Engineering

PQ Tests Used in HVAC Qualification for Pharmaceutical Facilities

PQ Tests Used in HVAC Qualification for Pharmaceutical Facilities

Airflow Visualization (Smoke Studies) Purpose: Confirms airflow patterns, particularly in cleanrooms and critical areas where contamination control is crucial. Process: Smoke or fog is introduced to visualize the airflow direction, ensuring it moves as intended (e.g., from high to low classification areas) and does not lead to recirculation or contamination risks. Focus Areas: Laminar flow…

HVAC Qualification Process

HVAC Qualification Process

Design Qualification (DQ) The DQ phase involves verifying that the HVAC system is designed according to the requirements of the facility, production process, and regulatory guidelines (e.g., WHO, EU GMP, FDA). It should ensure that: Room classification: Cleanrooms and controlled environments are designed to meet the required cleanliness level, such as ISO 7 or ISO…

Design of Pharmaceutical Water Stations

Design of Pharmaceutical Water Stations

  Pre-treatment system 1- Pretreatment process contains traditional processes, such as Feed water storage tankļ¼ŒHeat exchanger heating deviceļ¼ŒMechanical filtrater, activated carbon filtrater, softener,Precision Filter, dosing device, as well as ultra-filtration, residual chlorine removal UV, micro-filtration, etc.   Residual chlorine removal UV system 1- Using residual chlorine removal UV system in pretreatment, instead of activated carbon…