Cleanroom Microbiology for the Non-Microbiologist™

Available Locations


COURSE DETAILS

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.

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

"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