The latest in the series from Masden and Moldenhauer is available, covering such key topics as
- Regulatory changes relative to ISO 14644, Parts 1 and 2
- Updates to ISO 11737-1
- Risks of spores including preventive measures and disinfection
- Utilities, surfaces and practices that impact cleanrooms
- Cleanroom gowning and behavior
- Regulatory guidance and how-to relative to handwashing
- Contamination in water systems
- Contamination in gaskets, drains, cooling systems and many other problem areas
- And more, including chapters covering Monitoring relative to USP <1116>, control limits, excursions, risk-based big data in aseptic processing and methods for effective use of Maldi-Tof
Posted by Dr. Tim Sandle
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