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Principles and methods for testing the sealing performance of pre filled syringes
Date: 2025-10-28Read: 1


Syringe tightness testMainly used to test the sealing and leakage performance of syringes under positive pressure conditions, ensuring medication safety. The main basis for the tightness testGB 15810 "Disposable Sterile Syringes"National standards, the following are key testing points:


预灌封注射器密合性能测试原理与方法

  1. Principle of sealing test for pre filled syringes:

  2. 1. Sealed syringe cone hole: Use a reference steel inner cone joint that complies with GB/T 1962.1 or GB/T 1962.2 to seal the syringe cone hole.

  3. 2. Apply lateral force: Apply a lateral force of 0.25 N to 3 N from a direction perpendicular to the core rod, so that the core rod is in the maximum bending position. ‌

  4. 3. Apply axial pressure: Simulate injection pressure (200 kPa or 300 kPa), hold for 30 ± 5 seconds, and observe for any liquid leakage.


  5. Steps of syringe tightness test method:

  6. 1. Water injection and sealing: pump water exceeding the nominal capacity (temperature 18 ℃~28 ℃), discharge air and adjust it to the nominal capacity.

  7. 2. Device connection: Close the tapered hole with a dedicated device to ensure the system is sealed.

  8. Result judgment: Trace amounts of liquid are allowed to exist between the sealing rings, but there must be no significant leakage at the piston or sealing ring.



Pre filled syringe positive pressure sealing testerCan be used to test the sealing performance of syringes under positive pressure environment, usually in compliance with GB15810 standard, supporting touch screen operation and automatic printing of test reports, making testing more accurate and efficient