Sterilization Effects on Elastomers in Sterile Parenteral Drug Products
This article looks at data gathered from several studies of a widely marketed chlorobutyl rubber formulation used for vial stoppers and prefilled syringes.
Controlled Nucleation for a Monoclonal Antibody Formulation—A Case Study
This study evaluates the impact of controlled nucleation on the ability to optimize a lyophilization cycle for a monoclonal antibody formulation.
Validating and Implementing a Rapid Sterility Testing Method
Traditional sterility testing methods can take 14 days or longer to complete, so a growing number of pharmaceutical manufacturers and quality control
Disposable Technology versus Traditional Stainless Steel--When Time Means Money
The use of disposables requires careful consideration and planning.
Cleanroom and Facility Planning: Getting Beyond Cost Per Square Foot
Total cost of ownership, including operating costs, must be considered when deciding between flexible and traditional cleanroom systems.
Aging Facilities: Aseptic Manufacturing Faces the Future
Aging facilities and inadequate quality systems create drug shortages. Preventing them will require harmonized regulations, and management support for continuous improvement and innovation.
