Syringe Leak Test Method – Liquid Leakage Test

Ensuring the integrity of syringes is essential for patient safety and product quality in the medical and pharmaceutical industries. One of the most critical procedures for quality control is the syringe leak test method, which determines whether a syringe can prevent liquid leakage under specific conditions. This test is particularly crucial for both manually operated disposable syringes and prefilled syringes used in automated delivery systems.

Syringe Leak Test Method Overview

را syringe leak test method refers to the process of verifying whether liquid leaks from the syringe body or closure system when subjected to mechanical stress or internal pressure. Leakage can compromise sterility and dosage accuracy, posing serious risks to users.

There are two primary standards that govern syringe leakage testing:

• ISO 7886-1: Focuses on syringes for manual use, commonly known as disposable syringes.
• ISO 11040-4: Applies to glass barrels for prefilled syringes, especially those used in automated fill-finish processes.

Each standard defines specific apparatus, conditions, and test parameters to evaluate the leak resistance of different syringe types.

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Syringe Liquid Leakage Test under Compression

According to Annex D of ISO 7886-1, the goal is to assess leakage past the plunger stopper seal when force is applied. The steps include:

• Filling the syringe with distilled water above its nominal capacity.
• Expelling air, then adjusting water to the nominal volume.
• Sealing the syringe nozzle using a reference steel conical fitting compliant with ISO 80369-7.
• Applying a sideways force of 0.25–3 N to induce radial movement in the plunger.
• Applying axial pressure (200 or 300 kPa) to the plunger for 30–35 seconds.

معیارهای قبولی/شکست: No water should leak past the plunger stopper seal. Results must be documented with syringe capacity, leakage observations, and test date.

Recommended Instrument:

Cell Instruments’ SPPT-01 Syringe Plunger Leakage Tester automates this process, ensuring precise control of force and pressure, while offering easy test reporting.

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Leak Test for Prefilled Syringes (ISO 11040-4 Annex G3)

Syringe Closure System Leak Test

Recommended Instrument:

Cell Instruments’ MST-01 Medical Device Tester offers both air pressurization and mechanical compression options. It supports high-frequency sampling (≥100 Hz), increasing the accuracy and repeatability of results.

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Why Syringe Leak Testing Matters

Leakage in syringes not only leads to dosage loss and contamination but also fails regulatory compliance. Adhering to ISO 7886-1 و ISO 11040-4:

• Enhances patient safety and product reliability.
• Supports quality assurance during production.
• Ensures regulatory approval for domestic and international markets.

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Selecting the Right Medical Device Leak Tester

Choosing the correct medical device leak tester depends on syringe type, testing volume, and automation needs. For manufacturers dealing with a wide variety of syringes—including both disposable and prefilled options—it’s vital to use versatile instruments that can simulate all required forces and pressures as defined by the standards.

ابزارهای سلولی offers customizable, automated solutions like the SPPT-01 و SLT-01, ideal for both R&D and production line environments.

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Understanding the syringe leak test method is crucial for maintaining the quality and safety of medical devices. Whether you’re working with manual-use syringes or prefilled glass barrels, compliance with ISO 7886-1 و ISO 11040-4 ensures that every unit performs reliably under real-world conditions. By leveraging accurate and compliant leak testing instruments from ابزارهای سلولی, manufacturers can strengthen their quality control systems and meet global standards with confidence.