Microbiological considerations in cleanroom validation

Microbiological contamination is a major safety concern within the manufacturing and development of all pharmaceutical & medical devices. This article discusses how and why a cleanroom environment plays an important role during these processes.

An excerpt of this article as follows:

Cleanrooms and other controlled environments play a vital role in manufacturing and testing processes through the control of airborne and surface contamination as the levels of particles allowed within these environments are strictly regulated.

Cleanroom grading systems are governed by a number of regulatory bodies and standard-setting organisations, with classification assessing the level of cleanliness of the environment against a specified range. These grades take into consideration the measured or specified concentration of macroparticles per cubic metre of air, the airflow within the room and the condition of the room.

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