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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 1

ISA-88 Provides a Framework for a Pharmaceutical Process Module Library
Presented at the WBF North American Conference, April 13–16, 2003, by
Vince MillerTeam Leader, Automation Servicesmillerv@bek.comBE&K Engineering, 2450 PerimeterPark Drive, Morrisville, NC 27560

Abstract

Companies face tough economic realities in the business of discovering and bringing new pharmaceutical products to market. Only one in ten thousand new compounds discovered in the lab will survive to warrant commercial production. When a new product is approved, it is imperative to maximize the return on investment by scaling up to commercial production quickly.

Modular construction and design techniques are one answer to this challenge. Although this ...

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