Needle-Based Injection System Testing
Testing of needle-based injection systems, or auto-injectors, is most commonly based on ISO 11608, which specifies requirements and test methods for these drug/device combination products. While there are seven annexes within the standard, ISO 11608-5 identifies the requirements for testing the product in its final use case. The final use case of an auto-injector entails a patient removing the auto-injector safety cap, positioning the injector, and pressing down on the device to inject the drug. The injector should automatically release the accurate dose of medication in the appropriate amount of time. Both the manual action made by the patient and the automatic functions of the auto injector must be quantified during a test. This can lead to cumbersome test setups, customized software programs, and in some cases, multiple computers or data acquisition systems.
In order to streamline testing of needle-based injection systems, Instron® offers an integrated testing system that enables users to measure the following:
- Force to remove the safety cap
- Activation force and displacement of the auto-injector
- Injection time
- Weight of the drug volume using an integrated scale
- Effective length of the needle during injection using an optical micrometer
- Force to displace the needle guard
Our integrated test system allows for all required testing to be carried out in a single test for individual auto-injectors. In some cases, depending on speed, dose, and product requirements, an entire test can last under one minute. Despite the complexity of needle-based injection systems and their testing requirements, simplifying the test method into a single test helps ensure the accuracy of results and saves time.