White Paper

The Critical Formulation Temperature In Freeze-Drying

Source: SP Scientific

Click Here To Download:
Presentation: The Critical Formulation Temperature In Freeze-Drying

In order to develop an optimized freeze-drying process, we must access the "critical temperature" of a formulation, using a technology that provides accurate and representative measurements.

In R&D, the glass transition temperature of the maximally freeze-concentrated solute (Tg') is often used as the critical temparature, although Tg' and the collapse temperature (Tc) are frequently reported to show a bias for 1 - 50 C for the same formulation.

Important: a 10C increase in product temperature may result in as much as a 13% increase in a primary drying rate and therefore, shorter drying time.

For a solute system which remains amorphous during freezing and drying, Tc is the maximally tolerable product temperature during primary drying which ensures an elegant cake.

Primary drying Tc may result in:

  • an unacceptable appearance of the product
  • prolonged reconstitution times and/or an imcomplete reconstitution
  • elevated residual moisture levels in the product and
  • instability during storage due to elevated mobility within the matrix (proteins,peptides etc.,)

Click Here To Download:
Presentation: The Critical Formulation Temperature In Freeze-Drying