Syringe liquid leakage testers are essential tools in ensuring the safety and reliability of syringes used in medical applications. These instruments help manufacturers detect any leakage from syringes under pressure, ensuring that the syringes meet the stringent standards for functionality and safety, particularly in healthcare and pharmaceutical industries.
Cell Instruments’ Syringe Leak Testing Solution
At Cell Instruments, we offer the SPPT-01 Syringe Liquid Leakage Tester, a sophisticated solution designed to help manufacturers conduct syringe liquid leakage tests with precision and efficiency. This tester complies with ISO 7886-1 and is equipped with advanced features such as:
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PLC Control & 7-inch HMI Touchscreen: Easy operation and precise control of the testing process.
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Adjustable Test Speed: Allows flexibility in testing various syringe types.
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High Accuracy: With a load cell of up to 200N and an accuracy of 0.01mm, our tester ensures highly reliable results.
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Multiple Fixtures: Suitable for different syringe sizes and types, making it versatile for various testing requirements.
By using Cell Instruments’ syringe leak testing equipment, you can ensure that your syringes meet the highest quality standards and pass critical leakage tests.
Understanding Syringe Liquid Leakage Testing
Syringe liquid leakage testers are designed to check the integrity of syringes by simulating the conditions they will face during use. The primary purpose of these tests is to ensure that syringes do not leak under pressure, which could compromise their performance and patient safety. Leak testing involves applying pressure to the syringe and checking for any leakage past the plunger stopper seal.
The ISO 7886-1 testing standard is crucial for manufacturers when it comes to evaluating the leakage of syringes. It outlines the proper procedures for testing syringes to detect any leakage that might occur due to manufacturing defects, damage, or improper sealing. The ISO 7886-1 standard specifies methods for testing the syringe’s ability to maintain pressure and ensure that no liquid escapes during use.
Syringe Leak Testing Methodology: A Step-by-Step Process
The process for syringe leak testing is relatively straightforward but requires precise equipment to guarantee accurate results. Here’s an overview of the key steps involved:
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Filling the Syringe: The syringe is filled with distilled water to its nominal capacity. The water should be at a temperature between 18°C and 28°C to avoid any test discrepancies.
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Sealing the Nozzle: Once filled, the syringe nozzle is sealed using a suitable device, ensuring no air can escape during the test.
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Applying Sideways Force: A sideways force is applied to the syringe plunger at a right angle to the plunger’s motion. This force is applied in such a way as to swing the plunger radially about the piston seal, creating conditions that simulate real-world usage.
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Generating Pressure: Pressure, typically in the range of 200 kPa to 300 kPa, is applied to the syringe to test its resistance to leakage. The syringe must withstand the pressure without any liquid escaping past the stopper seal.
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Inspecting for Leakage: After maintaining the pressure for 30 to 35 seconds, the syringe is carefully examined for any signs of leakage. If any water is observed leaking past the stopper, the syringe fails the test.
This testing method ensures that the syringes manufactured meet the necessary safety standards and are reliable in medical procedures where leakage could lead to serious issues.
Relevant Standards: ISO 7886-1 Testing
ISO 7886-1 specifies the requirements for sterile hypodermic syringes intended for manual use. This standard includes a detailed procedure for testing syringe performance under different conditions, including the test for liquid leakage at the syringe plunger stopper under compression. By adhering to these standards, manufacturers can ensure that their products meet global safety requirements and are suitable for medical use.
Key aspects of ISO 7886-1 testing:
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Test Environment: The test must be conducted under controlled conditions, with the syringe filled with distilled water.
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Leakage Detection: Any leakage past the plunger stopper under the specified test conditions results in failure.
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Reporting: The test results must include details such as syringe identity, nominal capacity, and the presence of leakage.
The ISO 7886-1 standard helps to establish uniformity and consistency in syringe manufacturing, which is crucial for both manufacturers and end-users in the medical field.
Benefits of Using a Syringe Liquid Leakage Tester
Using a syringe liquid leakage tester offers several advantages:
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Ensures Patient Safety: By detecting any potential leakage, manufacturers can guarantee that their syringes will function as intended during medical procedures, preventing accidents and ensuring patient safety.
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Compliance with Industry Standards: Following the ISO 7886-1 standard ensures that syringes meet international safety and quality standards, which is critical for regulatory approvals and market acceptance.
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Prevention of Costly Failures: Testing syringes for leaks before they reach the market helps avoid costly recalls and damage to the manufacturer’s reputation.
Syringe liquid leakage testing is a crucial part of ensuring that medical syringes perform safely and reliably. The use of advanced testing equipment like the SPPT-01 Syringe Liquid Leakage Tester from Cell Instruments helps manufacturers meet the demanding requirements of standards such as ISO 7886-1, ensuring that their syringes are fit for use in medical procedures. By investing in quality testing equipment, manufacturers can improve product quality, enhance patient safety, and remain compliant with international standards.