The syringe leak tester is an essential tool for quality control in medical device manufacturing. Ensuring that syringes remain leak-free is vital for patient safety and product reliability. This article delves into the liquid leakage test process and highlights the importance of standards like ISO 7886-1 and ISO 11040-4 to help you understand how to effectively evaluate syringe performance.
Introduction
syringe leak tester is designed to assess the integrity of syringe components by measuring their resistance to liquid leakage. This testing process is crucial for preventing contamination, maintaining sterility, and complying with regulatory standards.
The tester typically consists of:
- A sealing device for the syringe nozzle.
- A mechanism to apply sideways and axial forces.
- Pressure generation systems.
- A visual inspection area to detect leakage.
By using precise instrumentation, the syringe leak tester helps ensure syringes meet stringent quality requirements.
Applications of Syringe Leak Testers
The syringe leak tester is widely used in:
- Medical device manufacturing to ensure compliance with global standards.
- Pharmaceutical filling processes to guarantee product safety during storage and transportation.
- Quality control laboratories for routine syringe batch testing.
- Research and development to validate new syringe designs.
At Cell Instruments, we specialize in providing advanced testing solutions, including customizable syringe leak testers that cater to specific needs in medical, pharmaceutical, and related industries.
Standard
Compliance with ISO 7886-1
ISO 7886-1 is a globally recognized standard that specifies the design and performance requirements for sterile hypodermic syringes for single use. Annex D of ISO 7886-1 provides the normative test method for liquid leakage at the syringe plunger stopper under compression.
This test method effectively simulates real-world stresses on the syringe, ensuring product integrity and compliance with ISO 7886-1.
Key Requirements from ISO 7886-1 Annex D
The liquid leakage test ensures that the plunger stopper seal can withstand internal pressure without allowing fluid to escape. Here’s a brief overview of the test procedure:
- Fill the syringe with distilled water (temperature: 18 °C to 28 °C) to its nominal capacity.
- Seal the syringe nozzle.
- Apply a sideways force (0.25 N to 3 N) at a right angle to the plunger. This ensures maximum deflection from the axial position.
- Apply an axial force to generate internal pressures of 200 kPa or 300 kPa.
- Maintain this pressure for 30 to 35 seconds.
- Visually inspect the syringe for any liquid leakage around the plunger stopper.
Compliance with ISO 11040-4
For prefilled syringes, the ISO 11040-4 standard is critical. Specifically, Annex G.2 addresses the liquid leakage test for syringe closure systems, including the tip cap and needle shield.
Key Requirements from ISO 11040-4 Annex G2
Key points of the liquid leakage test in ISO 11040-4 include:
- The syringe is filled to between 1/3 and 2/3 of its nominal volume with a reagent.
- A pressure of 110 kPa is applied for 5 seconds to simulate overpressure scenarios during filling or transportation.
- The force exerted is calculated based on the syringe barrel’s inner diameter, ensuring accurate and repeatable testing conditions.
- After pressure release, the syringe is examined visually for any droplets or displaced components.
Working Principle
A syringe leak tester operates by creating a controlled vacuum within the syringe while monitoring pressure stability. The SLT-02 Syringe Leak Tester, for example, utilizes:
Key Technical Specifications
| Load Cell | 200N (or as required) |
| Test Speed | 1~500mm/min |
| Accuracy | 0.01mm |
| Power | 110~220V 50/60Hz |
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