ISA-88 and ISA-95 in the Life Science Industries

THE WBF BOOK SERIES--ISA 88 and ISA 95 In Life Science Industries is a guide book to the ISA 88 and ISA 95 Manufacturing Protocols. The book features: -- How to set up a pharmaceutical module library using ISA 88 and how to implement ISA 88 across life Science Development Operations -- Understanding Product life cycle batches -- Case Studies on Risk-based engineering assessment and qualifications, a SCADA upgrade project, and more. The ISA (International Society of Automation) standards 88 and 95 are manufacturing standards established in the late 1990s and periodically updated by the governing bodies responsible for them -- the ISA and the WBF (World Batch Forum). The two standards set up protocols and uniform specifications for batch control systems, including types of control equipment, design of control systems and interpretation of batch control data. In Volume 1, ISA 88 and 95 are explained in the context of the pharmaceutical and medical industries. Examples of such batch processing procedures as fermentation, separation, and refinement are discussed and how the two standards affect the design of facilities and systems for performing these procedures. The ISA 88 and 95 standards have been around (and periodically updated) for nearly 20 years now, but little really helpful has been published on how to put those standards into use, particularly from a pragmatic, real-life experience point of view. The four books in this new series will do exactly that: explain to the manufacturing engineer, the controls engineers, and the industrial planner and manager alike how these standards translate into improved batch and continuous process operations -- and ultimately how those operations can be integrated and automated into general business operations (accounting, inventory, customer relations, product development) of the manufacturing concern.