Good Practice Guide: Sampling for Pharma Water, Steam, & Process Gases 2nd Edition

Published: July 2026
Pages: 156

• Table of Contents
• Special Pricing for Emerging Economies

Effective sampling is essential to the success of pharmaceutical critical utility systems, yet obtaining a truly representative sample remains complex and risk prone. Systems such as pharmaceutical water, pure steam, compressed air, and process gases can be influenced by environmental conditions, sampling techniques, equipment design, and handling practices, all of which may introduce errors.

The updated ISPE Good Practice Guide: Sampling for Pharmaceutical Water, Steam, and Process Gases (Second Edition) explains how improper sampling can lead to misleading results, unnecessary investigations, or missed quality issues that may ultimately affect patient safety or delay product release. It highlights regulatory expectations, including guidance from the FDA and USP, emphasizing the need for accurate, consistent, and purpose driven sampling practices.

The content explores key considerations such as sampling locations, frequency, valve design, and distinctions between quality control and process control sampling. It also examines the challenges of nonuniform attribute distribution and the importance of risk-based sampling strategies.

By outlining best practices and modern approaches, including the use of real time monitoring technologies, this guide helps organizations reduce variability, strengthen system control, and improve data reliability across utility systems. It also supports development of robust sampling plans, informed decision making, and continual improvement initiatives across facilities, engineering, quality, and operations teams involved in critical utility management efforts.

Guide Core Team

Brian Hagopian

Chemist and President

Clear Water Consulting, Inc.

Brian Pochini

Principal Engineer

Sanofi

Ariel Kehati

Sr. Manager - Clean Utilities EMEA

Johnson & Johnson

Joseph Manfredi

President

GMP Systems Inc

Rinke Nijland

Sr. Process Engineer

Bilthoven Biologicals

Christian Peterson

Senior Process Engineer- Clean Utilities

AbbVie, Inc.

Matthew Poch

Associate Director

Alnylam Pharmaceuticals

Anders Widov

Sales Director

BWT Pharma & Biotech AB

For the full list of contributors to this Guide see Guidance Document Teams