The 2025 edition of the Chinese Pharmacopoeia has put forward higher requirements for the testing of the pushing force of pre filled syringes. The testing must strictly follow the YY/T 0962-2021 standard and evaluate the pushing force performance by simulating clinical use conditions to ensure medication safety and user experience. The following are specific testing methods and equipment requirements:

1、 The core purpose of pushing force testing

Push force testing simulates actual injection scenarios to evaluate the smoothness of liquid injection during the use of the syringe. Excessive pushing force may lead to operational difficulties and affect patient compliance; If the pushing force is too small, it may cause unstable flow rate of the medication, resulting in inaccurate dosage. Therefore, precise control of pushing force is a key link in ensuring medication safety.

2、 Testing methods and standard requirements

1. test conditions

• Constant speed propulsionPush the push rod at a speed of 30mm/min to simulate clinical injection speed.

• Liquid mediumUse water or other simulated liquid medicine with labeled filling volume as the testing medium.

• Needle specificationsSelect the matching needle according to the type of syringe.

2. key parameters

• Pushing force curveRecord the changes in force values during the pushing process, analyze the maximum pushing force, average pushing force, and fluctuations.

• Qualification StandardThe pushing force must comply with the enterprise standard or quality agreement requirements, and the maximum pushing force usually does not exceed the specified threshold.

3. Test steps

• Sample fixationClamp the pre filled syringe in the dedicated fixture of the tester and set the testing distance to full range.

• Force measurementReal time recording of force changes during the pushing process through high-precision force sensors.

• data analysisTest the pushing force according to the prescribed method, record the maximum pushing force, minimum pushing force, and average pushing force values in the platform area of the pushing force curve

3、 Recommended testing equipment

1. HDT-02 Pre filled Syringe Pushing Force Tester

• Intelligent control system: supports constant speed propulsion to ensure testing consistency.

• Professional analysis software: Real time display of pushing force curve, automatic calculation of key parameters.

• Data Management: Supports data storage, printing, and permission management, in compliance with GMP requirements.

• Fixture adaptability: It can replace various specifications of fixtures and adapt to various specifications of syringe testing.

• Force measurement range: 0-50N, accuracy level 0.5.

• Speed control range: 0.05-500mm/min, infinitely adjustable.

• Sensor type: Equipped with advanced displacement control system to ensure accurate testing.

HDT-02 Pre filled Syringe Pushing Force Tester

4、 Key points of testing operation

1. Equipment CalibrationBefore starting up, it is necessary to calibrate the pressure and force sensors to ensure reliable test data.

2. Sample installationWhen fixing the syringe, ensure axial alignment to avoid deflection affecting the results.

3. Parameter SettingsAdjust the testing speed, force range, and other parameters according to the marked filling amount of the syringe.

4. Result determinationObserve whether the pushing force curve is stable, without any abnormal fluctuations or sudden increases.

Through pushing force testing, companies can optimize syringe design to ensure smooth injection and avoid recall risks caused by quality issues.