ISPE Releases Updated Sterile Product Manufacturing Baseline Guide

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Danielle Hould
ISPE Communications Manager
Tel: +1-813-960-2105, ext. 277
Fax: +1 813.264.2816

ISPE Releases Updated 
Sterile Product Manufacturing Baseline® Guide 

—Guide updated to cover advances in sterilization technology, current GMPs—

(TAMPA, FLORIDA, USA, 7 September 2011)ISPE, a global not-for-profit association of 22,000 pharmaceutical science and manufacturing professionals, today announced that it will soon release an update for its ISPE Baseline® Guide: Sterile Product Manufacturing Facilities (Second Edition). This update, which is intended to replace the original Guide, integrates and consolidates international practical solutions that address sterile manufacturing technological advances since the original Guide’s release.

“When the original Guide was released in 1999, it met a need in the marketplace by providing a comprehensive resource to help interpret and implement FDA regulations with respect to design and operations used for the manufacture of sterile pharmaceutical products,” said Bruce Davis, leader of the team responsible for the Guide update. “However, as technology advanced, aseptic processing in manned cleanrooms was no longer considered current GMP and ISPE began tracking and communicating new, better methods of sterile manufacturing design. What’s great about the new update is that it consolidates all of ISPE’s latest best practice recommendations on sterile manufacturing facility design into one document.”

The updated Baseline Guide is a complete revision of the original version, and contains recommendations to help facilitate compliance with the latest FDA and EMA guidance. The update is aimed at a truly international audience, as it incorporates a comprehensive tabulation, explanation, and comparison of the cleanliness designations found in FDA, EMA, and ISO guidance documents, allowing for better harmonization in global facility design and a wider breadth of regulatory compliance internationally.

Technical updates contained in the Guide include the use of RABS and isolator technology; facility design; best practices for terminally sterilized and aseptically processed sterile products; and updated guidance on quality attributes of construction and finishes solutions for different grades of facility. The Guide includes informative diagrams and thorough text to explain and compare GMP requirements, providing a platform for developing compliant solutions and allowing firms to follow several different routes to reach a compliant solution.

For more information on the ISPE Baseline Guide: Sterile Product Manufacturing Facilities (Second Edition), or to order a copy in either bound or electronic form, visit

About ISPE
ISPE, the International Society for Pharmaceutical Engineering, is a Society of 22,000 pharmaceutical professionals in 90 countries who use expert knowledge to create high-quality, cost-effective GMP solutions. ISPE is “Connecting a World of Pharmaceutical Knowledge” by providing Members with opportunities to develop their technical knowledge, exchange practical experience within their community, enhance their professional skills, and collaborate with global regulatory agencies and industry leaders. Founded in 1980, ISPE offers online learning opportunities for a global audience and has its worldwide headquarters in Tampa, Florida, USA; its European office in Brussels, Belgium; an Asia Pacific office in Singapore; and its newest office in Shanghai, China. Visit for additional Society news and information.



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