HVAC system validation

To provide the guideline for validation of the HVAC system to meet the design qualification requirement and to be capable of operating within established limits and tolerances... 

The qualification of the HVAC system should be described in a validation master plan (VMP). 

Pleating, Ventilation, and Air Conditioning (HVAC) Systems. This subsection must also include a general system description, a validation summary, and information on the routine monitoring system. 

DQ is performed by the supplier of the equipment or system at the supplier s factory as part of factory acceptance test. IQ (based on site acceptance test), OQ and PQ are performed on-site at the GMP facility. For a GMP manufacturing facility, the validation activities include the facility design, HVAC system, environment control, laboratory and production equipment, water system, gases and utilities, cleaning and analytical methods. Validation protocols (IQ, OQ and PQ) are prepared for each item, listing all critical steps and acceptance criteria. Deviations are reviewed and resolved before the validation activity proceeds to the next phase. 

When pharmaceutically critical systems (refrigerators, HVAC systems, purified water systems, etc.) are to be monitored by a building monitor system it has to be independent from more general systems in the building and its validity has to be assessed in advance. Additionally systems for the registration of measurements must be independent of systems that operate the installations and all installations (i.e. their sensors, adjustment tuners and alarm signals) must be fit to be coimected to the building control system. 

Qualification and validation can be outsourced. However, the responsibility remains in-house so the craitract-taker has to be approved according to current GMP requirements for outsourced activities [10]. For example, the following qualification and validation items can be outsourced LAF cabinets, safety cabinets, HVAC-systems, sterilisers, rinsing machines and devices for performing filter integrity testing. When tasks of qualification and validation are outsourced, internal approval of protocols, raw data and reports have to take place according to internal procedures. 

Both A and C weightings are based on pure tones (sine waves). The characteristics of the ear and the validity of dB(A) and dB(C) readings change markedly in the presence of random noise. Steady-state noise is often emitted by HVAC systems and IT equipment, whereas dialog, for example, is an example of random noise. In environments characterized by random noise,... 

Facilities and Equipment System This includes (1) buildings and facilities along with maintenance (2) equipment IQ, QQ, calibration, maintenance, cleaning, and validation of cleaning processes and (3) utilities such as HVAC, compressed gases, steam, and water systems. 

Some aspects of validation are unique to HVAC control systems. Although the controls are one of the last things to be fitted, they must not be planned last. The user must make many decisions before the controls are installed and there should be qualification meetings early in the process. Quality cannot be tested into a process. It has to be designed into each system. 

When used properly by trained personnel, employing adequate process controls, the LAP environment provides a reliable barrier to measurable airborne viable and non-viable, solid particulate contamination, which may defeat the aseptic process. LFCBs, BSCs, and heating, ventilation, and air conditioning (HVAC) installations are easily validated. These systems normally continue in operation with little or no variation in output quality for long periods of time, and are easily maintained and tested. 

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