Physical and chemical properties of a container closure system for parenterals may affect the drug manufacturing process, product quality and patient safety. In the case of a lyophilized product, the risks are mainly associated with design for manufacturability and impact on product quality.
An extended stability study was designed to evaluate three halobutyl elastomer formulations for lyophilization stoppers on drug product leachables, residual moisture and container closure integrity of a model lyophilized preparation. The simulated liquid drug product was filled into vials and subsequently lyophilized using suitable lyophilization processing parameters. The lyophilized product was stored at controlled room temperature to be analyzed periodically over 4 years. Real time storage data up to 6 months will be presented. The chemical and physical data generated provide a better understanding of potential risks.
This webinar will showcase a comprehensive approach to understand potential risks to lyophilized drug product quality based on chemical and physical performance testing. The discussion will cover key considerations in the study design for manufacturability and packaging leveraging this analytical approach.
