Advanced approach to build the design space for the primary drying of a pharmaceutical freeze‐drying process

Fissore, Davide; Pisano, Roberto

doi:10.1002/jps.22668

Cited by 106 publications

(108 citation statements)

References 27 publications

(45 reference statements)

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“…the value of K v vs. P c ), has been proposed to get the design space quickly, taking also into account the effect of parameters uncertainty and/or variability (Giordano et al, 2011). Due to batch non-uniformity, vials have to be divided in various subsets (as shown above), which are characterized by the same value of K v , and the design space (that is strongly dependent on the value of K v ) has to be built for each group (Fissore et al, 2011b). Of course, since the design space of edge-vials is more contracted than that of vials placed in the core, processing conditions has to be chosen according to the design space of those vials that can be more easily damaged by product overheating (i.e.…”

Section: Resultsmentioning

confidence: 99%

Heat Transfer in Freeze-Drying Apparatus

Pisano¹,

Fissore²,

Barresi³

2011

Developments in Heat Transfer

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Section: Resultsmentioning

confidence: 99%

Heat Transfer in Freeze-Drying Apparatus

Pisano¹,

Fissore²,

Barresi³

2011

Developments in Heat Transfer

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“…[38][39][40][41][42] shows various methods, using simple one-dimensional models, to calculate the design space of the primary drying stage of a freeze-drying process. This paper aims at developing a model-based approach to calculate the design space of the primary drying in case the product processed is characterized by a dried cake resistance dependent on the operating conditions of the process.…”

Section: Introductionmentioning

confidence: 99%

Computer-Aided Framework for the Design of Freeze-Drying Cycles: Optimization of the Operating Conditions of the Primary Drying Stage

Fissore

Pisano

2015

Processes

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This paper deals with the freeze-drying process and, in particular, with the optimization of the operating conditions of the primary drying stage. When designing a freeze-drying cycle, process control aims at obtaining the values of the operating conditions (temperature of the heating fluid and pressure in the drying chamber) resulting in a product temperature lower than the limit value of the product, and in the shortest drying time. This is particularly challenging, mainly due to the intrinsic nonlinearity of the system. In this framework, deep process knowledge is required for deriving a suitable process dynamic model that can be used to calculate the design space for the primary drying stage. The design space can then be used to properly design (and optimize) the process, preserving product quality. The case of a product whose dried layer resistance, one of the key model parameters, is affected by the operating conditions is addressed in this paper, and a simple and effective method to calculate the design space in this case is presented and discussed.

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“…This behavior is consistent with results shown in Refs. and was likely due to the presence of an open structure at top surface of the lyophilized product. As shown in Figure (bottom graph), the PDT gives quantitative accurate values of R p , usually within 5% as compared with PRT determination …”

Section: Resultsmentioning

confidence: 99%