Baseline Guide Vol 3: Sterile Product Manufacturing Facilities 3rd Edition
Published: April 2018
Pages: 244
Hear from two of the guide contributors, Gordon Leichter, PhD, Belimed Life Sciences and Jason Collins, AIA, IPS, on what you will take-away from purchasing this guide including practical and regulatory guidance, harmonization of standards between the US and EU, and more.
Executive Summary
This updated ISPE Baseline® Guide provides engineering and regulatory guidance for designing sterile pharmaceutical manufacturing facilities. It supports harmonization of global standards while promoting flexible, risk-based approaches to facility design and modernization.
What You'll Learn
This third edition of the ISPE Baseline® Guide: Sterile Product Manufacturing Facilities delivers essential guidance for designing and modifying sterile manufacturing environments. Key focus areas include:
- Risk-based approaches to facility and process design
- Classification of environments using consistent terminology
- Design strategies for both open and closed processing systems
- Use and integration of barrier and isolator technologies
- Cost-effective design principles that leverage modern technology
The guide addresses uncertainty around compliance by offering a clear and consistent interpretation of regulatory expectations, helping reduce investment and operational costs while enabling innovation in sterile manufacturing.
Who Should Use This Guide
This guide is intended for professionals involved in the design and operation of sterile pharmaceutical manufacturing facilities, including:
- Facility engineers and architects
- Process designers
- Quality and compliance professionals
- Regulatory affairs specialists
- Project managers in sterile manufacturing
Its global perspective makes it valuable for teams working across multiple regulatory jurisdictions.
New in This Edition
Significant updates in the third edition include:
- Harmonized area classification approaches
- A global strategy for facility design
- Expanded guidance on Local Protection/Grade A Air Supply (LP/GAAS)
- Enhanced content on barrier and isolator technologies
- Practical insights for particulate monitoring and control
Conclusion
The ISPE Baseline® Guide: Sterile Product Manufacturing Facilities (Third Edition) promotes best practices in sterile manufacturing by integrating risk-based design principles and global regulatory alignment. It serves as a foundational resource for designing facilities that support sterile pharmaceutical manufacturing at the highest standards.
Available in Japanese | |
| ISPE Baseline® Guide: 無菌製品製造施設,第3版 | |
 | Individual Download Member Price Non-member Price |