Design verification testing for an inhaler
Challenge
Our client asked us to perform comprehensive Design Verification Testing (DVT), under cGxP controls, for a breath-actuated pressurised metered dose inhaler (pMDI). We focused on the performance and reliability of the product’s mechanical function, in line with the latest standards and regulations.
Approach
We planned and completed a comprehensive DVT programme to test the performance of hundreds of pMDI samples through their 120-shot use life. For every shot, our testing captured data for eight key functional requirements. To achieve this high fidelity testing in the most efficient way possible, we developed and validated over 30 bespoke test methods and commissioned and qualified two sophisticated semi-automated test instruments which were used in-house throughout the programme.
Outcome
We successfully tested and analysed data from more than 120,000 actuations from over 1,000 inhaler samples. The evidence we gathered and reported for this DVT programme supported the launch of the product in Europe in September 2018 as an asthma treatment for adults and adolescents.