Bioreactor (Single-Use)

Bioreactor (Single-Use)

399.00

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.

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 stirring-type single use bioreactors that has plastic bioprocessing bags mounted on a vessel frame.

Quantity:
Get Access

Description:

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