Manufacturing, Aseptic Processing

Jul 01, 2016
BioPharm International
Revised versions of ISO 14644 Parts 1 and 2 introduce changes to sampling procedures and monitoring plans for cleanrooms and clean zones.
Jun 22, 2016
By BioPharm International Editors
The agency cited the company for sterile manufacturing violations.
May 01, 2016
BioPharm International
Material compatibility, material sourcing, facility layout, and training are crucial aspects of a successful disposable fill-finish system.
Nov 01, 2015
BioPharm International
Two experts discuss best practices to achieve acceptable sterility assurance levels for aseptically filled products.
Oct 02, 2015
BioPharm International
Isolators offer a safety and economic advantage for next-generation regenerative medicine products.
Sep 16, 2015
Preventing contamination requires quality systems to be in place, including routine cleaning, a robust cleaning validation program, and preventive maintenance.
Sep 10, 2015
By BioPharm International Editors
FDA announced the recall, citing deficiencies in Medistat’s aseptic processing areas and in its environmental monitoring procedures.
Aug 01, 2015
BioPharm International
Industry experts discuss challenges, trends, and innovations in fluid handling.
Aug 01, 2015
BioPharm International
Process maps and risk assessments are among the valuable tools operators can apply to reduce the risk of microbial contamination.
Jul 20, 2015
By BioPharm International Editors
Baxter has initiated a voluntary recall of two lots of IV solutions due to the potential presence of particulate matter.
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