Insights into Practical Issues Associated with Extractables Testing...
Presented by
Dennis Jenke at Triad Scientific Solutions and Pieter Van Wouwe at Nelson Labs
About this talk
Full title: Insights into Practical Issues Associated with Extractables Testing of Medical Devices
It is a well-known adage that “the devil is in the details.” As authoritative texts and regulatory guidelines that address the chemical characterization of medical devices usually present concepts and generalities and lack granularity, sponsors seeking to design and implement extraction studies for medical devices occasionally struggle to establish and justify critical experimental details that are scientifically sound, practical, achievable, and regulatorily compliant.
This presentation provides insights into several of these critical experimental details, addressing concepts that include:
The “It all comes out at Once” Paradox
Exhaustive Extractions as a Source of Kinetic Release Data
Predicting Exhaustive Extractions with a Minimum Number of Extraction Steps
A Rational (?) Approach to Quantitation and Managing the AET
Accurate versus Protective Quantitation
What exactly is a “Semi-polar” Solvent?
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