The Long Arm of S88

This quick, one-time registration gives you access to members-only site benefits. By Nick Basta, Contributing Editor Economic pressures and regulatory uncertainties are forcing many drug manufacturers today to operate in “hurry up and wait” mode. “Capital expenditures have to be made as late as possible in the drug-manufacturing process, yet companies must be ready to implement them once drugs meet regulatory approval,” says Lou Pillai, IT team leader at Pfizer, Inc. (New York, N.Y.). “Process design and specification used to be a somewhat unstructured process; now there’s a language and a methodology that allows everyone involved in design and process control to communicate with each other.” September 2004, p. 36) is helping drug makers manage these pressures in new plant construction. But for plant design, specification and validation, standards developed in the process control field are having a far-reaching impact on drug manufacturing. S88 ( ), which originated as a way to write control logic for batch processes, has become a preferred route for designing and specifying all the production equipment in a pharmaceutical plant. The standard, first established in the 1990s by the World Batch Forum under the imprimatur of ISA International (Raleigh, N.C.), began as an approach to process control for batch manufacturing. It has also influenced a broader, parallel program, S95, “Enterprise Control System Integration,” designed to rationalize how information leaves the plant floor and is transferred to enterprise IT systems. S88 is grounded on three principles: . This quick, one-time registration gives you access to members-only site benefits. Link to this article from your web site or blog Copyright © 2004 — 2009 Pharma Manufacturing.