The control and monitoring systems are considered the core of the environmental control system. The final performance of the environmental control system can be evaluated only after these have been validated.
PQ protocols covering this system, in general, include the performance challenges for the all the components of the environmental control system described in the foregoing. The system is challenged by simulating the process or at the time the aseptic processes qualification
or media fills are performed.
The validation protocols follow the same format structure outlined before for the architectural components.The following section provides a generic checklist approach used for the HVAC controls and monitoring systems validation. As indicated earlier, the HVAC systems could be either manually, electric, pneumatic, or electronically controlled, operated or monitored. Computer- or microprocessor- controlled equipment is subject to the software and hardware validation procedures that apply to computerized systems.
Presentation on concept of HVAC:
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