Manufacturing

Articles

FDA cites 17 observations including air handling, quality control, and deficient microbial monitoring at NIH’s Clinical Center Pharmaceutical Development Section.

Contamination Shuts Down NIH Pharma Development Facility

Jyoti Mundlia is research scholar at PDM College of Pharmacy, Bahadurgarh, India

Rakesh Kumar Marwaha is associate professor at Maharshi Dayanand University's Department of Pharmacy

Box-Behnken modeling was used to optimize a resinate complex, to mask the taste of levocetirizine dihydrochloride and montelukast sodium in orally disintegrating tablets.

Using a Dual-Drug Resinate Complex for Taste Masking

Grand River Aseptic Manufacturing named one of Michigan 50 Companies to watch.

Aseptic CMO Recognized as Company to Watch

OXY-CAPT brings together properties of plastic and glass containers through the combination of oxygen absorption and cyclic olefin copolymer (COP) high barrier layers.

Mitsubishi Introduces New Plastic Syringe and Vial for Parenteral Pharmaceuticals

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.

Symbiosis Launches Bulk Lyophilization Service

Andrea Straka is senior technical account specialist, West Pharmaceutical Services, Inc.

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

Sterilization Effects on Elastomers in Sterile Parenteral Drug Products

This study evaluates the impact of controlled nucleation on the ability to optimize a lyophilization cycle for a monoclonal antibody formulation.

Controlled Nucleation for a Monoclonal Antibody Formulation—A Case Study

Elodie Muller is head of the microbiology laboratory at Confarma France SAS.

Traditional sterility testing methods can take 14 days or longer to complete, so a growing number of pharmaceutical manufacturers and quality control

Validating and Implementing a Rapid Sterility Testing Method

The use of disposables requires careful consideration and planning.

Disposable Technology versus Traditional Stainless Steel--When Time Means Money

Total cost of ownership, including operating costs, must be considered when deciding between flexible and traditional cleanroom systems.

Aseptic/Sterile Processing