USP <665>: Testing Of Plastic Components And Systems Used In Pharmaceutical Manufacturing

Navigating USP <665> compliance for plastic manufacturing components requires a clear understanding of process equipment-related leachables and their potential impact on patient safety. Establishing robust chemical characterization protocols ensures that risk-based evaluations meet regulatory expectations without unnecessary delays.

Effective extractables testing depends on precise solvent selection, appropriate extraction durations, and well-defined study conditions tailored to specific risk levels. Whether determining the scope of covered equipment, designing defensible extraction parameters, or interpreting data against justified thresholds, mastering these technical requirements safeguards product quality throughout the biopharmaceutical lifecycle.

Watch the full webinar to explore strategies for building a defensible extraction study package and mastering compliance.