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Extractables and Leachables (E&Ls)
Extractable & Extractable Studies
Extractable Studies: Chemical analysis / testing that exposes a sample of the container closure system or manufacturing system part to a selected solvent system or conditions that either simulates the product formulation or aggressively extracts (but not destructs) the material at accelerated conditions in order to inform the potential for leachables under normal use. Therefore, extractables are the substances which are removed from the container closure or manufacturing material during studies. Extractable studies therefore can be used as a tool to assess risk from leachables.
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Leachable & Leachable Studies
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Leachable Studies: Chemical analysis of a drug product (or its surrogate) to detect the release of substances (leachables) that leach or are washed from the container closure system or manufacturing system into a drug product / medicine (placebo or active) under normal conditions of time and temperature and other relevant conditions that represent those of the intended use of the drug product. Leachables are therefore a potential risk to product quality and patient safety. Leachables studies (when done) are conducted as GMP activities in support of a drug product control strategy.
Maven E&L are subject matter expert in impurity management in pharmaceutical drug products, where these impurities are derived from materials used in container closure packaging or manufacturing process materials.
This is the topic area known as extractables and leachables (E&L). Maven E&L has experience in meeting regulatory expectations in this topic area over the last twenty years.
Over the last 15-20 years, regulatory interest has grow and expanded into a wide number of different dose form areas.
Starting in inhalation products (Metered Dose Inhalers (MDIs) Dry Powder Inhalers (DPIs) and Aqueous Nasal Sprays (ANSs)) then moving on to include small molecule parenterals, biopharmaceutical parenteral products and most recently gene therapies.
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E&L continues to develop, below is a 2024 Issues Map I have created which illustrates some of the current topics which are still being worked upon. Feel free to download a high resolution copy.
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2024 E&L Issues Map
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Maven E&L can offer:
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A personalised consultancy service to cover your Extractable and Leachable needs:
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Expert opinion on study design and study testing requirements
Creation of expert technical reports from your extractable or leachable test data ready for regulatory section compilation and submission
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Advice and access to analytical testing for extractables and leachables through our links to the best contract laboratories specialising in this area
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