Auto-Injector Testing
Auto-injectors and self-injection systems must deliver reliable, accurate doses safely and consistently in real-world use. These devices combine mechanical performance, usability, and drug delivery, making robust testing essential from early development through to regulatory submission and commercial production.
Testing programmes for auto-injectors are designed to evaluate activation forces, injection time, dose delivery, and long-term reliability. Alignment with the ISO 11608 series helps generate robust, regulator-ready data to support global approval and lifecycle management.
Why testing is critical for auto-injectors
Auto-injectors are designed for safe and intuitive use by patients, often outside clinical environments. This places significant emphasis on reliability, usability, and consistent dose delivery under a wide range of real-world conditions.
Key challenges include:
- Ensuring reliable activation and device function
- Maintaining consistent injection forces and injection time
- Delivering accurate and repeatable doses
- Demonstrating usability and safe operation
- Managing transport, storage, and ageing impacts on performance
- Supporting combination product regulatory expectations
Comprehensive testing helps identify potential risks early and provides the evidence required to demonstrate safe and effective use.
Auto-injector testing services across the device lifecycle
Analytical Chemistry
Material characterisation, extractables and leachables studies, elemental impurities, and particulate analysis support product safety and regulatory submissions.
Microbiology & Sterility
Bioburden, sterility, and endotoxin testing support microbiological safety for sterile combination products.
Physical & Packaging Testing
Performance testing evaluates activation force, injection time, dose accuracy, and long-term reliability, alongside packaging validation and transport simulation.
Biocompatibility & Toxicology
ISO 10993 biological evaluation and toxicological risk assessment support safe patient contact and regulatory compliance.
Consultancy & Scientific Support
Testing strategies, biological evaluation plans and reports, and submission support help navigate global regulatory pathways.
Supporting every stage of the Auto-Injector lifecycle
Auto-Injector standards and regulatory expectations
Testing programmes for auto-injectors are typically aligned with key international standards, including:
Alignment with recognised standards helps ensure robust, regulator-ready data for global submissions.
Partner with Cormica
Integrated testing programmes bring together expertise across microbiology, analytical chemistry, physical testing, and biocompatibility to support combination product development from concept through to commercialisation. Decades of experience across hundreds of device programmes worldwide help teams generate reliable data and move forward with confidence.
Laboratories near you, supporting global product success
With accredited laboratories in the UK, EU and US, we support pharmaceutical, medical device and combination product manufacturers worldwide. Local support combined with global quality, delivered by teams who understand your regulatory requirements.
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