January/February 2007 Volume 27, Number 1


On-Line Exclusive Articles

Best Practices for Qualification Success: A Statistical Analysis of Characteristics and Practices that Drive IQ and OQ Cost and Schedule
by Allison Aschman, Gordon Lawrence
The Product Quality Research Institute (PQRI) is This article presents a statistical analysis of planning and execution strategies for Installation Qualification (IQ) and Operational Qualification (OQ) activities carried out in 50 construction/modification projects.
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OSHA Limits Stainless Welding Fume Exposure to 5 µg/m3 – “What will it take to be Compliant?”
by Ed Ravert
This article presents the new OSHA regulation regarding permissible exposure limits to hexavalent chromium, a common by-product of welding stainless steel, and how to ensure compliance. The article explains the regulation, including reasons for the stricter limit, and quotes the OSHA standard. The process for calculating the amount of fumes generated in a facility is provided, along with an example.
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Numerical Methods for Particle Shape Analysis (PSA) and Applications to Pharmaceutical Manufacturing
by David A. Vetter
This article introduces numerical methods to characterize particle shape and applications in the pharmaceutical industry. Basic theory and computational methods are shown, followed by a discussion of selected applications within the pharmaceutical manufacturing cycle, such as equipment selection, process safety, process standardization, and counterfeit product detection.
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NIR spectrometry for the characterization of fuel components in a novel tamper-resistant pill bottle

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Choosing Technologies for Aseptic Filling: “Back to the Future
by James Agalloco, James Akers, Russell Madsen
This article reviews the considerations involved in the selection of appropriate technologies for aseptic processing. It compares and contrasts conventional cleanroom operations, Restricted Access Barrier Systems (RABS), and isolation technology with respect to the advantages/disadvantages of each for use in aseptic filling. It evaluates all aspects of the selection process, beginning with project time lines, facility concerns, operation, and compliance.
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Advanced Aseptic Processing: RABS and Isolator Operations
by Eric A. Isberg
This article compares the use of Restricted Access Barrier Systems (RABS) and Isolator Systems for product final fill operations.
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The Physical Chemistry of Decontamination with Gaseous Hydrogen Peroxide
by Carl Hultman, Aaron Hill, Gerald McDonnell
This article reviews the physical chemistry of the safe production of hydrogen peroxide vapor and how to maintain a constant concentration of the vapor in a chamber. This article also reviews the calculations and procedures used to obtain the maximum concentration of vapor without allowing condensation of liquid to occur.
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Automated Loading and Unloading Systems for Lyophilizers
by Peter Heyman
This article discusses the basics of Automated Loading and Unloading Systems (ALUS), including the differences between fixed and flexible systems, as well as covers the evolution of the technology, challenges associated with the use of such systems, industry growth, and recent technology trends.
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Biofilms – Survival and Growth of Bacteria in Compendial High Purity Water Systems
by Frank Riedewald, Aidan W. Sexton
This article presents an overview of how bacteria can grow and multiply in compendial water systems.
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The Use of Virtual Infrastructures in Pharmaceutical Manufacturing
by Adrian Wildangier, Jon Jensen
This article presents the ability to consolidate various regulated and non-regulated applications onto the same physical server hardware, and discusses how system virtualization works, benefits and limitations, and how to qualify such an infrastructure.
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Industry Interview Series:
Dr. Gold talks about the challenges of a small company bringing a drug to clinical trials and incorporating advanced manufacturing methods that involve cooperation between manufacturer and equipment vendors.
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Thin-Cake Filtration Technologies for Removing Activated Carbon, Catalysts, and other Trace Solids from Active Pharmaceutical Ingredient (API) Slurries
by Barry A. Perlmutter
This article discusses how the use of thin-cake vertical candle filters and horizontal pressure plate filters can efficiently remove activated carbon, metal catalysts, and trace insolubles from Active Pharmaceutical Ingredient (API) slurries.
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Global Regulatory News

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New Products and Literature

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Industry and People

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ISPE Update

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Classified Advertising

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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.)

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