In the Clean Room: Compliant Sterility

A clean room is a sterile environment in which processes that could be compromised by small particles are possible. The conditions in this room are set in such a way that contamination is at nil. It also provides the capability to manipulate other parameters like temperature. This is applicable in many sectors from aeronautics to healthcare. Only specifically trained personnel are allowed in this room. Even to do seemingly inane tasks like cleaning.

A regular room has about a million 0.5mm particles per cubic foot of air. No room has zero. Thus all air that enters a clean room should pass through a filter. There are two kinds of filters. The first is High-Efficiency Particulate Air or HEPA. The second is Ultra Low Particulate Air. The latter allows for especially strict sterility requirements. The clean room is entered through either air showers, airlocks or gowning rooms.

Classification

Sterile environments must adhere to ISO and Federal standards. These two authorities provide a classification of cleaning rooms. This directs how stringent the standard operating procedures should be. Classification is dependent on how clean the air in the room is. ISO groups the higher critical environments with 0.1 micron or larger particles … Read More