The International Society for Pharmaceutical Engineering (ISPE) have released their latest guide, ISPE Baseline® Guide: Sterile Product Manufacturing Facilities (Third Edition). This publication provides guidance on engineering facets of designing new sterile products manufacturing facilities and modifications of existing facilities.

“Understanding regulatory compliance is a challenging feat, one that can impact technological advancement and increase operational costs,” said John Bournas, ISPE CEO and President.“ This guide aims to offer a consistent interpretation of the latest FDA and EMA guidance, while allowing a flexible and innovative approach to facility design.”

The ISPE Baseline® Guide: Sterile Product Manufacturing Facilities (Third Edition) focuses on best practices for an approach that is effective, cost-efficient, and in compliance with the latest FDA and European Medicines Agency (EMA) guidance. The guide is based on key principles, including:

• The need to understand product and process requirements
• Use of risk-based approaches
• Role of barrier and isolator technology
• Use of consistent terminology for classified environments
• Categories for processing (open versus closed)
• An integrated facility design approach

Updates to this new edition include:

• Global facility design approach with examples of RABS, full isolator, and BFS recommended layouts
• Harmonized area classifications
• Additional details about local protection/Grade A air supply and particulate monitoring

To order your copy visit: www.ispe.org