Chemical characterization per ISO 10993-18 has become an important component of biocompatibility testing for medical devices. The Extractables and Leachables (E&L) study designs of pharmaceutical/biopharmaceutical products typically follow USP < 1663> / < 1664> and PQRI guidance, while chemical characterization of medical devices follows ISO 10993-18. Although the E&L analytical testing methodologies are similar, there are some differences in terms of study designs.
This presentation will overview the differences and similarity of E&L requirements between medical devices and pharmaceutical products. Several case studies related to recent regulatory expectations on the extractables and leachables testing of medical devices and combination products will be discussed.
Key Points: • Differences and Similarity on E&L study designs between ISO 10993-18 (Medical Device) and USP < 1663> / < 1664> (Drug Product). • Case studies related to recent regulatory expectations on the extractables and leachables testing of medical devices and combination products.
Learning Objectives:
Understand the concept of extractables and leachable testing
Know Differences and Similarity on E&L study designs between ISO 10993-18 (Medical Device) and USP / (Drug Product).
Understand recent regulatory expectations on the extractables and leachables testing of medical devices and combination products