March/April 2004 Volume 24, Number 2



Cleaning of a Tablet Packaging Machine Validated by a Contractor - A Case Study
by Heidi Meinertz Jensen
This case study describes a validation assignment carried out by a contractor for a client.
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Design Considerations for Aseptic Liquid Vial Filling and Lyophilization Operations Within High Containment Isolators - Part 1
by Michael P. DeBellis
This article discusses the many design considerations involved with interfacing a high containment isolator with an aseptic liquid vial filling and lyophilizer operation.
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Pharmaceutical Drug Substance Due Diligence - A CMC Technical Assessment - Part 1
by Thomas J. DiFeo
This article provides an overview of the Chemistry, Manufacturing, and Controls (CMC) information which should be reviewed as part of due diligence activities for drug substance.
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Installation of Pharmaceutical Process Piping - A Case Study Part 1 - Planning and Preparation
by Barbara K. Henon, Stephan E. Muehlberger, Gene DePierro
This two-part article is a case study tracking the installation of process piping for (product) filling lines 7 and 8 in Building 21 at the Sicor, Inc. (formerly Gensia Sicor Pharmaceuticals) plant in Irvine, California. Part 1 includes planning, demolition of existing structures, and preparation for the new installation.
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Using an Interactive CD-ROM to Teach Pharmacy Students Unit Operations
by N Tapia, Carlos Basualto, Jaime Sapag-Hagar, Fernando Valenzuela Lozano, Mauricio Muller, GianFranco Zunino
This article describes the basis and development of the solid dosage form section of an educational CD-ROM, including both the theoretical and self-evaluation sections.
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Water Systems Utilizing Multiple Effect and Vapor Compression Technologies Compared
by George Gsell
This article discusses the comparison of Multiple Effect and Vapor Compression for USP Purified and WFI quality water for the pharmaceutical industry.
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Use of Carr Index for Determination of Machinability of Phase I Formulations
by Mike Killeen
This article describes the measurement of Carr Indices for a powder flow evaluation that can help predict potential flow problems of new formulations prior to clinical supplies manufacturing.
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Fabrication and Study of Simple and Robust Microfluidic Devices
by Ryan Hill, Jeffrey Millman, Orlin D. Velev
Microfluidic devices on a chip promise to revolutionize many areas of analytical chemistry, chemical engineering, pharmaceuticals, and biotechnology.
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