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Syringe Leak Tester – QualiMed™ - SLT

Syringe Leak Tester
Product Categories
Medical Testing Equipment
Standards
ISO 7886-1

Syringe Leak Tester – QualiMed™ - SLT

Syringe Leak Tester – QualiMed™ - SLT is a precision instrument designed to verify the air-tightness and mechanical integrity of medical syringes under controlled negative pressure conditions.

By applying a programmable vacuum and monitoring pressure stability over a defined hold time, the system detects air leakage past the plunger stopper and evaluates stopper–plunger attachment integrity during aspiration.

Engineered for pharmaceutical manufacturers, syringe producers, and quality control laboratories, the QualiMed™ - SLT Syringe Leak Tester delivers repeatable, standard-compliant leak testing that supports patient safety, dosage accuracy, and sterile packaging assurance.

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Syringe Leak Tester – QualiMed™ - SLT

Syringe Leak Tester – QualiMed™ - SLT Applications

  • Disposable Medical Syringe Testing (ISO 7886-1)
    • Verifies air-leak prevention and stopper-plunger separation performance of single-use syringes during aspiration.
  • Pharmaceutical Quality Control
    • Ensures syringe sealing integrity to prevent air embolism risks, contamination, and dosing inconsistencies.
  • Syringe Manufacturing & Process Validation
    • Supports routine inspection, type testing, and batch validation of syringe assemblies under controlled vacuum conditions.
  • Regulatory Compliance & Documentation
    • Provides objective test results aligned with international syringe performance standards for audit and certification purposes.
Syringe Leak Tester – QualiMed™ - SLT
Syringe Leak Tester – QualiMed™ - SLTSyringe Leak Tester – QualiMed™ - SLT
Syringe Leak Tester – QualiMed™ - SLT

Syringe Holder

Standard:

ISO 7886-1 (Annex B)

International standard specifying test methods to evaluate air leakage past the plunger stopper and stopper–plunger separation of single-use medical syringes under vacuum conditions.

Syringe Leak Tester – QualiMed™ - SLT Key Features

  • Automatic Vacuum Test Sequence
    • Fully automated vacuum creation, hold timing, and air back-flush minimize operator influence and improve repeatability.
  • Wide Programmable Vacuum Range
    • Adjustable from 0 to –90 kPa to meet various syringe test requirements.
  • Extended Test Time Capability
    • Programmable hold time from 0.1 seconds up to 9,999 hours for standard and stress testing.
  • Venturi-Based Vacuum Generation
    • Stable vacuum without the need for an external vacuum pump, reducing maintenance and operational cost.
  • Adjustable Syringe Fixtures
    • Compatible with 1 mL to 50 mL syringes, accommodating different flange designs and formats.
  • Visual Failure Detection
    • Immediate identification of leakage bubbles or stopper movement during testing.
  • IQ/OQ/PQ Documentation Support
    • Suitable for regulated pharmaceutical environments requiring validation documentation.

Theory and Method

The Syringe Leak Tester operates on a vacuum differential principle. A syringe is partially filled with water (≥ 25% of nominal volume), mounted vertically, and sealed at the nozzle. When vacuum is applied above the liquid level, a pressure differential forms across the plunger stopper.

  • Air leakage is visually identified by bubble formation in the liquid.
  • Stopper–plunger separation is detected immediately if mechanical detachment occurs under negative pressure.

The automated test sequence includes vacuum generation, pressure holding, and air back-flush to ensure reliable and repeatable detection in accordance with ISO 7886-1 Annex B.

Syringe Leak Tester – QualiMed™ - SLT Technical Specifications

ParameterSpecification
Product NameSyringe Leak Tester – QualiMed™ - SLT
Vacuum Range0 to −90 kPa
Test Time Range0.1 s to 9,999 h
Gas Source Pressure≤ 0.7 MPa (user supplied)
Test MediumWater (≥ 25% syringe volume)
Detection MethodVisual bubble detection & stopper movement
Vacuum GenerationVenturi vacuum system
Syringe Capacity1–50 mL (custom fixtures available)
VoltageAC 110–220 V, 50/60 Hz
Operation ModeAutomatic
Application StandardsISO 7886-1 Annex B

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