Frozen storage of bulk drug substances (BDS), including bioprocess solutions, vaccines, blood components, and other delicate process fluids is common in the bioprocess industry. Vessels used to store those fluids must be capable of withstanding long-term storage in extremely cold temperatures (e.g., –85 °C or –196 °C), sometimes for very long time periods. They also must also maintain integrity after repeated thawing and subsequent refreeze. The study below was performed to characterize performance of fluoropolymer bottles with standard and two-piece…
Author Archives: Eric Isberg
Freeze Cycle Testing of
Benefits of Fluoropolymers for Frozen Storage of Bulk Drug Substance
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…