Environmental Monitoring in a (Bio)Pharmaceutical Manufacturing Facility

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Environmental monitoring (EM) of controlled areas is a critical component of a pharmaceutical manufacturing facility’s contamination control strategy and mandated by law.  (Bio)pharmaceutical drugs must be free from contamination by adventitious agents such as bacteria, fungi, mycoplasma and viruses to ensure not only consumer safety but also good business.  Participants in this half-day course will be introduced to the principles of environmental monitoring through lectures and hands-on activities.  During the lectures, students will learn about regulatory requirements, types and sources of contamination, cleanroom classifications, sampling methods and frequencies, interpretation of environmental testing results and types of cleanroom microorganisms.  Students will also develop a sampling plan, conduct environmental sampling, count surface and air sample plates and interpret the results.


  • Recognize the basics of what constitutes EM as it relates to the various cleanroom classifications
  • Define the role of EM as a critical component of the contamination control strategy
  • Identify types and sources of contamination
  • Define sampling methods and testing frequency for regulatory compliance
  • Interpret testing results obtained through a hands-on laboratory exercise
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Course Features

  • Lectures 0
  • Hands-On Training 0
  • Duration 4.5 hours
  • Skill level All Levels
  • Wet Lab No
  • Max Students 24
  • Assessments Yes