A Digital Book, 2013 Edition
PHARMACEUTICAL PLANT VALIDATION
 

Autoclaves

SYSTEM DESCRIPTION
The Autoclave is designed to provide sterilization exposure time and temperature conditions adequate to assure a probability of non-sterility not greater than one in a million for each approved loading configuration. It generates clean steam for its own use with USP purified water supplied from the plant utility system as feed water. The condensate of the clean steam meets the specification of WFI of US Pharmacopeia. The unit is designed to satisfy all cGMP requirements.


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