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CONTAINER CLOSURE SYSTEMS FOR LYOPHILIZED DRUG PRODUCTS

April 19, 2021 | (7:00PM)
USA
SHARESHARESHARE
This webinar will cover the basics of lyophilization, Container Closure System considerations for lyophilized drug products, and factors influencing lyophilization performance and drug moisture content.

Lyophilization is the process of dehydrating a material at low temperature and reduced pressure (i.e., freeze drying). It is used to extend the shelf life of drug products, especially biologics. Through 2019, the United States Food and Drug Administration had approved over 400 drug products in lyophilized form with over 90% being delivered in single-use vials. The container system is crucial in maintaining the stability and integrity of the lyophilized product through its shelf life. The components in the container system must be carefully selected to ensure no adverse interaction with the drug product, reduce risk for potential of moisture migration and be suitable for the lyophilization process.