Volume 23, Number 2
by Japan Affiliate
This section takes a look at the pharmaceutical industry in Japan; produced in collaboration with ISPE Japan.
This Executive Summary represents the draft of the ISPE Biopharmaceuticals Baseline® Guide that has been available to FDA and ISPE members for comment.
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)
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.
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.
by David Greene
An overview of CIP with a basis for establishing the flow rate of equipment cleaning.
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.
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.
by Patrick Chkroun, Philippe Jaunin, Denis Acker
This article describes a process description of the purified water generation.
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.
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 © ISPE. All rights reserved.)