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Utilities are the blood who keeps alive and functional a pharmaceutical plant.
Utility systems are very diverse and range from electricity to compressed air but they
share the common fact of possessing points of use. They can be divided into “industrial”
utilities which may interact with equipment but not with products and “pharmaceutical”
utilities that may interrelate with both. These latter are critical and as such they have to
be qualified and closely monitored. This is the only way for ensuring that they do not
affect negatively the quality of the products. Utilities are normally tailor-made for each
plant and as such a good study of their design is essential. Two utilities are particularly
relevant: HVAC and water for pharmaceutical use. The HVAC system, in combination
with the internal architecture, provides the controlled setting for the development of the
pharmaceutical operations. Any failure puts at risk the production environment. The
water for pharmaceutical use is a utility which provides water for cleaning but also
water for compounding. This latter function turns water into a very particular starting
material. It is obtained in situ and differently from other starting materials it is often
used before formal sampling, testing and liberation by QC. This explains why it is one
of the points of highest level of risk in a pharmaceutical plant. This chapter analyzes all
these aspects and provides keys to the most effective approaches for protecting the
quality of products.
AHU, biofilm, compressed air, dehumidifier, dew point, distiller, dust
exhaust, EDI, HVAC, lighting, nitrogen, passivation, pipework, P&IDs, point of
use, RO, steam, storage, water for pharmaceutical use, welding.
Glez. Tablas 17, Barcelona, Spain.