Intertek, a leading quality solutions provider to industries worldwide recently organised and presented a seminar ‘Manage your Extractable & Leachables Risk’ in Mumbai. The one-day seminar focused on providing detailed information and practical guidance on the issues associated with extractables and leachables (E/L) studies.
An important part of pharmaceutical development is the assessment of substances that could potentially leach (leachables) into the drug product from packaging, components of printing ink, catalyst residues and heavy metals. E/L studies provide qualitative and quantitative data to build a comprehensive profile of extractable components and determine the extent to which such components actually leach and potentially contaminate a drug substance or drug product.
The key topics of discussion were regulatory requirements and the basics of polymer stabilisation and degradation required in packaging of process, benefit of extractables and leachables testing for understanding the influence of material used in pharma process, concepts of designing and executing E&L studies of container closure system and E&L strategies for process material like tubing, filter media etc. The seminar provided insightful details regarding analytical approaches for evaluating E/L from different sources such as packaging or printing inks and also expert guidance on how to interpret analytical data in order to gain insight into risk assessment and validation of different manufacturing processes from an extractables and leachables perspective.
EP News Bureau – Mumbai
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