Vapor-Phase Hydrogen Peroxide Uptake by Silicone Tubing and Primary Packaging Components during Protein Drug Product Aseptic Filling: Impact of Pretreatment and Sterilization Process

Devon Roshan Eisner; Aaron Hubbard; Kirk Eppler; Vassia Tegoulia; Yuh-Fun Maa

doi:10.5731/pdajpst.2019.009928

References

1.↵
1. Müller H. J.,
2. Sommermeyer K.,
3. Cech F.
Permeation of Gaseous Hydrogen Peroxide and Peracetic Acid into IV Bags during Their Surface Sterilization. Hosp. Pharm. 2003, 10, 81–86.
OpenUrl
2.↵
1. Meszaros J. E.,
2. Antloga K.,
3. Justi C.,
4. Plesnicher C.,
5. McDonnell G.
Area Fumigation with Hydrogen Peroxide Vapor. Appl. Biosaf. 2005, 10 (2), 91–100.
OpenUrl CrossRef
3.↵
1. Unger-Bimczok B.,
2. Kottke V.,
3. Hertel C.,
4. Rauschnabel J.
The Influence of Humidity, Hydrogen Peroxide Concentration, and Condensation on the Inactivation of Geobacillus stearothermophilus Spores with Hydrogen Peroxide Vapor. J. Pharm. Innov. 2008, 3 (2), 123–133.
OpenUrl
4.↵
1. Krishna A. K.,
2. Lodhi S. A.,
3. Harris M. R.
Isolation Technology for Research and Development Applications: From Concept to Production. Pharm. Dev. Technol. 2000, 5 (4), 507–520.
OpenUrl CrossRef PubMed
5.↵
1. Thirumangalathu R.,
2. Krishnan S.,
3. Bondarenko P.,
4. Speed-Ricci M.,
5. Randolph T. W.,
6. Carpenter J. F.,
7. Brems D. N.
Oxidation of Methionine Residues in Recombinant Human Interleulin-1 Receptor Antagonist: Implication of Conformational Stability on Protein Oxidation Kinetics. Biochemistry 2007, 46 (21), 6213–6224.
OpenUrl
6.↵
1. Liu J. L.,
2. Lu K. V.,
3. Eris T.,
4. Katta V.,
5. Westcott K. R.,
6. Narhi L. O.,
7. Lu H. S.
In Vitro Methionine Oxidation of Recombinant Human Leptin. Pharm. Res. 1998, 15 (4), 632–640.
OpenUrl CrossRef PubMed Web of Science
7.↵
1. Simat T. J.,
2. Steinhart H.
Oxidation of Free Tryptophan and Tryptophan Residues in Peptides and Proteins. J. Agric. Food Chem. 1998, 46 (2), 490–498.
OpenUrl CrossRef PubMed Web of Science
8.↵
1. Requena J. R.,
2. Dimitrova M. N.,
3. Legname G.,
4. Teijeira S.,
5. Prusiner S. B.,
6. Levine R. L.
Oxidation of Methionine Residues in the Prion Protein by Hydrogen Peroxide. Arch. Biochem. Biophys. 2004, 432 (2), 188–195.
OpenUrl CrossRef PubMed Web of Science
9.↵
1. Mulinacci F.,
2. Poirier E.,
3. Capelle M. A. H.,
4. Gurny R.,
5. Arvinte T.
Influence of Methionine Oxidation on the Aggregation of Recombinant Human Growth Hormone. Eur. J. Pharm. Biopharm. 2013, 85 (1), 42–52.
OpenUrl CrossRef PubMed
10.↵
1. Hubbard A.,
2. Eppler K.
Measuring Hydrogen Peroxide Residuals and Product Exposure on Isolator and RABS Filling Lines. BioPharma Asia 2015, 4 (5), 26–33.
OpenUrl
11.↵
1. Saller V.,
2. Matilainen J.,
3. Rothkopf C.,
4. Serafin D.,
5. Bechtold-Peters K.,
6. Mahler H.-C.,
7. Friess W.
Preservative Loss from Silicone Tubing during Filling Processes. Eur. J. Pharm. Biopharm. 2017, 112, 109–118.
OpenUrl
12.↵
1. Colas A.,
2. Malczewski R.,
3. Ulman K.
Silicone Tubing for Pharmaceutical Processing. PharmaChem 2004, 30–36.
13.↵
1. Wijmans J. G.,
2. Baker R. W.
The Solution-Diffusion Model: A Review. J. Membr. Sci. 1995, 107 (1–2), 1–21.
OpenUrl CrossRef Web of Science
14.↵
1. Hubbard A.,
2. Roedl T.,
3. Hui A.,
4. Knueppel S.,
5. Eppler K.,
6. Lehnert S.,
7. Maa Y.-F.
