HVAC for non-sterile Pharmaceutical Products: Design, Qualification and Maintenance

Abstract

Heating, ventilation and air-conditioning (HVAC) system plays an important role to ensure the manufacture of quality pharmaceutical products. In this article, design consideration, qualification requirements and maintenance of HVAC has been discussed. Regulatory guidelines and risk-based approaches are considered. Pharmaceutical company should design HVAC, qualify and managed the HVAC system based on risk assessment.