May/June 2000 Volume 20, Number 3



Consumer Product Safety Commission Update on Child Resistant Packaging

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And So Was the Pharmaceutical Industry
by Dominick Smith
This article is about the fascinating history of a drug invented at the turn of the last century.
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The Implementation of a Manufacturing Execution System (MES) within a Biological Manufacturing Company
by Frank S. Kohn, David Williamson
A case study on implementation of a MES project.
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Baseline® Pharmaceutical Engineering Guides Update and a Preview of Volume 5: Commissioning and Qualification (Draft)
This article reviews the current status of the Baseline® Pharmaceutical Engineering Guides and includes a preview of the Commissioning and Qualification Guide.
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Technology Advances in the Manufacture and Control of Pharmaceutical Products - a Regulatory Review and Impact Assessment
by Thomas J. DiFeo
The NDA review of an old product in light of technology advances provides a useful means of examining current process and quality controls in light of current cGMP expectations.
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Making Your Process Deliver: Control and Operability Studies Improve Process Consistency and Product Quality
by Phillip Cheng, Sarah Gooda
This article describes a Right First Time (RFT) approach to batch manufacturing that has wide ranging benefits in project and commissioning success, manufacturing agility, consistency, and efficiency.
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Pharmaceutical Facility Costs: Variances
by Joseph A. Blanchard
An investigation of how pharmaceutical facilities varies in cost and some of the reasons why.
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Diaphragm Pumps - an Economic Solution for Hygienic Applications
by Kathleen Berry, Hans-Joachim Johl, Eberhard Schluecker
Diaphragm pumps provide key benefits for hygienic applications when compared to other pump types because they are hermetic, have no dynamic seals, are CIP and SIP-able, feature minimal hold-up volume, and provide gentle handling of fluids
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Integrated Transfer Panel Design for the Biopharmaceutical Industry
by Geoff Attenborough, Randy Cotter, Wei Huang
This article focuses on transfer panel technology for the biopharmaceutical industry.
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