-80˚C Seal Integrity Test

Rig for pressurizing and monitoring.

We’ve been asked if PharmaTainer™ bottles hold their seal at freezing temperatures.

Cellon recently finished demonstrating that they do.

Two representative single-use container sizes were chosen: 2L bottles representing sizes 2L and smaller with the 49 mm closure and 5L carboys representing the larger sizes with 70 mm closures.

The seal integrity test procedure was simple. Containers were filled to their nominal full capacity, 2L and 5L respectively, and then over-pressured to +/- 300 millibar. Subsequently the test samples were frozen to -80˚C and held for one day. The bottles were then thawed and allowed to come to room temperature so that ice thawed back to the same water volume as at the beginning of the test. Pressure was measured continuously during the whole process and it was found that the containers held pressure through the freeze and thaw.

If the seal had been broken at any point during the freeze thaw process, the over-pressure would have been lost.

This demonstrates that the PharmaTainer closure system maintains its seal down to -80˚C. A good choice for use in cold chain packaging.

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