ISO 11040-4:2024 "Pre filled syringes - Part 4: Glass sleeves for injection and semi assembled syringes to be filled after sterilization" is the core standard of the International Organization for Standardization for pre filled syringe packaging systems. It systematically specifies the technical requirements and operating specifications for the cap pull-out force tester to ensure the safety and reliability of the cap during transportation, storage, and clinical use. The following are the core requirements and key technical details of the testing equipment based on this standard:

1. Test purpose
Safety: Ensure that the protective cap does not come off during transportation and storage, avoiding needle contamination or drug leakage.
Usability: Ensure that medical staff or patients can remove the protective cap with a reasonable force during use, avoiding difficulties in operation or component damage caused by excessive pulling force.

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2. Testing methods

Axial stretching method: fix the syringe with a special fixture, pull the protective cap axially at a constant speed (100 ± 5mm/min), and record the maximum pulling force value (unit: N).
Force displacement curve analysis: The equipment needs to record the changes in force values in real time during the testing process, generate a curve to evaluate the stability of the combination between the protective cap and the syringe cone.

3. Key parameters
Pull out force range: Depending on the type and design of the protective cap, it is usually required to be between 4.0 and 45.0N.
Equipment accuracy: The indication error of the force measurement system should be ≤± 1%, and the displacement resolution should be ≥ 0.01mm.
Testing environment: The standard does not mandate temperature and humidity, but it is recommended to conduct the test in an environment of 23 ± 2 ℃ and relative humidity of 50 ± 5% to ensure data consistency.

4. Testing steps
Device initialization: Reset the sensor, set the testing speed to 100mm/min, and select the corresponding testing mode (such as "non locking protective cap pulling force").
Sample fixation: Fix the syringe vertically to the fixture, ensuring that the axis of the protective cap coincides with the direction of tension.
Test execution: Start the device until the protective cap is reachedallRemove the syringe and the system will automatically record the maximum force value and curve.
Result judgment: If the pull-out force is within the standard range and the curve has no abnormal fluctuations (such as a sudden decrease), it is judged as qualified; Otherwise, it is necessary to investigate the material, assembly process, or equipment status of the protective cap.