In the pharmaceutical and biomedical industry, it is not enough for a device to work. It must be proven that it works - in accordance with the specified requirements, under the actual operating conditions and over a defined period of time. This proof is provided by the qualification process, which consists of three successive stages: IQ (Installation Qualification), OQ (Operational Qualification) and PQ (Performance Qualification).
Every cryotank, every controlled rate freezer and every monitoring system in a GMP-regulated cryobank must undergo this process. Consarctic® offers a complete IQ/OQ service and also supports its customers in performing PQ.
In this article, we explain the three stages in a practical way and show what is important when qualifying your cryogenic infrastructure.
The IQ is the first stage and checks whether the equipment has been installed correctly and completely - in accordance with the manufacturer's specifications and the site-specific requirements.
An IQ document for a Consarctic® BSD+ stainless steel tank includes serial number verification, documentation of the installation position, verification of all connections and confirmation that the tank has been installed in accordance with the manufacturer's specifications.
The OQ proves that the equipment fulfills the specified functions under defined test conditions. In contrast to the IQ, which only tests the installation, the OQ tests the actual function.
For cryogenic tanks, temperature mapping is the core component of OQ. Calibrated temperature sensors are placed at defined positions within the tank - typically at the top, middle and bottom of several racks. The temperature distribution is recorded over a defined period (e.g. 24-72 hours).
With a controlled rate freezer, the OQ includes verification of all pre-installed freezing programs: Is the programmed cooling rate being maintained? Is the TC-Active function working? Is the final temperature reached? Is the data recorded correctly?
The PQ goes beyond the OQ and proves that the equipment functions reliably under real operating conditions - with actual samples, actual personnel and actual workflow.
The qualification documentation is a living document that forms the basis for the regulatory compliance of your cryobank. Inspectors from the competent authorities will specifically ask for the IQ/OQ/PQ documents during audits. Incomplete or incorrect documentation can lead to complaints.
Qualification is not a one-off process. Requalifications are required in the following situations:
Consarctic® offers a professional IQ/OQ service that includes full qualification documentation. Our trained technicians carry out all tests on site and prepare the documentation in accordance with current GMP requirements. On request, we can also provide support with the planning and implementation of the PQ.
Do you need qualification of your cryogenic infrastructure? Contact our qualification experts for a timely and professional implementation.