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While the development of single‐use process equipment and drug storage containers made from plastic materials has increased in line with demand, extractables and leachables from these materials have become a topic of concern for the pharmaceutical and biopharmaceutical industry. Consequently, appropriate testing strategies and practices are required to ensure the quality and safety of drug products.
This Extractables / Leachables section is a new and unique platform to discuss and develop scientific based and practical approaches to extractables and leachables testing.
A major focus will be on the process specific leachables testing using the actual product as test solution this is designed for individuals from development, manufacturing, validation, quality assurance and compliance who are confronted with the challenges of extractables and leachables testing in pharmaceutical and biopharmaceutical industry.