Extractables And Leachables – Assessing Risk In A Complex Landscape

By Lauren Orme, West Pharmaceutical Services

Within the medical device market, there is still confusion on the topics of extractable and leachable testing, as well as the process of making sense of and reporting the data to the regulatory authorities. This article offers an outlined process for extractable and leachable analysis which starts with the optimal component selection, assesses extractable information gaps and design fit, and defines the leachables testing plan. For more on the steps of this valuation and questions to consider for each step, download the full paper.