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Pharmaceutical Manufacturing and Packing Sourcer

Faster Moving E&L – A Reality

E&L studies are the evaluation of packaging and components used in manufacturing processes – for example, single-use technologies (SUT) – to ensure that they do not have a negative impact on the product or patient. E&L studies consider the migration of species from contact materials (of particular concern are elastomers and plastics) into a contact fluid stream or drug product.

The Challenge

Leachables, species that do migrate into the drug product, may be a hazard to the patient due to direct or indirect health (toxicological) effects, treatment efficacy, the manufacturing process, or by generating some other undesirable effect. Leachable studies are performed under real conditions and may be complex to establish or time consuming, such as in the case of primary packaging, the evaluation is performed over the duration of the product’s shelf life. Extractables are species that are forcibly extracted from contact materials, under a specific set of test conditions depending on the objective of that study. Extractable studies are, therefore, relatively ‘fast’, but some extractables may never actually become leachables.

Here lies the challenge:

  • Extractables can generally be quickly understood, however a large collection of potential leachables can be identified, making further evaluation challenging. A factor of extractable studies is that large amounts of data can be generated, meaning that true leachables are masked by dominant extractables or not generated if a leachable is only generated in the presence of the true contact fluid
  • Leachable studies are performed under accelerated or real-time conditions, performed over months and years. Additionally, extractables studies are often a prerequisite to a leachable study, and methods typically require evaluation and validation

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Michael Creese manages Smithers' E&L team of experts in the UK and works closely with Smithers’ E&L experts in the US. The E&L teams support pharmaceutical, biopharmaceutical, and medical devices manufacturers as well as organisations in the medical supply chain. Michael and the team perform risk evaluations, and manage and conduct E&L studies in cGMP laboratories, often working in parallel with other Smithers facilities conducting shipping and physical testing. He has been working with E&L for over 17 years and joined Smithers in 2009.
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Michael Creese
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