Chromatography Skid Validation Protocol

Chromatography Skid Validation Protocol

349.00

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.

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Description:

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