Gain a 6-month access to the Autoclavable 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 bioreactor setups that are sterilized using autoclaves or other heat-based sterilization equipment.
The Bioreactor (Autoclavable) protocol contains the following tests:
General Documentation Verification
Major Components Verification
Control System Verification
Software Installation and Configuration Verification
Materials of Construction
Surface Finish Verification
Preventive Maintenance Verification
Input/ Output Loop Test
PLC-HMI Communication Loss test
Audit Trail Verification
Power Failure and Recovery Test
Agitator Operation Test
Bioreactor Functional Operation Verification
Empty Vessel Temperature Distribution
Study for Autoclavable Bioreactor
Empty Vessel Sterilization for Autoclavable Bioreactor
Loaded Vessel Sterilization for Autoclavable Bioreactor