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.”

Thus, it is important to have ongoing environment monitoring of a clean room environment, so that quality and safety of the pharmaceutical product is assured. Also, a proper understanding and testing of the clean room environment according to international regulatory standards is important from a compliance perspective.

This webinar by expert speaker Roger Cowan will first explain the various US and international regulatory requirements for 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. Roger will provide a description of Action and Alert Levels and how these levels are determined for a particular facility.

Additionally, the session will aim to define corrective and preventative actions and review all current air monitoring systems for the measurement of non-viable particulate. The webinar will also discuss all current air and surface monitoring systems for the measurement of microbial contaminants in the clean room in detail. You will also get a better understanding of clean room contamination due to personnel, including both gowning technique and aseptic practices.

Course Objective:

• GMP compliance of cleanroom environment
• Regulatory cleanroom classification and requirements
• Environmental monitoring program
• Action and alert levels
• Corrective and preventive actions
• Current air monitoring systems for the measurement of non-viable particulate
• Current air and surface monitoring systems for the measurement of microbial contaminants in the cleanroom
• Non-viable particulate monitoring systems
• Microbial monitoring systems
• Personnel gowning and aseptic practices in the cleanroom
• Cleanroom monitoring practices - Frequency, locations, and investigations
• How environmental monitoring data is reviewed for product release
• Environmental monitoring data trend reports

Course Outline:

• Cleanroom – Definition
• Environmental Monitoring vs. Environmental Control
• GMP Regulations
• Environmental Monitoring Program
• Benefits
• SOPs
• Testing Requirements
• Regulatory Classifications
• Personnel Microbial Monitoring
• Microbiological Media Controls
• Microbiological Monitoring Programs
• Sterile Isolator and Closed RABS Technology
• Investigation of Alert/Action Level Excursions
• Release of Product

What You Get:

• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points

Who Will Benefit:

This webinar will provide valuable assistance to all personnel in:

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