Cleanroom Microbiology for the Non-Microbiologist

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Course Description

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.

Learning Objectives

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.

Past Participants' Comments

"This course gave a great introduction to cleanroom microbiology and the considerations needed to effectively control contamination. The instructor is very knowledgeable in the subject matter. Highly recommend to those interested in making sure your company is in compliance with contamination control practices." Ryan G., QC and Regulatory Compliance Mgr, Albaad USA
"I really enjoyed this course and found the information helpful and applicable to my current engineering job. The level of detail and content was ideal for my level of knowledge." Jeff B., Project Manager, Advanced Operations, Stryker Endoscopy
"A great class! The Course Director is a very knowledgeable teacher with good presentation of the material." Tim J., Facility Manager, Merit Medical Systems
"This course provided information that DIRECTLY impacted & related to my current job position. The Course Director was very knowledgeable and was able to relate the material to day-to-day 'real world' issues." Michelle C., Sr. Aseptic Technician, Eisai
"This class was exactly what I was looking for! I really enjoyed the format with free interaction and Q&A. I received the information I wanted and the class had a good balance of technical knowledge and practical applications." Mark R., Manufacturing Manager, Genzyme
"The Course Director was clearly very knowledgeable in the broad spectrum of topics covered within this course. I was anxious to learn and was not disappointed. I found the concepts are applicable throughout our facility, not only in aseptic filling but also in other controlled assembly areas." Chris K., QA Manager, Cook Urological
"Very informative seminar. Excellent facility used." Pete G., Associate Quality Engineer, Arrow International
"This course was very informative for me. It helped me to understand basic microbiology without having to take a microbiology course." Manager, Quality Assurance, Chiron
"Fantastic training course!. The instructor was very knowledgeable." David L., Manager, Quality Assurance, Johnson & Johnson
"This was one of the most detailed and thorough cleanroom/aseptic processing training courses I have ever attended! The instructor was very knowledgeable in all areas of the subject, and I truly appreciate the instructor’s help and attention!" Mike D., QA Manager, Sabin Corp.
"Extremely well presented course in a comprehensive and informative, yet easy-to-understand style. Excellent content and support notes." Martin P., Group Auditor
"This is an excellent training course for anyone who needs a basic introduction to cleanroom monitoring and the issues relevant to maintaining a cleanroom. The instructor was excellent and able to present the information in as easily understandable format." Patricia P., QA Manager, Baylor Research
"The course was well presented. The Course Director is extremely knowledgable." Paul L., Production Tech, SAFC Biosciences
"This course was extremely well-presented and relevant to my needs. The instructor was very knowledgeable and was able to answer questions and situations very well." Sean P., Senior Quality Engineer, SurModics
"Excellent course! Hit all the topics I was concerned with. I will recommend it!" Jim F., Quality System Manager, Cook Vascular

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.