Volume 24, Number 2
by Heidi Meinertz Jensen
This case study describes a validation assignment carried out by a contractor for a client.
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.
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.
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.
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.
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.
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.
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.
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 © ISPE. All rights reserved.)