Who Should Attend
This course 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 cleanroom standards, maintenance and operating procedures.
Learning Objectives
The course will provide a thorough understanding of the operations within a cleanroom environment and the challenges faced by cleanroom staff. In addition, the course will address management of the daily operations of a cleanroom, review of supply and garment usage, the efficiency of cleaning methods and overall cleanroom management.
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 the cleanliness levels required.
Topics to be discussed include:
- General product requirements
- Special requirements for sterile products
- Particles, microorganisms and pyrogens
- Review of terminal sterilization process
- Complexity of aseptic processing approaches
- Methods for proper aseptic surface contamination control
- Repair and maintenance technologies & how to start up a new facility
 View Course Agenda
Past Participants' Comments
"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
"Overall a good fundamental exposure to aseptic principles and cleanroom "health".
Loren M., Senior Manager, Supplier Audits, Wyeth
"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
"Good training course!. The instructor was very knowledgeable."
David L., Manager, Quality Assurance, Johnson & Johnson
"This was one of the most detailed and thorough cleanroom 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
"The course director showed a well-rounded knowledge of each of the topics he presented."
Beatriz L., QAU Tech Level II, The Rogosin Institute
"This is an excellent training course for anyone who needs a basic introduction to clean room monitoring and the issues relevant to maintaining a clean room. The instructor was excellent and able to present the information in as easily understandable format."
Patricia P., QA Manager, Baylor Research
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