Leak Testing Autoinjectors – Managing Risk In The Most Complex Combination Device Format

By Oliver Stauffer

Autoinjectors bring a level of complexity to pharmaceutical manufacturing that goes far beyond traditional parenteral presentations. By pairing a sterile drug container with a mechanical delivery system, they introduce layers of components, interfaces, and assembly steps that directly influence container closure integrity. Evaluating CCI in this environment is not a matter of adapting syringe testing methods—it requires rethinking how risk is introduced and where failure modes can emerge. Factors added during final assembly can meaningfully affect sterility and dose reliability, making the integrity of the fully assembled device the critical point of assessment. Explore why autoinjectors demand a different inspection strategy and how testing the complete, assembled system provides the most reliable safeguard for product quality.

Access the full application note to understand the testing approaches that meet these unique challenges.