Manufacturing, Aseptic Processing

Oct 01, 2016
BioPharm International
Laser-induced fluorescence, a rapid microbiology method for real-time airborne particle and microbial monitoring, enhances sterility assurance in pharmaceutical manufacturing.
Sep 23, 2016
By BioPharm International Editors
Wells Pharmacy Network is voluntarily recalling all of its products due to sterility concerns.
Sep 14, 2016
By BioPharm International Editors
FDA sent a warning letter to an Illinois compounding pharmacy for violations of the Federal Food, Drug, and Cosmetic Act.
Sep 01, 2016
BioPharm International
Improvements to aseptic manufacturing procedures are long overdue. But how feasible is it for manufacturers to modernize fill lines of legacy products?
Aug 01, 2016
BioPharm International
Industry experts discuss the challenges of using single-use systems in biopharma manufacturing.
Jul 19, 2016
By BioPharm International Editors
FDA issued a warning letter to the Worthing, UK facility for cross contamination and microbial contamination cGMP violations.
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.
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