Pp. 269-309 (41)
Pharmaceutical premises determine the manufacturing flows and provide the
setting for manufacturing equipment and for the complementary utilities. Clean rooms,
where production operations can be performed within a controlled environment, are the
result of combining sanitary internal architecture and HVAC systems. Premises have to
be well designed in order to impede the entrance of outside contamination and the
diffusion of internal cross-contamination. Moreover, personnel, because of their
inherent contamination, put at risk the quality of the internal environment of the
premises and therefore their access has to be controlled and performed through
changing rooms, where operators put on appropriate clothing for the operations to be
performed. When products happen to be potentially harmful, it is necessary to protect
operators and outside environment too. This requires specially designed premises where
the above-mentioned protection of products is coupled with the protection of operators
and environment. This latter requirement is fulfilled by means of two steps of
contention, primary within closed devices and secondary within the rooms by a
combination of differential pressure and air filtration. Qualification allows for the
demonstration that premises perform as intended.
Action limits, airborne particles, air changes, airflow, airlock, internal
architecture, clean area, clean room classification requirements, clean room
conditions, clean room monitoring, clean room qualification, clothing,
containment, design, differential pressure, material flow, personnel flow, sanitary
construction, turbulent airflow, UDAF.
Glez. Tablas 17, Barcelona, Spain.