Difference Between Classified and Non-Classified Areas in Pharmaceuticals

In Pharmaceuticals it is very important to maintain the area as per the products or requirements of GMP. so what if the area where the product is not manufactured? So Based on activity Pharmaceutical industries divided areas into classified and non-classified areas/ Unclassified. The few concepts while Understanding the basic difference between Classified and Non-classified areas.

Classified and Non-Classified Area

Classified Area

A classified Area having control of airborne particle amount is called a clean room or classified area. These areas are constructed to minimize the generation introduction and retention of airborne particles in the area. if say the area, where product Dispensing, manufacturing, and packing activity happens, it comes under a classified area.

An example of a classified area is Dispensing, Granulation, Compression, Coating, and Packing.

Non-classified/ Unclassified area

Non- classified areas have uncontrolled airborne particle amounts, but temperature and humidity are still maintained. is called non- classified/ unclassified area. Non- classifies area design as the non-process area or area in which the product does not comes in direct contact with air.

Example of Non-classified area is RM store, Packing material store, change room, packing hall, and quality control area.

Key Difference between classified and Non- classified areas

Classified AreaNon- Classified Area
Particle size and concentration maintained under controlParticle size and concentration not maintained under control
The temperature and Relative humidity of that area are maintainedThe temperature and Relative humidity of that area are maintained
Integration of HEPA FilterHEPA Filter does not integrated
Design to prevent the product from contamination and cross-contaminationDesign to prevent the Dust particle and outer environment effects

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