Published: April 2018
Note: Bound version of this guide will be available 4 May 2018
The ISPE Baseline® Guide: Sterile Product Manufacturing Facilities (Third Edition) covers engineering aspects of designing new sterile products manufacturing facilities and modifications of existing facilities. The Guide focuses on how to provide cost-effective facilities which make best use of available modern technologies to ensure that products of the highest quality are consistently manufactured.
Uncertainty about the requirements for regulatory compliance may discourage technological advancement, and can drive up investment and operational costs. ISPE Baseline® Guide: Sterile Product Manufacturing Facilities (Third Edition) aims to offer a consistent interpretation of the latest FDA and EMA guidance, while allowing a flexible and innovative approach to facility design. The Guide is based on key principles such as: 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), and an integrated facility design approach.
The ISPE Baseline® Guide: Sterile Product Manufacturing Facilities (Third Edition) is intended for a global audience of engineers, designers, and other professionals involved with facility design for sterile products manufacturing. Updates for the third edition of the Guide include: harmonized area classification, global facility design approach, Local Protection/Grade A Air Supply (LP/GAAS) for areas within lower classified areas, additional details about barrier and isolator technology, and practical information for particulate monitoring.