Industrialization of a breath-actuated inhaler

Challenge

Support our client with the industrialization and scale-up of a breath-actuated inhaler for the treatment of asthma.

Approach

We worked with a pharmaceutical company as device design partners. We integrated closely with several key functions across the client’s organization and a large number of partners including manufacturing organizations, specialist equipment suppliers and regulatory experts, to bring the device to market.

Outcome

The breath-actuated inhaler was successfully launched in Europe in 2018 as an asthma treatment for adults and adolescents.

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Client
Pharmaco

Sector
Drug delivery

Expertise
Engineering analysis
Mechanical engineering
Industrialization
Device testing
Design verification testing

Medical device industrialization partners

When our client came to us, 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 combination product during the process of industrialization, scale-up and commercial launch.

We put together an experienced team of mechanical and production engineers, as well as experts in device testing and verification. We collaborated closely across the broad client organization and worked 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.

person-looking-at-device-in-medical-manufacturing-plant-1

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 modeling. 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 optimization and implementing late-stage design modifications (including an enforced material change). The team managed the full CAD database throughout, working within the client’s quality management and change control system to ensure full traceability.

With final design modifications completed and production systems in place, the team played a major part in the design verification program, 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 program under tight timescales.

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