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Performed
validation to verify the Installational Qualification (IQ) and the Operational
Qualification (OQ) of the Finn-Aqua Sterilizer.
This sterilizer is a custom built unit from Finn-Aqua specifically designed
to meet cGMP and client's requirements. It is controlled by an external
PLC (Allen Bradley) through an operator interface. Various cycle types
can be programmed including wet and dry loads. All monitoring, controlling,
and recording of the sterilization operation were performed via the PLC.
The validation verified the temperature distribution around the chamber
via two pre-programmed cycles under loaded and unloaded conditions. Temperature
distribution was monitored and recorded using a Kaye Digistrip.
Operational qualification included all controls, digital display, alarm
functions, and cycle programs. Performance qualification included tests
on thermal mapping, chamber leak test, DART Test (Daily Air Removal Test),
and Heat Penetration Study.
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