Environmental Monitoring

A requirement for the production of biopharmaceutical products is to ensure freedom from contamination by adventitious agents such as bacteria, fungi, mycoplasma and viruses. Contamination issues may impact product safety and lead to lengthy investigations and costly recalls. Environmental monitoring of cleanrooms and adjacent areas is a critical component of a company’s contamination control strategy and is required for regulatory compliance. Participants in this course will be introduced to the principles of environmental monitoring including hands-on activities. Topics encompass regulatory requirements, types and sources of contamination, cleanroom classifications, sampling methods and frequencies, interpretation of environmental testing results, and types of cleanroom microorganisms.

 

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