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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

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