Azenta has developed protocols for Installation Qualification, Operational Qualification, and Performance Qualification (IQ-OQ-PQ) of our high-efficiency cryogenic freezers, outlining a recommended testing procedure along with associated acceptance criteria. As a customer, you should review all protocols to ensure they conform to your local quality system.
Installation Qualification (IQ)
The Installation Qualification (IQ) is the process that verifies that the cryo freezer is installed in accordance with manufacturer’s recommendations. Successful completion of this protocol shall provide documented evidence that the required equipment and its major components have been received and not damaged, have been installed properly, and that the “as-found” utility supply meets the required environmental specifications for installation.
Includes: Freezer delivery, replacement, power and LN2 supply, initial fill, controller information, WiFi/ LAN network, text/email notifications, lid access control, alarm contacts, user safety, SOP recommendations, and user defined settings.
Operational Qualification (OQ)
The Operational Qualification (OQ) confirms that the cryo freezer is operating properly, following manufacturer’s recommendations. Successful completion of this protocol shall provide documented evidence that the cryo freezer can operate reliably and consistently.
Includes: Temperature, LN2 level, usage verification, battery backup, alarm and alerts, freezer function test.
Performance Qualification (PQ)
The Performance Qualification (PQ) checklist verifies the proper performance of cryo freezers and should be performed in conjunction with the IQ and OQ checklists. Objective: Freezer performance is evaluated via temperature mapping. A pass/fail criterion will be used to test the freezer performance to critical temperature specifications.
Includes: Temperature mapping test and results reporting.