Manufacturing, Aseptic Processing

Jan 01, 2013
BioPharm International
By BioPharm International Editors
NIBRT's Ray O'Connor provides an overview of aseptic processing.
May 23, 2012
By BioPharm International Editors
Ray O'Connor, an operations consultant with NIBRT, addresses aseptic processing, including how to avoid contamination, and cleanroom best practices. Posted May 2012.
Sep 20, 2011
BioPharm International
By BioPharm International Editors
The International Society for Pharmaceutical Engineering (ISPE) will soon publish an update for its guide to sterile-product manufacturing facilities. The new publication will replace the original guide, ISPE Baseline Guide: Sterile-Product Manufacturing Facilities, and contain practical information about technological advances in sterile manufacturing.
Sep 01, 2010
BioPharm International
Use it label-free, or add labels to detect contaminants in solution.
Feb 01, 2010
BioPharm International
How this Big Pharma company successfully implemented disposable technologies in its manufacturing plant.
Dec 18, 2009
BioPharm International
Best methods to monitor product-related impurities throughout the production process.
Nov 02, 2009
BioPharm International
Many factors must be considered when choosing a sterile connector for a given process.
Nov 14, 2008
BioPharm International
By BioPharm International Editors
The European Medicines Agency (EMEA) has granted license approval to Bayer HealthCare LLC (Bayer, Berkeley, CA) for its new sterile filling facility on its Berkeley, CA, campus.
Jun 01, 2008
BioPharm International
By BioPharm International Editors
The industry needs to open up to validation failures.
May 01, 2008
BioPharm International
By BioPharm International Editors
Recent problems with food and pharmaceutical ingredients sourced from China highlight a major disadvantage of our complex international supply chains for food and drug ingredients. A global supply chain offers more opportunities for accidental contamination as well as intentional adulteration and counterfeiting. Sticking to minimal requirements may not be enough.
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