Challenges in Applying PSM to Production Pilot Plants & Laboratories

The CordenPharma Colorado, Inc. (CPC) site in Boulder includes at least eight production facilities. The majority (six) are production laboratories and pilot plants, with synthesizers and vessels of a few liters to a few thousand liters. All of the production process systems are connected to at least one of the site's bulk chemical tank farms, so even processes that are in lab hoods fall under the PSM rule. Because CPC manufactures a wide variety of peptides and small molecule pharmaceuticals for many customers, process and plant configurations are seldom static; some process trains are in use for only a few weeks at a time.

CPC strongly supports PSM as good engineering and operating (and lab) practice, but there are certainly challenges to complying with the intent and purpose of PSM in a dynamic, laboratory-scale operation, where reactors and vessels are glassware, and the interconnecting piping can be short runs of polymer hose. Further, CPC facilities include large, production-scale equipment that are usually considered lab equipment, such as High Pressure Liquid Chromatography columns, where there is little recognized good engineering practice to follow.

The site has solidly implemented discipline to assure that it is following PSM, and is open to sharing what has been learned with other small-scale production operations. These include learnings and practices in design and engineering, Mechanical Integrity, Process Safety Information packages, Change Management, incident reporting and investigation, inter-plant and inter-process emergency response, contaminant isolation and controls, and pressure safety controls, all of which will be briefly presented.