July/August 2009
Volume 29, Number 4

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 © 2009 ISPE. All rights reserved.)


 

Articles

Design of Pure Steam Generation and Distribution Systems
by Hugh Hodkinson
This article presents an overview of design requirements of pharmaceutical pure steam generation and distribution systems with particular emphasis on recommended terminology (clean vs. pure steam) and feed water quality requirements.
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Methods of Producing Water for Injection
by Henry Brush, Gary Zoccolante
This article presents the advantages and disadvantages of distillation-based and membrane-based methods for producing WFI, outlines international WFI regulatory requirements, discusses historical market penetration and performance of distillation and membrane-based WFI systems, and includes a membrane case study.
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Amplified Media Circulation – A New Way for Enhancing Sterilization Cycles
by David A. Karle, Gerald McDonnell, Teppo Nurminen
This article describes Amplified Media Circulation (AMC), which is an alternative option to the use of intrinsic sterilizer fans.
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Maintenance and Facilities Outsourcing Excellence – An Industry Case Study
by Padraig Liggan
This article presents a case study on the area of utilities and facilities maintenance outsourcing within the pharmaceutical industry. This approach shows how the future for outsourcing is moving toward full ownership of utilities and facilities systems through long-term fixed contracts which have shown clear benefits for both parties involved.
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Industry Interview Series: Sharon Bleach, Vice President, Global Quality, Operations, AstraZeneca
by Rochelle Runas
A veteran quality executive, Sharon Bleach discusses her philosophy on quality, her experience as previous chair of ISPE’s International Leadership Forum, and insight into AstraZeneca’s strategic approach to significant changes in the industry.
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Rouge in Pharmaceutical Water and Steam Systems
This article presents the outcome of a series of workshops on the effects of rouging in pharmaceutical water and steam systems.
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Departments

Global Regulatory News

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ISPE Update

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Classified Advertising with Advertiser’s Index

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Online Exclusive Articles

Electro Membrane Technology Boosting Bioreactor Processes
by Mr. Rene Fuhlendorff, Arvid Garde, Jens-Ulrik Rype
This article presents electro membrane technology for improving yield of bioreactor processes.
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Working Height Velocity Measurement in Conventional Cleanrooms
by William Mason, Bernard McGarvey, Thomas R. Spearman
This article presents the methods and results from performing Working Height Velocity studies in conventional cleanrooms.
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A Risk Assessment Approach to Planning an API Production Factory
by Kazuo Tozaki
This article presents an overview of the planning of an API production factory from the risk assessment viewpoint. Three risk assessment factors of severity, probability of occurrence, and detectability are discussed. An example of conceptual layout planning is presented.
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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 © 2009 ISPE. All rights reserved.)