Volume 20, Number 2
Structure for Compliance in the Supply of Containment Systems
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Heightening the Success of a Project Through the Use of a Technical Program
by Julie-Lea Lipszyc, Costa Nicolainas, Isabel Piraux, Martine Rondeau
A comprehensive look at the structure, content, and use of a technical program document which summarizes all aspects of a project such as its design, construction, start-up, and conformity.
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Process Validation - Establishing the Minimum Process Capability for a Drug-Product Manufacturing Process (Part 2 of 2: Content Uniformity Examples and Extension to other USP Tests)
by Paul G. King
This article discusses examples and formulas for determining the minimum capability of a pharmaceutical process at the unit dose stage.
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Containment: Reducing Operator Exposure
by Scott Kaplan
This article discusses the current trend in the pharmaceutical industry toward producing more potent compounds and the effects on facility design.
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Trigger Point Master Planning: A New Summary of Approach
by Jonathan Friedan, Travis Peyton
Site managers with mature and complex sites have a new approach to create quick yet comprehensive, responses to “what if” business scenarios presented at the executive level.
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The Impact of Elastomer Performance on Pharmaceutical Manufacturing Processes
by Timothy C. Duzick
This article compares the physiochemical performance of elastomers commonly used in the pharmaceutical industry, using PTFE as the baseline.
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Dust Explosion Protection in Pharmaceutical Processing
by Michael P. DeBellis
This article discusses protecting your pharmaceutical processing equipment from associated dust collectors.
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