SLT-02 Syringe Leak Tester

Overview of the SLT-02 Syringe Leak Tester

Syringes are fundamental to numerous medical procedures, delivering precise doses of medication and ensuring patient safety. Cell Instruments, a leader in leak detection solutions, is proud to showcase its expertise in syringe leak testing. Through our advanced pressure decay leak testers, we are committed to maintaining the quality and safety of each syringe, advocating for the highest standards of healthcare.

The SLT-02 Syringe Leak Tester is an advanced device designed to test the integrity of syringes used in medical applications. Its primary function is to detect air leakage past the syringe plunger stopper during aspiration and ensure that the plunger stopper remains securely attached to the plunger. This testing process is essential for preventing medical errors caused by inaccurate doses, air embolisms, and other complications associated with syringe failure. By adhering to internationally recognized standards such as ISO 7886-1 and GB 15810, the SLT-02 is a trusted tool in ensuring syringe reliability and patient safety.

Applications of the Syringe Leak Tester

The SLT-02 Syringe Leak Tester plays a critical role in ensuring the safety and functionality of syringes used across various medical and pharmaceutical settings. The device is primarily used in:

• Syringe manufacturing: Ensuring that syringes produced for clinical and pharmaceutical use are free from defects that could compromise the effectiveness of medication delivery.
• Quality control in medical packaging: Verifying the integrity of pre-filled syringes, ampoules, and other injectable packaging, ensuring a secure seal and preventing contamination.
• Pharmaceutical laboratories and R&D: Supporting research and development efforts focused on creating new and more efficient syringes for different medical applications.
• Regulatory compliance: Ensuring that syringes meet the rigorous safety standards set by regulatory bodies worldwide, including ISO 7886-1.

Given the critical nature of accurate medication delivery, the Pre-filled Syringes Leak Detector function of the Syringe Leak Tester ensures that syringes perform without malfunctioning during use.

Necessity of Syringe Leak Testing

Ensuring the integrity of syringes is vital for accurate dosing and patient safety. Here’s why the Syringe Leak Tester is indispensable in medical device testing:

1. Preventing air embolism and dosage inaccuracies: Air leakage past the plunger stopper can introduce air into the syringe, which may lead to inaccurate medication delivery or even air embolism. The Syringe Leak Tester ensures syringes are airtight.
2. Protecting against plunger stopper detachment: A detaching plunger stopper can cause the syringe to fail entirely, preventing proper fluid expulsion and causing medical errors. The Syringe Leak Tester detects this risk before it becomes a problem.
3. Regulatory requirements: Compliance with international standards such as ISO 7886-1 is crucial for manufacturers to meet safety protocols and regulatory guidelines. The Syringe Leak Tester’s alignment with these standards makes it a necessary tool for manufacturers aiming to achieve certification.
4. Enhancing patient safety: By ensuring that syringes function reliably and consistently, manufacturers can contribute to improving overall patient safety by eliminating potential causes of injection-related issues.

Working Principle of the SLT-02 Syringe Leak Tester

The SLT-02 Syringe Leak Tester operates using a simple but effective test procedure:

1. The syringe is partially filled with water, which mimics the fluid the syringe will contain during actual use.
2. The syringe nozzle is connected to a compatible connection pipe.
3. A controlled negative pressure is applied to the syringe through the nozzle. This causes the plunger stopper to be subjected to vacuum conditions.
4. The syringe is then inspected for:
   • Leakage past the plunger stopper: Any leakage indicates a faulty seal that could lead to air bubbles entering the medication.
   • Plunger stopper detachment: If the stopper detaches from the plunger under vacuum conditions, it indicates a defect that could cause the syringe to fail during use.

The system creates a stable vacuum within the syringe using a Venturi tube, which is powered by compressed air, ensuring an efficient and precise testing process.

Technical Specifications of the SLT-02 Syringe Leak Tester

The SLT-02 Syringe Leak Tester offers a range of technical features that contribute to its accuracy and efficiency in testing syringes:

• Test Range: 0~-90KPa
• Air Input: 0.6~0.7 Mpa
• Test Time: 9999 hours
• Power Supply: 220V
• Vacuum Holding: Stable vacuum holding ensures precise testing results without fluctuations.
• Fixture Adjustability: The adjustable fixture accommodates syringes of various volumes for versatile use across different syringe sizes.
• Automatic Testing: After initiating the test, the system automatically runs the test process, reducing operator error and increasing efficiency.

Advantages of the SLT-02 Syringe Leak Tester

The SLT-02 Syringe Leak Tester stands out for several reasons:

1. Efficiency and Speed: The automated testing process allows rapid evaluation of syringes, enhancing productivity in manufacturing environments.
2. Accuracy: The stable vacuum and consistent pressure application ensure precise, reproducible test results.
3. Long-lasting durability: Built to withstand continuous use, the Syringe Leak Tester offers a long service life, ensuring reliability over time.
4. User-friendly design: The system’s intuitive interface allows easy operation, minimizing the need for extensive training.
5. Compliance with global standards: With adherence to ISO 7886-1, manufacturers can trust the Syringe Leak Tester to meet international regulatory requirements for syringe testing.

Configurations and Accessories

The SLT-02 Syringe Leak Tester comes with the following configuration:

• Control Unit: The main unit that controls the testing process.
• Syringe Stand: Holds the syringe in place during testing.
• Tube: Connects the syringe to the control unit for pressure application.
• Power Cord and Fuse: Essential for powering the unit and ensuring operational safety.

Additional models, such as the MST-01 Medical Syringe Tester, provide complementary testing options for manufacturers seeking to perform other types of tests related to syringes and packaging integrity.

Adherence to Standards

The SLT-02 Syringe Leak Tester complies with the following standards, ensuring its reliability and credibility:

• ISO 7886-1: International standard for syringes used in medical applications. This standard outlines requirements for syringes used for injection and infusion, including testing methods for leakage and stopper integrity.
• GB 15810: A Chinese national standard that applies to the testing of syringes, ensuring they meet required safety and quality specifications.
• ISO 8537

By adhering to these standards, the SLT-02 Syringe Leak Tester ensures that manufacturers meet global safety requirements, which is crucial for regulatory approval and certification.

Support and Training for SLT-02 Users

We understand the importance of proper operation and maintenance of the SLT-02 Syringe Leak Tester, which is why we offer comprehensive support and training services for users. Our services include:

• Installation and setup assistance to get the device up and running smoothly.
• Operator training to ensure efficient use of the tester and accurate results.
• Ongoing technical support to resolve any issues or questions that may arise during the testing process.
• Maintenance services to extend the life of the device and ensure it continues to operate at peak performance.

Frequently Asked Questions (FAQ)

1. What is the SLT-02 Syringe Leak Tester used for?

The SLT-02 is used to test the integrity of syringes by detecting air leakage past the plunger stopper and verifying that the plunger stopper remains securely attached during operation.

2. How does the SLT-02 work?

The device applies a controlled negative pressure to the syringe, inspecting it for any leakage or detachment of the plunger stopper.

3. Which standards does the SLT-02 comply with?

The SLT-02 complies with ISO 7886-1 and GB 15810, ensuring it meets international quality and safety standards.

4. Can the SLT-02 test syringes of different volumes?

Yes, the SLT-02 features an adjustable fixture that can accommodate syringes of various sizes.

5. Is training available for using the SLT-02 Syringe Leak Tester?

Yes, we offer comprehensive training and technical support for users to ensure proper use and maintenance of the tester.