Evaluation of Container Closure System Integrity for Storage of Frozen Drug Products: Impact of Capping Force and Transportation

Alejandra Nieto; Holger Roehl; Michael Adler; Silke Mohl

doi:10.5731/pdajpst.2017.008383

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Evaluation of Container Closure System Integrity for Storage of Frozen Drug Products: Impact of Capping Force and Transportation

Alejandra Nieto, Holger Roehl, Michael Adler and Silke Mohl

PDA Journal of Pharmaceutical Science and Technology May 2018, pdajpst.2017.008383; DOI: https://doi.org/10.5731/pdajpst.2017.008383

Alejandra Nieto

1 F. Hoffmann- La Roche Ltd.;

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For correspondence: alejandra.nieto@roche.com

Holger Roehl

2 F. Hoffmann - La Roche Ltd.

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For correspondence: holger.roehl@roche.com

Michael Adler

2 F. Hoffmann - La Roche Ltd.

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For correspondence: michael.adler@roche.com

Silke Mohl

2 F. Hoffmann - La Roche Ltd.

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For correspondence: silke.mohl@roche.com

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pdajpst.2017.008383

DOI

https://doi.org/10.5731/pdajpst.2017.008383

PubMed

29853608

Published By

Parenteral Drug Association (PDA)

Print ISSN

1079-7440

Online ISSN

1948-2124

History

Received October 13, 2017
Accepted May 10, 2018
Published online May 31, 2018.

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Alejandra Nieto1,3 (alejandra.nieto{at}roche.com),
Holger Roehl2 (holger.roehl{at}roche.com),
Michael Adler2 (michael.adler{at}roche.com) and
Silke Mohl2 (silke.mohl{at}roche.com)

¹ F. Hoffmann- La Roche Ltd.;
² F. Hoffmann - La Roche Ltd.

↵* Corresponding author; email: alejandra.nieto{at}roche.com

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Evaluation of Container Closure System Integrity for Storage of Frozen Drug Products: Impact of Capping Force and Transportation

Alejandra Nieto, Holger Roehl, Michael Adler, Silke Mohl

PDA Journal of Pharmaceutical Science and Technology May 2018, pdajpst.2017.008383; DOI: 10.5731/pdajpst.2017.008383

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Evaluation of Container Closure System Integrity for Storage of Frozen Drug Products: Impact of Capping Force and Transportation

Alejandra Nieto, Holger Roehl, Michael Adler, Silke Mohl

PDA Journal of Pharmaceutical Science and Technology May 2018, pdajpst.2017.008383; DOI: 10.5731/pdajpst.2017.008383

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Keywords

Capping
Container closure integrity
Frozen drug product
headspace analysis
Helium leakage test
Vial

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