Manufacturing

Articles

The effect of absorbed vapor-phase hydrogen peroxide on a lyophilized product Protein Z, was studied by spiking experiments with different amounts of hydrogen peroxide.

Determining Protein Oxidation Induced During Fill-Finish Operations

Mark Leykin is senior validation engineer, EMD Millipore.

Andrea Detroy is head of QC packaging materials projects, Medical Devices & Disposables, Roche Diagnostics GmbH, Mannheim, Germany.

Christian Matz is global project manager, Biologics Manufacturing Science and Technology, F. Hoffmann-La Roche Ltd, Basel, Switzerland.

Ross W. Acucena is regulatory consultant, Provantage Services, EMD Millipore

Application of single-use technology in a parenteral facility for syringe filling.

Single-Use Technology in Parenteral Fill/Finish

The ionHP biodecontamination hydrogen peroxide-based sterilization technology is designed for use in aseptic enclosures.

ionHP Biodecontamination Technology for Aseptic Systems

The AdvantaPass wall pass-through system from AdvantaPure permits aseptic transfer of fluids between suites.

Wall Pass-Through System Enhances Aseptic Transfer

Susan Haigney is lead editor of Pharmaceutical Technology and Pharmaceutical Technology Europe.

Industry experts discuss the application, challenges, and benefits of a quality-by-design approach to sterile manufacturing.

Implementing QbD in Sterile Manufacturing

Pfizer, Eli Lilly, and several other pharmaceutical companies are participating in the development of automated sampling technology and associated software that improve process control and reduce development times in biopharmaceutical manufacturing.

Sterile, Automated Sampling Enabling PAT for Biopharmaceutical Manufacturing

Cynthia A. Challener is a contributing editor to Pharmaceutical Technology.

Measuring headspace gas composition and pressure allows sterile product manufacturers to simultaneously monitor important quality parameters rapidly and nondestructively.

Laser Headspace Analysis Advantageous for Monitoring Sterile Fill-Finish Operations

Restricted access barrier systems (RABS) maximize product control but minimize operator interaction in aseptic manufacturing.

Best Practices for Restricted Access Barrier Systems

RABS is a flexible barrier system that maximizes product control but minimizes operator interaction when best practices are followed.

Best Practices for Restricted Access Barrier Systems in Aseptic Manufacturing

Report outlines recommended practices for control and evaluation of operations.

Aseptic/Sterile Processing