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.
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
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.
FAQ
1. What is the main function of the Prefilled Syringe Plunger Force Tester?
The Prefilled Syringe Plunger Force Tester is primarily used to test the push-force performance of prefilled syringes during the injection process. It measures key force parameters such as starting force, maximum force, minimum force, and average force while simulating real injection conditions at controlled speeds. By accurately recording real-time force curves and numerical data, the tester helps evaluate whether the syringe plunger operates smoothly and consistently, ensuring compliance with relevant standards and supporting quality assurance, performance evaluation, and product optimization in the medical device industry.
2. How does this tester support quality control and product optimization?
In quality control, the tester is used by medical device manufacturers to verify that prefilled syringes meet applicable national and industry standards, including YY/T 0962-2021. It ensures product safety and consistency by detecting abnormal push-force values. For performance evaluation and optimization, the instrument compares push-force data across different syringe models and specifications. By analyzing parameters such as maximum, minimum, and average plunger force, manufacturers and R&D teams can identify design or process issues, optimize syringe performance, and improve overall product quality and reliability.
3. Which standards does the Prefilled Syringe Plunger Force Tester comply with?
The tester complies with YY/T 0962-2021. which specifies the determination of push-force for prefilled syringes. This standard defines test requirements and ensures the accuracy and reliability of push-force measurement results.
4. What force and speed ranges can the instrument measure?
The instrument has a force measuring range of 0–50 N, which can be customized according to actual testing needs. The test speed is continuously adjustable from 0.05 to 500 mm/min, allowing simulation of different injection scenarios and syringe operating conditions.
5. What data and test results does the tester provide during operation?
During testing, the instrument displays real-time force curves on the touch screen and records starting force, average force, and maximum force values. After the test, it automatically stores the data, determines whether the results are qualified, and supports report output via a built-in micro printer or USB interface.
6. What features improve data security and data management?
The tester has powerful built-in data storage capable of storing more than 50.000 data entries. Its computer software complies with GMP “Computerized Systems” requirements and includes user management, permission management, and data audit trail functions, ensuring data integrity and traceability.
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