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Challenges

Solving the Challenge of High pH Injectable Drug Products
Click Here

Solving the Challenge of Single-Use Large-Volume Delivery for Patient Self-Injection
Support
Regulatory Support
West Regulatory Affairs provides a single point of contact to assist with global registration strategies for all West products and processes.
Regulatory Support
Knowledge Center
The West Knowledge Center provides scientific insight and more detailed technical information on key areas of expertise featuring technical reports, bulletins and science posters.
Knowledge Center
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December 09, 2019
Evaluation of Container Systems with Residual Seal Force (RSF)
Parenteral drug products must be stored in a container system that provides good container closure integrity (CCI) over shelf life for the purpose of preventing environmental contamination. This system typically comprises a glass vial, elastomer stopper, and an aluminum seal. USP Chapter <1207> <em>Packaging Integrity Evaluation – Sterile Products</em> discusses in detail methods to measure CCI to determine if the system can meet the maximum allowable leak limit (MALL) for its specific drug product (i.e., the smallest gap, or leak rate, that places quality at risk). Critical to achieving good CCI is proper capping of the vial with the stopper and seal, making sure that the compression level of the stopper is appropriate.

Mary Tan
Specialist, Scientific Affairs, Singapore, Jurong
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