11.02.22 -- Reduce Risk Of Drug Product Filing Delays

Container closure integrity (CCI) is essential to protect the drug product through its shelf life and to demonstrate an integral system to regulatory agencies. A proper risk-based approach enables the creation of a robust data file that can assist in the timely approval of regulatory applications.

Theoretical calculations can provide insight into how much a drug component will interact with delivery system materials. Predicting these interactions can enable scientists to exclude potentially problematic excipients and select the right packaging solution for their specific formulation.

There has been interest in early adoption of the new chapter and implementation of the various tests required by General chapter USP <382> Elastomeric Component Functional Suitability in Parenteral Product Packaging/Delivery Systems. Explore the scope and testing procedures.

Review the comparison of two container closure systems that differ by stopper hardness using comprehensive stack-up calculations performed by West’s DeltaCube™ Modeling Platform, and understand how the predictions link to small-scale capping studies and CCI evaluation.

The pharmaceutical and biotech industries face many challenges when selecting the appropriate vial, stopper, and seal combination for a drug product. Examine a case study where two 20 mm vial CCSs were compared using the DeltaCube Modeling Platform and experimentally show the link between prediction and real performance.

It is important to take a system approach when selecting vial container closure system (CCS) components and designing a fill/finish process. The DeltaCube Modeling Platform facilitates data-driven selection and optimization of vial CCS components.