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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Fine tuning of process parameters for improving biocompatibility of prefillable syringes. ONdrugDelivery, 2010, (16), 18–22.
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1. Santucci-Aribert V.,
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1. Lawson S.,
2. Flannigan C.,
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5. Burns A.,
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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.
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1. Polin J. B.
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1. Loosli V.,
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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.
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1. Yoshino K.,
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4. Abe Y.,
5. Iwasaki K.,
6. Kanazawa Y.,
7. Funatsu K.,
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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.
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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.
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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.
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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.
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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.↵
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.↵
1. Thornton J. D.,
2. Jonsen D. E.,
3. Sakhrani V.
Next-Generation Lubrication Solutions for Pharmaceutical Packaging. ONdrugDelivery 2015, (61), 10–16.
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.
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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.
OpenUrl Abstract/FREE Full Text
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.
OpenUrl CrossRef PubMed
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.
OpenUrl Abstract/FREE Full Text
22.↵
Parenteral Drug Association Inc. Technical Report No. 73: Prefilled Syringe User Requirements for Biotechnology Applications; PDA: Bethesda, MD, 2015.
23.↵
1. Reuter B.,
2. Petersen C.
Syringe Siliconisation: Trends, Methods, Analysis Procedures. ONdrugDelivery 2013, (43):16–19.
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.↵
1. Funke S.
Cartridge Filling with Biopharmaceuticals with Focus on the Optimization of the Siliconization Process, Doctoral dissertation, LMU, 2016.
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.
OpenUrl Abstract/FREE Full Text
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.↵
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.
OpenUrl Abstract/FREE Full Text
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.
OpenUrl PubMed
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.
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1. Clifton P. A.
Strained Silicon with Elastic Edge Relaxation. U.S. Patent 7,338,834, March 4 2008.
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.↵
1. Rößler R.
Arzneibuch Kommentar 3.1.8, Silikonöl zur Verwendung als Gleitmittel. Wissenschaftliche Buchgesellschaft Stuttgart, 2021.
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.
OpenUrl PubMed
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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Keywords

[1] 1.↵
Rios M.,
Harrison B.
Big Shot: Developments in Prefilled Syringes. Pharm. Technol. 2007, 31 (3).

[2] Rios M.,

[3] Harrison B.

[4] 2.↵
Ingle R. G.,
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

[5] Ingle R. G.,

[6] Agarwal A. S.

[7] 3.↵
Sassalos T. M.,
Paulus Y. M.
Prefilled Syringes for Intravitreal Drug Delivery. Clin. Ophthalmol. 2019, 13, 701–706.
OpenUrl

[8] Sassalos T. M.,

[9] Paulus Y. M.

[10] 4.↵
Sardella A.
Fine tuning of process parameters for improving biocompatibility of prefillable syringes. ONdrugDelivery, 2010, (16), 18–22.

[11] Sardella A.

[12] 5.↵
Petersen C.,
Fries A.,
Zeiss B.
Trends in Pharmaceutical Primary Packaging for Injectables - Solutions for New Challenges. ONdrugDelivery 2012, (30), 8–12

[13] Petersen C.,

[14] Fries A.,

[15] Zeiss B.

[16] 6.↵
Santucci-Aribert V.,
Rossito E.
Lubricant Coating for Medical Container. U.S. Patent 10, 066,182, 2018.

[17] Santucci-Aribert V.,

[18] Rossito E.

[19] 7.↵
Lawson S.,
Flannigan C.,
Green C.,
Freeburn L.,
Burns A.,
McCann J.,
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

[20] Lawson S.,

[21] Flannigan C.,

[22] Green C.,

[23] Freeburn L.,

[24] Burns A.,

[25] McCann J.,

[26] Bourke T.

[27] 8.↵
Polin J. B.
The Ins and Outs of Prefilled Syringes. Pharm. Med. Packaging News 2003, 11 40–44.
OpenUrl

[28] Polin J. B.

[29] 9.↵
Makwana S.,
Basu B.,
Dharamsi A.,
Makasana Y.
Prefilled Syringes: An Innovation in Parenteral Packaging. Int. J. Pharm. Invest. 2011, 1 (4).

[30] Makwana S.,

[31] Basu B.,

[32] Dharamsi A.,

[33] Makasana Y.

