Designing Robust Studies To Meet Auto-Injector Performance Requirements

By Mike Ulman

Auto-injectors are devices designed to simplify the process of administering injectable pharmaceuticals at home. They are particularly useful for individuals who need to self-administer medication on a regular basis. These devices typically consist of a drug-filled syringe and an automated injection mechanism. They are used for both emergency situations and chronic conditions.

Regulatory approval for these devices is provided by the FDA, and ISO 11608-5:2022 outlines the performance testing requirements. Critical tests for auto-injector performance include cap removal force, activation force, injection time, dose accuracy, extended needle length, and needle guard lockout.

In this article, learn more about the critical tests for ensuring proper performance.