Vapor Phase Hydrogen Peroxide Sanitization of an Isolator for Aseptic Filling of Monoclonal Antibody Drug Product–Hydrogen Peroxide Uptake and Impact on Protein Quality. PDA J Pharm. Sci. Technol 2018, 72 (4), 348–366.
OpenUrl Abstract/FREE Full Text
15.↵
1. LaVerne L.
Sterilization—Tough on Germs Tough on Plastics, Too. Plastics Design Forum 1994, 19 (6), 16–22.
OpenUrl
16.↵
1. Gautriand E.,
2. Stafford K. T.,
3. Adamchuk J.,
4. Simon M. W.,
5. Ou D. L.
Effect of Sterilization on the Mechanical Properties of Silicone Rubbers. BioProcess Int. 2010, April Supplement. https://bioprocessintl.com/manufacturing/monoclonal-antibodies/effect-of-sterilization-on-the-mechanical-properties-of-silicone-rubbers-239379/ (accessed Aug 30, 2019).
17.↵
1. Rogers W. J.
Sterilisation of Polymer Healthcare Products; Rapra Technology: Shrewsbury, U.K, 2005; pp 24–143.
18.↵
1. Palsule A. S.,
2. Clarson S. J.,
3. Widenhouse C. W.
Gamma Irradiation of Silicones. J. Inorg. Organomet. Polym. Mater. 2008, 18 (2), 207–221.
OpenUrl
19.↵
1. Kiminami H.,
2. Krueger A. B.,
3. Abe Y.,
4. Yoshino K.,
5. Carpenter J. F.
Impact of Sterilization Method on Protein Aggregation and Particle Formation in Polymer-Based Syringes. J. Pharm. Sci. 2017, 106 (4), 1001–1007.
OpenUrl
20.↵
1. Chen L.,
2. Sloey C.,
3. Zhang Z.,
4. Bondarenko P. V.,
5. Kim H.,
6. Sekhar Kanapuram D. R.
Chemical Modifications of Therapeutic Proteins Induced by Residual Ethylene Oxide. .J Pharm. Sci. 2015, 104 (2), 731–739.
OpenUrl CrossRef PubMed
21.↵
1. da Cunha Mendes G. C.,
2. da Silva Brandão T. R.,
3. Miranda Silva C. L.
Ethylene Oxide Potential Toxicity. Expert Rev. Med. Devices 2008, 5 (3), 323–328.
OpenUrl PubMed
22.↵
1. Konda N.,
2. Prashanth P.,
3. Arvind G.,
4. Shah S.
Pharmaceutical Development and Compatibility Studies on Cytarabine Injection. Asian J. Pharm. Clin. Res. 2013, 6(3), 142–145.
OpenUrl
23.↵
American Coatings Association website, Pharmaceutical Vial Coatings Make a Big Difference. https://www.paint.org/article/pharmaceutical-vial-coatings-make-big-difference (accessed Feb 5, 2018).
24.↵
Schott website, SCHOTT TopLyo® Vials. http://www.schott.com/d/pharmaceutical_packaging/7f629b7e-e978-4417-a15e-8621f969d225/1.1/schott-datasheet-schott-toplyo-english-14062017.pdf (accessed Feb 5, 2018).
25.↵
Westpharma website, FluroTec Barrier Film® Stoppers. https://www.westpharma.com/products/vial-containment-solutions/stoppers/flurotec-barrier-film-stoppers (accessed Feb 5, 2018).
26.↵
1. Hui A.,
2. Lam X. M.,
3. Kuehl C.,
4. Grauschopf U.,
5. Wang Y. J.
Kinetic Modeling of Methionine Oxidation in Monoclonal Antibody from Hydrogen Peroxide Spiking Studies. PDA J. Pharm. Sci. Technol. 2015, 69 (4), 511–525.
OpenUrl Abstract/FREE Full Text
27.↵
1. Zhang H.,
2. Cloud A.
The permeability characteristics of silicone rubber. Presented at SAMPE Fall Technical Conference on Global Advances in Materials and Process Engineering, Dallas, Texas, Nov 6–9, 2006.
28.↵
1. Traeger R. K.,
2. Castonguay T. T.
Effect of γ-Radiation on the Dynamic Mechanical Properties of Silicone Rubbers. J. Appl. Polym. Sci. 1966, 10 (4), 535–550.
OpenUrl
29.↵
1. Mazor E.,
2. Zilberman M.
Effect of Gamma-Irradiation Sterilization on the Physical and Mechanical Properties of a Hybrid Wound Dressing. Polym. Adv. Technol. 2017, 28 (1), 41–52.
OpenUrl

