Good Practice Guide: Heating, Ventilation & Air Conditioning 2nd Edition
Published: September 2024
Pages: 272
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
For the full list of contributors to this Guide see Guidance Document Teams