Method Comparison Study—One Step Forward toward Robust Silicone Layer Thickness Measurements

Safia Lotfi; Fabio Montagner; Christian Proff; Sascha Dreher; Ulla Grauschopf; Chiara De Zorzi; Odra Pinato; Serena Panighello; Stefanie Funke

doi:10.5731/pdajpst.2020.012567

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Method Comparison Study—One Step Forward toward Robust Silicone Layer Thickness Measurements

Safia Lotfi, Fabio Montagner, Christian Proff, Sascha Dreher, Ulla Grauschopf, Chiara De Zorzi, Odra Pinato, Serena Panighello and Stefanie Funke

PDA Journal of Pharmaceutical Science and Technology November 2021, 75 (6) 474-489; DOI: https://doi.org/10.5731/pdajpst.2020.012567

Safia Lotfi

1F. Hoffmann-La Roche Ltd, Device and Packaging Development, PTD Biologics Europe (PTDE-D), Basel, Switzerland; and

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Fabio Montagner

1F. Hoffmann-La Roche Ltd, Device and Packaging Development, PTD Biologics Europe (PTDE-D), Basel, Switzerland; and

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Christian Proff

1F. Hoffmann-La Roche Ltd, Device and Packaging Development, PTD Biologics Europe (PTDE-D), Basel, Switzerland; and

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Sascha Dreher

1F. Hoffmann-La Roche Ltd, Device and Packaging Development, PTD Biologics Europe (PTDE-D), Basel, Switzerland; and

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Ulla Grauschopf

1F. Hoffmann-La Roche Ltd, Device and Packaging Development, PTD Biologics Europe (PTDE-D), Basel, Switzerland; and

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Chiara De Zorzi

2SG Lab Analytics, Nuova Ompi, Stevanato Group, Padova, Italy

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Odra Pinato

2SG Lab Analytics, Nuova Ompi, Stevanato Group, Padova, Italy

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Serena Panighello

2SG Lab Analytics, Nuova Ompi, Stevanato Group, Padova, Italy

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Stefanie Funke

1F. Hoffmann-La Roche Ltd, Device and Packaging Development, PTD Biologics Europe (PTDE-D), Basel, Switzerland; and

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For correspondence: stefanie.funke@roche.com

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vol. 75 no. 6 474-489

DOI

https://doi.org/10.5731/pdajpst.2020.012567

PubMed

33990422

Published By

Parenteral Drug Association (PDA)

Print ISSN

1079-7440

Online ISSN

1948-2124

History

Published online November 29, 2021.

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previous version (May 14, 2021 - 13:18).
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Author Information

Safia Lotfi¹,
Fabio Montagner¹,
Christian Proff¹,
Sascha Dreher¹,
Ulla Grauschopf¹,
Chiara De Zorzi²,
Odra Pinato²,
Serena Panighello² and
Stefanie Funke¹,*

¹F. Hoffmann-La Roche Ltd, Device and Packaging Development, PTD Biologics Europe (PTDE-D), Basel, Switzerland; and
²SG Lab Analytics, Nuova Ompi, Stevanato Group, Padova, Italy

↵*Corresponding Author: F. Hoffmann-La Roche Ltd, Device and Packaging Development, PTD Biologics Europe (PTDE-D), 4070 Basel, Switzerland. E-mail: stefanie.funke{at}roche.com

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Method Comparison Study—One Step Forward toward Robust Silicone Layer Thickness Measurements

Safia Lotfi, Fabio Montagner, Christian Proff, Sascha Dreher, Ulla Grauschopf, Chiara De Zorzi, Odra Pinato, Serena Panighello, Stefanie Funke

PDA Journal of Pharmaceutical Science and Technology Nov 2021, 75 (6) 474-489; DOI: 10.5731/pdajpst.2020.012567

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Method Comparison Study—One Step Forward toward Robust Silicone Layer Thickness Measurements

Safia Lotfi, Fabio Montagner, Christian Proff, Sascha Dreher, Ulla Grauschopf, Chiara De Zorzi, Odra Pinato, Serena Panighello, Stefanie Funke

PDA Journal of Pharmaceutical Science and Technology Nov 2021, 75 (6) 474-489; DOI: 10.5731/pdajpst.2020.012567

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Keywords

Comparison study
silicone oil layer thickness and distribution
white light reflectometry
laser interferometry
glide forces
Fourier transform infrared spectroscopy
baked-on siliconized syringes

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