Syringe Testing2018-08-16T16:52:07+00:00

STANDARDIZED SYRINGE TESTING

The medical device community is continually faced with the challenge of providing patients with reliable solutions for drug delivery.  One of the “go-to” delivery platforms are syringes.   Glass or plastic syringes are often used in connection with Luer fittings for injection needles, adapters or transfer devices.   Another common syringe platform is pre-filled syringes, filled with a fixed dose of drug product in a combination product.

Standardized testing per ISO Syringe Testing standards provides medical device manufacturers and drug delivery experts a common basis for producing reliable test results.

Our syringe test programs support our clients during product development, functional performance and design verification testing to ensure your product is ready for submission to the appropriate regulatory agency.

WE ROUTINELY PERFORM TESTING ON A VARIETY OF SYRINGE TYPES, INCLUDING:

  • Prefilled syringes
  • Hypodermic syringes
  • Glass syringes
  • Plastic syringes
drug delivery device - prefilled syringes

TEST STANDARDS

ZebraSci offers a complete portfolio of test solutions to the following standards. In addition, our experienced team is adept at method development and validation of non-standard testing; we can help you quantifiably assess properties outside the boundaries of standard tests.
  • ISO 11040-4 – Pre-filled syringes – Part 4: Glass barrels for injectables and ready-to-use pre-fillable syringes
  • ISO 11040-6 – Pre-filled syringes – Part 6: Plastic barrels for injectables
  • ISO 11040-8 – Pre-filled syringes – Part 8: Requirements and test methods for finished prefilled syringes
  • ISO 7886-1 – Sterile hypodermic syringes for single use – Part 1: Syringes for manual use.
  • ISO 7886-2 – Sterile hypodermic syringes for single use – Part 2: Syringes for use with power-driven syringe pumps.
  • ISO 7886-3 – Sterile hypodermic syringes for single use – Part 3: Auto-disable syringes for fixed-dose immunization.
  • ISO 7886-4 – Sterile hypodermic syringes for single use – Part 4: Syringes with re-use prevention feature.

Additional standards related to syringe testing include:

  • ISO 8537 – Sterile single-use syringes, with or without needle, for insulin.
  • ISO 11608 – Needle-based injection systems
With a wealth of knowledge and experience in laboratory testing and regulatory guidance’s, ZebraSci partners with our clients to mitigate the risks associated with developing container/package systems for pharmaceutical, biotechnology and medical device. Contact us today to learn more about syringe testing.

ISO 11040-4 TESTING

ISO 11040-4 Prefilled syringes — Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling defines the following tests:

ISO 11040-6 TESTING

ISO 11040-6 Prefilled syringes — Part 6: Plastic barrels for injectables defines the following tests:

ISO 11040-8 TESTING

ISO 11040-8 Prefilled syringes — Part 8: Requirements and test methods for finished prefilled syringes defines the following tests:
ZebraSci offers a complete portfolio of test solutions for all types of syringes.

Contact ZebraSci today to learn more about syringes and our drug delivery / combination product development solutions.