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Leachables are chemical species that migrate from packaging or other components into the drug product under normal conditions. Request for the leachables data is typically raised on dossier submission and/or during audits.
Currently, the data necessary to identify and qualify leachables does not seem to be enforced consistently , but we are observing an increasing trend in the request for leachables data. The data to be submitted is recommended in guidance documents and USP recent chapters, but there are no common specifications for leachables as this is drug specific.
General lab screening methods for leachables may provide qualitative results only and cannot always detect what is selected or seen on a potential extractables list due to drug product interference. Hence, test methods should be developed and validated to deliver both qualitative and quantitative results specific to a drug product.
West is happy to discuss options and offerings available in support of drug manufacturers for extractables and leachables data. Please feel free to contact your Technical Customer Support representative for more information.
Every year, on November 11, countries from around the globe celebrate Veterans Day to honor the brave men and women who have served in the military.
West’s turns 100 today! A milestone that we are very proud of, and something few companies have the opportunity to celebrate. In honor of our 100th anniversary we are spotlighting our former President, Bill West, son of our founder Herman O. West.
Parenteral drug products must be stored in a container system that provides good container closure integrity (CCI) over shelf life for the purpose of preventing environmental contamination. This system typically comprises a glass vial, elastomer stopper, and an aluminum seal. USP Chapter <1207> <em>Packaging Integrity Evaluation – Sterile Products</em> discusses in detail methods to measure CCI to determine if the system can meet the maximum allowable leak limit (MALL) for its specific drug product (i.e., the smallest gap, or leak rate, that places quality at risk). Critical to achieving good CCI is proper capping of the vial with the stopper and seal, making sure that the compression level of the stopper is appropriate.
West Analytical Services, LLC continues to invest in the expertise and technology needed to support and partner with customers. This is essential to enable customers to pair new and more complex drug products with the right containment systems, delivery systems and combination products – and navigate the challenging, and ever-changing, regulatory environments. Expansion of the capabilities is focused in four critical areas: (1) extractables and leachables (E&L); (2) container closure integrity (CCI); (3) particle analysis; and (4) testing for packaging, devices and combination products.
Regulatory agencies are driving the pharmaceutical industry to continuously improve the quality of drug products, but what is the reality for a drug developer who is expected to make parenteral preparations “practically free from particles”? Expectations of packaging are changing fast but how well prepared is the packaging to meet these needs?
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