A cell culture laboratory within a large Midwestern pharmaceutical company needed to upgrade their current cell freezing process. the project included replacing an older and increasingly unreliable controlled rate freezer with a new controlled rate freezer. Additionally, the actual freezing rate of the cells within the controlled rate freezer was needed to be determined to ensure cell viability.
Performance Validation (PV) was selected for the project because of their temperature mapping expertise, internal equipment inventory and history of many successful validation projects for the cell culture laboratory. PV collaborated directly with cell culture laboratory site engineers and technical services personnel on devising load configurations and containment for various engineering studies, followed by a complete IQ/OQ/PQ qualification package. Validation testing included the freezing processes of both cryogenic straws and vials. Temperatures were measured through the load during the freezing process for a number of temperature profiles and loading parameters (vial quantity, vial size, vial configuration and containment, rack type, etc.). The data was analyzed after each run and incremental changes were made and retested until satisfactory results were obtained.
The end result was a defined freezing profile and vial load that would provide the desired cell freezing rate expected to maintain cell viability. The type of information gathered and plotted by PV had not been previously obtainable from any other sources for either the controlled rate freezer used or the cell vial load being frozen. The temperature mapping results demonstrated the impact of the vial size, loading pattern, freezing profile, and resulting phase change heat-of-fusion characteristics on the overall freezing rate of cells for the cell culture laboratory throughout the entire load.
The project accomplished the following for the cell culture laboratory:
- A new and more reliable cell freezing process
- A qualified controlled rate freezer with documented cell freezing profiles throughout the entire load meeting acceptance criteria, ensuring cell viability
- An in-depth understanding, with supporting data, of the impact of the type, size, and configuration of the cell load along with the freezing profile of the controlled rate freezer on the cell freezing process.
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Vice President, Indiana Division Director
Performance Validation, Inc