HVAC system provides a safe and controlled environment for pharmaceutical manufacturing because most of the pharmaceutical drugs are temperature and humidity sensitive. It also helps to maintain the classified area by controlling the dust particles and microbial load.
Checks before Installation of HVAC System:- Make sure that the supplied has calculated the actual load of the area using Manual J calculation.
- Windows and doors should be included in the calculation of rooms.
- Check all the equipment if they are energy efficient.
- Check if all civil work is completed.
Checks during Installation of HVAC System:
During HVAC installation following work should be done properly.
During HVAC installation following work should be done properly.
- All joints of ducts should be sealed properly to avoid the air leakage.
- Thermostats should be checked and calibrated.
Checks after Installation of HVAC System:
- Get an operational manual and warranty card from the manufacturer.
- Make sure to get a copy of checklist of installation and procedures followed during installation.
- Get a maintenance agreement from the manufacturer.
- Validate the area for temperature and relative humidity.
- Validate the area for all HVAC system validation tests.
- Area should be validated for non viable and viable particle count.
- Check integrity for all HEPA filters located in the clean room areas.
- Check air changes per hour for all rooms for each class.
A properly installed and validated HVAC system shall help to achieve and maintain the desired cleanliness class in a pharmaceutical plant.
Very useful and detailed infromation provede by Mr. Ankur Choudhary on all the topice with latest guidelines.
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