This educational special edition on utility qualification discusses technical and scientific methods to ensure proper qualification. The special edition also discusses regulatory and best practices to ensure compliance.

Water Systems: The Basics - Part 1: Design as a Prelude to Validation
Bob Elms and Cindy Green

Water Systems: The Basics - Part 2: Validation and Maintenance
Bob Elms and Cindy Green

A Guide to Validating Purified Water or Water-For-Injection System
Benjamin J. Roczniak

Proper Validation of a Water Purification System: An Inherently Flawed Process?
William V. Collentro

Validation of HVAC Systems in Pharmaceutical & Biotechnology Facilities - Part I
Brian Scott, Jeff Hargroves, and Jerry Bauers

Validation of HVAC Systems in Pharmaceutical & Biotechnology Facilities - Part II
Brian Scott, Jeff Hargroves, and Jerry Bauers

Pyrogens and Endotoxins: Their Generation and Prevention in Pharmaceutical Water Systems
Drew Coleman and Douglas Burns

Conducting a Water Quality Failure/Incident Investigation
Shahid T. Dara

Validating Building Controls Systems
Jeffrey L. Waters

Special Report: A Pocket Guide to Auditing Pharmaceutical Water Systems
Graham Bunn

Facility Validation: Validating USP Purified Water, Compressed Air and HVAC Systems
Jean-Pierre Thiesset

Key Aspects of Validating Hydrogen Peroxide Gas Cycles in Isolator Systems
James R. Rickloff

Validation of Process Gas Systems
Jeff Hargroves

Purified Water Systems: A System Perspective Under the New USP Quality Requirements
Tod E. Ransdell

Management Considerations in Water Purification Systems Validation
Shahid T. Dara

The Study of the Design of Production Systems of Purified Water for the Pharmaceutical Industry
I. Lerin Riera, R. Salazar Macian, J.M. S~uné Negre and J.R. Ticó Grau

Autoclave Qualification: Some Practical Advice
Gamal Amer, Ph.D. and Robert G. Beane, Jr.

Qualification of Purified Water Systems
David W. Vincent