Freeze-Thaw Performance and Robustness Assessment of Celsius FFT 6L - Can this freeze-thaw system handle frozen solutions without compromising container integrity or product quality? - BioPharm

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Freeze-Thaw Performance and Robustness Assessment of Celsius FFT 6L
Can this freeze-thaw system handle frozen solutions without compromising container integrity or product quality?


BioPharm International
Volume 22, Issue 12


Figure 5
Thaw at room temperature with the Celsius FFT 6 L standing flat on a bench was also tested. Thaw profile at room temperature is shown in Figure 5. It took 13.5 h to bring all the thermocouples from –45 C to at least +2 C with an average ambient temperature of 20 C.


Figure 6
The relatively rapid freeze-and-thaw kinetics observed with Celsius FFT are largely caused by specific design features of the protective shell shown in Figure 1 and Figure 6. The shell provides large peripheral venting holes and recessed, partially open, top and bottom surfaces. These features are favorable for unhindered heat transfer fluid circulation (cold air or hot water) between stacked shells and exposure of the bag surface to the process temperature.


Table 2: Results of the physical challenge tests with the Celsius FFT 6 L
In addition, the small thickness of the shell and the bag film, the low thermal mass of the container itself, and the relatively small freezing distance are favorable for rapid freeze-and-thaw kinetics.


Table 3: Acceptance criteria of the physical challenge test
The results of the physical challenge test are summarized in Table 2. The acceptance criteria used to assess the results of the physical challenge tests are summarized in Table 3.

These physical challenge conditions selected for the Celsius FFT 6 L exceed the requirements defined in ISO 15747 for an infusion container. The Celsius FFT 6 L containers withstood the physical challenge test with no evidence of leakage. The results confirm that the flexible freeze-thaw system provides a simple and efficient method for handling frozen solutions without compromising the container integrity and the product quality.

Nicolas Voute is a global product manager for fluid management technologies at Sartorius Stedim Biotech S.A., Aubagne, France,


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