Cover Image

Downloads

Volume 22, Number 3

Table of Contents

Articles

Containment Considerations

by James P. Wood
This article highlights key elements to consider in approaching the containment of pharmaceutical operations.

Silicone Use: The Next Generation

by Stephen Warburton-Pitt
This article highlights advancements in the use of silicone rubber, explores current approaches, and presents changes in silicone rubber connection.

Quantitative Economic Evaluation of Single Use Disposables in Bioprocessing

by Andrew Sinclair, Miriam Monge
Economic evaluation of single use disposables compared to stainless steel vessels in the manufacture of a therapeutic protein.

What is Biotechnology?

by Jeffery N. Odum
A basic definition of biotechnology and the operations required for manufacturing biologics.

Development of Biotechnology Curriculum for the Biomanufacturing Industry

by Robert L. McKown, George L. Coffman
This article describes the development of a curriculum in a hands-on biomanufacturing laboratory.

Requirements for Process Validation of Biotech Active Pharmaceutical Ingredients

by Reiner Kirrstetter
This article outlines the scope of process validation for biotech Active Pharmaceutical Ingredients (APIs).

Guidelines for Assessing the Particulate Containment Performance of Pharmaceutical Equipment

by Paul Gurney-Read, Martin Koch
History and content of draft guideline for containment testing of pharmaceutical equipment, expected to be published late 2002

Baseline® Pharmaceutical Engineering Guide Series: Biopharmaceuticals Outline

This article provides a high-level overview of the current content and structure of the Biopharmaceuticals Baseline® Guide, which is the sixth volume in the Baseline® Guide series.

Biotech Glossary of Terms

by Jeffery N. Odum
Biotech Glossary of Terms: The terms given in this article are specific to their application in biotechnology.

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.)