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THE WBF BOOK SERIES--ISA 88 and ISA 95 in the Life Science Industries by The WBF

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CHAPTER 2

ISA-88 Design and Implementation Case Study for a Complex Bulk Pharmaceutical Batch Process
Presented at the WBF North American Conference, April 13–16, 2003, by
Scott C. ClarkSr. Engineerscott_clark@merck.comMerck & Co., Inc., 2778 South East SideHighway, Elkton, VA 22827, USA

Abstract

This chapter presents an ISA-88.01 implementation case study derived from a complex, multistep bulk pharmaceutical process. It methodically steps through the design process used to build the application software components that would ultimately control a campaign style of processing, consisting of five distinct trains and a representative cross-section of unit operations seen in Active Pharmaceutical Ingredient (API) bulk processing. Software ...

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