Validation and Various Qualifications in HVAC System - A Review from Pharmaceutical Quality Assurance Prospect

Abstract

The safety of personnel and efficacy of the material including raw ingredients, in-process goods and finished products as well as machineries in the pharmaceutical industry is majorly impacted by the air ventilation quality within the industry. HVAC system stands for Heating, Ventilation and Air Conditioning system, which ensures the optimum quality of air environment as directed by regulatory authorities. The performance of HVAC system is ascertained by conducting validation of this system within specified duration. Validation of HVAC system is achieved at three levels such as installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ); Which is subject to provide documented evidence about the accuracy of results produced by it. The validation of HVAC system involves systemized and assembled documents of its functional specifications such as design drawings, plans, and specifications; followed by validation master plan involving testing, adjusting, and balancing (TAB); and finally, the startup reports. The parameters analyzed are air flow velocity, air flow pattern, air changes per hour, filter leak test, particle count, viable monitoring, filter integrity test, pressure difference, recovery test for temperature and humidity, temperature and humidity uniformity, and fresh air determination.