Validation Exercise for Facility GMP HVAC System
De la Torre Vázquez, Damilette
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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.