USP <381>

Smithers Rapra can perform the complete chemical analysis and physical testing requirements of USP <381> for Elastomeric Closures for Injections typically used as part of a vial, bottle, or pre-fill syringe package system.

Testing is performed to assess the chemical safety of packaging systems and materials.

USP <381> testing includes:

Physicochemical tests:

  • Turbidity (opalescence) of a WFI extraction solution
  • Colour of a WFI extraction solution
  • Acidity or Alkalinity of a WFI extraction solution
  • Absorbance of a WFI extraction solution
  • Reducing Substances of a WFI extraction solution
  • Heavy metals of a WFI extraction solution
  • Extractable Zinc of a WFI extraction solution
  • Ammonium of a WFI extraction solution
  • Volatile sulphides

Functional tests:

  • Penetrability
  • Fragmentation
  • Self-Sealing

Components tested:

All elastomeric closures for injections typically used as part of a vial, bottle, or pre-fill syringe package system. 

Expert support for USP testing

Smithers are experts in materials, testing and have the capability to perform all physicochemical, chemical and physical testing detailed in USP <381>.

The combination of our experience and capabilities makes us an ideal partner for your studies.

Standards and Accreditation

All our work is performed to the requirements of ISO 17025:2005 and to the principals of cGMP. We are an FDA registered laboratory.