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,...
iSpeak Blog
Two of the contributors for the ISPE Baseline Guide: Sterile Product Manufacturing Facilities, discuss the modern technologies and break down of regulatory guidelines that will greatly assist pharmaceutical professionals and their facility...
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.
Special Reports
In recent years we have observed misunderstanding and confusion over correlation between the 2004 US Food and Drug Administration (FDA) environmental cleanliness requirements for sterile product manufacture 1 and those of the European Medicines Agency...
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
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...
iSpeak Blog
As co-chairs of the Barrier Track program at the 2018 ISPE Aseptic Conference, Michael Faia and I built this year’s program around real-world case studies from an all-star line-up of leading sterile manufacturers including:  Biogen Bristol Meyers...