Human Microbiome and Implications for Contamination Control
Duration: 60 Minutes
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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.
07/26/2018 10:00 AMTraining Topic: Human Microbiome and Implications for Contamination ControlInstructor: Tim Sandle
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
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.
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
Who will Benefit
Maintenance / engineer staff
Pharmaceuticals - sterile and non-sterile
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?