International Research Journal of Education and Technology

HVAC system is an integral part of Pharmaceutical system and qualification of HVAC system in an oral solid dosage facility widely impacts the formulation activities during the process. HVAC system is qualified annually based on the protocol. Based on protocol, DQ Design Qualification, IQ Installation Qualification, OQ Operation Qualification and PQ Performance Qualification is verified and after obtaining satisfactory results as per the protocol and with respect to Regulatory Guidelines required for the facility.

The test parameters 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. Obtaining results within the acceptance criteria and providing a documented evidence for the HVAC qualification carried out as pre-determined protocol is the basic requirement for HVAC validations.

Qualification of HVAC system is conducted and based on the results Facility declared fit for pharmaceutical production of Drug substances, HVAC system is qualified.

Key Words: Validation, AHU qualification, HVAC Qualification, Installation qualification, Operational qualification and performance qualification