Industrialisation of a breath-actuated inhaler
MundiPharma
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.
When Mundipharma came to Team Consulting they already had a developed product, manufacturable from low volume production systems. They required a new device design partner, to be responsible for the device constituent part of their product during the process of industrialisation, scale-up and launch.
For this project Team provided an experienced team of mechanical and production engineers, as well as experts in device testing and verification. We collaborated closely across the broad client organisation and worked throughout with a network of toolmakers, device manufacturers, automated assembly and test equipment suppliers. With most of the design specification fixed and the product submission filed, all work was carried out within full cGxP controls and scope for change was extremely constrained.
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.
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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