Breaking Loose and Glide Force Testing: Ensuring Compliance with USP 382 and ISO 7886-1
Understanding the Importance of Break Loose and Glide Force Testing
In the medical and pharmaceutical industries, the reliability and performance of syringes are crucial for patient safety and effective medication delivery. Breaking loose and glide force testing is a critical process that evaluates the force required to initiate and maintain the movement of a syringe plunger within the barrel. This testing ensures that syringes operate smoothly, delivering medication without excessive force that could compromise patient safety.
USP 382 and ISO 7886-1 Standards for Testing Syringe Plunger Force
USP 382 and ISO 7886-1 are key standards that outline the requirements for testing syringe plunger force. These standards ensure that syringes meet high performance and safety criteria. USP 382 focuses on the functional requirements of syringes, while ISO 7886-1 Annex E specifies the test methods for determining the forces required to operate the syringe piston, including the push plunger force test.
Key Requirements of USP 382
- Objective: Ensure syringe functionality and safety.
- Parameters: Initial force, maximum force, sustained force.
- Significance: Compliance guarantees reliable syringe performance in clinical settings.
ISO 7886-1 Annex E: Push Plunger Force Test
- Objective: Measure the force required to move the plunger through the syringe barrel at a controlled speed.
- Procedure: Place the syringe in the tester and move the plunger at a predetermined rate.
- Parameters: Initial, maximum, and sustained forces are measured and compared against standard limits.
- Significance: Ensures syringes meet force requirements, crucial for safety and functionality.
Testing Syringe Plunger Force with Cell Instruments MST-01
The Cell Instruments MST-01 Syringe Plunger Force Tester is designed to meet the rigorous demands of medical device testing. It provides precise measurements of the force required to push the plunger of a syringe, ensuring that each syringe meets the high standards of performance and safety required in medical and pharmaceutical applications.
Technical Specifications of MST-01
- Test Range: 50N (or as required)
- Stroke: 200mm (without clamp)
- Test Speed: 1~500mm/min
- Displacement Accuracy: 0.01mm
- Accuracy: 0.5% F.S.
- Output: Screen, Microprinter, RS232(optional)
- Power: 110~220V
Key Features and Benefits
- Reliability and Precision: High accuracy and reliability with PLC control.
- Ease of Use: User-friendly interface for all skill levels.
- Durability: Built with high-quality materials for long-term use.
- Customer Support: Comprehensive support for installation, training, and maintenance.
Test Methods for Breaking Loose and Glide Force
Calibration and Setup
- Calibration: Calibrate the tester according to the specific syringe size and type.
- Setup: Secure the syringe in the testing fixture of the device.
Testing Process
- Initiate Test: Measure the force required to move the plunger.
- Data Collection: Record and display real-time data for immediate analysis.
Data Interpretation and Result Analysis
- Initial Force: The force needed to start moving the plunger.
- Maximum Force: The highest force recorded during the plunger’s movement.
- Sustained Force: The force required to maintain the plunger’s movement.
Analyzing these metrics helps determine whether a syringe meets the necessary performance standards. Data can be exported for further analysis and reporting, ensuring comprehensive documentation of each test.
Applications and Importance of Breaking Loose and Glide Force Testing
Medical Device Testing
Ensures syringes perform reliably and safely, critical for patient care.
Pharmaceutical Industry
Verifies syringes used for drug delivery meet safety and performance standards.
Quality Control in Manufacturing
Maintains high quality control standards, ensuring each syringe batch meets regulatory requirements.
Research and Development
Supports the development of new syringe designs and technologies with crucial data.
Customization and Automation Solutions by Cell Instruments
Customization Options
Tailored solutions to meet diverse testing needs, adapting the tester for different syringe sizes or integrating additional features.
Automation Transformation Servces
Enhancing productivity by automating the testing process, improving consistency, and reducing human error.
FAQ
A1: Breaking loose force testing measures the force required to initiate the movement of a syringe plunger within the barrel.
A2: Glide force testing ensures that the syringe plunger moves smoothly without excessive force, crucial for accurate and safe medication delivery.
A3: The MST-01 measures the force needed to push the syringe plunger, providing real-time data and analysis to ensure syringes meet performance standards.
A4: USP 382 and ISO 7886-1 are the key standards that outline the requirements for testing syringe plunger force.
A5: Yes, Cell Instruments offers customization options to adapt the tester for different syringe sizes and integrate additional features.
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