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Syringe testing: ISO 11040-4, ISO 11040-6, ISO 11040-8: (prefilled syringes)

referenced in USP (United States Pharmacopeia) Chapter 1382 and USP 382

The market for prefilled syringes (PFS) continues to grow. They are used for a wide variety of applications, from anticoagulants and biologics to autoinjectors. However, these devices are prone to failure due to their complex action mechanics and sensitivity to storage. They are therefore strictly regulated by international standards.

Syringe testing to ISO 11040 – Prefilled syringes is critical for safe dispensing of medications, anticoagulants and biologics. To meet the strict requirements of the annexes to the standard, the testing machine to be used must be equipped with a wide variety of interchangeable test fixtures that can accommodate a multitude of syringe types. Some of these tests also require a superimposed torsion drive.

ZwickRoell offers the right testing system for standardized syringe testing on prefilled syringes to EN ISO 11040 (ISO 11040-4, ISO 11040-6, ISO 11040-8) Thesetests are also referenced in USP (United States Pharmacopeia) Chapter <1382> and <382>.

Name Type Size Download
  • Industry brochure: Medical PDF 6 MB
  • Product Information:Traceable and reliable test results in accordance with FDA 21 CFR Part 11 PDF 1 MB

Overview of ISO 11040 – Prefilled syringes

  • ISO 11040-4: Glass barrels for injectables and sterilized subassembled syringes ready for filling (ISO 11040-4:2015)
  • ISO 11040-6: Plastic barrels for injectables and sterilized subassembled syringes ready for filling
  • ISO 11040-8: Requirements and test methods for finished prefilled syringes

USP (United States Pharmacopeia) Chapter 1382 and USP 382

  • ISO 11040-4, ISO 11040-6, and ISO 11040-8 are referenced in the United States Pharmacopeia USP <1382>
    The chapter <1382> provides information and guidance to assist in evaluating the functional proficiency of elastomeric components as part of packaging/drug delivery systems intended for parenteral dosage forms.
  • In addition, ISO 11040-4 and ISO 11040-8 are refrenced in the USP Chapter <381>. Chapter <382> addresses functional proficiency requirements for packaging/drug delivery systems intended for parenteral dosage forms.

What does USP (United States Pharmacopeia) mean?

ISO 11040-4: Mechanical testing on glass barrels for injectables

The ISO 11040-4 standard has ten annexes, in which the required mechanical tests are described:

  • C1: Flange breakage resistance
  • C2: Luer cone breakage resistance
  • E: Glide force test method to evaluate syringe lubrication
  • F: Needle penetration test
  • G1: Needle pull-out force
  • G2: Closure system liquid leakage test
  • G3: Luer lock adapter collar pull-off force
  • G4: Luer lock adapter collar torque resistance
  • G5: Luer lock rigid tip cap unscrewing torque
  • G6: Pull-off force of the tip cap or the needle shield

The interchangeable test fixtures are ideal for various syringe types and ensure that the testing of prefilled syringes is standardized.

Video: ISO 11040-4 and 11040-8: Syringe testing – prefilled syringes

Demonstration of test method to ISO 11040-8 and ISO 11040-4 with the zwickiLine materials testing machine, all necessary test fixtures and the testXpert III testing software.

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Testing system for syringes to ISO 11040

As a manufacturer of materials testing machines, ZwickRoell offers a complete product portfolio for testing to ISO 11040. With interchangeable testing adapters, the solution can be effortlessly adapted to different types of syringes and ensures that testing of prefilled syringes is standardized. The zwickiLine is the ideal single-column testing machine for this application, designed for testing with low forces up to 5 kN.

Traceable, tamper-proof test results in accordance with FDA 21 CFR Part 11

Traceable tamper-proof test results
  • Ever-increasing demands are placed on software used in the medical and pharmaceutical industries to document the traceability of completed actions.
  • With the traceability option, testXpert III enables logging of all actions and changes before, during and after the test, making test results and the documentation traceable and protecting them from manipulation.
  • Integrated user management and functions such as electronic records and electronic signature ensure that test results are always protected from tampering.
  • Together with the organizational measures and procedure instructions that apply to the individual companies themselves, the requirements of FDA in 21 CFR Part 11 are fulfilled.
  • ZwickRoell also offers a qualification service package (DQ/IQ/OQ) for validation support.
  • testXpert III logs all test and system related actions and settings and can therefore always answer the question  “When does who do what, why and who is responsible?”

Learn more about the testXpert III
Traceability option.