HVAC Improvement for a Granulation Room of a Solid Dosage Manufacturer

Abstract

A pharmaceutical facility located in Vega Baja, Puerto Rico is dedicated to the manufacturing and packaging of prescription and consumer products that include tablets, caplets, capsules and powder for oral suspensions. A study was performed by a multidisciplinary team with the main objective of enhance the current Good Manufacturing Practice (cGMP) conditions of the existing Heating, Ventilating, Air Conditioning (HVAC) system for a manufacturing building of this facility. As a part of this study was determined to install a dedicate Dehumidifier Air Handling Unit to one of the manufacturing room dedicated to the Granulation process. The main purpose of this project is the validation of the new HVAC system and the facility of the Granulation room to demonstrate that the new design comply with the cGMP, 21 CFR Part 210 and 211, International Cleanroom Standard (ISO) 14644, World Health Organization (WHO) Guidelines on Good Manufacturing Practice for heating, ventilation and air-conditioning system for non-sterile pharmaceutical dosage form and International Society for Pharmaceutical Engineering (ISPE) HVAC Good Practice. Key terms: CFR, cGMP, Facilities Qualification, HVAC, ISO.