Volume 29, Number 4

Table of Contents

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.

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.

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.

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.

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.

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.

Departments

Global Regulatory News

ISPE Update

Classified Advertising with Advertiser’s Index

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