Identification of Approaches to Simulated Leachable Studies

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Presented by

Jason Creasey, Managing Director at Maven E&L and Karen Pieters, Ir. Team Leader E&L at Nelson Labs Europe

About this talk

Full Title: Identification of Approaches to Simulated Leachable Studies: What are They? When to do Them? Presented by Jason Creasey, Managing Director at Maven E&L Ltd. Followed by an Industry Perspective presentation presented by Karen Pieters, Ir. Team Leader Extractables and Leachables at Nelson Labs Europe The term “Simulated leachable studies” is open to interpretation. I hope to provide a definition of this term and in doing so suggest when they can and should be used. The general aim of such studies is to provide an accurate qualitative and quantitative description of the substances which might be present as leachables in a pharmaceutical drug product (DP) derived from container closure system (and sometimes its manufacturing process) when the drug product is stored up to and including its shelf-life. Simulated studies provide an alternative to analysis of leachables directly in the drug product. A simulated study aims to avoid some of the downfalls of leachable analysis such as; inaccurate analysis of leachables due to interference from drug product and/or formulation elements, availability of stored DP samples, reaching required limits of detection in the DP and time / resource constraints associated with complex method development using DP. Simulated leachable studies must be able to accurately simulate the expected leachables in a DP and should be carefully crafted to achieve this. The system used for extraction must have similar propensity to leach from materials under study a drug product and care must be taken not to use system which either leach too much (potentially masking other substance) or too little.

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