Environmental Monitoring of Cellular Therapy Laboratory
Yvette C. Tanhehco PhD, MD, MSDirector of Cellular Therapy Laboratory
NewYork-Presbyterian Hospital/Columbia University Irving Medical Center
New York City, New York, USA
Brief Summary:
- Environmental monitoring is required by regulatory and accreditation standards.
- Environmental parameters such as temperature, humidity, pressure, air viable and nonviable particles, and surface contaminants may affect cellular therapy product safety, purity and potency so must be monitored.
- Environmental parameters that are out of predetermined specification must be investigated and corrective and preventive action plans implemented.
- Electronic databases are useful for storing the large amount of environmental monitoring data and enable easy tracking and trending over time.
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