Newsletter | November 2, 2022

11.02.22 -- Reduce Risk Of Drug Product Filing Delays

Container Closure Integrity: A Risk-Based Approach

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.

Streamlining Primary Container And Device Selection With Predictive Calculations

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.

Packaging/Delivery System Integrity And Self-Sealing Capacity Of Vial Systems

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.

Experimental And Theoretical Evaluation Of Vial Container Closure System Components

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.

Comparing Vial Container Closure Systems Using The DeltaCube Modeling Platform

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.

Selecting A Vial Container Closure System With The DeltaCube Modeling Platform

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.

De-Risk Container Closure Selection: DeltaCube Modeling Platform

West’s DeltaCube Modeling Platform was developed to help customers mitigate issues during the early phase of their component selection. This online, subscription-based modeling tool provides you with a data-driven approach to guide your vial, stopper, and seal combination selection.

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