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20 Ways to Test a Syringe

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Learn testing solutions for pre-filled, hypodermic, single-use, and needle-based injection systems, as required per ISO 11040-4, ISO 7886-1, ISO 8537, ISO 80369-20, and ISO 11608.

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20 Ways to Test a Syringe

  1. 1. Elayne Gordonov Biomedical Market Manager 20 Ways to Test a Syringe
  2. 2. 22 Agenda • Review of syringe components and injector types • 20 Tests for a variety of different syringes and injectors • Luer lock testing • Plastic single-use syringes • Glass pre-filled syringes • Pen-injectors • Auto-injectors • Q&A
  3. 3. 33 Luer Fittings Tapered and Locked Fittings
  4. 4. 44 Pre-filled Glass Syringes Needles with either Luer fitting or Adhesive
  5. 5. 55 Pen Injectors & Auto Injectors Cap Removal, Dial-dose, Button Ejection, and Needle Shield Activated
  6. 6. 66 Linear-Torsion Universal Test Systems Measure: • Axial Force • Torque • Linear Displacement • Rotational Displacement Add Torsion Capability to Your 5900 Test System
  7. 7. 77 Overview for Syringes and Syringe Components 20 Ways to Test a Syringe
  8. 8. 88 5 Standards- 20 Methods • ISO 80369-20 1. Resistance to separation from axial force 2. Resistance to separation from unscrewing 3. Resistance to overriding 4. Disconnection by unscrewing • ISO 7886-1 5. Force to operate plunger 6. Liquid leakage • ISO 8537 Annex C 7. Force to operate the plunger • ISO 11040-4 8. Flange breaking resistance 9. Luer cone breaking resistance 10. Glide force 11. Needle penetration 12.Needle pull-out 13. Closure- liquid leakage test 14. Luer lock adapter collar pull-off 15. Luer lock adapter torque resistance 16. Luer rigid tip cap unscrewing 17. Pull-off force for needle shield • ISO 11608-5 18. Cap removal 19. Activation and glide force 20. Ejected mass and needle length
  9. 9. 99 ISO 80369-20 Small-bore connectors for liquids and gases in healthcare applications • Assemble slip connector: assemble by applying an axial force of between 26.5 N and 27.5 N for 5 s to 6 s while rotating the connector under test to a torque of between 0.08 N·m and 0.1 N·m and a rotation not exceeding 90° • Assemble locking connector with fixed threads: assemble by applying an axial force of between 26.5 N and 27.5 N for 5 s to 6 s while rotating the connector under test to a torque of between 0.08 N·m and 0.12 N·m • Assemble connector with a floating or rotatable collar: assemble by introducing the mating features (i.e. connector taper) together with an axial force of between 26.5 N and 27.5 N for 5 s to 6 s while rotating the collar of the connector under test to a torque of between 0.08 N·m and 0.12 N·m
  10. 10. 1010 (1-4) ISO 80369-20 Small-bore connectors for liquids and gases in healthcare applications 1. Resistance to separation from axial force Results: maximum axial force, duration of test, and presence or absence of separation 2.Resistance to separation from unscrewing Results: maximum unscrewing torque, duration of test, presence or absence of separation 3.Resistance to overriding Results: maximum torque, duration of the test, presence or absence of separation and cocking 4.Disconnection by unscrewing Results: maximum unscrewing torque, duration of the test, presence or absence
  11. 11. 1111 ISO 80369-20 Small-bore connectors for liquids and gases in healthcare applications 1. Resistance to separation from axial force 2.Resistance to separation from unscrewing 3.Resistance to overriding 4.Disconnection by unscrewing Test Parameters Test Speed 10 N/s Data Rate 100 Hz Maximum Expected Load or Torque 50 N or 0.02 Nm Overall Result Visual Inspection (Pass/Fail) ISO 80369 replaces ISO 594 for Luer connections. The FDA will be accepting conformity to ISO 594 until December 31st, 2019. In addition, this standard requires the use of reference connectors which Instron can provide through our custom engineering group.
  12. 12. 1212 ISO 7886-1 Sterile Hypodermic Syringes for Single Use – Part 1: Syringes for Manual Use 5. Annex G - Test Method for Forces Required to Operate Plunger 6. Annex D - Test Method for Liquid Leakage at Syringe Piston Under Compression
  13. 13. 1313 (5) ISO 7886-1 Annex G Test Method for Forces Required to Operate Plunger
  14. 14. 1414 ISO 7886-1 Annex G Test Method for Forces Required to Operate Plunger Test Parameters Test Speed 100 mm/min Cyclic Test Data Rate 100 Hz Maximum Expected Load 50 N Results Initial Plunger Force Mean Return Force Max Return Force Min Return Force
  15. 15. 1515 (6) ISO 7886-1 Annex D Test Method for Liquid Leakage at Syringe Piston under Compression
  16. 16. 1616 ISO 7886-1 Annex D Test Method for Liquid Leakage at Syringe Piston under Compression Test Parameters Test Speed N/A Ramp to specified pressure and hold Data Rate 65 Hz or Higher Maximum Expected Load < 250 N Result Visual Inspection of Closure Device (Pass/Fail)
  17. 17. 1717 (7) ISO 8537 Annex C: Test Method for Force required to Operate the Plunger- Single-Use Syringe for Insulin
  18. 18. 1818 (8-17) ISO 11040-4 Prefilled syringes - Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling C.1 Flange Breaking Resistance C.2 Luer Cone Breakage Resistance E.1 Glide Force F.1 Needle Penetration Test G.1 Needle Pull-Out Force G.2 Closure System Liquid Leakage Test G.3 Luer Lock Adaptor Collar Pull- Off Force G.4 Luer Lock Adaptor Collar Torque Resistance G. 5 Luer Lock Rigid Tip Cap Unscrewing Torque G.6 Pull-Off Force of the Tip Cap or the Needle Shield
  19. 19. 1919 Instron Fixtures Compatible for all ISO 11040-4 Syringe Dimensions
  20. 20. 2020 (18-20) ISO 11608-5 Automated Needle Based Drug Delivery Systems– Requirements and Test Methods 18.) Measurement of Cap Removal Force 19.) Activation and Glide Force 20.)Total Ejection Time, Mass, and Needle Length
  21. 21. 2121 ISO 11608-5 Testing Injection Systems including Auto injectors and Pen injectors Optical Micrometer
  22. 22. 2222 Adding Automation to Syringe Testing
  23. 23. 2323 5 Standards- 20 Methods • ISO 80369-20 1. Resistance to separation from axial force 2. Resistance to separation from unscrewing 3. Resistance to overriding 4. Disconnection by unscrewing • ISO 7886-1 5. Force to operate plunger 6. Liquid leakage • ISO 8537 7. Force to operate the plunger • ISO 11040-4 8. Flange breaking resistance 9. Luer cone breaking resistance 10. Glide force 11. Needle penetration 12.Needle pull-out 13. Closure- liquid leakage test 14. Luer lock adapter collar pull-off 15. Luer lock adapter torque resistance 16. Luer rigid tip cap unscrewing 17. Pull-off force for needle shield • ISO 11608-5 18. Cap removal 19. Activation and glide force 20. Ejected mass and needle length
  24. 24. 2424 Want to learn more? www.instron.com/en/our-company/contact-us

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