Sterile Manufacturing

Video
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...
Guidance Docs
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.
Technical
The following is an example of an evaluation of room air change rates for potential reduction using QRM, providing more detail on engineering considerations.
Guidance Docs
16 April 2018
News & Press Releases
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...