Pharmaceutical Area classification with respect to filters used as per WHO guidelines

Pharmaceutical Area classification with respect to filters used as per WHO guidelines

WHO gmp guidelines describes area in a pharmaceutical Manufacturing facility, as

Level 1 level 2 and level 3 areas.

Level 1 Area is a place where there is no possibility of contamination of product.

Level 2 Area is an area where the raw and packing material is stored in closed condition, this area is controlled with respect to temperature and humidity. These areas are not provided with coarse filters, the working benches and dispensing places may be provided with UDF units. (UDF unit is a unit having vertical laminar air flow) 

Level 3. Is an area where actually pharmaceutical ingredients, raw material or under process product is exposed to the environment, therefore this area is required to control for its quality of air and cleanness. This area is called a controlled area; these areas are supplied air filtered through HEPA filters.

Which Filters can be used as per WHO GMP guidelines for Level 1 level 2 and level 3 areas

Level 1: EN 779 G4 filters

Level 2: EN 779 G4 plus F8 or F9 filters

Level 3: EN 779 G4 plus F8 plus EN 1822 H13 filters

Pharmaceutical Clean Room Classification : https://www.pharmacistspharmajournal.org/2010/02/clean-room-classification-aspects-of.html

Leave a Reply