Human Microbiome and Implications for Contamination Control
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People are the biggest source of contamination in cleanrooms. The findings from the human microbiome project suggest an overview of controls is required. This presentation reviews the latest research into the human microbiome, especially in relation to the skin, and looks at the levels of controls and risks required, such as behaviors and gowning practices. The presentation also considers the impact of the knowledge on the use of environmental isolates for culture media testing and applied areas like disinfectant efficacy testing.
Why Should you Attend
To understand the complexities and challenges that people pose to cleanroom environments and to consider the controls required to minimize contamination impact.
Areas Covered
- The human skin ecosystem
- The Human Microbiome Project and the microorganisms found in association with both healthy and diseased humans. How the human microbiome research has impacted on cleanroom activities including gowning practices
- Selection of cleanroom garments like fabric types, garment lifespan, recycling, laundering, human changing procedures, training, behavior, hand sanitization, ongoing assessments, and associated topics
Objectives of the Presentation
- To understand the latest research on the human microbiome
- To learn about the reasons for microbial survival in people and in cleanrooms
- To understand the types and ranges of microorganisms on human skin, and how these relate to objectionable organisms
- Review staff gowning and personnel behavior in pharmaceutical cleanrooms
- Consider good glove sanitization practices
- Learn how cleanroom risk can be minimized
- Review training for all cleanroom staff
- Look at the use of environmental isolates for media and disinfectant efficacy testing
Topic Background
Most contamination within the pharmaceutical facility can be traced to humans working in cleanrooms. This is, in some way, evidenced from the association of microorganisms transient or residential to a skin being the primary isolates from environmental monitoring in controlled environments. Human personnel shed high numbers of skin cells mostly as skin flakes. The cleanroom garments worn by personnel cannot contain all human detritus. How effective are these controls in relation to new insights into the human microbiome?
- Engineers
- Lecturers
- Production managers
- Microbiologists
- Quality Assurance
- Production staff
- Maintenance / engineer staff
- Medical staff
- Pharmaceuticals – sterile and non-sterile
- Biotechnology
- Healthcare
- Academia
Instructor Profile:
Tim Sandle
Dr. 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.
Additional information
| Purchase Options | Live Access, Recorded Access, Training CD/DVD, USB Flash Drive, Live+Recorded Access, Live Access+CD/DVD, Live Access+USB Flash Drive |
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