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Understanding Risks of Steam vs. Gamma Processing of Elastomeric Components


To understand the impact of typical sterilization methods on elastomeric components, West Pharmaceutical Services, Inc. conducted a study that evaluated extractables, physical properties and functional properties of common elastomer formulations after exposure to either steam and gamma irradiation. The processing used on any component can have a significant impact on extractable profiles, physical properties and functional properties; therefore, the method of sterilization should be evaluated thoroughly to understand possible effects.

The data generated in these studies showed that  high-dose gamma irradiation had a greater negative impact to elastomers than steam, indicated by the higher number of extractables for gamma irradiated samples. As the gamma irradiation energy level increased, the amount of extractables was found to increase as well. 

The study showed that processing can potentially effect closure performance and drug-closure  interactions.  As a result, the method of sterilization of the elastomeric components should be evaluated thoroughly to understand possible effects to ensure a safe, efficacious and deliverable drug product.

For more information and detailed study results, customers can register to access West's library of technical information to read the full report. The West Technical Resource Library includes:

  • Technical reports and bulletins
  • Scientific posters
  • Component drawings
  • Seminar presentations

Visit to register now.