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Equipment Capability Measurement of Laboratory Freeze-Dryers: a Comparison of Two Methods.
Srinivasan, Jayasree M; Sacha, Gregory A; Kshirsagar, Vaibhav; Alexeenko, Alina; Nail, Steven L.
Afiliação
  • Srinivasan JM; Pharmaceutical R&D, Baxter Healthcare, 927 S. Curry Pike, Bloomington, Indiana, 47403, USA. jayasree_srinivasan@baxter.com.
  • Sacha GA; Pharmaceutical R&D, Baxter Healthcare, 927 S. Curry Pike, Bloomington, Indiana, 47403, USA.
  • Kshirsagar V; Present Address: IMA Life, Inc., Tonawanda, New York, 14150, USA.
  • Alexeenko A; School of Aeronautics and Astronautics, Purdue University, West Lafayette, Indiana, 47907, USA.
  • Nail SL; Davidson School of Chemical Engineering, Purdue University, West Lafayette, Indiana, 47907, USA.
AAPS PharmSciTech ; 22(1): 53, 2021 Jan 19.
Article em En | MEDLINE | ID: mdl-33469853
ABSTRACT
The objective of this investigation was to evaluate two methods for measuring the maximum sublimation rate that a freeze-dryer will support-the minimum controllable pressure method and the choke point method. Both methods gave equivalent results, but the minimum controllable pressure method is preferred, since it is easier, faster, and less subjective. The ratio of chamber pressure to condenser pressure corresponding to the onset of choked flow was considerably higher in this investigation (up to about 201) than in previously published reports. This ratio was not affected by the location of the pressure gauge on the condenser; that is, on the foreline of the vacuum pump versus on the body of the condenser itself. The total water loss due to sublimation as measured by tunable diode laser absorption spectroscopy was consistently within 5% of gravimetrically determined weight loss, regardless of whether the measurement took place during choked versus non-choked process conditions.
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Liofilização Idioma: En Revista: AAPS PharmSciTech Assunto da revista: FARMACOLOGIA Ano de publicação: 2021 Tipo de documento: Article País de afiliação: Estados Unidos

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Liofilização Idioma: En Revista: AAPS PharmSciTech Assunto da revista: FARMACOLOGIA Ano de publicação: 2021 Tipo de documento: Article País de afiliação: Estados Unidos