January/February 2008
Volume 28, Number 1

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 © 2008 ISPE. All rights reserved.)


 

Articles

How Smart Is Your On-Line TOC Analyzer?
by Nissan Cohen, Terry Stange
This article presents the development and integration of an Ultraviolet (UV) sensor for on-line TOC analyzers and demonstrates the efficacy of this critical component, its life cycle, and the usage of PAT in its determination.
Download Article... (,474.Kb)

Improving Water System Performance: A Continuous TOC Measurement Technology to Enhance Real-Time Process Control
by Giovanni De Dona, Robert Theriault
This article discusses real time TOC tracking in the water purification process and the importance of rapid, continuous, and reliable TOC monitoring for real time critical water release.
Download Article... (,780.Kb)

Process Gases and Distribution Systems in Pharmaceutical Production
by Katrin Åkerlindh, Michael Vestermark, Helene Olsson, Anders Ernblad, Markus Birath, Nils Lindman, Sa Klang, Linda Cypriansen
This article discusses the use of process gases in the pharmaceutical industry.
Download Article... (,204.Kb)

Industry Interview Series: Uri Boneh
The Director of Engineering of the Global Generic Resources Group for Teva Pharmaceuticals discusses how solid management, strategic thinking, and proper execution have helped make Teva one of the top 20 pharmaceutical companies and one of the largest generic pharmaceutical companies in the world.
Download Article... (,109.Kb)

GAMP 5 – Enabling Innovation
by Sion Wyn
The new GAMP 5: A Risk-Based Approach to Compliant GxP Computerized Systems provides pragmatic and practical industry guidance that aims to achieve compliant computerized systems that are fit for intended use in an efficient and effective manner, while also enabling innovation and technological advance. The revised Guide describes a flexible risk-based approach to compliant GxP regulated computerized systems, based on scalable specification and verification. A robust quality risk management process based on ICH Q9 principles is central to the approach. GAMP 5 also contains new information on outsourcing, electronic batch recording, end user applications (such as spreadsheets and small database applications), and patch management.
Download Article... (,227.Kb)

AL-6XN® Weld Discoloration and Effect Corrosion Resistance
by John Tverberg, Ken Kimbrel
This article identifies the source of discoloration that can appear on sanitary welds of AL-6XN material and its effect on the corrosion resistance of the material. 
Download Article... (,1.Mb)

Automatic Pill Bottle Opener
by Jorge DaSilva, Jay Peterson, Murat Kocak, William Indoe, Richard Berkof
This article describes the design of an innovative Automatic Pill Bottle Opener, which was a Senior Design Project in the Mechanical Engineering Department at Stevens Institute of Technology, completed in May 2007. 
Download Article... (,378.Kb)

Departments

ISPE Update

Download Article... (,281.Kb)

Classified Advertising

Download Article... (,184.Kb)

Global Regulatory News

Download Article... (,104.Kb)

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 © 2008 ISPE. All rights reserved.)