An increased use of drugs in home-care situations has resulted in the growth of prefilled syringe (PFS) use due to their inherent benefits in convenience and handling over more traditional syringes. 

We help clients by performing PFS testing as part of their product development testing or to show conformance with appropriate standard requirements and/or demonstrate that the functional performance of the product satisfies the design requirements.

Expert support with prefilled syringes and accessories

Our experts provide guidance and support throughout the process ensuring clients have complete confidence in their prefilled syringe and its eventual use. Smithers has extensive experience supporting clients with characterisation and verification tests. We also develop and validate bespoke tests, which are subsequently used to provide evidence for regulatory submissions applicable to prefilled syringes for lyophilized drug/biologic and diluent syringe. 

Standard Testing

Typical standards we perform prefilled syringe testing to includes:
  • EN ISO 7886-1
  • EN ISO 8537
  • BS EN 20594-1 (ISO 594-1)
  • BS 3930-2 (ISO 594-2)
  • BS EN 1707
  • BS EN ISO 80369-1
  • BS EN ISO 80369-7
  • BS EN ISO 80369-20
  • BS EN ISO 7864
  • BS ISO 11608-1
  • BS ISO 11040-4
  • BS ISO 11040-5
  • BS ISO 11040-8
  • ISO 8362-5
  • ISO 8871-5

Depending on the intended use, prefilled syringes may require preparation before the drug can be administered. For example, often lyophilised active drug products are contained within a separate vial and a reconstitution process is required. In these cases where additional syringe components are required, it is essential that components not only comply with relevant standards, but are compatible with each other. 
  • Smithers can advise clients on additional tests that are not addressed in the relevant ISO standards but are still critical to demonstrate acceptable connectivity.
  • We offer performance testing on individual syringe components and the final assembled product filled with the drug or biologic.
See Syringe Testing for a full list of functional performance of the syringe and accessories.

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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