Volume 22, Number 4

Table of Contents

Articles

Process Containment Design for Development Facility - Part 1

by Lewis Walker
This article discusses the problems associated with handling of potent solids in development stage manufacture of Active Pharmaceutical Ingredients (APIs). (Part 1 of 2)

Capacitance: Key Design Consideration for Refrigerated Central Cooling Systems for Batch Process Plants

by Peter N. Notwick
This article presents three major elements of central cooling systems for batch manufacturing plants: chilling, distribution, and capacitance.

Using Exposure Tests to Examine Rouging of Stainless Steel

by Troels Mathiesen, Jan Rau, Jorma Ter, Ke Bj, Jan E. Frantsen, Benedikt Henkel
This article presents the results of an experimental study conducted to support the basic understanding of the rouging phenomenon that often occurs on stainless steel in WFI systems.

Practical Guide to Autoclave Validation

by Raymond G. Lewis
The practical experience that the article is based on may provide assistance in ensuring an effective, efficient validated process for steam sterilization.

Airflow Measurement and Control in Pharmaceutical HVAC Applications

by Ken Kolkebeck
This article provides the technical understanding needed to select and apply airflow measurement devices for HVAC control applications in the pharmaceutical industry.

Satisfying Both Clinical Supply and Process Development with a “State-of-the-Art” Kilo Lab Facility

by Edward Kobelski, Thomas Staigers, Charles Sullivan
This article presents a unique approach of building a facility to be used both for process development and scale-up, and for manufacturing of APIs for clinical supply.

Transferring a Genetically Engineered Biopharmaceutical from Research to Clinical Development - Impact on Facility Design and Build Projects

by Declan Greally, Rodger Edwards
This article deals with design and build issues related to biopharmaceutical facilities.

Security Planning and Design for Twenty-First Century Pharmaceutical Facilities

by Jeffrey Cosiol, James Lindquist
Elements of the design process relevant to security planning.

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