Pharmaceutical Manufacturing Handbook: Production and

DESIGN OPTIONS 219
FIGURE 12 The wall system used in the facility incorporates a monolithic sheet vinyl fl ooring
junction between fl oor and wall face. Note the coving run up the wall around the edges
to provide a smooth surface for cleaning. ( Courtesy of Portafab. )
FIGURE 13 The air handler has several stages of fi ltration combined with heating, cooling,
humidifi cation, and dehumidifi cation capability. ( Courtesy of Air Enterprises. )
leakage. Make - up air should be drawn from the outdoors, conditioned, and fi ltered
as necessary before being introduced into the clean - room recirculation air stream.
Care should be taken to ensure that make - up air intakes are not drawing in contaminated
air.
The potential for cross - contamination is an issue that should be addressed. A
fl exible manufacturing facility is one in which a variety of products can be manufactured
simultaneously. If the facility has a single air - handling system, the likelihood
of materials from one space intruding into an adjacent space is high. For this
reason each fi lling or compounding operation, or operation where noncompatible
product can be expected to be picked up by the air stream, should be served by its
own air - handling system (Figure 13 ). Isolated systems will minimize the possibility
of cross - contamination. This can be a costly option and should not be undertaken