For this client, making lyophilized bead manufacturing had been tried before using large, cumbersome equipment but the process proved too expensive and dangerous. The old equipment was placed in storage.

However, R&D and the Process Transfer group resurrected the Lyo-Bead project and asked me to engineer a higher output and safer production process. First, I worked with the R&D scientists dropping enzyme reagents into a bear sieve in an LN2 bath using a pipette, setting up a positive displacement pump. This was a huge improvement. I then designed the first rotary 4-pump channel unit for him and had one of my automation vendors build it.

After that early success, I placed an order for a second unit for the Process Transfer group so they could begin their manufacturing efforts. I also designed additional equipment to lyophilize the frozen beads and fill the 2x6 cartridges. The bead was extremely delicate. Figuring out the handling process was a major challenge.

We successfully created the end-to-end production process. When management saw the results, they went into full production mode. I ordered more copy units with some slight modifications for quick changeovers and we designed and built a whole manufacturing suite, including a dry room.

Production grew rapidly. When management asked for a higher throughput unit, I wrote the URS for an eight-channel system with separated chambers and a quick changeover feature. We had to excahnge the LN2 tanks in the material hallway behind the room, so I contracted a cryo-vendor to design, build, and install the piping and controls for an auto-tank transfer. I also worked with the automation vendor to design an open-tank LN2 level control for the machine, which proved quite complicated.

In the end, the higher throughput system worked as designed and we validated it and moved to production. I even designed  a manual bead transfer tooling to fill the four-up 2x6-cartridge tooling.

I was proud to secure two patents in this very successful project and glad to have contributed to the company’s expanded Diagnostic product offerings.