Auto injector devices offer simplicity and safety for patients who have to administer injections themselves - although this can make testing their durability problematic for manufacturers.

Smithers can provide standard and non-standard testing on needle based and needle-free auto injector devices.

We assist clients with testing as part of their product development testing or to show conformity with appropriate standard requirements and/or demonstrate that the functional performance of the product satisfies design requirements.

We also develop and validate custom test protocols, which are subsequently used to provide evidence for regulatory submissions.

Typical tests for auto injector devices include:        

 Applicable standards:                                 

  • Activation/Actuation force
  • Dose accuracy / uncertainty
  • Expulsion time
  • Needle shielding
  • Pre-filled syringe testing
  • BS EN ISO 21649
  • ISO 11608-1
  • ISO 11608-2
  • ISO 11608-3
  • ISO 11608-4

Accreditation and Quality

Our laboratories are UKAS accredited to ISO 17025, and we can undertake activities with GMP compliance if required.
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