Building knowledge of the device's detailed design
Our team first needed to fully understand the device’s detailed design, its history and its current performance characteristics. Engineering analysis was carried out, together with tolerance analyses and mathematical modelling. In conjunction with extensive device testing, critical to quality attributes were confirmed.
This knowledge and understanding supported the procurement and qualification of multi-cavity production tooling as well as fully automated assembly systems. Understanding the device’s detailed design was also instrumental in completing the final stages of troubleshooting, carrying out performance optimisation and implementing late-stage design modifications (including an enforced material change). Team managed the full CAD database throughout, working within the client’s change control system to ensure full traceability.
With final design modifications completed and production systems in place, Team played a major part in the design verification programme, working to an agreed test plan in line with ISO 20072 and other applicable standards as part of the client’s regulatory strategy. We developed and validated test methods and supported specification, procurement and commissioning of bespoke automated test equipment to enable high throughput testing of the inhalers. We then executed and reported the design verification test programme under tight timescales.
The breath-actuated inhaler was launched in Europe in 2018.