ISO 11608-5 Multiple Testing of Autoinjectors with Screw Caps

The DIN EN ISO 11608-5 standard describes autoinjector testing. ZwickRoell provides testing systems that automate the measurement of various characteristic values of autoinjectors, including torsion, which is crucial for comprehensive device testing. Objective of the autoinjector test according to DIN EN ISO 11608-5 An autoinjector is a medical instrument (medical device) with which liquid medication can be administered and is therefore subject to strict quality controls. Key factors that promote the use of autoinjectors are: • Growing biotech sector: injection is a must (oral administration is not an option). • The viscosity range of biologics is wider than that of normal drugs and requires adapted test procedures. • The trend towards self-medication is increasing - injection via autoinjector is a proven, simple and safe way of self-treatment with a drastic reduction in user errors and maximum dosing accuracy. The correct injection and proper dose of the medication are crucial for optimal therapeutic success. The latest guidelines stipulate that autoinjector testing must accurately simulate patient use: the patient simply removes the safety cap, positions the injector and injects the medication. The FDA specifies which results are required based on the essential performance requirements (EPRs). The most important of these include the injection volume, the injection depth and the injection duration as well as the forces/results that can occur as a result of the application. ZwickRoell offers testing systems with which the following sequential tests can be performed: • Torsion test: measurement and analysis of the torsional forces that can occur during activation and use of the autoinjector to ensure that the mechanics of the device remain stable and function correctly • Pull-off force of the safety cap • Activation force and travel when actuating the autoinjector • Injection depth and injection time with different test methods and accuracies • Determination of the volume of medication administered, including the last drops with integrated, high-resolution scales • Safety function of the needle shield • Testing of injectors with/without actuating button • Color recognition on the autoinjector • Acoustic recognition from beginning/end of the injection • Prevention of incorrect injector-specific test device 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 control and evaluation of these additional functions, overseeing the entire test sequence with determination of the test results, traceable according to FDA specifications. 00:00 – 00:07 Autoinjector with torsion 00:08 – 00:21 Injector pen specific jaws 00:22 – 00:24 Poka Yoke 00:25 – 00:28 Torsion fixture + sensors 00:29 – 01:04 Test sequence 01:05 – 01:33 Daily Check autoinjector torsion 01:32 – 01:40 Summary