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Volume 26, Number 2

Table of Contents

Articles

Large-Scale Chromatography Becoming State-of-the-Art

by Roy Greenwald, Bill Rochelle
This article describes the process, design, and fabrication considerations to take into account for large-scale chromatography control and dilution equipment.

Energy Saving Tips for Designing Air Handling Units (AHUs) in Cleanrooms

by Xingyun Mao
This article provides recommendations for designing Air Handling Units (AHU) that will improve system operation and performance.

Equipment Cleaning Validation Modeling Approach for Clinical Trial Compounds

by Lisa Ray, Brian Pack, Lisa Wenzler, Travis Coy
This article outlines the theory and implementation of the equipment cleaning validation strategy in Clinical Trial Packaging at Eli Lilly and Company using model compounds, and describes the process for managing the equipment cleaning validation program.

Aseptic Filling of Closed

by Jacques Thilly, Doris Conrad, Christian Vandecasserie
This article presents a closed vial filling technology. It details the vial and stopper design, manufacturing, the e-beam surface sterilization unit, the filling equipment and process, and sealing laser technology.

Interview with Norikazu Eiki, President and Representative Director, Bayer Yakuhin, Ltd.

by Joe Phillips, Shinichi Osada, Gloria Hall
This article presents a closed vial filling technology. It details the vial and stopper design, manufacturing, the e-beam surface sterilization unit, the filling equipment and process, and sealing laser technology.

Operational Qualification (OQ) Testing of Integrated

by Poul Grav Petersen
This article describes the challenges in planning, executing, evaluating, and reporting OQ activities upon a brief introduction to OQ for automated systems.

The Power of Planning and how it Translates to Commissioning Efforts

by Katie Henchir
This article explores one planning approach for commissioning efforts that divides planning into four categories.

Departments

New Products and Literature

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