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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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References

  1. 1.↵
    1. Rios M.,
    2. Harrison B.
    Big Shot: Developments in Prefilled Syringes. Pharm. Technol. 2007, 31 (3).
  2. 2.↵
    1. Ingle R. G.,
    2. Agarwal A. S.
    Pre-Filled Syringe-a Ready-to-Use Drug Delivery System: A Review. Expert Opin. Drug Delivery 2014, 11 (9), 1391–1399.
    OpenUrl
  3. 3.↵
    1. Sassalos T. M.,
    2. Paulus Y. M.
    Prefilled Syringes for Intravitreal Drug Delivery. Clin. Ophthalmol. 2019, 13, 701–706.
    OpenUrl
  4. 4.↵
    1. Sardella A.
    Fine tuning of process parameters for improving biocompatibility of prefillable syringes. ONdrugDelivery, 2010, (16), 18–22.
  5. 5.↵
    1. Petersen C.,
    2. Fries A.,
    3. Zeiss B.
    Trends in Pharmaceutical Primary Packaging for Injectables - Solutions for New Challenges. ONdrugDelivery 2012, (30), 8–12
  6. 6.↵
    1. Santucci-Aribert V.,
    2. Rossito E.
    Lubricant Coating for Medical Container. U.S. Patent 10, 066,182, 2018.
  7. 7.↵
    1. Lawson S.,
    2. Flannigan C.,
    3. Green C.,
    4. Freeburn L.,
    5. Burns A.,
    6. McCann J.,
    7. Bourke T.
    Intubation Drug Pack Containing Pre-Filled Syringes Reduces the Time to Endotracheal Intubation in a Simulated Paediatric Emergency. BMJ Simul. Technol. Enhanc. Learn. 2020, 6 (2), 105–107.
    OpenUrl
  8. 8.↵
    1. Polin J. B.
    The Ins and Outs of Prefilled Syringes. Pharm. Med. Packaging News 2003, 11 40–44.
    OpenUrl
  9. 9.↵
    1. Makwana S.,
    2. Basu B.,
    3. Dharamsi A.,
    4. Makasana Y.
    Prefilled Syringes: An Innovation in Parenteral Packaging. Int. J. Pharm. Invest. 2011, 1 (4).
  10. 10.↵
    1. Loosli V.,
    2. Germershaus O.,
    3. Steinberg H.,
    4. Dreher S.,
    5. Grauschopf U.,
    6. Funke S.
    Methods to Determine the Silicone Oil Layer Thickness in Sprayed-on Siliconized Syringes. PDA J. Pharm. Sci. Technol. 2018, 72 (3), 278–297.
    OpenUrlAbstract/FREE Full Text
  11. 11.↵
    1. Yoshino K.,
    2. Nakamura K.,
    3. Yamashita A.,
    4. Abe Y.,
    5. Iwasaki K.,
    6. Kanazawa Y.,
    7. Funatsu K.,
    8. Yoshimoto T.,
    9. Suzuki S.
    Functional Evaluation and Characterization of a Newly Developed Silicone Oil-Free Prefillable Syringe System. J. Pharm. Sci. 2014, 103 (5), 1520–1528.
    OpenUrlPubMed
  12. 12.↵
    1. Gerhardt A.,
    2. Nguyen B. H.,
    3. Lewus R.,
    4. Carpenter J. F.,
    5. Randolph T. W.
    Effect of the Siliconization Method on Particle Generation in a Monoclonal Antibody Formulation in Pre-Filled Syringes. J. Pharm. Sci. 2015, 104 (5), 1601–609.
    OpenUrl
  13. 13.↵
    1. Funke S.,
    2. Matilainen J.,
    3. Nalenz H.,
    4. Bechtold-Peters K.,
    5. Mahler H.-C.,
    6. Vetter F.,
    7. Müller C.,
    8. Bracher F.,
    9. Friess W.
    Optimization of the Bake-on Siliconization of Cartridges. Part II: Investigations into Burn-in Time and Temperature. Eur. J. Pharm. Biopharm. 2016, 105, 209–222.
    OpenUrl
  14. 14.↵
    1. Sacha G.,
    2. Rogers J. A.,
    3. Miller R. L.
    Pre-Filled Syringes: A Review of the History, Manufacturing and Challenges. Pharm. Dev. Technol. 2015, 20 (1), 1–11.
    OpenUrl
  15. 15.↵
    1. Nashed-Samuel Y.,
    2. Liu D.,
    3. Fujimori K.,
    4. Perez L.,
    5. Lee H.
    Extractable and leachable implications on biological products in prefilled syringes. Am. Pharm. Rev. 2011.
  16. 16.↵
    1. Funke S.,
    2. Matilainen J.,
    3. Nalenz H.,
    4. Bechtold-Peters K.,
    5. Mahler H. C.,
    6. Friess W.
    Analysis of Thin Baked-on Silicone Layers by FTIR and 3D-Laser Scanning Microscopy. Eur. J. Pharm. Biopharm. 2015, 96, 304–313.
    OpenUrl
  17. 17.↵
    1. Thornton J. D.,
    2. Jonsen D. E.,
    3. Sakhrani V.
    Next-Generation Lubrication Solutions for Pharmaceutical Packaging. ONdrugDelivery 2015, (61), 10–16.
  18. 18.↵
    1. Jezek J.,
    2. Darton N. J.,
    3. Derham B. K.,
    4. Royle N.,
    5. Simpson I.
    Biopharmaceutical Formulations for Pre-Filled Delivery Devices. Expert Opin. Drug Delivery 2013, 10 (6), 811–828.
