Cost considerations when controlling air quality: the options when designing a clean room or controlled environment are numerous. The advantages and disadvantages of designs and recommendations on cost-effectiveness are outlined.(manufacturing)

Medical Device Technology, January, 2005 by Govier, J.

Clean-rooms defined

It is generally accepted that a controlled environment, that is, a clean room in which particles of dust and microbial growth are controlled is the most suitable environment for the production of medical devices. Table I shows the definition of a clean room.

The most common method used to control the airborne particulate is to introduce high-efficiency particulate air (HEPA) filtered air through the room on a repeated basis, therefore, diluting any contaminated air within the room. The introduction of the additional air and restriction of the airflow from the room creates a pressure differential between the inside and the external contaminated area. Ingress is therefore difficult and the main source of contamination within the...

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