Leachables from container closure systems (both primary and secondary packaging component) that migrate into injectable vaccines and related biological products can have a potentially negative impact on safety and efficacy.    To assess the risk from leachables, extraction studies are designed to simulate both intended use and “worst case scenario” models to identify as extractables the leachables that could migrate.  At the end of the extraction study, an assessment of the observed extractables is done to determine if the risk justifies the need for additional leachables studies.

At Pine Lake Laboratories, we have extensive experience performing extraction studies on container closure systems commonly used for injectable vaccines and related biological products.   The extraction study design followed at Pine Lake Laboratories for injectable vaccines and related biological products is based upon the PQRI guidance for Parenteral and Ophthalmic Drug Products.

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