    OpenUrl
  19. 19.↵
    1. Sluzky V.,
    2. Tamada J. A.,
    3. Klibanov A. M.,
    4. Langer R.
    Kinetics of Insulin Aggregation in Aqueous Solutions upon Agitation in the Presence of Hydrophobic Surfaces. Proc. Natl. Acad. Sci. U.S.A. 1991, 88 (21), 9377–9381.
    OpenUrlAbstract/FREE Full Text
  20. 20.↵
    1. Jones L. S.,
    2. Kaufmann A.,
    3. Middaugh C. R.
    Silicone Oil Induced Aggregation of Proteins. J. Pharm. Sci. 2005, 94 (4), 918–927.
    OpenUrlCrossRefPubMed
  21. 21.↵
    1. Chan E.,
    2. Hubbard A.,
    3. Sane S.,
    4. Maa Y.-F.
    Syringe Siliconization Process Investigation and Optimization. PDA J. Pharm. Sci. Technol. 2012, 66 (2), 136–150.
    OpenUrlAbstract/FREE Full Text
  22. 22.↵
    Parenteral Drug Association Inc. Technical Report No. 73: Prefilled Syringe User Requirements for Biotechnology Applications; PDA: Bethesda, MD, 2015.
  23. 23.↵
    1. Reuter B.,
    2. Petersen C.
    Syringe Siliconisation: Trends, Methods, Analysis Procedures. ONdrugDelivery 2013, (43):16–19.
  24. 24.↵
    1. Funke S.,
    2. Matilainen J.,
    3. Nalenz H.,
    4. Bechtold-Peters K.,
    5. Mahler H. C.,
    6. Friess W.
    Silicone Migration from Baked-on Silicone Layers. Particle Characterization in Placebo and Protein Solutions. J. Pharm. Sci. 2016, 105 (12), 3520–3531.
    OpenUrl
  25. 25.↵
    1. Funke S.
    Cartridge Filling with Biopharmaceuticals with Focus on the Optimization of the Siliconization Process, Doctoral dissertation, LMU, 2016.
  26. 26.↵
    1. Bee J. S.,
    2. Frey V. V.,
    3. Javed U.,
    4. Chung J.,
    5. Corcoran M. L.,
    6. Roussel P. S.,
    7. Krause S. O.,
    8. Cash P. W.,
    9. Bishop S. M.,
    10. Dimitrova M. N.
    Characterization of the Initial Level and Migration of Silicone Oil Lubricant in Empty Prefilled Syringes for Biologics Using Infrared Spectroscopy. PDA J. Pharm. Sci. Technol. 2014, 68 (5), 494–503.
    OpenUrlAbstract/FREE Full Text
  27. 27.↵
    European Committee for Standardization. EN ISO 11040-4:2015 Prefilled syringes—Part 4: Glass Barrels for Injectables and Sterilized Subassembled Syringes Ready for Filling. 2015.
  28. 28.↵
    1. Wen Z. Q.,
    2. Vance A.,
    3. Vega F.,
    4. Cao X.,
    5. Eu B.,
    6. Schulthesis R.
    Distribution of Silicone Oil in Prefilled Glass Syringes Probed with Optical and Spectroscopic Methods. PDA J. Pharm. Sci. Technol. 2009, 63 (2), 149–158.
    OpenUrlAbstract/FREE Full Text
  29. 29.↵
    1. Depaz R. A.,
    2. Chevolleau T.,
    3. Jouffray S.,
    4. Narwal R.,
    5. Dimitrova M. N.
    Cross-Linked Silicone Coating: A Novel Prefilled Syringe Technology That Reduces Subvisible Particles and Maintains Compatibility with Biologics. J. Pharm. Sci. 2014, 103 (5), 1384–1393.
    OpenUrlPubMed
  30. 30.↵
    1. Felsovalyi F.,
    2. Janvier S.,
    3. Jouffray S.,
    4. Soukiassian H.,
    5. Mangiagalli P.
    Silicone-Oil-Based Subvisible Particles: Their Detection, Interactions, and Regulation in Prefilled Container Closure Systems for Biopharmaceuticals. J. Pharm. Sci. 2012, 101 (12), 4569–4583.
    OpenUrlPubMed
  31. 31.↵
    1. Clifton P. A.
    Strained Silicon with Elastic Edge Relaxation. U.S. Patent 7,338,834, March 4 2008.
  32. 32.↵
    1. Khandke L.,
    2. Malone R.,
    3. Yang X.,
    4. H. Han H.,
    5. Look J. L.,
    6. Jin Z.,
    7. Seid R. C.,
    8. Chen J. R. Y.
    Novel Formulations Which Stabilize and Inhibit Precipitation of Immunogenic Compositions, U.S Patent Appl. Pub. No. US 2011/0172393A1, 2011.
  33. 33.↵
    1. Rößler R.
    Arzneibuch Kommentar 3.1.8, Silikonöl zur Verwendung als Gleitmittel. Wissenschaftliche Buchgesellschaft Stuttgart, 2021.
  34. 34.↵
    1. van Pinxteren M.,
    2. Paschke A.,
    3. Popp P.
    Silicone Rod and Silicone Tube Sorptive Extraction. J. Chromatogr. A 2010, 1217 (16), 2589–2598.
    OpenUrlPubMed
  35. 35.↵
    1. Buddrick O.,
    2. Jones O. A. H.,
    3. Morrison P. D.,
    4. Small D. M.
    Heptane as a Less Toxic Option than Hexane for the Separation of Vitamin e from Food Products Using Normal Phase HPLC. RSC Adv. 2013, 3 (46), 24063.
    OpenUrl
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PDA Journal of Pharmaceutical Science and Technology: 75 (6)
PDA Journal of Pharmaceutical Science and Technology
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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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