Case Studies
96+ projects. These are seven of them.
Every case study on this page came from a real problem — a manufacturer who needed to automate, a process that didn’t have a defined spec, equipment ordered without documentation, or a production timeline that couldn’t move. The GAMP process exists because of projects like these. Read what actually happened.
Small Fill for Bottle With Foamy Reagent
A CMO in Carlsbad needed two custom fill units for an odd-shaped bottle with a foamy reagent — in under two months. Both units were delivered on time and outperformed the original lab setup.
Validating a Retrofitted Off-the-Shelf Filling Machine
An engineer purchased cheap industrial fill equipment and skipped the GAMP process to save money. When the Quality team asked how to validate it, there were no answers. MEPSCo retrofitted the machine, reprogrammed the controls, and got it released to manufacturing.
On-Time Equipment Delivery for the DOD During the Pandemic
During COVID-19, Hologic needed to scale from one 70 PPM filling machine to multiple 200 PPM lines in the US and UK — fast, with a reduced engineering team. $150M in equipment validated in one year. No change orders.
From Disney Imagineering to Mag-Particle Fill Process
A manual fill process required hours of pre-weighing and produced frequent waste. Applying fluid behavior knowledge from water sculpture design and Disney Imagineering special effects, a new continuous suspension mixing and filling process eliminated pre-weighing entirely and reduced sampling by 95%.
High Throughput Lyophilized Bead Manufacturing Process
A dangerous and expensive lyo-bead process had been abandoned. R&D resurrected it. Reza engineered a scalable production process from a 4-channel rotary unit to an 8-channel high-throughput system with auto LN2 level control. Two patents resulted.
Product Transfer and Scale Up from R&D to Engineering
A penetrable cap product transferred from R&D with only partially defined process parameters. Reza improved the process 5x, then 8x (from 1,000 to 5,000 to 40,000 caps per shift), procuring and qualifying machines to reach 80 PPM at 95% uptime running 24/7.