Analysis of Environmental Microbiology Data from Cleanroom Samples

Publication
Article
Pharmaceutical TechnologyPharmaceutical Technology-05-01-2004
Volume 2004 Supplement
Issue 3

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.

External Link - article-95525.pdf

Articles in this issue
Implementing Total Organic Carbon Analysis for Cleaning Validation
Perspectives on Aseptic Guidance A Critical Review of FDA's 2003 Draft Guidance and a Proposed Alternative
The Future of Aseptic Processing?An Update
Analysis of Environmental Microbiology Data from Cleanroom Samples
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