Ultrafiltration/Diafiltration Validation Protocol

Ultrafiltration/Diafiltration Validation Protocol


Gain a 6-month access to the Ultrafiltration/Diafiltration 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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The Ultrafiltration/Diafiltration protocol contains the following tests:


Installation Qualification:

  • General Documentation Verification

  • Major Components Verification

  • P&ID Drawing Verification

  • Control System Verification

  • Software Installation and Configuration Verification

  • Surface Finish Verification

  • Materials of Construction

  • Passivation Verification

  • Piping Slope Verification

  • Hydrostatic Pipe Leak Test

  • Sprayball Assembly 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

  • Agitator Operation Test

  • Sprayball Coverage Test

  • Recipe Verification

  • Clean-In-Place Verification

  • Empty Vessel Temperature Distribution Study

  • Filtration Parameter and Quality Testing

  • Diafiltration Parameter and Quality Testing