Expo and PAT
Engineering the physical interface between PAT probes and powder processes
The early 2000s marked a turning point for Process Analytical Technology (PAT). With the FDA’s 2004 PAT Guidance and the introduction of Quality by Design (QbD) in ICH Q8 in 2006, pharmaceutical manufacturers began investing seriously in real‑time process understanding. But as PAT adoption accelerated, a major bottleneck emerged: applying analytical technologies to powders and granules was far more challenging than applying them to liquids.
Some challenges were fundamental. Unlike liquid systems, powder blends and granules are heterogeneous at the scale at which most PAT probes measure. Achieving representative sampling requires careful mechanical design. Other issues emerged at the application level: solids foul probe windows, exhibit irregular or disperse flow, and often generate spectroscopic signals with unstable baselines or poor signal‑to‑noise ratios. And unlike liquid-phase PAT—where lab or pilot-scale calibration is often sufficient—solid-dose applications frequently demand model development at full manufacturing scale, driving up the cost of equipment and material.
Very quickly, the physical interface between probe and process became the limiting factor for PAT in oral solid dose manufacturing (OSD).
The earliest engineered solutions to this problem were conceived and prototyped by our founders while leading process analytics teams within global pharmaceutical innovators. The success of those prototypes led directly to the formation of our company, Expo Process Analytics — a company dedicated to taking these devices from bespoke engineering concepts to fully robust, manufacturing‑ready products. The technical challenge was substantial: transforming delicate, high‑precision mechanical assemblies into devices capable of meeting GMP requirements for robustness, hygienic manufacturing, HSE compliance, and ATEX certification.
Nearly fifteen years later, those solutions have matured into a product range now used in GMP manufacturing environments across most of the top 20 global pharmaceutical companies. While widely adopted in continuous OSD processing, they are increasingly being deployed in advanced batch applications as well — supporting an industry‑wide shift toward deeper process understanding and greater manufacturing control.