[34] 10.↵
Loosli V.,
Germershaus O.,
Steinberg H.,
Dreher S.,
Grauschopf U.,
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.
OpenUrl Abstract/FREE Full Text

[35] Loosli V.,

[36] Germershaus O.,

[37] Steinberg H.,

[38] Dreher S.,

[39] Grauschopf U.,

[40] Funke S.

[41] 11.↵
Yoshino K.,
Nakamura K.,
Yamashita A.,
Abe Y.,
Iwasaki K.,
Kanazawa Y.,
Funatsu K.,
Yoshimoto T.,
Suzuki S.
Functional Evaluation and Characterization of a Newly Developed Silicone Oil-Free Prefillable Syringe System. J. Pharm. Sci. 2014, 103 (5), 1520–1528.
OpenUrl PubMed

[42] Yoshino K.,

[43] Nakamura K.,

[44] Yamashita A.,

[45] Abe Y.,

[46] Iwasaki K.,

[47] Kanazawa Y.,

[48] Funatsu K.,

[49] Yoshimoto T.,

[50] Suzuki S.

[51] 12.↵
Gerhardt A.,
Nguyen B. H.,
Lewus R.,
Carpenter J. F.,
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

[52] Gerhardt A.,

[53] Nguyen B. H.,

[54] Lewus R.,

[55] Carpenter J. F.,

[56] Randolph T. W.

[57] 13.↵
Funke S.,
Matilainen J.,
Nalenz H.,
Bechtold-Peters K.,
Mahler H.-C.,
Vetter F.,
Müller C.,
Bracher F.,
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

[58] Funke S.,

[59] Matilainen J.,

[60] Nalenz H.,

[61] Bechtold-Peters K.,

[62] Mahler H.-C.,

[63] Vetter F.,

[64] Müller C.,

[65] Bracher F.,

[66] Friess W.

[67] 14.↵
Sacha G.,
Rogers J. A.,
Miller R. L.
Pre-Filled Syringes: A Review of the History, Manufacturing and Challenges. Pharm. Dev. Technol. 2015, 20 (1), 1–11.
OpenUrl

[68] Sacha G.,

[69] Rogers J. A.,

[70] Miller R. L.

[71] 15.↵
Nashed-Samuel Y.,
Liu D.,
Fujimori K.,
Perez L.,
Lee H.
Extractable and leachable implications on biological products in prefilled syringes. Am. Pharm. Rev. 2011.

[72] Nashed-Samuel Y.,

[73] Liu D.,

[74] Fujimori K.,

[75] Perez L.,

[76] Lee H.

[77] 16.↵
Funke S.,
Matilainen J.,
Nalenz H.,
Bechtold-Peters K.,
Mahler H. C.,
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

[78] Funke S.,

[79] Matilainen J.,

[80] Nalenz H.,

[81] Bechtold-Peters K.,

[82] Mahler H. C.,

[83] Friess W.

[84] 17.↵
Thornton J. D.,
Jonsen D. E.,
Sakhrani V.
Next-Generation Lubrication Solutions for Pharmaceutical Packaging. ONdrugDelivery 2015, (61), 10–16.

[85] Thornton J. D.,

[86] Jonsen D. E.,

[87] Sakhrani V.

[88] 18.↵
Jezek J.,
Darton N. J.,
Derham B. K.,
Royle N.,
Simpson I.
Biopharmaceutical Formulations for Pre-Filled Delivery Devices. Expert Opin. Drug Delivery 2013, 10 (6), 811–828.
OpenUrl

[89] Jezek J.,

[90] Darton N. J.,

[91] Derham B. K.,

[92] Royle N.,

[93] Simpson I.

[94] 19.↵
Sluzky V.,
Tamada J. A.,
Klibanov A. M.,
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.
OpenUrl Abstract/FREE Full Text

[95] Sluzky V.,

[96] Tamada J. A.,

[97] Klibanov A. M.,

[98] Langer R.

[99] 20.↵
Jones L. S.,
Kaufmann A.,
Middaugh C. R.
Silicone Oil Induced Aggregation of Proteins. J. Pharm. Sci. 2005, 94 (4), 918–927.
OpenUrl CrossRef PubMed

[100] Jones L. S.,

[101] Kaufmann A.,

[102] Middaugh C. R.

