Chromatography Skid Validation Protocol

Chromatography Skid Validation Protocol


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.

Feel free to call us at 415-854-0320 or send a message through our live chat if you have any questions or need assistance. 

Click here to learn more about QualPrime Author.

*Applicable to all traditional chromatography skid systems used for separation processes (such as protein and impurity isolation) in the biopharmaceutical industry.

Get Access


The Chromatography Skid protocol contains the following tests:


General Forms:

  • Signature and Training Log

  • Deviation Form

  • Test Instrument Calibration

  • SOP Verification Form

Installation Qualification:

  • General Documentation Verification

  • Major Components Verification

  • P&ID Drawing Verification

  • Control System Verification

  • Software Installation and Configuration Verification

  • Materials of Construction

  • Surface Finish Verification

  • Passivation Verification

  • Utilities Supply Verification

  • Preventive Maintenance Verification

Operational Qualification:

  • HMI Verification

  • Data Entry

  • Input/Output Loop Test

  • PLC HMI Communication Loss Test

  • Audit Trail Verification

  • Alarm Verification

  • User Security Access Test

  • Pump Capacity Test

  • Power Failure and Recovery Test

  • Recipe Verification

  • UV Detector Linearity Test

  • UV Step Gradient Test

  • UV Linear Gradient Test