November/December 2000 Volume 20, Number 6



Operation and Maintenance of Process Control Systems in the Pharmaceutical Industry
by Volker Teuchert
This article presents a summary of VDI/VDE 3517, Part 4: Operation and Maintenance of Validated Systems (ongoing validation).
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Using Clinical Supplies Operations as a Competitive Advantage
by Maheshwar Singh, Mark E. Stesney
This article will discuss the tools, techniques, and practices that top pharmaceutical performers use to turn their trial supplies operations into a competitive advantage.
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Fluid Bed Spray Drying of a Protein Formulation - A Case Study
by Orapin Rubino
This article addresses a case study of the development of a fluid bed spray drying process for a protein for agricultural use.
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Factory Acceptance Testing (FAT) of Pharmaceutical Equipment
by Matthew G. Roberge
A guide for planning and executing factory acceptance tests.
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Meeting the Challenges of R&D Facility Design in a Dynamic Technology Business (Part 2 of 2)
by Joseph M. Phillips, Jay Shoemaker
R&D facility design in the dynamic business environment of pharmaceuticals requires an understanding of important trends and basic human performance issues.
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Application of a Capability Study to a Syringe Filling Operation (Part 1 of 2)
by Peter A. Hugunin
Discussed is the value of capability studies (machine, process, short-term, and long-term) and their relationship to the mission of equipment qualification and validation.
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Hot Water Sanitization of a Continuous Electrodeionization Systems
by Junya Hirayama, Shigeaki Satoh, Jonathan Wood
New electrodeionization water purification devices can be sanitized with hot water, avoiding many of the problems associated with chemical disinfection.
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