Gain a 6-month access to the Single-Use 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 stirring-type single use bioreactors that has plastic bioprocessing bags mounted on a vessel frame.
The Bioreactor (Single-Use) 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