This course provides practical information on contamination control and cleanroom management. Extensive guidance is presented for the critical daily aseptic maintenance and housekeeping functions necessary to maintain required cGMP cleanliness levels.
Topics to be discussed include:
- Basics of microbial biology and physiology
- Cleanroom design requirements
- Sources of microbial contamination in cleanrooms
- Non-viable airborne particle standards and monitoring
- Airborne and surface microbial standards and monitoring
- Origin and minimization of pyrogen contamination
- Cleaning technologies and operations
- Disinfection and sanitization materials and techniques
- Rapid microbial monitoring methods
- Training methods for proper contamination control
An extensive appendix providing tables and monograph and scientific literature references is included with the course notes.
Who Should Attend
This is an introductory course that is designed for management and staff involved in cleanroom operations who will benefit from a better understanding of how microbiology impacts cleanroom technology. Although this course will benefit experienced cleanroom personnel, it is primarily designed for those who require a basic understanding of cleanroom operations. The course focuses on basic microbiology, cleanroom standards, maintenance, monitoring, and operating procedures. The latest developments in methods and techniques are emphasized.
The course will provide a thorough understanding of the operations within a cleanroom environment and the challenges faced by cleanroom staff in minimizing microbial contamination. In addition, the course will address management of the daily operations of a cleanroom, review of training requirements, the efficiency of cleaning methods and overall cleanroom management.