A Digital Book, 2013 Edition
PHARMACEUTICAL PLANT VALIDATION
 

Air Locks – Gowning

SYSTEM DESCRIPTION
The Air Lock - Gowning in the laboratory of the biotechnology plant provides operators with space for gowning before they enter the cleanroom from the corridor. It is designed for Class 100,000, while the cleanroom for Class 10,000. Corridors are controlled but unclassified areas. The supply air to the air lock is terminal filtered by HEPA filters mounted on the ceiling. A portion of the exiting air from the air lock is re-circulated to the AHU by a return fan, while the remaining exiting air is directly exhausted to the atmosphere by an exhaust fan. The air lock is provided with pressure, temperature, and humidity sensors, and the data are recorded by the PLC serving for building management.


PROTOCOL NAME UNIT PRICE  
DQ (Design Qualification) Protocol, Air Locks - Gowning US$ 100.00
IQ (Installation Qualification) Protocol, Air Locks - Gowning US$ 100.00
OQ (Operational Qualification) Protocol, Air Locks - Gowning US$ 100.00
PQ (Performance Qualification) Protocol, Air Locks - Gowning US$ 100.00
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