During the production of biologics, some chemicals or microorganisms may migrate through the packaging material into the biologic drug and eventually contaminate the product. Understanding the safety and suitability of the packaging material are key to being able to identify these impurities. The two main methods for testing the integrity of container closures are the Dye Ingress Method and the Microbial Ingress Method (both probabilistic tests).
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Sealing Test of Pharmaceutical Packaging Materials