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.

A 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:

  • Csúcs behatolási erő: 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

A 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 és 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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Ready to ensure your syringe needle meet the required standards? Access detailed testing reports, request a quote, or contact our team for more information about our Penetrability Test services.
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