A Digital Book, 2013 Edition
PHARMACEUTICAL PLANT VALIDATION
 

Cleanrooms – Aseptic

SYSTEM DESCRIPTION
The Cleanroom - Aseptic in the laboratory of the biotechnology plant is accessible through an air lock from the corridor. It is designed for Class 10,000, while the air lock for Class 100,000. Corridors are controlled but unclassified areas. Clean benches in the cleanroom are designed for Class 100. The supply air to the cleanroom is terminal filtered by HEPA filters mounted on the ceiling. A portion of the exiting air from the cleanroom 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 cleanroom 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, Cleanrooms - Aseptic US$ 100.00
IQ (Installation Qualification) Protocol, Cleanrooms - Aseptic US$ 100.00
OQ (Operational Qualification) Protocol, Cleanrooms - Aseptic US$ 100.00
PQ (Performance Qualification) Protocol, Cleanrooms - Aseptic US$ 100.00
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