Good Practice Guide: Heating, Ventilation & Air Conditioning 2nd Edition

Published: September 2024 
Pages: 272

• Table of Contents
• Special Pricing for Emerging Economies

Executive Summary

This updated guide provides comprehensive best practices for the design, operation, and lifecycle management of HVAC systems in pharmaceutical manufacturing. It reflects current global regulatory expectations and includes expanded content on sustainability, energy efficiency, and commissioning and qualification strategies.

What You'll Learn

The second edition of the ISPE Good Practice Guide: HVAC builds on the foundational principles of the first edition, incorporating advancements in technology, updated industry standards, and expanded application guidance. This edition:

• Emphasizes a risk-based approach to HVAC system design and operation
• Aligns with ICH Q9 and Q10 principles
• Integrates sustainability and energy efficiency into lifecycle management
• Provides strategies for effective commissioning and qualification (C&Q)
• Supports the application of ISPE Baseline® Guide Volume 5: Commissioning and Qualification (Second Edition)
• Addresses key HVAC topics including system classification, air change rates, containment, and cleanroom requirements

Who Should Use This Guide

This guide is intended for professionals involved in the design, operation, and regulatory compliance of HVAC systems in GMP environments, including:

• Process and facility engineers
• HVAC system designers and operators
• QA and validation specialists
• Regulatory affairs professionals
• Project managers overseeing pharmaceutical facility design and upgrades

New in This Edition

The second edition includes several critical updates and additions:

• Enhanced discussion of energy management and HVAC sustainability
• Updated guidance on risk-based qualification approaches
• Integration with contemporary global regulatory expectations
• Practical examples and decision-making tools for system design and operation

Conclusion

The ISPE Good Practice Guide: HVAC, Second Edition, is an essential resource for professionals responsible for ensuring the reliable, efficient, and compliant operation of HVAC systems in pharmaceutical manufacturing.

Guide Core Team

Christopher Anderson

HVAC Engineer

Hikma

Martina Antalova

Mechanical and Built Environment SME

AstraZeneca

Keith Beattie

Director

Energy Efficiency Consultancy Ltd.

Yusuf Ishak Bhetasiwala

Colin Dennedy

Director

EWA Controls Ireland Ltd

Douglas Ebert

Director- Engineering

Eli Lilly and Co

Michael Egan

Lead Validation Engineer II

Novo Nordisk

William Gantz

Senior Director, Global Technical Service

Bristol Myers Squibb

Nick Haycocks

Mechanical Engineer, Senior Specialist Quality Assurance

Retired

Allen Koester

Senior Project Manager

Salas O'Brien

Kevin LaPlante

Principal Engineer, Project Team Leader

CHA Consulting

Martin McKeon

Engineering Manager

Novo Nordisk

Mark Muench

Associate Director - Global Engineering Assurance

AbbVie, Inc.

Ian Noble

EECO2

James A. Quinn, PE, CPIP

Mechanical Engineer

CRB Group

Edward Rosario

Associate Director Utilities/HVAC Global Engineering

Bristol-Myers Squibb

Josh Williams

Sr. Mechanical Engineer

Genesis AEC

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