Process analytical technologies (PAT) in freeze-drying of parenteral products.
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.
Patel
Sajal Manubhai
SM
Department of Pharmaceutical Sciences, School of Pharmacy, University of Connecticut, USA.
Pikal
Michael
M
D002623:Chemistry Techniques, Analytical / Q000295:instrumentation / Q000379:methods*; D005612:Freeze Drying / Q000295:instrumentation / Q000379:methods*; D011786:Quality Control; D013678:Technology, Pharmaceutical / Q000295:instrumentation / Q000379:methods*