Published: July 2014
Pages: 120
Water and steam may be used in the manufacture of products, cleaning operations, and laboratory activities within pharmaceutical or biopharmaceutical operations. Systems that generate and distribute water and steam that may come into contact with product/or process contact surfaces, or that are used in the testing of product, are subject to commissioning and qualification (verification) practices.
This second edition of the ISPE Good Practice Guide: Approaches to Commissioning and Qualification of Pharmaceutical Water and Steam Systems, discusses practices and activities associated with the commissioning and qualification (verification) of pharmaceutical water and steam systems. The guide focuses on items which directly affect quality attributes of water or steam during production, storage, and distribution.
ISPE members located in nations with emerging economies* are eligible for a 50% discount on publications from the regular member price. To receive the discount, members must be logged in with their ISPE member account. Contact Member Services at ask@ispe.org for more information or if you have questions about your membership status or this discount program. Discounts do not apply to Accuris (formerly Techstreet) document downloads.
*Based on the World Bank's system for classifying national economies by GNI per capita. Includes low-income, lower middle-income, and upper middle-income economies. To learn more about the World Bank classification system, please click here. Currently includes the following nations, except where international sanctions apply: