A Digital Book, 2013 Edition
PHARMACEUTICAL PLANT VALIDATION
 

HVAC Systems

SYSTEM DESCRIPTION
The HVAC System is designed to serve the laboratory suite of the biotechnology plant including cell culture rooms, aseptic rooms, preparation rooms, and air locks. The laboratory rooms are designed for Class 10,000 and the air locks for Class 100,000. Corridors are controlled but unclassified areas. Clean benches in the Class 10,000 laboratory rooms are designed for Class 100. The outside air, combined with the return air, is treated by AHU-101 and supplied to the laboratory area. A part of the air exiting from the laboratory rooms is directly exhausted into the atmosphere by an exhaust fan, while the remaining air is re-circulated to the AHU as return air by a return fan. The air entering the AHU is filtered by pre-filters and medium filters and then air conditioned for humidity and temperature control, and is supplied to the laboratory area by a supply fan at desired pressure. The supply air is terminal filtered by HEPA filers at the entrance to the cleanrooms. The system is designed to satisfy all cGMP requirements.


PROTOCOL NAME UNIT PRICE  
DQ (Design Qualification) Protocol, HVAC Systems US$ 100.00
IQ (Installation Qualification) Protocol, HVAC Systems US$ 100.00
OQ (Operational Qualification) Protocol, HVAC Systems US$ 100.00
PQ (Performance Qualification) Protocol, HVAC Systems US$ 100.00
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