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Syringe Positive Pressure Tightness Tester – QualiMed™ SPPT

Syringe Positive Pressure Tightness Tester
Product Categories
Medical Testing Equipment
Standards
ISO 7886-1
ISO 8537
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Syringe Positive Pressure Tightness Tester – QualiMed™ SPPT

Syringe Positive Pressure Tightness Tester – QualiMed™ SPPT is a precision testing system designed to evaluate the sealing integrity of medical syringes under positive internal pressure combined with axial and lateral stress. This advanced syringe positive pressure tightness tester simulates real-world conditions that may cause liquid leakage past the plunger stopper during injection or handling.

Using controlled compression and lateral deflection, the QualiMed™ SPPT accurately detects leakage caused by seal failure, ensuring syringe designs meet strict quality, safety, and regulatory requirements. PLC control, a touchscreen HMI, and precision mechanical components make the system ideal for routine quality control and regulatory compliance testing in syringe manufacturing environments.

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Syringe Positive Pressure Tightness Tester – QualiMed™ SPPT

Syringe Positive Pressure Tightness Tester – QualiMed™ SPPT Applications

The QualiMed™ SPPT - Syringe Positive Pressure Tightness Tester is used for:

  • Medical Syringe Manufacturing – Verifying plunger stopper sealing performance during design validation and batch release testing
  • Quality Control Laboratories – Detecting leakage risks that could lead to dosage loss or contamination
  • Regulatory Compliance Testing – Performing standardized tightness tests required by international syringe standards
  • R&D and Product Development – Evaluating syringe designs under combined axial and lateral stress conditions
  • Pharmaceutical Packaging Testing – Ensuring safe and accurate drug delivery through leak-free syringe systems
Syringe Positive Pressure Tightness Tester – QualiMed™ SPPTSyringe Positive Pressure Tightness Tester – QualiMed™ SPPT

Standards

The QualiMed™ SPPT 1 is designed to conform to internationally recognized syringe testing standards:

  • ISO 7886-1 Annex D – Test method for liquid leakage at the syringe plunger stopper under compression
  • ISO 8537 Annex E – Test method for liquid leakage at syringe piston, nozzle, hub, or needle/barrel unions during compression

Syringe Positive Pressure Tightness Tester – QualiMed™ SPPT Key Features

  • PLC-Controlled System with 7″ Touchscreen HMI
    • Enables intuitive setup, programmable test routines, and repeatable operation
  • Precision Ball Lead Screw Drive
    • Ensures accurate and consistent application of lateral deflection and axial pressure
  • Adjustable Test Speed and Force Range
    • Adapts to different syringe sizes, materials, and compliance requirements
  • Multiple Interchangeable Syringe Fixtures
    • Supports a wide range of syringe types and volumes
  • Integrated Safety Protections
    • Includes overload protection and automatic return after test completion
  • Built-In Microprinter with Optional RS-232 Output
    • Provides immediate test records and traceable QC documentation

Theory and Method

The Syringe Positive Pressure Tightness Test evaluates whether liquid leaks past the syringe plunger seal when subjected to realistic mechanical stresses:

  1. Syringe Preparation – The syringe is filled with water to nominal capacity and the nozzle is sealed.
  2. Lateral Deflection – A controlled sideways force is applied to the plunger to create radial misalignment.
  3. Axial Pressure Application – The plunger is compressed to generate internal pressure for a defined holding time.
  4. Leak Detection – The operator visually inspects for any fluid leakage past the plunger stopper; absence of leakage indicates a pass.

This combined axial and lateral loading method reveals seal weaknesses that may not appear under straight compression alone.

Syringe Positive Pressure Tightness Tester – QualiMed™ SPPT Technical Specifications

ParameterSpecification
Force Range200 N (customizable)
Speed Range1 – 500 mm/min
Accuracy0.01 mm / 0.5% FS force
Lateral ForceApplied by standard weight (as required)
FixturesInterchangeable syringe accessories
Control SystemPLC with touchscreen HMI
VoltageAC 110–220 V
Safety & OutputOverload protection, auto return, microprinter, RS-232

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