A medical device company required the transfer from their R&D group to Engineering for a penetrable cap product. The product only had partially defined process parameters and Quality Specification.

Each foil was delivered to Engineering with a 3.5-second weld process at the bottom and top, with a very difficult-to-process wiping material in between. This required a proper production process.

The initial manual process took six operators and three shifts to produce 1,000 caps per shift. During the POP and POC process, I improved both welds as well as the cutting and placing of the wiping material while implementing the improved manual production equipment into the process. We achieved a throughput of 5,000 caps per shift.

Following this 5x increase, I developed the URS for a 40 PPM machine and managed the procurement and qualification of the first machine. Shortly afterward, two more 40 PPM machines were ordered and installed. The demand for production capacity increased due to the company’s novel automated assay systems. We targeted a new production rate of 80 PPM.

I developed the URS for the 80 PPM assembly equipment and started the vendor selection process with automation companies. We were able to compare three vendor quotes and select the best partner by performing an in-depth KT analysis. The process and choice yielded a valuable partner relationship. We placed additional orders for this equipment and placed them within multiple CMOs. I worked with each CMO to correctly place and qualify the first few units before handing off a well-defined process to other engineers.

The 80 PPM machines boast a 95% uptime running 24/7. This high uptimes was achieved via my selection of quick consumable change-outs, a maintainable design philosophy, and following proper GAMP documentation process.