Environmental Monitoring for Pharmaceutical Clean Rooms

Roger Cowan

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Course Summary

Environmental Monitoring looks at the end  results of the Environmental Control program – the microbiological and  particulate quality of the clean room.

As the FDA Guideline on Aseptic Processing GMP (2004) states: “In aseptic processing, one of the most important laboratory controls is the environmental monitoring program. This program provides meaningful information on the quality of the aseptic processing environment (e.g., when a given batch  is being manufactured) as well as environmental trends of ancillary clean areas. Environmental monitoring should promptly identify potential routes of contamination, allowing for implementation of corrections before product contamination occurs.”

Therefore, ongoing environmental monitoring of a clean  room environment is necessary to assure the quality and safety of the pharmaceutical product.

Also, a proper understanding and  testing of the clean  room environment according to international regulatory standards is important from a compliance perspective.

Learning Objectives :

  • GMP Compliance of Clean  Room  Environment
  • Regulatory Clean Room Classification and Requirements
  • Environmental Monitoring Program
  • Action and Alert Levels
  • Non-Viable Particulate Monitoring Systems
  • Microbial Monitoring Systems
  • Personnel Gowning and  Aseptic Practices in Clean Room
  • Clean Room  Monitoring Practices - Frequency, Locations, and Investigations
  • Product Release
  • Environmental Monitoring Data Trend  reports

Who should Attend : 

This webinar will provide valuable assistance to all personnel in:

  • Quality Assurance
  • Environmental Monitoring
  • Microbiology
  • Manufacturing
  • Validation
  • Engineering
  • Maintenance

Topic Background :

This webinar first explains the various US and  international regulatory requirements for the various clean room classifications as well as the environmental monitoring of clean  room environments.

Next, the presentation details the benefits, the  regulatory requirements and  the testing  requirements for a comprehensive Environmental Monitoring Program.

A description of Action and Alert Levels follows along with a discussion of  how these levels are determined for a particular facility.  Corrective and  Preventative Actions are defined.

All current air  monitoring systems for the measurement of non-viable particulate are fully reviewed.

All current air and surface  monitoring systems for the measurement of microbial contaminants in the clean  room are discussed  in detail.

The subject of clean room contamination due  to personnel is discussed.  This includes both  gowning technique and aseptic practices.

Ongoing monitoring  practices for the clean  room  environment are discussed with respect to sampling  frequency, sampling  locations, and the investigation of  action  level excursions.

This is followed by a discussion of  how environmental monitoring data is reviewed for product release.

Finally, a comprehensive look  is  taken  of  the  current  thinking  about  the  generation  and  review of  Environmental  Monitoring  Data  Trend  Reports.

Webinar Events
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Training CD-DVD

Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment

Recorded video

Recorded video session

Speaker: Roger Cowan,

Roger Cowan is the founder and owner of R Cowan Consulting Services LLC, a consulting company specializing primarily in the area of pharmaceutical contract manufacturing. He has 36 years experience in pharmaceutical quality assurance and manufacturing. In his career, Roger has held various manager / director positions in Quality Assurance, QC Laboratory, Technical Services Validation, Manufacturing, and Clinical Supply manufacturing and distribution. Roger has taught courses in microbiology at Seneca College (Pharmaceutical Technology Program) in Toronto, Canada. Roger's areas of expertise include: aseptic pharmaceutical manufacture, GMP facility audits, technical transfer, microbiology, environmental monitoring/contamination control, product sterilization, process development, process validation, clinical supply manufacturing, labeling and distribution, US / International regulatory requirements, regulatory submissions, and quality assurance/control.

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