John P. Gardner1, Jacob R. Remacle1, Steven J. Doherty2, Daniel J. Creeden2, Kevin D. Seibert3, Zhonghui Wan4, Amanda L. Mc Daniel4, John P. Schafer1, and Gary A. Richardson1. (1) API Operations Engineering, Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN 46285-4816, (2) PAT, Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN 46285-4816, (3) Development Engineering, Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN 46285-4816, (4) Chemical Product Research and Development, Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN 46285-4816
In the course of manufacturing an Active Pharmaceutical Ingredient (API) to supply material to support toxicology studies and clinical trials, it is often desirable to monitor by-products of the chemical processes. Mass Spectrometry (Mass Spec) is a reliable method for tracking the gaseous by-products of the reactions or vapor emissions during drying procedures. Additionally, it is useful for determining the efficiency of a scrubber or for optimizing the spin time during centrifugation operations.
The authors will present a comparison of results from laboratory experiments with Pilot Plant campaigns and discuss equipment configuration for monitoring gas streams. Example applications include monitoring corrosive by-products from an acyl chloride formation, insights into the mechanism and scrubber efficiency of an oxidation reaction and determination of the drying cycle during centrifugation of an API.