Add Multiple New Variants with no Capacity Impact, Validated in Weeks? – No Problem.

Quvara had a prototype assembly line for this injector pen that had been adapted into a higher volume series production line with a few variants of the product. The request now was to rapidly produce many new variants with different coloured buttons, a new plunger rod and dosing knobs. These had to be produced on the same line used for series production whilst continuing to keep up supply with minimum down time. The upgraded line needed to accommodate a much wider product mix, with the same capacity and throughput, meaning rapid changeovers, robust line clearance and additional in-line testing. It was also a requirement to produce variable batch sizes from a few hundred parts to hundreds of thousands. New testing was required for these variants, including a new dosing test.

The in-house engineering team mapped out the requirements for the new variants, defined the validation criteria and set to work designing line upgrades to produce the new variants.  The new plunger rod was longer than the existing type so could not be clipped into the mating part with the current production method. A new solution was designed with additional pneumatic actions, which would work with different plunger rod lengths.

Some of the new button colours were very similar, so a high end, in-line vision system was employed and validated to guarantee to differentiate between the colours. The new dosing knob required different artwork and positioning, so the printing and registration system was modified to deliver different variants, and a new vision system used to differentiate between them. A new dosing test system was designed, 3D printed and validated to cope with different dosing delivery requirements. Another new component had a different internal slot design which could not be visually detected, so an interlock solution was designed to ensure the correct variant was assembled.

A production software “recipe” was developed for all variants. This activates the correct assembly process for that device and uses the specific in-line testing and monitoring sensors and criteria to ensure the right variant was produced and checked. A complex recipe management and validation system was developed to allow rapid switching between the variants with 100% product conformance.

Quvara has a very experienced in-house process engineering team which created and implemented the line upgrades working closely with key vendors for sensors and automation.
The quality team helped define the validation criteria for all variants and supported the IQ, OQ and PQ validation work, with regular customer interaction to ensure fast, but thorough testing and sign-off by all parties. The project was controlled by the project management team, using a robust stage gate process and proven tools to keep everything on track including timing, compliance and finances.

In-house 3D printing was used to produce production fixtures, dummy challenge sample parts and various testing stations to check torques and dosing.