Pharmaceutical Technology-05-15-2015

This article looks at data gathered from several studies of a widely marketed chlorobutyl rubber formulation used for vial stoppers and prefilled syringes.

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.