SLT-02 Syringe Air Leakage Tester

To ensure the safety and performance of medical syringes, rigorous testing methods are critical. Among them, the syringe air leakage tester is a vital instrument that plays a central role in identifying potential leaks and plunger detachment during aspiration. Designed to comply with ISO 7886-1 and particularly Annex B, the SLT-02 Syringe Leak Tester from Cell Instruments delivers highly reliable results for professionals involved in syringe leak detection and ISO 7886 testing.

Understanding ISO 7886-1 Annex B and Syringe Leak Detection

ISO 7886-1, titled “Sterile hypodermic syringes for single use – Part 1: Syringes for manual use,” is the global standard outlining performance and safety requirements for medical syringes. Within this standard, Annex B describes the test method for air leakage past the syringe plunger stopper during aspiration, as well as the detection of plunger separation.

This method is crucial because air leakage in a syringe could compromise sterility, dosage accuracy, and patient safety. The procedure involves:

• Filling the syringe with at least 25% of its nominal capacity with water (18–28°C),

• Creating a vacuum pressure of 88 kPa below ambient pressure,

• Observing for any air leakage or plunger stopper detachment.

The SLT-02 is precisely engineered to replicate these conditions in a controlled, automated, and repeatable manner.

SLT-02 Syringe Air Leakage Tester

The SLT-02 Syringe Air Leakage Tester integrates a sophisticated vacuum generation system and stable control mechanism, enabling operators to efficiently perform syringe leakage tests with accuracy and consistency. Here’s what makes it a standout solution:

Key Features:

1. Stable vacuum holding for precise measurement.

2. Venturi tube technology for efficient negative pressure generation.

3. Adjustable clamping system accommodates various syringe volumes.

4. Automatic operation after test initiation—minimal user intervention required.

5. Durable construction ensures long service life in high-volume QC labs.

Technical Specifications:

Test Range	0~-90KPa
Input Air Pressure	0.6~0.7 Mpa
Test Duration	Up to 9999 hours (programmable)
Power Supply	220V

The tester includes a leak tester control unit, syringe stand, connection tubing, and necessary accessories, all built to meet stringent compliance requirements from GB 15810 and ISO 7886-1 Annex B.

Applications in Medical and Pharmaceutical Quality Control

The syringe air leakage tester is indispensable across multiple sectors, including:

• Medical device manufacturing, ensuring conformance with regulatory standards,

• Pharmaceutical packaging labs, for sterile product assurance,

• Third-party testing agencies, verifying product safety and consistency,

• R&D labs, for evaluating prototype syringe designs or materials.

Professionals involved in quality assurance and syringe leak detection rely on tools like the SLT-02 to not only meet compliance requirements but also to enhance their credibility and reduce product failure risks in the market.

Why Choose Cell Instruments’ SLT-02 for ISO 7886 Testing

As a leader in materials and packaging testing solutions, Cell Instruments Co., Ltd. offers not only robust hardware but also exceptional service, including:

• Customizable fixtures for special syringe sizes or requirements,

• Automation transformation services for production lines,

• Technical support rooted in deep knowledge of ISO 7886-1 and other international standards.

Our commitment to quality, precision, and customer satisfaction ensures your syringe testing meets the highest expectations.

The SLT-02 syringe air leakage tester is more than a device—it’s a comprehensive solution tailored for medical-grade accuracy and reliability. With full compliance to ISO 7886-1 Annex B, it supports professionals in conducting efficient, traceable, and standardized syringe leak detection.

Equip your lab with the SLT-02 from Cell Instruments—because syringe safety should never be compromised.

FAQs

1. What is the purpose of the syringe air leakage tester?
It is used to detect air leakage past the syringe plunger stopper and check if the plunger stopper becomes detached during aspiration.

2. Which standard governs the air leakage test for syringes?
The test is defined in ISO 7886-1 Annex B, which provides a detailed method for air leakage and plunger separation testing.

3. What type of syringes can be tested using the SLT-02?
The SLT-02 supports a wide range of syringe sizes and types designed for manual use, as outlined in ISO 7886-1.

4. How does the SLT-02 generate vacuum pressure?
It uses compressed air and venturi tube technology to create a controlled vacuum of up to -90 kPa.

5. Can the tester be customized for special syringe configurations?
Yes, Cell Instruments specializes in custom testing solutions and can tailor the device for unique syringe designs or test requirements.