Inhaler & OINDP Testing
Inhalers and orally inhaled and nasal drug products (OINDPs) must deliver consistent doses safely and effectively through complex drug-device systems. Performance, materials safety, and microbiological control are critical throughout development, regulatory submission, and commercial production.
Testing programmes for inhalers and OINDPs evaluate dose delivery, aerosol performance, material compatibility, and microbial risk. Alignment with standards such as ISO 20072, ISO 27427, and ISO 18562 supports the generation of robust, regulator-ready data for global submissions.
Why testing is critical for inhalers and OINDPs
Inhalation and nasal drug delivery systems present unique challenges due to the complexity of aerosol generation, drug-device interaction, and patient use variability. Reliable performance and materials safety are essential to ensure consistent therapeutic delivery and patient safety.
Key challenges include:
- Achieving accurate and consistent dose delivery
- Demonstrating aerosol and device performance
- Managing extractables and leachables from materials
- Controlling microbial and contamination risks
- Supporting long-term stability and lifecycle performance
- Meeting global regulatory expectations for combination products
Comprehensive testing helps identify potential risks early and provides the evidence required for regulatory approval.
Inhaler and OINDP testing services across the device lifecycle
Analytical Chemistry
Material characterisation, extractables and leachables studies, and impurity analysis support product safety and regulatory submissions.
Microbiology & Sterility
Microbiological testing supports contamination control and product safety.
Physical & Packaging Testing
Performance testing evaluates device functionality and reliability, alongside packaging validation and distribution simulation.
Biocompatibility & Toxicology
ISO 10993 biological evaluation and toxicological risk assessment support safe patient contact and regulatory compliance.
Consultancy & Scientific Support
Testing strategies and submission support help navigate global regulatory pathways.
Supporting every stage of the inhaler lifecycle
Inhaler standards and regulatory expectations
Testing programmes for inhalers and OINDPs are typically aligned with key international standards, including:
- ISO 20072 for aerosol drug delivery devices
- ISO 27427 for nebulising systems and components
- ISO 18562 for biocompatibility of breathing gas pathways
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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