Aseptic/Sterile Processing

Jun 04, 2015
By Pharmaceutical Technology Editors
FDA cites 17 observations including air handling, quality control, and deficient microbial monitoring at NIH’s Clinical Center Pharmaceutical Development Section.
May 31, 2015
PTSM: Pharmaceutical Technology Sourcing and Management
By Pharmaceutical Technology Editors
Grand River Aseptic Manufacturing named one of Michigan 50 Companies to watch.
May 21, 2015
By Pharmaceutical Technology Editors
OXY-CAPT brings together properties of plastic and glass containers through the combination of oxygen absorption and cyclic olefin copolymer (COP) high barrier layers.
May 20, 2015
PTSM: Pharmaceutical Technology Sourcing and Management
By Pharmaceutical Technology Editors
Symbiosis Pharmaceutical Services is now offering a new bulk lyophilization (freeze drying) service in response to increasing demand in the manufacture of bulk intermediates and APIs by lyophilization.
May 15, 2015
Pharmaceutical Technology
Aging facilities and inadequate quality systems create drug shortages. Preventing them will require harmonized regulations, and management support for continuous improvement and innovation.
May 15, 2015
Pharmaceutical Technology
Total cost of ownership, including operating costs, must be considered when deciding between flexible and traditional cleanroom systems.
May 15, 2015
Pharmaceutical Technology
The use of disposables requires careful consideration and planning.
May 15, 2015
Pharmaceutical Technology
Traditional sterility testing methods can take 14 days or longer to complete, so a growing number of pharmaceutical manufacturers and quality control
May 15, 2015
Pharmaceutical Technology
This study evaluates the impact of controlled nucleation on the ability to optimize a lyophilization cycle for a monoclonal antibody formulation.
May 15, 2015
Pharmaceutical Technology
This article looks at data gathered from several studies of a widely marketed chlorobutyl rubber formulation used for vial stoppers and prefilled syringes.
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