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Research ArticleResearch

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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Abstract

In the past decades, the silicone layer thickness and its distribution on the inner glass barrels of prefilled syringes have been characterized in several studies. However, the limited number of adequate methods to characterize thin baked-on silicone layers and the destructive nature of some analytical techniques suggest challenges to the inter-lab reproducibility of some methods. In this study, the measured silicone layer thickness of baked-on siliconized syringes was compared between two laboratories, both equipped with white light reflectometry coupled to laser interferometry instrumentation (Bouncer, LE UT 1.0, LE UT 2.0). The quantity of silicone oil of a subset of those syringes was measured by Fourier transform infrared spectroscopy. Glide force tests were realized as complementary measurements on both syringes analyzed by white light reflectometry coupled to laser interferometry instrumentation and on non-analyzed identical syringes from the same lot. Silicone profiles of all prefilled syringes including the limit of detection results replaced with 20 nm were comparable, but values were slightly lower when measured with the Bouncer instrument. An increase of the layer thickness from the finger flange to the needle side was found for all syringes with all instruments (20 nm to 130–140 nm). Glide force results were similar except for a difference in peak width in the break loose region between the laboratories. The mean quantities of silicone oil found by both laboratories were similar (64 µg/syringe and 69 µg/syringe). Overall, comparable results between laboratories suggest a good reproducibility of the thickness measurement method as a result of thorough method understanding and defining key method parameters. Hence this study presents a robust inter-lab comparison between silicone layer thickness measurements that has been a lack in the literature up to now.

  • Comparison study
  • silicone oil layer thickness and distribution
  • white light reflectometry
  • laser interferometry
  • glide forces
  • Fourier transform infrared spectroscopy
  • baked-on siliconized syringes
  • © PDA, Inc. 2021
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PDA Journal of Pharmaceutical Science and Technology: 75 (6)
PDA Journal of Pharmaceutical Science and Technology
Vol. 75, Issue 6
November/December 2021
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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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