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LPC Snapshot January 2023


Environmental Monitoring of Cellular Therapy Laboratory

Yvette C. Tanhehco PhD, MD, MS
Director of Cellular Therapy Laboratory
NewYork-Presbyterian Hospital/Columbia University Irving Medical Center
New York City, New York, USA


Brief Summary:

  1. Environmental monitoring is required by regulatory and accreditation standards.
  2. 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.
  3. Environmental parameters that are out of predetermined specification must be investigated and corrective and preventive action plans implemented.
  4. 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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