Using Extractables Data of Sterile Filter Components for Scaling Calculations

Ina Pahl; Roberto Menzel; Armin Hauk; Thomas Loewe

doi:10.5731/pdajpst.2018.009647

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Using Extractables Data of Sterile Filter Components for Scaling Calculations

Ina Pahl, Roberto Menzel, Armin Hauk and Thomas Loewe

PDA Journal of Pharmaceutical Science and Technology November 2019, 73 (6) 523-537; DOI: https://doi.org/10.5731/pdajpst.2018.009647

Ina Pahl

Sartorius Stedim Biotech GmbH, August-Spindler-Straße 11, D-37079 Göttingen, Germany

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For correspondence: ina.pahl@sartorius-stedim.com

Roberto Menzel

Sartorius Stedim Biotech GmbH, August-Spindler-Straße 11, D-37079 Göttingen, Germany

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Armin Hauk

Sartorius Stedim Biotech GmbH, August-Spindler-Straße 11, D-37079 Göttingen, Germany

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Thomas Loewe

Sartorius Stedim Biotech GmbH, August-Spindler-Straße 11, D-37079 Göttingen, Germany

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vol. 73 no. 6 523-537

DOI

https://doi.org/10.5731/pdajpst.2018.009647

PubMed

31101707

Published By

Parenteral Drug Association (PDA)

Print ISSN

1079-7440

Online ISSN

1948-2124

History

Published online December 10, 2019.

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previous version (May 17, 2019 - 05:08).
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Ina Pahl*,
Roberto Menzel,
Armin Hauk and
Thomas Loewe

Sartorius Stedim Biotech GmbH, August-Spindler-Straße 11, D-37079 Göttingen, Germany

↵* Corresponding Author: Sartorius Stedim Biotech GmbH, August-Spindler-Straße 11, D-37079 Göttingen, Germany. Telephone: 0049 551 308 2241; e-mail: ina.pahl{at}sartorius-stedim.com

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Using Extractables Data of Sterile Filter Components for Scaling Calculations

Ina Pahl, Roberto Menzel, Armin Hauk, Thomas Loewe

PDA Journal of Pharmaceutical Science and Technology Nov 2019, 73 (6) 523-537; DOI: 10.5731/pdajpst.2018.009647

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Using Extractables Data of Sterile Filter Components for Scaling Calculations

Ina Pahl, Roberto Menzel, Armin Hauk, Thomas Loewe

PDA Journal of Pharmaceutical Science and Technology Nov 2019, 73 (6) 523-537; DOI: 10.5731/pdajpst.2018.009647

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Keywords

Filter cartridges
Filter family
Component approach
Extractables profile
UPLC-HRMS (QTOF)
Diffusion and partition coefficient
Effective filtration area

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