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Development and Validation of a Customized Amplex UltraRed Assay for Sensitive Hydrogen Peroxide Detection in Pharmaceutical Water

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Keywords

[1] 1.↵
Müller H. J.,
Sommermeyer K.,
Cech F.
Permeation of Gaseous Hydrogen Peroxide and Peracetic Acid into IV Bags during Their Surface Sterilization. Hosp. Pharm. 2003, 10, 81–86.
OpenUrl

[2] Müller H. J.,

[3] Sommermeyer K.,

[4] Cech F.

[5] 2.↵
Meszaros J. E.,
Antloga K.,
Justi C.,
Plesnicher C.,
McDonnell G.
Area Fumigation with Hydrogen Peroxide Vapor. Appl. Biosaf. 2005, 10 (2), 91–100.
OpenUrl CrossRef

[6] Meszaros J. E.,

[7] Antloga K.,

[8] Justi C.,

[9] Plesnicher C.,

[10] McDonnell G.

[11] 3.↵
Unger-Bimczok B.,
Kottke V.,
Hertel C.,
Rauschnabel J.
The Influence of Humidity, Hydrogen Peroxide Concentration, and Condensation on the Inactivation of Geobacillus stearothermophilus Spores with Hydrogen Peroxide Vapor. J. Pharm. Innov. 2008, 3 (2), 123–133.
OpenUrl

[12] Unger-Bimczok B.,

[13] Kottke V.,

[14] Hertel C.,

[15] Rauschnabel J.

[16] 4.↵
Krishna A. K.,
Lodhi S. A.,
Harris M. R.
Isolation Technology for Research and Development Applications: From Concept to Production. Pharm. Dev. Technol. 2000, 5 (4), 507–520.
OpenUrl CrossRef PubMed

[17] Krishna A. K.,

[18] Lodhi S. A.,

[19] Harris M. R.

[20] 5.↵
Thirumangalathu R.,
Krishnan S.,
Bondarenko P.,
Speed-Ricci M.,
Randolph T. W.,
Carpenter J. F.,
Brems D. N.
Oxidation of Methionine Residues in Recombinant Human Interleulin-1 Receptor Antagonist: Implication of Conformational Stability on Protein Oxidation Kinetics. Biochemistry 2007, 46 (21), 6213–6224.
OpenUrl

[21] Thirumangalathu R.,

[22] Krishnan S.,

[23] Bondarenko P.,

[24] Speed-Ricci M.,

[25] Randolph T. W.,

[26] Carpenter J. F.,

[27] Brems D. N.

[28] 6.↵
Liu J. L.,
Lu K. V.,
Eris T.,
Katta V.,
Westcott K. R.,
Narhi L. O.,
Lu H. S.
In Vitro Methionine Oxidation of Recombinant Human Leptin. Pharm. Res. 1998, 15 (4), 632–640.
OpenUrl CrossRef PubMed Web of Science

[29] Liu J. L.,

[30] Lu K. V.,

[31] Eris T.,

[32] Katta V.,

[33] Westcott K. R.,

[34] Narhi L. O.,

[35] Lu H. S.

