21 CFR 1271 Summary: Expert Explanation of the Requirements

The Food and Drug Administration (FDA) requires human cell, tissue, and cellular and tissue-based product establishments to follow the current Good Tissue Practice (GTP), which governs the methods used in, and the facilities and controls used for, the manufacture of human tissue and cellular and tissue-based products. The following regulation is to be enforced as of May 25, 2005: 21 CFR 1271—Human Cells, Tissues, and Cellular and Tissue-Based Products 21 CFR 1271.195 Environmental control and monitoring. 

Section 1271 requires facilities to establish and maintain procedures to adequately control and monitor
environmental conditions
and to provide proper conditions for operations. The regulations were created to improve protection of the public health. Section 1271.195 specifies the monitoring parameters required. The excerpt from the regulation is below.

  1. Environmental control. Where environmental conditions could reasonably be expected to cause contamination or cross-contamination of HCT/Ps or equipment, or accidental exposure of HCT/Ps to communicable disease agents, you must adequately control environmental conditions and provide proper conditions for operations. Where appropriate, you must provide for the following control activities or systems:
  • Temperature and humidity controls
  • Ventilation and air filtration
  • Cleaning and disinfecting of rooms and equipment to ensure aseptic processing operations
  • Maintenance of equipment used to control conditions necessary for aseptic processing operations
  1. Inspections. You must inspect each environmental control system periodically to verify that the system, including necessary equipment, is adequate and functioning properly. You must take appropriate corrective action as necessary.
  2. Environmental monitoring. You must monitor environmental conditions where environmental conditions could reasonably be expected to cause contamination or cross-contamination of HCT/Ps or equipment, or accidental exposure of HCT/Ps to communicable disease agents. Where appropriate, you must provide environmental monitoring for microorganisms
  3. Records. You must document, and maintain records of, environmental control and monitoring activities. 

The primary purpose behind these requirements is to prevent the contamination of tissues or tissue/cellular products. The regulations specify that the ventilation and air filtration system requires monitoring. Standard monitoring procedures include particle counting and air velocity monitoring within the clean zone and differential pressure monitoring between adjacent areas. Monitoring proves control over products directly exposed to the air quality of the clean zone, and it also protects adjacent rooms from cross-contamination. 

In addition to particle counting... 

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