Risk Mitigation Strategies for Pre-filled Syringe Systems
US FDA Guidance defines the criteria for extractable and leachable testing
of container closure packaging components of pre-filled syringe systems; by
adopting strategies, such as the use of a barrier film on syringe plungers and
ready-to-sterilise components, the risk of such contamination can be mitigated.
Frances L DeGrazio, West Pharmaceutical Services, Inc (September 2010)
Keywords: US FDA Guidance extractable leachable testing
container closure packaging components pre-filled syringe systems strategies barrier film syringe plungers sterilise components contamination mitigated