Process analytical technologies (PAT) in freeze-drying of parenteral products
SM Patel, M Pikal - Pharmaceutical development and technology, 2009 - Taylor & Francis
SM Patel, M Pikal
Pharmaceutical development and technology, 2009•Taylor & FrancisQuality by Design (QbD), aims at assuring quality by proper design and control, utilizing
appropriate Process Analytical Technologies (PAT) to monitor critical process parameters
during processing to ensure that the product meets the desired quality attributes. This review
provides a comprehensive list of process monitoring devices that can be used to monitor
critical process parameters and will focus on a critical review of the viability of the PAT
schemes proposed. R&D needs in PAT for freeze-drying have also been addressed with …
appropriate Process Analytical Technologies (PAT) to monitor critical process parameters
during processing to ensure that the product meets the desired quality attributes. This review
provides a comprehensive list of process monitoring devices that can be used to monitor
critical process parameters and will focus on a critical review of the viability of the PAT
schemes proposed. R&D needs in PAT for freeze-drying have also been addressed with …
Quality by Design (QbD), aims at assuring quality by proper design and control, utilizing appropriate Process Analytical Technologies (PAT) to monitor critical process parameters during processing to ensure that the product meets the desired quality attributes. This review provides a comprehensive list of process monitoring devices that can be used to monitor critical process parameters and will focus on a critical review of the viability of the PAT schemes proposed. R&D needs in PAT for freeze-drying have also been addressed with particular emphasis on batch techniques that can be used on all the dryers independent of the dryer scale.