Drug delivery device problem solving and production acceptance testing
22 March 2022
A client had failed design verification testing for one of their drug delivery devices. One of the test failures was caused by a sub-assembly jamming in a small percentage of their devices. They needed to find a solution as quickly as possible and get the device on the market as the drug combination product was estimated to be worth up to EUR 1 million per day.
They approached Springboard to help identify why the mechanism was jamming and to devise a solution. We were able to identify the root-cause and implement a design change to one of the components to fix the problem. To ensure that there would be no further delays to the project, and because the failure had only been observed at very low occurrence rates, Springboard also designed and built an in-line test station for our client’s assembly line, so that they could do 100% inspection of this sub-assembly and have confidence that they would pass verification testing second time round.
Identifying the root cause of the problem by hoping to observe it ourselves was not possible because of the very low failure-rate. Instead, Springboard used a combination of CT scans of the failed devices and methodically altering components to be able to recreate the failure mode in our lab. In this way we were quickly able to pinpoint the cause to a single spring. We then worked closely with the supplier of the component to change the design in such a way to avoid the specific failure mode.
Developing a test fixture for the device high-volume production line
To avoid any further costly delays it was decided that the sub-assembly should be 100% tested in production to ensure that it functioned as intended. Springboard rapidly designed, built, and tested an in-line test fixture to do this. The test fixture applied a controlled force to the sub-assembly and measured it to ensure that it moved to the correct distance and communicated the result to the operator with a simple light indicating a pass or fail.
The test fixture was designed with the requirements of our client’s GMP production line in mind and with consideration of the throughput required and ergonomics for the operator. As well as providing the test fixture, Springboard provide detailed SOPs and a training video for the use of the fixture. We travelled to our client’s site to install the test fixture on the assembly line and carry out an IQ, OQ, PQ validation process, and to train the operators in its use. We also provided ‘go/no-go’ calibration pieces to enable the test fixture to be rapidly checked by the production engineers.
Our clients were delighted with the speed with which we were able to solve their problem, and that they were able to repeat design verification with confidence that they would not have the same issue due to the test station on the production line.
Our flexible teams operating within an ISO 13485 Quality Management System gave us the ability to produce a test station with all of the necessary validation testing and documentation to meet the stringent requirements of a production environment, but in an extremely short period of time. When every day was costly, this was something which none of our client’s other suppliers were able to provide.
This led to further work for this client and our relationship continues to flourish.
Springboard skills used in this project:
- Forensic Engineering
- Root-Cause Analysis
- Mechanical Engineering and test fixture design
- IQ, OQ, PQ process validation and documentation