Gain a 6-month access to the Steam-In-Place Bioreactor Validation Protocol* in QualPrime Author. This protocol includes comprehensive, easy-to-follow procedures and test forms for each qualification activity listed in the description below.
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*Applicable to all bench-top, pilot-plant, small-scale, and large-scale bioreactors that utilizes steam from a clean steam system to perform Steam-in-Place (SIP).
The Steam-in-Place Bioreactor contains the following tests:
General Documentation Verification
Major Components Verification
P&ID Drawing Verification
Control System Verification
Software Installation and Configuration Verification
Materials of Construction
Surface Finish Verification
Piping Slope Verification
Sprayball Assembly Verification
Hydrostatic Pipe Leak Test
Utilities Supply Verification
Preventive Maintenance Verification
Input/Output Loop Test
Audit Trail Verification
User Security Access Test
Power Failure and Recovery Test
Agitator Operation Test
Bioreactor Functional Operation Verification
Sprayball Coverage Test
Empty Vessel Temperature Distribution Study
Empty Vessel Sterilization
Loaded Vessel Sterilization