Primera works closely with our clients to design an Extractable and Leachable Study (E&L) that provides crucial information about their product. With many years of experience in designing and performing these studies, we can provide guidance for the recommended stress conditions and testing.
Protocols will be prepared that utilizes Product Quality Research Institute (PQRI), GMP, and USP guidance to assess the potential extractables and leachables. Although these studies can be done concurrently, Primera strongly recommends that they are done separately.
Simulation studies that reflect the expected product conditions (controlled conditions) can be customized to fit a client’s specific E&L needs.
When potential leachable substances are identified, Primera will work with our clients and their partners for in vitro toxicological risk assessment to facilitate regulatory filing of extractable leachable study results.
We can provide GMP method development and validation for the leachables of concern for monitoring in stability and product release programs.