The lab at Trudell Medical International uses a variety of recognized standardized procedures and innovative techniques for evaluation of our products.
Design verification in our aerosol laboratory shortens time to market and provides a reliable indication of how the device is likely to perform in a clinical setting. We utilize a variety of techniques and the following provides an overview of the function and environment in which the laboratory operates.
Our staff works actively in the scientific community to:
Develop in vitro test methodology and standards
Publish and present papers at scientific meetings and in peer-reviewed journals
Improve the understanding of aerosol science associated with inhalation therapy
Equipment and Techniques Employed
Aerodynamic particle size is routinely measured using cascade impactors according to compendial practices of the US and European Pharmacopeias;
Appropriate products are tested in accordance with Canadian Standard CAN/CSA/Z264.1-02;
For products primarily intended for adult use, an Andersen Eight-Stage Impactor or Next Generation Pharmaceutical Impactor (NGI) are used;
Products intended for pediatric use are tested with a purpose-built low-flow Marple-Miller Impactor;
Assessment of aqueous aerosols from nebulizers measured in accordance with CEN standard EN 13544-1:2007 as well as other recognized global standards;
We routinely validate our measurements by mass balance assessments;
We measure particle size using laser diffractometry, a useful technique for liquid droplets from our nebulizer systems;
We employ different types of breathing simulators to test the performance of our products under conditions that simulate actual patient use.
This has helped us:
Develop a device that simulates delayed inhalation to simulate poor timing between operation of drug delivery device and inhalation maneuver;
Mimic in vivo drug delivery to patients with low inspiratory flow rates (e.g. infants);
Test drug delivery rates over several respiratory cycles (especially useful when testing nebulizers);
Develop infant, small child and adult face models (ADAM – Aerosol Delivery to Anatomical Model) with realistic surface texture to test facemask fit and aerosol delivery with face mask intact for products intended for use by infants, small children and adults.
Through our commitment to aerosol-based drug delivery standards we are continuously developing better ways of performing in vitro measurements on our products and support the development of improved testing methodologies;
We participate in the development of international standards by working with committees such as the ISO/TC84/JWG5 committee from the International Standards Organization;
We participate in industry-wide technical expert bodies, such as the European Pharmaceutical Aerosol Group (EPAG) and in the activities of the US-based Product Quality Research Institute (PQRI) to help develop better guidelines for regulatory testing.
Review our Latest Publications
We publish and prsent papers at scientific meetings and in peer-reviewed journals.
Our History
Discover where Trudell Medical International has come from.
