Validation Exercise for Facility GMP HVAC System
Resumen
The client developed Technology
Transfer Project to retrofit out of use
manufacturing existing facilities and utilities to
provide adequate area for the commercial
manufacturing of new products. To achieve the
Technology Transfer Project goals for new
products manufacturing, the facilities and utilities
must be designed, retrofitted, and validated
successfully. The focus of this project is the design,
retrofit, and validation of the Facility HVAC
System (Heating, Ventilation, and Air Conditioning
System) for the retrofitted manufacturing Facility.
After the design and retrofit activities, the Facility
HVAC System—which includes five Air Handling
Units (AHUs), two Exhaust Fans (EF), and one
Dust Collector (DC)—was successfully validated.
This validation process includes control systems to
maintain the Facility HVAC System within
specifications and environmental controls. By
providing this controlled Facility HVAC System,
the client can perform Good Manufacturing
Practices (GMP) and controlled manufacturing
processes complying with the Food and Drug
Administration (FDA) requirements as per 21 Code
of Federal Regulations (CFR).
Key Terms ⎯ Air Handling Unit, Critical
Process Parameter, HVAC System, Validation.