[36] 7.↵
Simat T. J.,
Steinhart H.
Oxidation of Free Tryptophan and Tryptophan Residues in Peptides and Proteins. J. Agric. Food Chem. 1998, 46 (2), 490–498.
OpenUrl CrossRef PubMed Web of Science

[37] Simat T. J.,

[38] Steinhart H.

[39] 8.↵
Requena J. R.,
Dimitrova M. N.,
Legname G.,
Teijeira S.,
Prusiner S. B.,
Levine R. L.
Oxidation of Methionine Residues in the Prion Protein by Hydrogen Peroxide. Arch. Biochem. Biophys. 2004, 432 (2), 188–195.
OpenUrl CrossRef PubMed Web of Science

[40] Requena J. R.,

[41] Dimitrova M. N.,

[42] Legname G.,

[43] Teijeira S.,

[44] Prusiner S. B.,

[45] Levine R. L.

[46] 9.↵
Mulinacci F.,
Poirier E.,
Capelle M. A. H.,
Gurny R.,
Arvinte T.
Influence of Methionine Oxidation on the Aggregation of Recombinant Human Growth Hormone. Eur. J. Pharm. Biopharm. 2013, 85 (1), 42–52.
OpenUrl CrossRef PubMed

[47] Mulinacci F.,

[48] Poirier E.,

[49] Capelle M. A. H.,

[50] Gurny R.,

[51] Arvinte T.

[52] 10.↵
Hubbard A.,
Eppler K.
Measuring Hydrogen Peroxide Residuals and Product Exposure on Isolator and RABS Filling Lines. BioPharma Asia 2015, 4 (5), 26–33.
OpenUrl

[53] Hubbard A.,

[54] Eppler K.

[55] 11.↵
Saller V.,
Matilainen J.,
Rothkopf C.,
Serafin D.,
Bechtold-Peters K.,
Mahler H.-C.,
Friess W.
Preservative Loss from Silicone Tubing during Filling Processes. Eur. J. Pharm. Biopharm. 2017, 112, 109–118.
OpenUrl

[56] Saller V.,

[57] Matilainen J.,

[58] Rothkopf C.,

[59] Serafin D.,

[60] Bechtold-Peters K.,

[61] Mahler H.-C.,

[62] Friess W.

[63] 12.↵
Colas A.,
Malczewski R.,
Ulman K.
Silicone Tubing for Pharmaceutical Processing. PharmaChem 2004, 30–36.

[64] Colas A.,

[65] Malczewski R.,

[66] Ulman K.

[67] 13.↵
Wijmans J. G.,
Baker R. W.
The Solution-Diffusion Model: A Review. J. Membr. Sci. 1995, 107 (1–2), 1–21.
OpenUrl CrossRef Web of Science

[68] Wijmans J. G.,

[69] Baker R. W.

[70] 14.↵
Hubbard A.,
Roedl T.,
Hui A.,
Knueppel S.,
Eppler K.,
Lehnert S.,
Maa Y.-F.
Vapor Phase Hydrogen Peroxide Sanitization of an Isolator for Aseptic Filling of Monoclonal Antibody Drug Product–Hydrogen Peroxide Uptake and Impact on Protein Quality. PDA J Pharm. Sci. Technol 2018, 72 (4), 348–366.
OpenUrl Abstract/FREE Full Text

[71] Hubbard A.,

[72] Roedl T.,

[73] Hui A.,

[74] Knueppel S.,

[75] Eppler K.,

[76] Lehnert S.,

[77] Maa Y.-F.

[78] 15.↵
LaVerne L.
Sterilization—Tough on Germs Tough on Plastics, Too. Plastics Design Forum 1994, 19 (6), 16–22.
OpenUrl

[79] LaVerne L.

[80] 16.↵
Gautriand E.,
Stafford K. T.,
Adamchuk J.,
Simon M. W.,
Ou D. L.
Effect of Sterilization on the Mechanical Properties of Silicone Rubbers. BioProcess Int. 2010, April Supplement. https://bioprocessintl.com/manufacturing/monoclonal-antibodies/effect-of-sterilization-on-the-mechanical-properties-of-silicone-rubbers-239379/ (accessed Aug 30, 2019).

[81] Gautriand E.,

[82] Stafford K. T.,

[83] Adamchuk J.,

[84] Simon M. W.,

[85] Ou D. L.

