GMP Environmental Monitoring for Pharmaceutical Clean Rooms

Why Should You Attend:

As per FDA Guideline on Aseptic Processing GMP (2004) one of the most important laboratory controls is the environmental monitoring program which 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.

Hence a proper understanding and testing of the clean room environment and ongoing environmental monitoring of a clean room environment is necessary from a product compliance perspective.

Attend this webinar to understand the various US and international regulatory requirements, the testing requirements for the various clean room classifications as well as the environmental monitoring of clean room environments. It will describe the Action and Alert Levels and how these levels are determined for a particular facility along with Corrective and Preventative Actions are defined.

We will discuss all current air & surface monitoring systems for the measurement of non-viable particulate, microbial contaminants in the clean room . The subject of clean room contamination due to personnel is discussed including both gowning technique and aseptic practices. Then 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 (Data Trend Reports) for product release.

Areas Covered in the Webinar:

• 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

Frequently Asked Questions:

1. What's the difference between a building automation system and an environmental monitoring system?

Who Will Benefit:

This webinar will provide valuable assistance to all personnel in:

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

Roger Cowan
Pharmaceutical Consultant, R Cowan Consulting Services LLC

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 35 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.

Frequently Asked Questions:

1. What are the Temp. ranges for Relative Humidity, Pressure Differential ranges for ISO Class 5.
2. Microbial monitoring - how about beginning of production? - Personnel wears and gears
3. How many days to take samples for initial qualification?

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