Gain a 6-month access to the Chromatography Skid 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 traditional chromatography skid systems used for separation processes (such as protein and impurity isolation) in the biopharmaceutical industry.
The Chromatography Skid protocol contains the following tests:
Signature and Training Log
Test Instrument Calibration
SOP Verification Form
General Documentation Verification
Major Components Verification
P&ID Drawing Verification
Control System Verification
Software Installation and Configuration Verification
Materials of Construction
Surface Finish Verification
Utilities Supply Verification
Preventive Maintenance Verification
Input/Output Loop Test
PLC HMI Communication Loss Test
Audit Trail Verification
User Security Access Test
Pump Capacity Test
Power Failure and Recovery Test
UV Detector Linearity Test
UV Step Gradient Test
UV Linear Gradient Test