critical demands on primary packaging. Often the selection of packaging materials is considered too late in the development cycle of a lyophilized drug product to fully evaluate these complexities. Choosing an optimized container closure early for your drug application can improve yield, reduce line downtime, influence lyophilization performance and speed time to market.
Different stopper designs and elastomer formulations have different chemical, physical and functional characteristics. In the case of a lyophilized product, the choice of stopper and vial combination contribute not only to the ease of manufacturing, but also to product quality and stability. This free webinar will explore considerations of primary packaging selection and review potential risks based on chemical, physical and functional testing. The discussion will cover container closure challenges such as:
- Feeder bowl clumping and twinning
- Continuous feed along the rails
- Stability in the vented position
- Sticking to the lyo shelves
- Residual moisture content
- Drying and sterilization
- Extractables and leachables
President, Lyophilization Technology Inc.
Technical Account Manager, TCS, NA West Pharmaceutical Services