Volume 25, Number 6

Table of Contents

Articles

Process Modeling Proposition in Biopharmaceutical Manufacturing

by Sei Murakami, Peter Watler, Takashi Ishihara, Shuichi Yamamoto
This article describes advancements in process modeling in biopharmaceutical manufacturing focusing on fermentation and chromatographic separation.

Project Scope Determination and Cost Control Using Technology Assessment Diagrams – A Biopharmaceutical Example

by Mary Ellen Craft
This article describes the use of a technology assessment diagram in the biologics and pharmaceutical industry, and presents the steps to develop, and evaluate the scope options for a facility or process.

Practically Validated – Maintaining the Tested Baseline

by David Paspa
This article presents ways to improve documentation structure incorporating requirements traceability and risk analysis.

Safe Access using Glove Ports – Facts and Fiction

This article describes procedures to test gloves, shortcomings of plastic glove behavior, and glove fixation. In addition, it presents a new impulse technique for the improvement of reproducibility and repeatability of a pressure decay test.

The Case for cGMP Compliant Plant Access Control Solutions for Pharmaceutical Laboratories and Manufacturing Areas

by Walfried Laibacher
This article considers the benefits of validating plant access control systems to support consistent product quality and to lift productivity improvement.

The Staging Option and Drug Development

by Neal Lewis, David Enke, David Spurlock
This article investigates the staging option to analyze an existing case study that involves the potential licensing of a drug compound that is in development. It demonstrates how options analysis is a useful tool in adding insight to the decision making process when conventional valuation methods are not decisive.

Country Profile: India - Nov/Dec 2005

by India Affiliate
This section takes a look at the pharmaceutical industry in India.

Key Principles and Considerations for the Testing of GxP Systems

This article presents key principles of GxP critical testing including test objectives and business benefits. The final published GAMP® Good Practice Guide may differ from this article as a result of the ISPE external review.

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.)