Heat transfer systems are vital to most pharmaceutical manufacturing operations. In fact, some pharmaceutical plants will not operate unless the heat transfer fluid system operates. Therfore, when a pharmaceutical company launches a new product, it must ensure that both the product and process are safe, effective and reliable.
When Searle (now Pharma-cia) was planning the launch of its arthritis medication Celebrex, it assigned the manufacturing of the drug to its chemical and manufacturing operations in Puerto Rico. There, Searle operates a pharmaceutical plant in the city of Caguas and had recently acquired a chemical plant in the town of Barceloneta. The active ingredient in Celebrex, Celecoxib, is made at the Barceloneta facility and shipped to the Caguas plant, where it is formulated into various delivery forms.
The Barceloneta plant was designed for manufacturing processes different from those used in making Celecoxib. Specifically, the heat transfer systems installed at the plant were glycol-based and only effective down to temperatures of approximately 23oF (-5oC). Below that point, the water in the glycol solution would freeze, making the system inoperable. The production of Celecoxib requires temperatures as low as -22oF (-30oC), so changes had to be made. Producing Celecoxib with the glycol-based heat transfer system would have required slowing down the process considerably, resulting in unacceptably long cycle times and drastically reducing the plant's productivity.
A technology transfer team including representatives from Searle's research and development center evaluated the operation and recommended the substitution of the existing glycol-based heat transfer fluid with Therminol D-12 heat transfer fluid, which is manufactured by Solutia Inc., St. Louis, MO. The heat transfer system was drained and flushed, and approximately 10,000 gal of Therminol D-12 were introduced. Commercial production began with no problems from the heat transfer system. An added benefit is the staff at Searle's Barceloneta facility no longer had to handle and dispose of hazardous glycol-based derivatives.