The use of pre-filled glass and cyclic olefin polymer (COP) syringes is becoming more and more prevalent as the preferred delivery device for drugs and vaccines. Pre-filled syringes are a more efficient, reliable and convenient method for drug administration, helping to reduce drug waste and dosage errors while also improving safety.
A number of testing standards have been developed for the testing of syringes; however, significant gaps remain regarding the performance requirements of pre-filled syringes. The ISO standards related to pre-filled or pre-fillable syringes are:
- 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
In April 2013, the FDA released a guidance document on the use of ISO standards in the testing of pre-filled glass syringes in response to adverse events related to connectivity problems when certain glass syringes are used with connecting devices such as needles, needleless Luer connectors, adapters, and transfer units. As a reaction to the need for control and consistency of finished, pre-filled syringes, the ISO board released part 8 of the 11040 standard in 2016 to establish device requirements and methods for testing devices against those requirements.
DDL has assisted many customers in testing their pre-filled syringes per the recommendations set out by the FDA in their guidance document and is well prepared to help customers with their ISO 11040 testing needs.
Hypodermic Syringe Testing
One of the most common methods to administer therapies is the use of hypodermic syringes to inject substances into the body.
DDL performs the following testing for hypodermic syringe testing:
- 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
Please contact us for more information on pre-filled syringe and hypodermic syringe testing.