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.

1. Elayne Gordonov
Biomedical Market Manager
20 Ways to Test
a Syringe

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. 33
Luer Fittings
Tapered and Locked Fittings

4. 44
Pre-filled Glass Syringes
Needles with either Luer fitting or Adhesive

5. 55
Pen Injectors & Auto Injectors
Cap Removal, Dial-dose, Button Ejection, and Needle Shield Activated

6. 66
Linear-Torsion Universal Test Systems
Measure:
• Axial Force
• Torque
• Linear Displacement
• Rotational Displacement
Add Torsion Capability to Your 5900 Test System

7. 77
Overview for Syringes and Syringe Components
20 Ways to Test a Syringe

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. 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. 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. 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. 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. 1313
(5) ISO 7886-1 Annex G
Test Method for Forces Required to Operate Plunger

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. 1515
(6) ISO 7886-1 Annex D
Test Method for Liquid Leakage at Syringe Piston under Compression

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. 1717
(7) ISO 8537
Annex C: Test Method for Force required to Operate the Plunger- Single-Use Syringe for Insulin

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. 1919
Instron Fixtures Compatible for all ISO 11040-4 Syringe Dimensions

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. 2121
ISO 11608-5
Testing Injection Systems including Auto injectors and Pen injectors
Optical Micrometer

22. 2222
Adding Automation to Syringe Testing

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. 2424
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