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Pharmaceutical Manufacturing and Packing Sourcer

Application of Simulation Studies to E&L Programmes



The primary aim of ‘extractables and leachables’ (E&L) projects is to protect patients through correct selection of packaging systems, or other materials used in the manufacture of drug products and delivery systems/devices. E&L studies are well understood in the field of medicinal products with clear definitions. The US Pharmacopeia (USP) 43-NF 38 <1663> defines extractables and leachables as the following:

“Extractables are organic and inorganic chemical entities that are released from a pharmaceutical packaging/delivery system, packaging component, or packaging material of construction and into an extraction solvent under laboratory conditions. Extractables themselves, or substances derived from extractables, have the potential to leach into a drug product under normal conditions of storage and use and thus become leachables.”

“Leachables are foreign organic and inorganic chemical entities that are present in a packaged drug product because they have leached into the packaged drug product from a packaging/delivery system, packaging component, or packaging material of construction under normal conditions of storage and use or during accelerated drug product stability studies.”

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About the author


Michael Creese manages Smithers’ E&L and chemical analysis consultancy team in the UK. He has been working with E&L for over 16 years both for biopharmaceuticals and pharmaceuticals, and joined Smithers in 2009. Previously, Michael worked in the validation department for one of the largest single-use system suppliers and, previous to that, a petrochemical organisation. His expertise lies in E&L, chemical analysis, method validation, method development, and training. Michael has used this expertise to solve the challenges of the assessment of E&Ls for single-use system suppliers and users (bags, tubing, filters, and connectors) and final container closure systems (pMDIs, stoppers, vials, pre-filled syringes, and cartridges). Michael’s team supports a diverse range of clients and industries require the support of analytical experts working within a cGMP and ISO17025 environment.
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