2 Mar 2023

Design of a New Elastomer Formulation for Lyophilization Applications

4040/40 elastomer formulation was designed with ‘future in mind’ to meet the ever-increasing performance & quality standards expected of primary drug packaging. The presentation will summarize the extensive Quality by Design (QbD) process that was undertaken to develop this new formulation as well as considerations taken for closure design dedicated for Lyophilization applications. Details of the extensive characterization that was performed as part of product development as well as data to demonstrates the overall performance of the new rubber formulation for lyophilization stoppers with respect to Extractables/Leachables, Particulates, Moisture, Container Closure Integrity (CCI), Particles and Manufacturability will be presented.

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West Pharmaceutical Services, Inc.

  • US
  • 2017
    On CPHI since
  • 4
  • 5000+
Company types
Drug delivery device Supplier/Manufacturer
Packaging supplier/manufacturer
Primary activities
Contract Manufacturer
Laboratory Services
Medical Devices
Packaging & drug delivery
Regulatory Affairs

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