January/February 2010
Volume 30, Number 1

NOTE: Pharmaceutical Engineering article PDF documents are not to be posted on any Web site, blog site or page, or any other internet site without prior permission from ISPE. (Copyright © 2010 ISPE. All rights reserved.)


 

Articles

Case Study: Project Execution Strategy for MAB Building 95, Overall Winner, 2009 Facility of the Year Awards
by Rochelle Runasy
This case study focuses on the plan, design, and construction of the unique concept and layout of Roche's biotech facility, MAB Building 95, Overall Winner of the 2009 Facility of the Year Awards.
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Case Study: Utilizing Electron Beam Surface Decontamination to Transfer Sterile Syringe Barrels into an Isolated Aseptic Syringe Filling Line
by Mr. Oliver Vogt
This case study presents a project within Hospira, Inc., utilizing an Electron Beam Surface Decontamination system integrated into an isolated aseptic syringe filling line to transfer pre-sterilized syringes into the filling line.
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Microreactor Technology: Innovations in Production Processes
by Dr. Yukako Asano, Togashi Shigenori, Tsudome Hidekazu, Sei Murakami
This article presents microreactor technology providing the effective numbering-up processes from R&D to plant construction, which enables facility and equipment installation times to be reduced and yields and product qualities to be improved.
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Pharmaceutical Engineering Interviews Wesley P. Wheeler, CEO and President, Patheon
by Gloria Hall
Wesley P. Wheeler discusses the current state of contract manufacturing in a challenging economic environment and how Patheon strives for efficiency and service excellence under his leadership.
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Test Automation in GxP Regulated Environments
by Ms. Radha Ramesh
This article covers the methods, technologies, and case studies for the automated testing of an installed system.
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A Synopsis of Explosion Hazards During the Transfer of Powders into Flammable Solvents and Explosion Preventative Measures
by Martin Glor
This article presents the explosion hazards associated with powder transfer into vessels, which may contain flammable solvent vapors. The formation of explosive atmospheres and occurrence of ignition sources such as static electricity are described. Preventive measures and technical equipment are outlined and discussed.
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Departments

Classified Advertising with Advertiser’s Index

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Online Exclusive Articles

Streamlining of Raw Material and Culture Media Testing and Release for Clinical Manufacturing
by Kelli Pardue, Marshall Gayton, Raymond Kaiser, Susan Gibbons, Jocelyn Lazor, Vicky Griffin, Dr. Beth Junker, Monica Storz
This article presents a Lean/Kaizen team effort to improve raw material and culture media testing and release cycle times for clinical manufacturing campaigns.
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Life-Enhancing Biotherapeutics Company Nets Healthier Equipment
by Kevin Pait, Preston Ingalls
This article shows the impact of an organized and focused continuous improvement effort using teamwork on equipment reliability.
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NOTE: Pharmaceutical Engineering article PDF documents are not to be posted on any Web site, blog site or page, or any other internet site without prior permission from ISPE. (Copyright © 2010 ISPE. All rights reserved.)