Depyrogenation Oven Validation Protocol

Depyrogenation Oven Validation Protocol


Gain a 6-month access to the Depyrogenation Oven 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 Depyrogenation Oven 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

  • Weld Inspections

  • 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

  • Power Failure and Recovery Test

  • Air Flow Velocity Test

  • Non-Viable Particulates

  • Air Pattern Test

  • HEPA Filter Leak Test

  • Empty Chamber Heat Distribution Study

Performance Qualification:

  • Endotoxin Challenge