HCT/P Environmental Monitoring Requirements
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 paper includes recommendations for monitoring solutions to meet regulatory requirements including the Lasair III for Particle Counting and the MiniCapt Mobile for Microbial Monitoring.
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