
Challenge
Support MundiPharma with the industrialisation and scale-up of a breath-actuated inhaler for the treatment of asthma.
Approach
We worked with MundiPharma as device design partners, integrating closely with several functions across the client’s organisation and a large number of partners including manufacturing organisations, specialist equipment suppliers and regulatory experts, to bring the device to market.
Outcome
The breath-actuated inhaler was launched in Europe in 2018 and is available as an asthma treatment for adults and adolescents.
At a glance
Client
MundiPharma
Sector
Drug delivery
Services
Project management
Industrialisation
Device verification
Design management
Engineering testing
Technical support
Manufacture support
Due diligence
Team staff in project
Up to 20
Understanding design
Our team first needed to fully understand the device’s detailed design, its history and its current performance characteristics. Tolerance analyses and mathematical models were generated, and engineering analyses carried out. Hence, and 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, and of fully automated assembly systems. It was also instrumental in completing the final stages of troubleshooting and performance optimisation, and on the implementation of late stage design modifications including an enforced material change.

Team managed the full CAD database throughout, working within MundiPharma’s change control system to ensure full traceability.
Chris Bunce, Project Manager
Bespoke automated testing

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, to tight timescales, the design verification test programme.

The breath-actuated inhaler was launched in Europe in 2018 and is now commercially available.
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