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Vial system integrity and lack of sterility assurance are some of the leading causes of parenteral drug product recalls from a regulatory and patient safety perspective. According to USP <1207>, “Inherent package integrity is a measure of the leak tightness of a container-closure system, given anticipated variables of material composition, dimension, processing, assembly, package storage, distribution and use.” It can be challenging for pharmaceutical companies to develop truly integral vial systems due to limited knowledge surrounding container closure integrity (CCI) and sufficient data on primary packaging component variability. This webinar will focus on:

  • The regulatory expectations for container closure integrity (CCI).
  • Historic market challenges with sterile vial systems.
  • A new approach to container closure selection that utilizes component dimensional variability and big data

The DeltaCube™ Modeling Platform from West Pharmaceutical Services will also be introduced. This platform uses component dimensional data as a leading indicator to rapidly evaluate multiple CCSs. It also provides initial processing targets for rubber stopper compression and computes the most likely distribution of seal metal skirt length that will be available to crimp. The talk will detail how the platform complements a robust Quality by Design (QbD) approach to package development and links component selection, capping optimization and CCI to mitigate risk to vial system integrity, using both predictive and confirmatory assurance techniques. This can result in significant time savings when selecting CCS components, optimizing capping processes and predicting future vial system performance.

Anthony Bucci

Principal Research Engineer, Scientific Insights Lab, West Pharmaceutical Services

Anthony Bucci received his Ph.D. in Chemical Engineering from Drexel University. After graduating, he worked for the USDA as a Research Chemical Engineer and joined West Pharmaceutical Services in 2018. His focus at West is breaking down data silos and developing advanced analytics to support the selection, usage, and optimization of container closure system components. Anthony and is the technical lead for the DeltaCube Modeling Platform.

Jen Roark

Technology Manager, Container Closure Integrity, West Pharmaceutical Services

As Technology Manager, Jen supports West Pharmaceutical Services as a subject matter expert in container-closure Integrity testing. She has over 26 years of experience in analytical chemistry and quality control testing in a GMP environment; and over 15 years of experience with methods development and validation. Jen participates in standards development with AAMI, ASTM, and USP. She has co-published a series of articles on methods validation and co-instructed three Container-Closure Integrity Workshops for the Parenteral Drug Association in Europe.