ISPE Baseline Guide. Volume 4. Water and Steam Systems.

International Society for Pharmaceutical Engineering / 2001 / 228 pages

ISBN: 1931879036

Replaced by ISPE Baseline Guide: Volume 4 – Water and Steam Systems, Second Edition


This Guide is intended for the design, construction, and operation of new water and steam systems. The purpose of this Guide is to focus upon engineering issues and provide cost-effective water and steam systems. The Guide is intended primarily for regulatory compliance for the domestic US market, and follows US standards and references. Issues relating to Europe are discussed in the Guide’s appendix.

The Water and Steam Systems Baseline Guide places emphasis on how system design should be determined based upon the quality of feed water, the design of pretreatment and final treatment systems, the storage and distribution system design, and the operation/maintenance procedures. It aims to improve consistency of pharmaceutical water and steam quality throughout the industry as a result of system performance and reliability improvements. In addition, the Guide also provides the user with alternative basic system building blocks to permit reliable and consistent generation of required water or steam quality.

The validation of water and steam systems, which is comprised of commissioning and qualification activities, is not discussed in-depth in this Guide. Where non-engineering issues are covered (i.e., microbiological topics), the information is included to stress the importance of such topics and the impact they have on water and steam system design. Such non-engineering topics are not comprehensively covered.

The key concepts defined and used as a basis for this Guide include:

- methodology for defining the required water quality and configuring a water delivery system
- critical process parameters including temperature, UV intensity, ozone concentration, and circulating systems under positive pressure
- good engineering practice (GEP)
- design options.