USP <382>: New Standards for Elastomeric Components in Injectable Pharmaceutical Packaging/Delivery Systems

USP <382>: New Standards for Elastomeric Components in Injectable Pharmaceutical Packaging/Delivery Systems
The pharmaceutical industry is entering a new era of quality and compliance with the introduction of USP <382>. This whitepaper from Smithers provides a comprehensive overview of the transition from USP <381> to USP <382>, detailing the implications for manufacturers, packaging engineers, and quality professionals.

With a focus on harmonization with international standards and FDA guidance, USP <382> establishes a standardized approach to assessing the functional suitability of elastomeric components in injectable packaging and delivery systems. 

What You’ll Discover in the Whitepaper

  • Key differences between USP <381> and USP <382>, and what they mean for functional testing.
  • Practical guidance for compliance, lifecycle management, and supplier requirements.
  • Overview of elastomeric components in packaging and delivery systems, including vial stoppers, syringe plungers, cartridge seals, and septa.
  • Summary of relevant standards, such as USP <1207>, USP <788>, ISO 11040, ISO 7886, ISO 8537, ISO 13926, ISO 11608, ISO 15747, ISO 15759, ISO 8362, ISO 8536, and ISO 8871.
  • Key mechanical performance assessments for closures, including self-sealing, penetrability, fragmentation, container closure integrity, and resealability.

Ready to navigate the new USP <382> landscape?

Download the whitepaper to gain expert insights and a clear understanding of how to future-proof your packaging and delivery systems.
Smithers_USP-382_Whitepaper_2025
Smithers_USP-382_Whitepaper_2025
Cancel
Show Policy

Latest Resources

See all resources