This webinar considers the important considerations for the control of operators in cleanrooms so that microbial and particulate contamination can be reduced. The focus is with people being the main contamination source within cleanrooms.
Considered in the webinar are: Selection of gowns, gowning requirements, gowning tests, environmental monitoring associated with people, selection of gloves and facemasks. Other topics considered include the differences between disposable gown and re-laundered gowns, gown repair policy, and sterilization of gowns.
Considered in the webinar are: Selection of gowns, gowning requirements, gowning tests, environmental monitoring associated with people, selection of gloves and facemasks. Other topics considered include the differences between disposable gown and re-laundered gowns, gown repair policy, and sterilization of gowns.
Learning Objectives:
- Major contamination sources within cleanrooms
- Trends in operator derived contamination
- Cleanroom design and operation
- Variances with particle generation
- How to select gowns, gloves and face masks
- How operators should be trained
- How to target microbiological environmental monitoring
- Investigating out of limits events
- Data review
Why Should You Attend:
To develop or review a site cleanroom gown policy, to consider the quality of gowns, gloves and face masks and their suitability as contamination control items. For example, what is the bacterial filter efficacy of the gown? Are the glove used resistant to the chemicals found in the cleanroom? Which locations should be selected for gown monitoring?
These fundamental questions required for any good personnel or gown control policy will be discussed.
Areas Covered
- Cleanrooms
- Contamination risk factors
- Focus on people
- Particle generation
- Cleanroom clothing
- Gowns
- Gloves
- Face-masks
- Training
- Monitoring of personnel
Instructor Profile:
Dr. Tim Sandle has over twenty-five years experience of microbiological research and biopharmaceutical processing. He is Head of Microbiology at Bio Products Laboratory (U.K.) and a visiting tutor with The University of Manchester School of Pharmacy.
Dr. Sandle serves on several national and international committees relating to pharmaceutical microbiology and cleanroom contamination control. He is a committee member of the Pharmaceutical Microbiology Interest Group (Pharmig); and is a member of several editorials boards for scientific journals.
Dr. Sandle has written over three hundred book chapters, peer reviewed papers and technical articles relating to microbiology. Dr. Sandle's current research interests are cleanroom fungi; microbiology of water; disinfectants; and rapid microbiological methods.
In addition, Dr. Sandle serves on several national and international committees relating to pharmaceutical microbiology and cleanroom contamination control (including the ISO cleanroom standards). He is a committee member of the Pharmaceutical Microbiology Interest Group (Pharmig); serves on the National Blood Service advisory cleaning and disinfection committee; and is a member of eleven editorials boards for scientific journals.
Dr. Sandle has acted as a consultant, expert witness and technical advisor to sterile and non-sterile manufacturing facilities, microbiology laboratories, the medical device industry and hospitals. Dr. Sandle has also undertaken several technical writing and review projects.