C&Q lead for a new auto-injector assembly line

At one of our clients a project for a new auto-injector assembly line was initiated to meet increasing demand. Our senior consultant Rob Severijnse supported the client’s project team as C&Q lead.

The scope of the project was the implementation of a new assembly, labelling and packaging line for auto-injector devices in the client’s packaging facility. The device consisted of a labeled disposable auto-injector pen containing a syringe with biopharmaceutical product. The portfolio included multiple different injector/product combinations.

We chose a pragmatic matrix approach to equipment testing and qualification. By using a matrix approach only a selection of device combinations representing the entire scope needed to be tested. Thanks to this streamlined approach the equipment was tested and qualified within the given time frame for commercial readiness.

Besides leading the C&Q team, I used my expertise on packaging processes to support drafting of the URS, equipment design review and design of equipment characterization and testing.

After an extensive FAT period at the equipment vendor and installation of the equipment on site, qualification was performed in a joined effort by the C&Q team, packaging operators and technical engineers. This resulted in successful completion of the equipment C&Q and Process Performance Qualification and made the auto-injector assembly line ready in time for the planned commercial production date.