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.
Why You Should Attend:
This webinar 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.
Areas Covered in the Session :
Understanding Cleanroom
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
Who Should Attend:
Quality Departments
Environmental Monitoring Departments
Microbiology
Manufacturing Departments
Validation Departments
Engineering Departments
Maintenance Departments