E&L for Injectable Vaccines and Related Biological Products
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. Analytical methods are needed to detect leachable in injectable vaccines and related biological products so that the toxicological risk can be assessed.
The first step toward developing analytical methods for leachables is to identify the extractables from the CCS that could become leachables by doing extraction studies. Extraction studies are designed to simulate both intended use and “worst case scenario” models to identify as extractables the leachables that could migrate. Analytical methods are then developed with sensitivity to detect the leachables in the finished product at the threshold determined by the toxicity of the leachable.
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.