15 Sep 2022

Freeze Drop Testing of Bulk Drug Substance Bottles

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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 (also called flash freezing).

Most containers used to store BDS have glass transition temperatures well above -196°C; many containers structurally fail during the rapid descent through glass transition. Even worse, these failures are rarely detected until after the container is thawed, which can be days if not weeks or months after the freezing is completed.

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  • US
  • 2022
    On CPHI since
  • 25 - 49
Company types
Primary activities
Packaging & drug delivery
Packaging materials

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