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.
This course has been pre-approved by the Regulatory Affairs Professionals Society (RAPS) as eligible for 12 credits towards a participant's RAC recertification upon full completion.
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.
Frequently Asked Questions
Who are “non-microbiologists”?
This would be defined as anyone who has never taken a course in present-day microbiology or who needs a refresher. The level of this course is suitable for anyone who has a high school education. For participants who have had previous college-level courses in microbiology, the course may be a review with the addition of the results of new research. The course is updated with the results of new research each time it is presented.
I have no formal training in science at any level. Will I be able to understand the subject matter in this course?
Yes. Microbiology is a very descriptive science and the basic concepts are not difficult for anyone to understand. The course starts by establishing a background for understanding the biology of microorganisms and then proceeds to apply this background to the practical problem of keeping cleanrooms and products produced in cleanrooms free of microorganisms.
What microbiology topics and what cleanroom topics are covered?
The microbiology topics include discussions of the general features of microbials and the common contaminants of cleanrooms: bacteria, bacterial spores, biofilms, mycoplasmas and fungi.
Major cleanroom topics that are covered include; airflow in cleanrooms, sources of microbial contamination, non-microbial airborne particle counting, airborne microbial counting, surface cleaning for removal of microbial contamination, determination of surface microbial contamination, and basic validation of microbial removal. There is also a discussion of emerging methods in preventing, removing, and quantitating microbial contamination.
How much are cGMP governmental standards and regulations covered?
Current US and EU standards for non-viable particle and microbial airborne and surface contamination are presented. However, this is not a course where detailed cGMP regulations and auditing are presented and discussed in depth.
Will someone from the medical device industry profit from this course?
Yes. While the standards and regulations for allowable amounts of microbial contamination in medical devices are different and more complex than those for parenteral drugs, the problems of keeping environments where medical devices are manufactured free from microbial contamination are very similar and often identical to the same problems in drug production.