[103] 21.↵
Chan E.,
Hubbard A.,
Sane S.,
Maa Y.-F.
Syringe Siliconization Process Investigation and Optimization. PDA J. Pharm. Sci. Technol. 2012, 66 (2), 136–150.
OpenUrl Abstract/FREE Full Text

[104] Chan E.,

[105] Hubbard A.,

[106] Sane S.,

[107] Maa Y.-F.

[108] 22.↵
Parenteral Drug Association Inc. Technical Report No. 73: Prefilled Syringe User Requirements for Biotechnology Applications; PDA: Bethesda, MD, 2015.

[109] 23.↵
Reuter B.,
Petersen C.
Syringe Siliconisation: Trends, Methods, Analysis Procedures. ONdrugDelivery 2013, (43):16–19.

[110] Reuter B.,

[111] Petersen C.

[112] 24.↵
Funke S.,
Matilainen J.,
Nalenz H.,
Bechtold-Peters K.,
Mahler H. C.,
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

[113] Funke S.,

[114] Matilainen J.,

[115] Nalenz H.,

[116] Bechtold-Peters K.,

[117] Mahler H. C.,

[118] Friess W.

[119] 25.↵
Funke S.
Cartridge Filling with Biopharmaceuticals with Focus on the Optimization of the Siliconization Process, Doctoral dissertation, LMU, 2016.

[120] Funke S.

[121] 26.↵
Bee J. S.,
Frey V. V.,
Javed U.,
Chung J.,
Corcoran M. L.,
Roussel P. S.,
Krause S. O.,
Cash P. W.,
Bishop S. M.,
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.
OpenUrl Abstract/FREE Full Text

[122] Bee J. S.,

[123] Frey V. V.,

[124] Javed U.,

[125] Chung J.,

[126] Corcoran M. L.,

[127] Roussel P. S.,

[128] Krause S. O.,

[129] Cash P. W.,

[130] Bishop S. M.,

[131] Dimitrova M. N.

[132] 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.

[133] 28.↵
Wen Z. Q.,
Vance A.,
Vega F.,
Cao X.,
Eu B.,
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.
OpenUrl Abstract/FREE Full Text

[134] Wen Z. Q.,

[135] Vance A.,

[136] Vega F.,

[137] Cao X.,

[138] Eu B.,

[139] Schulthesis R.

[140] 29.↵
Depaz R. A.,
Chevolleau T.,
Jouffray S.,
Narwal R.,
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.
OpenUrl PubMed

[141] Depaz R. A.,

[142] Chevolleau T.,

[143] Jouffray S.,

[144] Narwal R.,

[145] Dimitrova M. N.

[146] 30.↵
Felsovalyi F.,
Janvier S.,
Jouffray S.,
Soukiassian H.,
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.
OpenUrl PubMed

[147] Felsovalyi F.,

[148] Janvier S.,

[149] Jouffray S.,

[150] Soukiassian H.,

[151] Mangiagalli P.

[152] 31.↵
Clifton P. A.
Strained Silicon with Elastic Edge Relaxation. U.S. Patent 7,338,834, March 4 2008.

[153] Clifton P. A.

[154] 32.↵
Khandke L.,
Malone R.,
Yang X.,
H. Han H.,
Look J. L.,
Jin Z.,
Seid R. C.,
Chen J. R. Y.
Novel Formulations Which Stabilize and Inhibit Precipitation of Immunogenic Compositions, U.S Patent Appl. Pub. No. US 2011/0172393A1, 2011.

[155] Khandke L.,

[156] Malone R.,

[157] Yang X.,

[158] H. Han H.,

[159] Look J. L.,

[160] Jin Z.,

[161] Seid R. C.,

[162] Chen J. R. Y.

[163] 33.↵
Rößler R.
Arzneibuch Kommentar 3.1.8, Silikonöl zur Verwendung als Gleitmittel. Wissenschaftliche Buchgesellschaft Stuttgart, 2021.

[164] Rößler R.

[165] 34.↵
van Pinxteren M.,
Paschke A.,
Popp P.
Silicone Rod and Silicone Tube Sorptive Extraction. J. Chromatogr. A 2010, 1217 (16), 2589–2598.
OpenUrl PubMed

[166] van Pinxteren M.,

[167] Paschke A.,

[168] Popp P.

[169] 35.↵
Buddrick O.,
Jones O. A. H.,
Morrison P. D.,
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

[170] Buddrick O.,

[171] Jones O. A. H.,

[172] Morrison P. D.,

[173] Small D. M.

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

References

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