Industrialisation of a breath-actuated inhaler

Challenge

We supported our client with the industrialisation and scale-up of a breath-actuated pressurised metered dose inhaler (pMDI) for the treatment of asthma.

Approach

We worked with our client as device design partners, integrating closely with several functions across the client organisation and a large number of partners including manufacturing organisations, specialist equipment suppliers and regulatory experts, to bring the device to market.

Outcome

The product was launched in Europe in 2018 as an asthma treatment for adults and adolescents.

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Sector
Drug delivery

Services
Mechanical engineering
Production engineering
Device testing
Design verification testing

A partner for the industrialisation of an inhaler

When our client approached Team Consulting, they had already developed a product which was manufacturable from low volume production systems. They needed 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, we assembled an experienced team of mechanical and production engineers and experts in testing and design verification. We collaborated closely across the broad client organisation and, throughout the project, we worked with a network of toolmakers, device manufacturers, automated assembly and test equipment suppliers. Most of the product design specification had been fixed and the product submission had already been filed, which meant that the scope for change was extremely constrained and we had to work within full cGxP controls throughout the project.

Understanding the design of the inhaler

The team needed to fully understand the device’s detailed design, its history and its current performance characteristics. We generated tolerance analyses and mathematical models, and carried out engineering analyses. These analyses, in conjunction with extensive device testing, helped confirm critical to quality attributes.

This knowledge and understanding supported the procurement and qualification of multi-cavity production tooling and fully automated assembly systems. It was also instrumental in completing the final stages of troubleshooting, performance optimisation and implement late-stage design modifications including an enforced material change.

We managed the full CAD database throughout, working within our client’s change control system to ensure full traceability.
Chris Bunce, Programme Manager, Team Consulting

Bespoke automated testing for a breath-actuated inhaler

With final design modifications completed and production systems in place, Team played a major part in the overall design verification programme, supporting the client to plan design verification testing (DVT) 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 a comprehensive DVT programme against a tight timescale.

The breath-actuated inhaler was launched in Europe in 2018.