March/April 2003 Volume 23, Number 2



Country Profile: Japan - March/April 2003
by Japan Affiliate
This section takes a look at the pharmaceutical industry in Japan; produced in collaboration with ISPE Japan.
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ISPE Biopharmaceuticals Baseline® Guide - Executive Summary
This Executive Summary represents the draft of the ISPE Biopharmaceuticals Baseline® Guide that has been available to FDA and ISPE members for comment.
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Design Criteria and Evaluation of Pharmaceutical Containment Systems
by Osamu Suzuki, Morihiko Takeda, Koji Tanaka, Mikio Inoue
This article describes criteria as a strategy for containment systems (isolation systems) applicable to pharmaceutical facilities handling Active Pharmaceutical Ingredients (APIs)
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Step-Variable Air Volume Fume Hood Control - A Case Study
by Sarla M. Patel, Martin J. Wendel
This article describes an innovative design of a fume hood control system, combining the best features of traditional constant volume and variable volume control.
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An Automation and Validation Strategy for an Automated API Manufacturing Plant
by Jorge Manuel C Pastilha
Redefining an Automation and Validation Strategy allowed a plant to be revised and designed for a new treatment product within three months of start-up.
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Practical CIP System Design
by David Greene
An overview of CIP with a basis for establishing the flow rate of equipment cleaning.
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The Effect of Passivation on AL-6XN Alloy Compared to the Traditional 304L and 316L Stainless Steel Alloys
by Arnie Grant, John Jermain
This study compares the passivation of AL-6XN to 316L and 304L using G/Fe Ratio and Pitting Potential as evaluation criteria.
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Quality Systems in the Pharmaceutical Industry
by Lorna Foote
This article describes, through comparison with the GAMP guide, how software suppliers achieving high levels of the Capability Maturity Model can case the validation burden when implementing IT systems.
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Production of Purified Water in the Biotechnology Industry
by Patrick Chkroun, Philippe Jaunin, Denis Acker
This article describes a process description of the purified water generation.
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Barrier Isolation History and Trends
by Jack Lysfjord, Michael Porter
This article summarizes survey results taken in 2002 on the use of barrier isolators in fill/finish applications in the parenteral industry.
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