Contamination Control in Healthcare Product Manufacturing, Volume 4

9781933722986: Contamination Control in Healthcare Product Manufacturing, Volume 4

Edited by experts and written by global subject matter professionals, this vital addition to the Contamination Control series offers new chapters covering current, relevant information including:

  • 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
  • This text is an essential complement to a contamination control library as a guide and reference when combined with the previous three volumes.

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