Manufacturing, Aseptic Processing

Dec 02, 2013
By BioPharm International Editors
Drug Quality and Security Act gives FDA authority over compounding pharmacies.
Dec 01, 2013
BioPharm International
By BioPharm International Editors
Wolfgang Weikmann of Vetter Pharma discusses the implementation of quality by design in sterile manufacturing.
Sep 27, 2013
By BioPharm International Editors
ATMI has invested in sterile-connector and sterile-fill technology developed by Medical Instill Technologies.
Aug 09, 2013
By BioPharm International Editors
FDA receives adverse event reports related to calcium gluconate infusions.
Jul 12, 2013
By BioPharm International Editors
Vetter has ready-to-submit documentation for this service in Common Technical Document (CTD) formats for the US, Europe and Japan.
Apr 23, 2013
By BioPharm International Editors
Third compounding pharmacy recalls products due to FDA inspection.
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.
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