The goal of this paper is to review the available process analytical technology tools for monitoring the batch freeze-drying process for pharmaceuticals. These systems aim evaluating in-line product temperature, sublimation flow rate, and values of some model parameters in such a way that it can be used for in-line or off-line process optimization. A detailed survey of the systems proposed in the literature is presented, grouping them on the basis of monitored variable, namely, product temperature, heat flux to the product, sublimation flux, and, finally, other variables. The advantages and drawbacks of the techniques are critically assessed, taking into account the possibility of using them not only at lab-scale but also at production scale, beside, obviously, the possibility of getting reliable measurements of the desired variables.

Process Analytical Technology for monitoring pharmaceuticals freeze drying - A Comprehensive Review / Fissore, D.; Pisano, R.; Barresi, A. A.. - In: DRYING TECHNOLOGY. - ISSN 0737-3937. - STAMPA. - 36:15(2018), pp. 1839-1865. [10.1080/07373937.2018.1440590]

Process Analytical Technology for monitoring pharmaceuticals freeze drying - A Comprehensive Review

Fissore D.;Pisano R.;Barresi A. A.
2018

Abstract

The goal of this paper is to review the available process analytical technology tools for monitoring the batch freeze-drying process for pharmaceuticals. These systems aim evaluating in-line product temperature, sublimation flow rate, and values of some model parameters in such a way that it can be used for in-line or off-line process optimization. A detailed survey of the systems proposed in the literature is presented, grouping them on the basis of monitored variable, namely, product temperature, heat flux to the product, sublimation flux, and, finally, other variables. The advantages and drawbacks of the techniques are critically assessed, taking into account the possibility of using them not only at lab-scale but also at production scale, beside, obviously, the possibility of getting reliable measurements of the desired variables.
File in questo prodotto:
File Dimensione Formato  
83.DT_2018_vol36.pdf

non disponibili

Descrizione: versione editoriale
Tipologia: 2a Post-print versione editoriale / Version of Record
Licenza: Non Pubblico - Accesso privato/ristretto
Dimensione 1.26 MB
Formato Adobe PDF
1.26 MB Adobe PDF   Visualizza/Apri   Richiedi una copia
83.DT_2018_vol36.pdf

accesso aperto

Tipologia: 2. Post-print / Author's Accepted Manuscript
Licenza: PUBBLICO - Tutti i diritti riservati
Dimensione 1.07 MB
Formato Adobe PDF
1.07 MB Adobe PDF Visualizza/Apri
Pubblicazioni consigliate

I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.

Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11583/2704855