March/April 2003
Volume 23, Number 2

Theme: Direct Impact Systems

Table of Contents

Articles

Country Profile: Japan
by ISPE 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 by ISPE This Executive Summary represents the draft of the ISPE Biopharmaceuticals Baseline® Guide that has been available to FDA and ISPE members for comment. Download Article...

Design Criteria and Evaluation of Pharmaceutical Containment Systems by Osamu Suzuki, PhD, Morihiko Takeda, Koji Tanaka & Mikio Inoue, PhD This article describes criteria as a strategy for containment systems (isolation systems) applicable to pharmaceutical facilities handling Active Pharmaceutical Ingredients (APIs) Download Article...

Step-Variable Air Volume Fume Hood Control - A Case Study by Sarla M. Patel, PE & Martin J. Wendel, Jr. This article describes an innovative design of a fume hood control system, combining the best features of traditional constant volume and variable volume control. Download Article...

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. Download Article...

Practical CIP System Design by David Greene An overview of CIP with a basis for establishing the flow rate of equipment cleaning. Download Article...

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. Download Article...

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. Download Article...

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. Download Article...

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. Download Article...