Lyophilization process design space
SM Patel, MJ Pikal - Journal of pharmaceutical sciences, 2013 - Elsevier
SM Patel, MJ Pikal
Journal of pharmaceutical sciences, 2013•ElsevierThe application of key elements of quality by design (QbD), such as risk assessment,
process analytical technology, and design space, is discussed widely as it relates to freeze-
drying process design and development. However, this commentary focuses on constructing
the Design and Control Space, particularly for the primary drying step of the freeze-drying
process. Also, practical applications and considerations of claiming a process Design Space
under the QbD paradigm have been discussed.
process analytical technology, and design space, is discussed widely as it relates to freeze-
drying process design and development. However, this commentary focuses on constructing
the Design and Control Space, particularly for the primary drying step of the freeze-drying
process. Also, practical applications and considerations of claiming a process Design Space
under the QbD paradigm have been discussed.
Abstract
The application of key elements of quality by design (QbD), such as risk assessment, process analytical technology, and design space, is discussed widely as it relates to freeze-drying process design and development. However, this commentary focuses on constructing the Design and Control Space, particularly for the primary drying step of the freeze-drying process. Also, practical applications and considerations of claiming a process Design Space under the QbD paradigm have been discussed.
Elsevier