Facility Design and Engineering

Mar 01, 2008
By Pharmaceutical Technology Editors
Pre-Interphex Showcase: Cleanrooms
Oct 09, 2007
PTSM: Pharmaceutical Technology Sourcing and Management
Contract manufacturers slim down to improve profitability.
Sep 02, 2007
Pharmaceutical Technology
Contract manufacturers slim down to improve profitability.
Aug 24, 2006
ePT--the Electronic Newsletter of Pharmaceutical Technology
By Pharmaceutical Technology Editors
The International Organization for Standardization (ISO, www.iso.org) has formally issued and published standard ISO 4644-8:2006, Cleanrooms and associated controlled environments-Part 8: Classification of airborne molecular contamination. The document covers the classification of airborne molecular contamination (AMC) in cleanrooms and associated controlled environments in terms of airborne concentrations of specific chemical substances (individual, group, or category) and provides a protocol to include test methods, analysis, and time-weighted factors within the specification for classification.
May 01, 2006
Pharmaceutical Technology
Calculations show the predicted contamination levels in cleanrooms with turbulent mixing air and with vertical unidirectional airflow when people are dressed in modern cleanroom clothing systems. Comparisons are made between operation theatres and cleanrooms.

May 01, 2004
Pharmaceutical Technology
Current microbiological methods cannot measure microbial contamination at the levels that engineers and regulators seek to establish for aseptic processing cleanrooms. New approaches for assessing data and establishing alert and action levels are advocated, and an example of one analytical tool is considered.
Feb 02, 2003
Pharmaceutical Technology
Facilities with rigidly controlled environmental parameters can take steps to meet precise and repeatable conditions.
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