Nebulizer Testing to ISO 27427: Validate Your Device Performance
Ensure the safety, efficacy, and regulatory compliance of your nebulizing systems with world-leading testing and advising experts.
Assessing a nebulizer’s performance in accordance with ISO 27427 is a critical milestone for medical device developers and pharmaceutical manufacturers. This standard dictates strict requirements for the safety, output, and aerodynamic performance of general-purpose nebulizing systems.
As a highly specialized boutique expert CRO, we offer comprehensive nebulizer testing according to ISO 27427. We provide the precise, reliable data required by regulatory authorities—including the FDA, EMA, and MHRA—to characterize device performance and accelerate your path to market.
Our ISO 27427 Testing Capabilities
We combine rigorous standardized testing with deep scientific understanding, acting as a flexible, uncomplicated partner for your testing needs. Our testing services for all types of nebulizers include:
- Clinically Relevant Breathing Simulation: We evaluate the delivered dose from your nebulizer using advanced lung simulators that generate precise, tidal inhale/exhale breathing patterns through the device.
- Aerosol Characterization (APSD): Characterizing nebulized droplets requires specialized handling. We perform cascade impactor testing (APSD) to evaluate the aerodynamic particle size distribution. To effectively slow down the evaporation of droplets during the test, we utilize cooled impactor parts, ensuring accurate particle size data.
Pharmacopeial Compliance & Tailored Methods
While ISO 27427 provides the framework for medical device performance, navigating the full regulatory landscape often requires additional pharmaceutical assessments. Emmace routinely conducts pharmacopeial assessments of nebulizers as described in European Pharmacopeia 2.9.44 and US Pharmacopeia <1601>. See related information here.
Need something beyond the standard? Because our niche focus is an exclusive specialization in inhalation, we can adapt our state-of-the-art laboratory instrumentation to test prototypes, exploratory formulations, and highly customized experimental setups. See more information on: https://www.emmace.se/analytical-services/inhaler-nasal-nebulizer/nebulizer-testing/
Strategic Advising for Regulatory Success
With hundreds of years of combined experience from Big pharma, academia, and leading CROs, we do more than just deliver test results. We offer advising in the characterization and evaluation of nebulizers, helping you interpret complex data for your regulatory submissions.
Ready to validate your nebulizer’s performance?
Contact our team to discuss your ISO 27427 testing needs and secure your regulatory success.