Bioreactor (Steam-In-Place) Validation Protocol

Bioreactor (Steam-In-Place) Validation Protocol

399.00

Gain a 6-month access to the Steam-In-Place 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. 

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*Applicable to all bench-top, pilot-plant, small-scale, and large-scale bioreactors that utilizes steam from a clean steam system to perform Steam-in-Place (SIP).

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Description:

The Steam-in-Place Bioreactor contains the following tests:

 

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

  • Weld Inspections

  • Piping Slope Verification

  • Sprayball Assembly Verification

  • Hydrostatic Pipe Leak Test

  • Utilities Supply Verification

  • Preventive Maintenance Verification

Operational Qualification

  • HMI Verification

  • Data Entry

  • Input/Output Loop Test

  • Audit Trail Verification

  • User Security Access Test

  • Alarm Verification

  • Power Failure and Recovery Test

  • Agitator Operation Test

  • Recipe Verification

  • Bioreactor Functional Operation Verification

  • Sprayball Coverage Test

  • Empty Vessel Temperature Distribution Study

Performance Qualification

  • Empty Vessel Sterilization

  • Loaded Vessel Sterilization

  • Sterile Integrity

Need further customization for this equipment? Call us at 415-854-0320 or drop us a message.