The use of pre-filled syringes is becoming more and more prevalent as the preferred delivery device for parenteral drug products. 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.
For a pre-fillable syringe, ISO 11040 Part 4 (for glass barrels) or Part 6 (for plastic barrels) is the primary reference. For a finished pre-filled syringe, ISO 11040 Part 8 defines the required performance and design attributes. DDL assists a variety of customers with performance and mechanical testing of their prefilled syringes per the recommendations set out by the FDA and the related industry standards, including long-term stability studies to validate performance throughout the target shelf-life.
- ISO 11040 (Pre-filled syringes and related components)
- ISO 594 (Conical fittings with 6% (Luer) taper for syringes, needles and certain other medical equipment
- ISO 80369 (Small bore connectors for liquid and gases in healthcare applications)
- ISO 23908 (Needle Safety Devices)
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
Contact us for more information or to talk to an engineer.