Prefilled Syringe Plunger Force Tester

The Prefilled Syringe Plunger Force Tester is widely used in the medical device industry, mainly for testing the push - force performance of prefilled syringes during the injection process.

Applications

- Quality Control and Supervision The push - force tester for prefilled syringes is an important tool for medical device manufacturers to conduct product quality control and supervision. Through testing, it can be ensured that the produced prefilled syringes comply with relevant national standards and regulations, thus improving product quality and safety.

- Performance Evaluation and Optimization This tester can be used to evaluate the push - force performance of prefilled syringes of different models and specifications, including parameters such as maximum push - force, minimum push - force, and average push - force. Through the analysis and comparison of test data, it can provide strong support for product performance optimization.

- R & D Support During the R & D process of prefilled syringes, the tester can be used to test the R & D effects and performance improvement of new products. The feedback of test data can help R & D personnel promptly identify problems and make improvements, thereby accelerating the product R & D progress and enhancing product quality.

- Fault Diagnosis and Repair For prefilled syringes with malfunctions, the tester can be used to identify fault points and determine repair solutions. Through the analysis of test data, the causes of faults can be found, and corresponding repair measures can be taken to ensure the normal operation of the equipment.

Standards

YY/T 0962 - 2021 : Determination of Push-force for Prefilled Syringes, etc.

Features

• A 7-inch color touchscreen with intelligent data processing functions provides users with a comfortable and smooth operating experience.

• Equipped with an advanced displacement control system to ensure testing accuracy.

• Simple and intuitive operation interface, convenient user-defined testing functions, and comprehensive data analysis and reporting capabilities.

• Automatic calibration and adjustment, making the operation simple and convenient.

• Brand new UI interface design and intuitive operation interface significantly improve the user experience.

• Automated design: the instrument automatically determines the end of the experiment and whether the results are qualified.

• Supports testing of various syringe sizes.

• Test fixtures designed strictly according to standards for easy clamping.

• Results display starting force, average force, and maximum force.

• During the test, the curve displays the test force value in real time.

• Speed is continuously adjustable from 0.05-500 mm/min.

• Features automatic data storage and power-off memory functions.

• Micro printer and universal USB data interface for convenient data output and transfer.

• The device has powerful built-in data storage capabilities, storing over 50.000 data entries.

• The computer software fully complies with GMP "Computerized Systems" requirements and includes user management, permission management, and data audit trail functions.

Technical Parameters

Serial No.	Parameter Item	Parameter Details
1	Force Measuring Range	0 - 50N (customizable according to actual needs); used to measure the push-force magnitude during prefilled syringes' injection process
2	Force Accuracy	Level 0.5 (error ±0.5%); ensures the accuracy and reliability of test results
3	Time Setting	Freely set within 0 - 9999 seconds; test time can be flexibly adjusted per test requirements
4	Test Speed	0.05 - 500mm/min (or customizable according to actual needs); controls the speed during injection process to simulate actual usage scenarios
5	Speed Accuracy	Level 1 (error ±1%); ensures the stability and accuracy of the test speed
6	Nominal Capacity	0 - 100ml (or customizable according to actual needs); suitable for testing prefilled syringes of different capacities
7	External Dimensions	e.g., 300mm×300mm×500mm (specific dimensions vary by model); facilitates placement and operation
8	Weight	Moderate; easy to carry and move
9	Power Supply	Usually 220V, 50Hz (customizable according to local electrical standards); ensures the tester's normal operation
10	Standard Configuration	Includes main unit, miniature printer, touch screen, test fixtures, etc.; meets test requirements and provides convenient operation interface & data recording functions

Accessoriess

Standard configuration: main unit, miniature printer, touchscreen, test fixture

Test Procedures

1. Preparation Before Operation

Equipment and Accessories Check:

Confirm that the instrument's power supply (220V 50Hz, customizable to local voltage) and standard configuration (main unit, miniature printer, touch screen, test fixture) are in normal working order; check the compatibility of the test fixture to ensure it matches the specifications of the syringe to be tested.

Sample Preparation:

Select pre-filled syringes that meet the test requirements (capacity 0-100ml, customizable as needed), ensuring that the syringes are undamaged, the plungers move smoothly, and they meet medical device cleanliness standards.

Environment and Standard Matching:

Place the equipment on a vibration-free workbench at 20±5℃, clearly define the standards that the test must meet, and confirm the acceptable threshold for plunger force.

2. Equipment Calibration

Start the instrument and enter the "Calibration Interface" via the touch screen;

Calibrate the force sensor (0.5 grade accuracy, error ±0.5%) and test speed (1 grade accuracy, error ±1%): Use standard weights to calibrate the force value, and verify the stability of the test speed using a standard speed source to ensure that the test accuracy meets the requirements.

3. Parameter Settings

Select the "Pre-filled Syringe Plunger Force Test" mode on the touch screen interface.

Set the core test parameters:

Force measurement range: 0-50N (customizable as needed);

Test speed: 0.05-500mm/min (simulating actual injection scenarios, adjustable as needed);

Test time: 0-9999 seconds (set according to syringe specifications);

Syringe capacity: Match the nominal capacity of the sample to be tested (0-100ml).

4. Sample Installation

Fix the pre-filled syringe in the dedicated test fixture, adjust the fixture position so that the syringe plunger is precisely aligned with the instrument's force measuring mechanism;

Confirm that the syringe is securely fixed, and the plunger is free from jamming or misalignment, to avoid improper installation affecting the test results.

5. Test Execution

After confirming that the parameters and sample installation are correct, click "Start Test";

The instrument automatically drives the force measuring mechanism to simulate the injection process and collects real-time plunger force data (including maximum plunger force, minimum plunger force, average plunger force, etc.);

During the test, the force curve can be monitored through the touch screen. If abnormal fluctuations occur (such as force exceeding the limit), the test can be paused to troubleshoot sample or equipment problems.

6. Data Processing and Application

After the test is completed, the instrument automatically stores the data and supports outputting a standard report through a miniature printer;

The report includes key plunger force parameters (maximum/minimum/average plunger force) and the judgment result of compliance with the standard, which can be used for:

Quality control: verifying whether the syringe meets national/industry standards;

Performance optimization: comparing plunger force data of different syringe models to support product improvement;

Fault diagnosis: analyzing the cause of plunger force fluctuations for abnormal samples and locating the fault point.

7. Post-Test Maintenance

Turn off the equipment power, remove the syringe under test, and clean residual impurities from the test fixture and force measuring mechanism;

Organize and archive the test report, check the remaining amount of equipment accessories (such as printer consumables), and regularly recheck the equipment calibration status to ensure long-term stable operation.

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