March/April 2007 Volume 27, Number 2


On-Line Exclusive Articles

Achieving Six Sigma Quality in Medical Device Manufacturing by Use of Design of Experiments and Statistical Process Control
by Per Vase
This article highlights how a manufacturer of medical devices obtained Six Sigma quality in production by the use of Design of Experiments (DoE) and Statistical Process Control (SPC) and discusses how these tools can be an important step toward the Future Desired State.
Download Article... (,585.Kb)

Barrier Vial Technology: A Global Approach to the Aseptic Filling Process
by Diego L, Sergi Roura, J.A. Garcia
This article describes Barrier Vial Technology (BVT) a technology for the filling of liquids under aseptic conditions.
Download Article... (,527.Kb)

Pharmaceutical Manufacturing: Linking Vision and Decision-Making to Achieve a Roadmap Toward cGMPs for the 21st Century
by Beatrijs Van Liedekerke, Ingrid Maes
This article presents the changing manufacturing environment and how companies can develop an infrastructure to continue to meet their strategic objectives.
Download Article... (,484.Kb)

Using a Process Description to Define Automation Needs for a Life Sciences Project
by Steve Murray, Amit Shah, Dawn Marruchella
This article describes how a detailed Process Description (PD) can help to alleviate many of the pitfalls that are encountered in the automation of a life sciences process.
Download Article... (,295.Kb)


Eight Steps to PAT: Using the Design for Lean Six Sigma Toll-Gate Process as Best Practice
by Bikash Chatterjee, Jeremy Green
This article outlines an eight-step six Sigma toll-gate approach to PAT implementation.
Download Article... (,470.Kb)

Lean Data Analysis: Simplifying the Analysis and Presentation of Data for Manufacturing Process Improvement
by Malcolm Moore
This article introduces a data analysis maturity model that maps various tools and methodologies aimed at predicting, analyzing, improving, or controlling the drivers of product quality to the extent to which these techniques may help reduce defects. By mapping tools currently deployed in a particular manufacturing facility to the maturity model, it is possible to define a cost-effective road map for various initiatives aimed at improving product quality through increased process understanding. Pragmatic data analysis and reporting approaches are introduced to aid process understanding for mainstream users and the deployment of that understanding in manufacturing to increase product performance.
Download Article... (,885.Kb)

Introduction to Real Time Process Determination
by Kim Walter
This article introduces a state-of-the-art method to track conditions for wet processes that provides continuous operating guidance through a combination of measured and calculated values.
Download Article... (,508.Kb)

Cost and Benefit Analysis of Validation Strategies
by Kent Lohrey
This article evaluates the time (labor effort) required to validate computer or software systems as a function of the applied validation strategy.
Download Article... (,211.Kb)

Industry Interview Series: Richard S. Overton, Vice President of Operations and Facilities, Forest Laboratories
This once aspiring professional basketball player talks about his unconventional career path into the pharmaceutical industry and Forest Laboratories; his experience running company operations and facilities in different parts of the globe; his thoughts on Quality by Design; the therapeutic areas to watch; and the major industry challenges ahead.
Download Article... (,134.Kb)

The Use of Exponentially Weighted Process Statistics (EWPS) and Statistical Process Control (SPC) in High Frequency Data Acquisition of Pharmaceutical Water Systems Instrumentation
by Nissan Cohen
The article presents high frequency data acquisition in continuous pharmaceutical processes and illustrates, through the use of EWPS, the need for process understanding, control, and improvement.
Download Article... (,637.Kb)

Unified Manufacturing Control System (MCS) Architecture for Pharmaceutical and Biotech Manufacturing
by Ronald E. Men, Darrell Tanner
This article reports on a unified MCS architecture using commercially available MES and PCS. It explains the steps in moving beyond paperless functionality to a unified system helping manage information, processes, and people.
Download Article... (,573.Kb)

Pharmaceutical Standards for Computerized Systems
by Siri H. Segalstad
This article compares the requirements in the 21 CFR Part 11, EU GMP Annex 11, and Part 11’s EU counterpart PI 011-2.
Download Article... (,161.Kb)

The FDA Answers Your Questions on Barrier Isolation Technology
The following questions and answers were provided by panelists Rick Friedman and Bob Sausville during the ISPE 15th Annual Barrier Isolation Conference, held in June 2006. These responses do not necessarily represent the positions or policies of the FDA. They are simply the panelists’ interpretations of these cGMP matters and are based on their collective experiences with isolator technology.
Download Article... (,111.Kb)


Global Regulatory News

Download Article... (,102.Kb)

New Products and Literature

Download Article... (,330.Kb)

Industry and People

Download Article... (,146.Kb)

ISPE Update

Download Article... (,560.Kb)

Classified Advertising

Download Article... (,152.Kb)

 Get the Pharmaceutical Engineering App
Available for
Available at the App Store
Available on Google Play
Available for Amazon Kindle