Frozen storage of bulk drug substance (BDS) at temperatures at or below –70°C is common in the bioprocess industry. Storage at temperatures below –80°C can lead to spontaneous failure of typical BDS containers, particularly if container temperature is reduced rapidly (known as flash freezing).

Most containers used to store BDS have glass-transition temperatures well above –196°C, and many containers structurally fail during rapid descent through glass transition. Even worse, such failures often are detected after a container is thawed, which can take weeks to months after freezing is completed.

By contrast, materials composed of fluoropolymers typically do not change structurally when flash frozen. Thus, a container system manufactured from fluoropolymers can not only survive flash freezing, but also retain the same functionality it had when at room temperature.

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