Syringe Needle Penetrability Tester

Precision in medical injection devices is non-negotiable, and one of the key parameters in ensuring this accuracy is needle penetration performance. The needle penetrability tester is a critical instrument for evaluating the force required for syringe needles to pierce a substrate, reflecting both safety and usability.

Why Syringe Needle Penetrability Testing Matters

Injections are among the most common drug delivery methods. Whether prefilled syringes or single-use hypodermic needles, penetration force directly impacts patient comfort and device functionality. Excessive penetration force may indicate design issues, while insufficient force might lead to reliability concerns.

The needle penetrability tester helps quantify this force precisely, providing manufacturers and quality control labs with essential data to validate product performance and compliance with regulatory requirements.

Testing Standards: ISO 11040-4 and ISO 7864

ISO 11040-4: Prefilled Syringes – Glass Barrels and Subassemblies

Annex F of ISO 11040-4 describes a test method where a needle penetrates a test foil under controlled speed and displacement, recording the force needed to do so. Key highlights include:

  • Test speed range: 20 mm/min to 200 mm/min
  • Force range: up to 10 N (or as agreed upon)
  • Specimen: Pre-siliconized or untreated needles on syringes
  • Setup: Needle fixed perpendicular to a tension-free test foil
  • Output: Force-displacement curve to identify peak penetration force

This method evaluates penetration performance in prefilled syringe configurations and helps detect manufacturing variability in subassemblies.

ISO 7864: Hypodermic Needles – Sterile, Single Use

Annex D of ISO 7864 describes the penetration of a needle into a compliant substrate (such as latex) and captures both:

  • Peak penetration force: Maximum resistance at initial substrate puncture
  • Drag force: Frictional force as the needle continues to move through the material

Standard parameters include:

  • Penetration speed: Typically 100 mm/min
  • Penetration depth: 80% of needle length
  • Sample requirement: Each needle tests a fresh substrate site

This method emphasizes both comfort and usability from a clinical perspective.

Test Methodology: How the Needle Penetrability Tester Works

The needle penetrability tester simulates real-life syringe usage by controlling test speed, insertion depth, and recording force values during penetration and withdrawal. A high-resolution load cell measures force in real time, ensuring both accuracy and repeatability.

Standard test steps include:

  1. Mount the needle securely on the test fixture.
  2. Align the needle axis perpendicular to the substrate (foil or latex).
  3. Set test speed (e.g., 100 mm/min).
  4. Begin penetration to a pre-set depth (typically 80% of needle length).
  5. Record force-displacement curve.
  6. Calculate:
    • Peak force
    • Drag force (average frictional force through the substrate)

Each test uses a new substrate site or foil, ensuring reliable, uncontaminated results.

NPT-01 Needle Penetrability Tester from Cell Instruments

For laboratories and manufacturers seeking reliable, repeatable results, Cell Instruments’ NPT-01 Needle Penetrability Tester offers full compliance with both ISO 11040-4 and ISO 7864. It features:

  • Precision-controlled motion (speed, depth)
  • High-resolution force sensors
  • User-friendly software for curve analysis and reporting
  • Customizable fixtures for different syringe and needle types

Its flexible design makes it suitable for R&D, quality control, and regulatory verification in syringe manufacturing.

Syringe Needle Penetrability Tester
Needle Penetrability Tester

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