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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 25

Batch Release and Material Use Reporting: A Case Study
Presented at the WBF North American Conference, May 15–18, 2005, by
Scott C. ClarkSr. Project Engineerscott_clark@merck.comMerck & Co., Inc, PO Box 7,Elkton, VA 22801 USA

Abstract

This chapter will discuss and explore the enhanced benefits gained from fully utilizing the ISA-88 standard when applying it to batch release and raw material usage reporting. During the development of a complex bulk pharmaceutical facility’s automation system, batch reporting was integrated into the procedural models to provide Critical Process Parameter (CPP) and critical alarm reporting that used native control system data historians, kept in lockstep with the master recipes. This fully ...

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