OR WAIT null SECS
May 15, 2015
This study evaluates the impact of controlled nucleation on the ability to optimize a lyophilization cycle for a monoclonal antibody formulation.
Traditional sterility testing methods can take 14 days or longer to complete, so a growing number of pharmaceutical manufacturers and quality control
The use of disposables requires careful consideration and planning.
Total cost of ownership, including operating costs, must be considered when deciding between flexible and traditional cleanroom systems.
Aging facilities and inadequate quality systems create drug shortages. Preventing them will require harmonized regulations, and management support for continuous improvement and innovation.
May 06, 2015
The company voluntarily recalls select lots of Adrucil due to particulate matter.
May 02, 2015
The author reports results of evaluations and concludes that a disinfectant composed of a low-concentration suspension of silver ions is completely sporicidal with only a one-minute contact time.
April 10, 2015
FDA issues a Warning Letter to Hospira S.p.A. for GMP violations at the company’s Liscate, Italy facility.
Baxter voluntarily recalls select lots of IV solutions due to possible particulate matter.
April 09, 2015
Flow indicators maximize the view into sterile processes.