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Cleanroom Classification in Pharmaceutical Industry

A cleanroom is highly designed controlled environment where the particulate matters are controlled to ensure the good manufacturing practice (GMP) with low levels of particulates, such as dust, airborne organisms, or aerosol particles. 

Cleanrooms are classified according to the number and size of particles permitted per volume of air. And the different class maintained in different area of pharmaceutical industry to ensure product quality and compliance.

Cleanroom Classification as per ISO standard

Here, ISO class 3, 4, 5, 6, 7 & 8 are equivalent to FS Cleanroom Class 1, 10, 100, 1000, 10000 and 100000.

ISO Class 5 is a super clean cleanroom classification, ISO Class 6 is very clean cleanroom classification and ISO Class 7 is a common cleanroom classification.

Recommend air changes per hour for ISO class 5, 6 & 7 are 240-600, 150-240 & 60-150.

Cleanroom Classification as per EU GMP 

Grade A, B & C usually used in only for sterile product manufacturing. Where solution preparation or preliminary mixing performed in Grade C and filling and sealing performed in Grade A & B. Grade D used other product manufacturing including solid products.

Bioburden is the main source of clean room contamination and human body is the primary source of bioburden. So it’s necessary to keep the clean room contaminant free thorough following standard procedure.

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