July/August 1997
Volume 17, Number 4

Theme: Biotechnology

Table of Contents

Articles

New UV System Technology and Validation Method for Pass Throughs by Marc J. Scanlon New UV system technology for pass throughs, integrating material handling methodologies with high intensity UV light, coupled with a user friendly validation procedure. Download Article...

Leveraging Automation Technology Breakthroughs on Small Processes to Achieve Solid Bottom-Line Impact by Joanne M. Salazar & Cindy A. Scott Computer technology breakthroughs are enabling cost effective automation of auxiliary manufacturing processes. Download Article...

Volatile Solvents for Drying and Microbial Kill in the Final Container, A Proposal and a Review, with Emphasis on t-Butanol by Wayne P. Olson Volatile solvents, such as t-butanol, offer the prospect of filling and drying of lipoid solutes from a microbicidal recyclable liquid. Download Article...

A TQM Approach to Meeting FDA Regulations in the Design and Construction of Pharmaceutical Manufacturing Facilities by Jeffery N. Odum The article provides an established program for meeting GMP requirements and maintaining quality in design and construction execution. Download Article...

Pharmaceutical Engineering Interviews Larry W. Kranking, ISPE President and Vice President of Operations for Eisai Inc. by  Larry W. Kranking Pharmaceutical Engineering Interviews Larry W. Kranking, ISPE President and Vice President of Operations for Eisai Inc. Download Article...

Biodecontamination of a Large Volume Filling Room with Hydrogen Peroxide by Dr. Michael Jahnke & Gerhard Lauth A suitable treatment cycle for hydrogen peroxide biodecontamination of 56 cu. m. (1970 cu. ft.) has been developed and the effectiveness of biodecontamination demonstrated. Download Article...

Continuous Production UV Sterilization Transport Applications by Paul J. Haas & Hans L. Melgaard Application and design considerations for ultraviolet surface decontamination/sterilization using automated product transport. Download Article...

Proposed Attributes of a Computerized Clinical Supplies Management System by Michael G. Dragoon, Gerald W. Taber & George Youreneff This article reviews the opportunities from and possible approaches to computerizing Clinical Trial Management Systems. Download Article...