The DIN EN ISO 11608-5 standard describes the testing of auto-injectors. ZwickRoell offers test systems for the automated measurement of various characteristic values of autoinjectors.
► Objective of the autoinjector test to DIN EN ISO 11608-5 ◄
An autoinjector is a medical instrument (medical device) used to administer liquid medication and is therefore subject to strict quality controls. The main factors driving the use of autoinjectors are:
• Growing biotech sector - injection is a must (oral administration is not possible)
• Viscosity range of biologics is wider than "normal" drugs and requires adapted testing procedures
• The trend towards self-medication is increasing - injection by autoinjector is a proven, simple and safe way of self-treatment with a drastic reduction of user errors at maximum dosing accuracy
• Correct injection and the correct dosage of the drug are crucial for optimal therapeutic success
Recent guidance specifies that tests on autoinjectors must simulate patient usage: the patient simply removes the safety cap, positions the injector and injects the drug.
The FDA specifies the required outcomes based on the essential performance requirements (EPRs). Key ones include injection volume, injection depth, and injection duration, as well as forces/outcomes that may occur as a result of use.
ZwickRoell offers test systems that can be used to perform the following sequential tests:
• Removal force of the safety cap downwards / optionally upwards
• Activation force and travel when the auto-injector is triggered
• Injection depth and injection time with different test methods and accuracies
• Determination of the administered drug volume, including the last drops with an integrated high-resolution scale
• Safety function of the needle protection
• Testing of injectors with/without release button
• Acoustic recognition of start/end of injection
• Avoidance of "wrong" injector-specific test fixture components and verification with test program (Poka-Yoke)
• Measurement of ambient humidity and temperature
The machine is equipped with safety devices in accordance with DIN EN ISO 13849. The testXpert III testing software takes over the control and evaluation of these additional functions as well as the entire test sequence with determination of the results, traceable according to FDA specifications.
00:05 - Daily checks confirm the systematic function of all sensors in use
00:13 - Coding of change parts provides fault protection - guarantees correct configuration for the injectors and the corresponding results
00:21 - Simply insert the injector and start the test with a touch
00:28 - Cap gripper removes injector caps regardless of design
00:33 - Removal force of cap is measured and cap is ejected into container
00:38 - Injection activation - release force measurement - sound detection of the “Click”
00:43 - Precise measurement of the injection depth and injection time
00:48 - The last drops are relevant for the injection volume
00:54 - Measurement of the needle shield overriding force
00:57 - Color detection of any area within the field of view
01:03 - Clear and comprehensive documentation at a glance
01:08 - Green “OK” indicator for passed test results
01:18 - Removal of injector caps in upward motion for any autoinjector
01:22 - Removal force of cap is measured and cap is ejected into container
01:31 - Flexible system for almost all autoinjector types with or without trigger button
01:40 - Traceability according to detailed ZwickRoell whitepaper FDA 21 CFR Part 11
01:44 - ZwickRoell provides support from URS to system qualification