ISO 11040-4

เข็มฉีดยาสำเร็จรูป
Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling
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บทสรุปมาตรฐาน

The syringe leak test aims to verify the liquid leakage resistance of syringe closure systems under defined pressure conditions. According to Annex G2 of ISO 11040-4, the test simulates internal overpressure (typically 110 kPa) that syringes may experience during filling or transportation.

This test evaluates both needle shields และ tip caps, ensuring these closures remain secure and do not leak under stress.

ISO 11040-4

Such evaluation is vital for pharmaceutical quality control, preventing contamination, and safeguarding dosage accuracy.

Syringe Closure System Liquid Leakage Test Method

Key Test Steps (as per ISO 11040-4 Annex G2):

  • การเตรียมตัวอย่าง: Use sterilized, subassembled syringes ready for filling. Avoid disturbing the closure before the test.
  • Waiting Period: Allow a minimum of 12 hours between closure setting and testing.
  • Filling: Fill the syringe to between 1/3 and 2/3 of its nominal volume with distilled or equivalent-purity water.
  • การเพิ่มแรงดัน: Apply 110 kPa pressure using compressed air or a universal tensile and compression testing machine. Hold for 5 seconds.
  • Monitoring: Observe for liquid leakage during and after the test. Leakage appears as visible droplets on the outer closure surface.
  • Pass Criteria: No droplets should be visible, and the closure (tip cap or needle shield) must remain in place.

The testing is valid for both syringe barrels and sterile subassemblies. Visual inspection is essential to determine pass/fail results.

Essential Equipment for Syringe Leak Testing

The equipment setup for this test includes:

  • Universal tensile and compression tester หรือ compressed air pressurization system
  • Syringe holder with a secure sealing mechanism
  • Pressure gauge or software capable of achieving and maintaining 110 kPa
  • High-sampling rate data acquisition system (recommended 500 Hz for peak measurements)

Cell Instruments' Solutions:

To perform syringe leak tests in accordance with ISO 11040-4, Cell Instruments offers customizable syringe testing platforms, compatible with both compressed air and mechanical force application methods. Our systems ensure:

  • Accurate control of internal pressure
  • High-frequency sampling up to 500 Hz
  • Full compliance with ISO testing procedures
  • Automated documentation features for audit-ready reporting

Cell Instruments' Solutions:

To perform syringe leak tests in accordance with ISO 11040-4, Cell Instruments offers customizable syringe testing platforms, compatible with both compressed air and mechanical force application methods. Our systems ensure:

  • Accurate control of internal pressure
  • High-frequency sampling up to 500 Hz
  • Full compliance with ISO testing procedures
  • Automated documentation features for audit-ready reporting

Data Recording and Documentation

According to Annex G2, a complete test report must include:

  • Applied pressure (kPa) or equivalent force (N)
  • Number of tested syringes
  • Number of passed/failed samples
  • Visual observations or deviations

  • Traceability of setup parameters (manually or via software)

By documenting test conditions and outcomes, manufacturers demonstrate compliance with ISO 11040-4 and ensure regulatory traceability—a must for pharmaceutical quality systems.

Calculating Internal Force

For facilities applying mechanical force instead of air pressure, the required force (F) to simulate 110 kPa internal pressure can be calculated using the formulas from ISO 11040-4:

F = p × π/4 × d² × 10⁻³
Where:

  • F = Force in Newtons
  • p = Pressure (110 kPa)
  • d = Syringe internal diameter (mm)

This calculation helps ensure accurate test replication and device calibration.

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