Extractable and Leachables Studies: Designed and Performed to Meet all Intended Needs

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Since the FDA released their Container Closure Systems for Packaging Human Drugs and Biologics guidance in 1999, evaluation of final packaging components for extractables and leachables has become the expectation within the industry. Additionally, the increase in the use of single-use systems in manufacturing has drawn scrutiny as another potential source of extractables and leachables.

Extractables are compounds that can be extracted from a product contact material under exaggerated conditions such as elevated temperatures, extended storage times, or exposure to harsh extraction solutions. Leachables, which are typically a subset of extractables, are compounds that leach from product contact materials into the drug product under normal conditions of use. Sources of extractables and leachables compounds include antioxidants, antiozonants, UV stabilizers, plasticizers, processing aids, accelerants, coatings, elastomers, inks and vulcanizing agents, to name a few. Both extractables and leachables represent potential contaminants to a final product and may affect the pH or color of the product, impact the efficacy of the product, or alter the active ingredient. In addition, extractables and leachables compounds may be toxic.

This whitepaper provides an assessment of E&L testing guidances and typical approaches utilized.