Article: Evaluating CCI of sterile vials using gas ingress
Posted: 20 May 2021 | Lighthouse Instruments | No comments yet
The article describes how CCI can be determined using Headspace gas ingress as a CCI test.
To ensure patient safety, pharmaceutical products must be kept properly packaged prior to use and container closure integrity (CCI) tests must be performed to ensure the package has not been compromised. One way to test for proper CCI is to analyse the headspace gas composition of the vial, and determining headspace gas ingress through a leak. This method is very similar to the probabilistic blue dye ingress method but has significant advantages.
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Analytical techniques, Biologics, Biopharmaceuticals, Biosimilars, Formulation, Freeze Drying, Manufacturing, QA/QC, Research & Development (R&D)
