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Manufacture Packaging, Quality & Compliance, Analytical Science, Standards & Regulation, Technology and Equipment

Extracting Sense From E&L Science

Give us the quick lowdown on E&L…

Leachables are substances that come from – or “leach” out of – pharmaceutical packaging or manufacturing components and enter the drug product, resulting in patient exposure. Leachables can also stem from medical devices and transfer to the patient through contact with the medical device, either directly or indirectly. Extractables are substances that are observed to extract under laboratory conditions. Put another way, extractables are the components that may come out of a medical product, while leachables are compounds that do come out.

E&L analysis for drug products is required by regulators, including the FDA: “Drug product containers and closures shall not be reactive, additive, or absorptive so as to alter the safety, identity, strength, quality or purity of the drug beyond the official or established requirements”(1). The goal of E&L analysis is to protect patient safety and support drug and device manufacturers by identifying toxic leachables before they reach the patient.

Can you tell us more about the importance of understanding “materials of construction?”

Actually, the first step in conducting a proper E&L analysis is the determination of the materials of construction and product configuration. This information is essential for several reasons. First, it establishes the theoretical worst-case chemical release; in other words, which configuration of the product will release the most leachables. Second, it informs all of the data interpretation that will occur in any subsequent E&L studies. Over many years of practicing E&L analysis – and seeing many thousands of extractable compounds – I’ve found that most extractables and leachables can be logically related to one of the materials of construction. For this reason, it is important that the chemists interpreting E&L data have a clear picture of the material composition and configuration.

A thorough understanding of the product should include information on each of the materials of construction, such as the identities of each polymer and its additives package. This should also include the proportion of each material and its physical state (surface area and topography), along with the geometric distribution of the materials in the finished article. Information on any expected processing residues is also helpful, and the potential effects of sterilization should also be considered. Finally, it is advisable to consider if any of the materials of construction are likely to have constituents from the cohort of concern (3). Given the importance of this information for informing an E&L study, it begs the question: how is this information determined? The supplier is generally the primary source for information about the materials of construction, but in cases where the supplier is either unable or unwilling to provide comprehensive information then compositional testing is the next best alternative.

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