SYRINGE TESTING 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:
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.
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.