Sterile Manufacturing

iSpeak Blog

Is Your Pharma Manufacturing Facility in Compliance?

12 March 2019

Special Reports

Understanding Cleanliness Classifications for Life Science Facilities

1 March 2017

Technical

Applying QRM to Air Change Reduction

1 July 2017

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 Baseline Guide: Sterile Product Manufacturing Facilities (Third Edition) cover

Press Releases

NEW Baseline Guide: Sterile Product Manufacturing Facilities 3rd Edition

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...