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HVAC VALIDATION IN ORAL SOLID DOSAGE FACILITY AND ITS SIGNIFICANCE IN PHARMACEUTICAL INDUSTRY
Author Name

Mr. Sandeep Sharma, Dr. Praveen Kumar Ashok and Ms. Gulfsha Parveen

Abstract

HVAC system is a major requirement of anydrug manufacturing facility. ... Heating, Ventilation and Air Conditioning is a system which controls the air temperature by controlling the air filtration and the moisture present in the air.

A pre-defined Protocol/ mechanism is used For Qualification / Requalification of Air Handling Unit / System (AHU). It describes the procedure for different tests parameters, acceptance criteria, re-qualification criteria and other documentation to be used for requalification of Air handling unit (AHU) serving to manufacturing area of Drug Product.

Procedure for validation of HVAC system and details of tests in pharmaceutical industry: Air Flow Pattern, Air Flow Velocity & Change Per Hour, Filter Leak Test, Particles Count Test; Viable & Non-Viable Monitoring, Filter Integrity Test (PAO Test), Pressure Difference, Recovery, Temperature and Humidity Uniformity Test 

HVAC System is the Heating Ventilation Air Conditioning System which is implied in the Pharmaceutical industry with a purpose to achieve the desired environmental conditions specific for the products manufacturing and humans’ exposure.

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

Keywords: Validation, AHU qualification, HVAC Qualification, Installation qualification, Operational qualification and performance qualification.



Published On :
2022-08-14

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