ISO 11040-4

Smithers Pira tests prefilled syringes to ISO 11040-4, assessing their characteristics and functional performance against the requirements set out in the standard.

Standard name: Prefilled syringes - Part 4: Glass barrels for injectables and sterilised sub-assembled syringes ready for filling (ISO 11040-4:2015)

Applicable medical devices:

This standard section applies to both tubing-glass barrels (single-chamber design) for injection preparations and sterilised sub-assembled syringes, ready for filling, but excludes plastic barrels for injectables and the glass cylinders, plunger stoppers and seals for dental local anaestetic cartridges.

Components which might complete the sub-assembled syringe (such as plunger or rod) are not covered as part of this standard section. Also demonstrating conformity to ISO 11040-4 standard alone does not ensure that the glass syringes can be properly connected to connecting devices (needles for injection, intravenous line luer connections, needleless luer locks, adapters, and transfer units), therefore to demonstrate this aspect all glass syringes intended to deliver drug or biological products have to meet the luer lock design as per ISO 594-2:1998. When a glass syringe is used with an injector or another device, additional ISO standards may apply.

Other ISO 11040 Sections that apply:

  • ISO 11040-1: 2015 Glass cylinders for dental local anaestetic cartridges
  • ISO 11040-2: 2011 Plunger stoppers for dental local anaesthetic cartridges
  • ISO 11040-3: 2012 Seals for dental local anaesthetic cartridges
  • ISO 11040-5: 2012 Plunger stoppers for injectables
  • ISO 11040-6: 2012 Plastic barrels for injectables and sterilized subassembled syringes ready for filling
  • ISO 11040-7: 2015 Packaging systems for sterilized subassembled syringes ready for filling
  • ISO 11040-8: 2016 Requirements and test methods for finished prefilled syringes

This standard section specifies materials, dimensions, quality, and performance requirements – along with the test methods to assess these elements.

Testing capabilities to ISO 11040-4 include:

  • Ease of assembly
  • Dimensions- syringe inner and outer diameter
  • Functional testing of Luer connection with refrence fittings
  • Hydrolitic resistance
  • Annealing quality
  • Lubrication of the inner surface
  • Luer cone breakage resistance (Break Force)
  • Barrel – lubrication gliding test force
  • Staked Needle – dimensions, design, lubrication, and pull out/off force/removal
  • Needles or syringes with Staked Needle – penetration force
  • Closure system – liquid leakage resistance, luer lock adaptor (LLA) collar pull-out force, and LLA collar torque resistance
  • Luer lock rigid tip cap unscrewing torque
  • Needle Shield/tip Cap Removal or pull-off force
  • Container closure integrity – dye solution tightness test

Bespoke Testing

In many instances, testing requirements are beyond the test method parameters set out in a standard. Alongside our standard testing services, our expert team is able to develop a custom testing programme to meet your specific testing requirements and resolve and design any functionality issues you might have.

Please note: The information outlined above is to be used as a reference. Please refer to the appropiate competent standards agency in your country for full details and implementation of ISO 11040-4:2015.

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