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.
The following is an example of an evaluation of room air change rates for potential reduction using QRM, providing more detail on engineering considerations.
ISPE announced the release of 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...
