Bioreactor (Single-Use) Validation Protocol

Bioreactor (Single-Use) Validation Protocol


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.

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The Bioreactor (Single-Use) protocol contains the following tests:


Installation Qualification:

  • General Documentation Verification

  • Major Components Verification

  • Control System Verification

  • Software Installation and Configuration Verification

  • Materials of Construction

  • Surface Finish Verification

  • Preventive Maintenance Verification

Operational Qualification:

  • HMI Verification

  • Data Entry

  • Input/ Output Loop Test

  • PLC-HMI Communication Loss test

  • Audit Trail Verification

  • Alarm Verification

  • Power Failure and Recovery Test

  • Agitator Operation Test

  • Recipe Verification

  • Bioreactor Functional Operation Verification

Performance Qualification:

  • Sterile Integrity