Recent Development of Optimization of Lyophilization Process

Table 1

Potential critical material attributes, critical process parameters, and critical quality attributes.

Critical material attributes (CMAs)	Critical process parameters (CPPs)	Critical quality attributes (CQAs)
(i) Glass transition temperature	(i) Freezing temperature	(i) Related substances
(ii) Eutectic temperature	(ii) Freezing rate	(ii) Appearance
(iii) Cake collapse temperature	(iii) Annealing temperature/time	(iii) Water content
(iv) Product temperature	(iv) Primary drying temperature/pressure/time	(iv) Reconstitution time
(v) Water vapor transfer resistance of the dried layer (Rp)	(v) Secondary drying temperature/pressure/time