Basic Documentation

Clean Rooms
Clean Room Pressurization Applications
Figure 9 shows a simplified clean room arrangement for a pharmaceutical processing
application. The cleanest area is the aseptic
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filling area, which is most likely where the
finished product is packaged (oral tablets, medications, etc.).
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PREPARATION
AREA
ASEPTIC FILLING
AREA
ENTRY &
GOWNING
AIRLOCK
EXIT &
DE-GOWNING
AIRLOCK
FINISHED
PRODUCT
OUTLET
AIRFLOW
DIRECTION
ARROWS
PERSONNEL CORRIDOR
LAB0200R1
Figure 9. Potential Clean Room Arrangement for Pharmaceutical Processing.
Workers enter and exit through the respective airlock in which they either put on the required
outer garments for entry or remove them upon exiting. The airlocks are each equipped with
two sets of doors (sliding or hinged) with an electrical interlocking arrangement that allows a
door to be open only when the other door is fully closed
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. By allowing only one door to be
open at a time, the amount of air that can flow out of the clean spaces through an airlock is
limited. Using airlocks for the entry and exit provisions ensures that the required level of
positive pressurization in the clean spaces is always maintained.
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Aseptic refers to a space or area in which the bacterial count is contained within required limits. Although it is not a 100%
sterile space it enables pharmaceutical products to be processed with a high degree of purity. Aseptic areas are generally
Class 100 per FE 209E.
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In some airlock arrangements a time delay of as much as several minutes is also incorporated to allow time to ventilate the
airlock before the other door can be opened.
Siemens Building Technologies, Inc. 33