Design verification testing for an inhaler

Challenge

Our client asked us to perform comprehensive Design Verification Testing (DVT), under cGxP controls, for a breath-actuated pressurised metered dose inhaler (pMDI). We focused on the performance and reliability of the product’s mechanical function, in line with the latest standards and regulations.

Approach

We planned and completed a comprehensive DVT programme to test the performance of hundreds of pMDI samples through their 120-shot use life. For every shot, our testing captured data for eight key functional requirements. To achieve this high fidelity testing in the most efficient way possible, we developed and validated over 30 bespoke test methods and commissioned and qualified two sophisticated semi-automated test instruments which were used in-house throughout the programme.

Outcome

We successfully tested and analysed data from more than 120,000 actuations from over 1,000 inhaler samples. The evidence we gathered and reported for this DVT programme supported the launch of the product in Europe in September 2018 as an asthma treatment for adults and adolescents.

A testing programme within full cGxP controls

Our client partnered with Team Consulting for the industrialisation, scale-up and Design Verification Testing (DVT) of their novel, breath-actuated pMDI for treatment of asthma. The product submission had already been filed which meant that the scope for change was extremely constrained and the project team had to work within full cGxP controls throughout.

We completed detailed tolerance analysis and built mathematical models to understand the design parameters of the device. Alongside this, we also carried out testing programmes to de-risk the design and optimise performance prior to DVT.

Intro image (2)

A unique drug delivery testing challenge

The inhaler’s design complexity presented a testing challenge because up to eight functions needed to be measured for each actuation, throughout each device’s 120 shot use life.

To meet statistical sampling requirements and the requirements of ISO 20072:2013, we needed to test and gather data from over 1,000 pMDI samples ‘through life’. We designed, commissioned and validated bespoke semi-automated test instruments which became the ‘work horses’ of DVT, outputting comprehensive data for detailed analysis.

All testing work was performed in Team’s laboratory facilities which could maintain the closely controlled ISO 20072 ‘standard atmosphere’ test environment needed for inhaler DVTs.

The amount of information we needed to gather and analyse during this DVT programme was daunting and would not have been feasible with traditional, manual testing. Developing and commissioning test equipment suitable for high throughput testing meant we were able to gather large volumes of detailed information. This, coupled with the insights from our team of technicians and analysts, allowed us to capture comprehensive information about the inhaler’s key inhaler functions quickly and with a high level of confidence.

Jamie Greenwood, Managing Consultant, Team Consulting

Environment, health and safety matters during device testing

The potent nature of the drug product, coupled with the need to fire numerous doses in testing, meant that we had to implement containment measures to avoid exposure. To achieve this, we commissioned bespoke containment facilities and implemented ongoing environmental monitoring to ensure the health and wellbeing of our staff throughout testing.

Untitled design – 2024-05-30T115321.110

A multidisciplinary design verification testing programme

The analysts’ familiarity with the device characteristics brought the more subjective observations like the sounds and the feel of the device to the front. This helped the design and engineering team target specific solutions to optimise manufacturing parameters at the component level, thus ensuring capable moulding and assembly processes leading to a robust product.

The analysts’ familiarity with the device characteristics brought the more subjective observations like the sounds and the feel of the device to the front. This helped the design and engineering team target specific solutions to optimise manufacturing parameters at the component level, thus ensuring capable moulding and assembly processes leading to a robust product.

Chris Hurlstone, Director of Drug Delivery, Team Consulting

Automated dose counter assessment

The product includes an integrated, mechanical dose counter which indicates the number of puffs remaining. This information needs to be presented clearly and correctly to end users. This meant the dose counter was a performance-critical function and needed to be comprehensively tested to ensure it was accurate and reliable.

The challenge was to develop a test method which allowed for the dose counter to be assessed in an objective way while complying with current data integrity requirements. To achieve this, the dose counter display had to be captured by pictography after every actuation. To support the need for high throughput, we automated this process and the result was a validated methodology, built on our detailed understanding of the inhaler functions, which produced comprehensive and robust data to support detailed assessments of the dose counter’s performance in DVT.

Copy of Untitled Design

Outcome

This DVT programme supported the launch of this breath actuated inhaler in Europe in September 2018 as an asthma treatment for adults and adolescents.

Wonder how we could help?

Let’s start working together on your next challenge.