Volume 21, Number 2

Table of Contents

Articles

Addressing 21 CFR Part 11 Requirements with an Automated Configuration Audit Trail and Version Management System

by David Deitz
This article describes a computer based configuration audit trail that facilitates 21 CFR Part 11 compliance.

Commissioning and Qualification: The ISPE Baseline® Guide

by Christopher Wood
This article provides a summary of the philosophy and concepts embodied within the Baseline® Commissioning and Qualification Guide.

Biowaste Spool Piece Corrosion Failure Analysis Points to Chemical Makeup of 316L Stainless Steel

by Sunniva Collins
A failure analysis of a corroded spool piece indicated that variations in corrosion resistance of different components could be attributed to different heats of steel.

Productivity in Pharmaceutical Research and Development

by Michael R. Pavia
The opportunities available from sequencing the human genome will only be realized by judicious use of new technologies and a process focus.

Economic and Reliable Power Sources for Pharmaceutical Facilities

by Joseph F. Maida
This article describes the history of the electrical utility industry deregulation and the changes that have taken place within the industry that directly relate to pharmaceutical facilities.

Barrier Isolation History and Trends

by Jack Lysfjord, Michael Porter
This article is a summary of survey results taken in the spring of 2000 on the use of barrier isolators in fill/finish applications in the parenteral industry.

Baseline® Guides Update – Commissioning and Qualification Executive Summary

Baseline® Guides Update – Commissioning and Qualification Executive Summary

Pharmaceutical Glossary: A-B

by Michelle M. Gonzalez
Part One (A-B) of a glossary that can be viewed in its entirety on the ISPE Web site

Airlocks for Biopharmaceutical Plants

by Manuel A. del Valle
In pharmaceutical/biopharmaceutical facilities, airlocks help maintain separation between different air cleanliness rooms and between biocontained and non- biocontained areas.

Strategic Step-by-Step Approach for Managing Efficiency

by Scott Canute
This article describes why managing for internal efficiencies in pharmaceutical companies is an attractive alternative to pursuing quick gains through mergers and acquisitions.

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.)