[86] 17.↵
Rogers W. J.
Sterilisation of Polymer Healthcare Products; Rapra Technology: Shrewsbury, U.K, 2005; pp 24–143.

[87] Rogers W. J.

[88] 18.↵
Palsule A. S.,
Clarson S. J.,
Widenhouse C. W.
Gamma Irradiation of Silicones. J. Inorg. Organomet. Polym. Mater. 2008, 18 (2), 207–221.
OpenUrl

[89] Palsule A. S.,

[90] Clarson S. J.,

[91] Widenhouse C. W.

[92] 19.↵
Kiminami H.,
Krueger A. B.,
Abe Y.,
Yoshino K.,
Carpenter J. F.
Impact of Sterilization Method on Protein Aggregation and Particle Formation in Polymer-Based Syringes. J. Pharm. Sci. 2017, 106 (4), 1001–1007.
OpenUrl

[93] Kiminami H.,

[94] Krueger A. B.,

[95] Abe Y.,

[96] Yoshino K.,

[97] Carpenter J. F.

[98] 20.↵
Chen L.,
Sloey C.,
Zhang Z.,
Bondarenko P. V.,
Kim H.,
Sekhar Kanapuram D. R.
Chemical Modifications of Therapeutic Proteins Induced by Residual Ethylene Oxide. .J Pharm. Sci. 2015, 104 (2), 731–739.
OpenUrl CrossRef PubMed

[99] Chen L.,

[100] Sloey C.,

[101] Zhang Z.,

[102] Bondarenko P. V.,

[103] Kim H.,

[104] Sekhar Kanapuram D. R.

[105] 21.↵
da Cunha Mendes G. C.,
da Silva Brandão T. R.,
Miranda Silva C. L.
Ethylene Oxide Potential Toxicity. Expert Rev. Med. Devices 2008, 5 (3), 323–328.
OpenUrl PubMed

[106] da Cunha Mendes G. C.,

[107] da Silva Brandão T. R.,

[108] Miranda Silva C. L.

[109] 22.↵
Konda N.,
Prashanth P.,
Arvind G.,
Shah S.
Pharmaceutical Development and Compatibility Studies on Cytarabine Injection. Asian J. Pharm. Clin. Res. 2013, 6(3), 142–145.
OpenUrl

[110] Konda N.,

[111] Prashanth P.,

[112] Arvind G.,

[113] Shah S.

[114] 23.↵
American Coatings Association website, Pharmaceutical Vial Coatings Make a Big Difference. https://www.paint.org/article/pharmaceutical-vial-coatings-make-big-difference (accessed Feb 5, 2018).

[115] 24.↵
Schott website, SCHOTT TopLyo® Vials. http://www.schott.com/d/pharmaceutical_packaging/7f629b7e-e978-4417-a15e-8621f969d225/1.1/schott-datasheet-schott-toplyo-english-14062017.pdf (accessed Feb 5, 2018).

[116] 25.↵
Westpharma website, FluroTec Barrier Film® Stoppers. https://www.westpharma.com/products/vial-containment-solutions/stoppers/flurotec-barrier-film-stoppers (accessed Feb 5, 2018).

[117] 26.↵
Hui A.,
Lam X. M.,
Kuehl C.,
Grauschopf U.,
Wang Y. J.
Kinetic Modeling of Methionine Oxidation in Monoclonal Antibody from Hydrogen Peroxide Spiking Studies. PDA J. Pharm. Sci. Technol. 2015, 69 (4), 511–525.
OpenUrl Abstract/FREE Full Text

[118] Hui A.,

[119] Lam X. M.,

[120] Kuehl C.,

[121] Grauschopf U.,

[122] Wang Y. J.

[123] 27.↵
Zhang H.,
Cloud A.
The permeability characteristics of silicone rubber. Presented at SAMPE Fall Technical Conference on Global Advances in Materials and Process Engineering, Dallas, Texas, Nov 6–9, 2006.

[124] Zhang H.,

[125] Cloud A.

[126] 28.↵
Traeger R. K.,
Castonguay T. T.
Effect of γ-Radiation on the Dynamic Mechanical Properties of Silicone Rubbers. J. Appl. Polym. Sci. 1966, 10 (4), 535–550.
OpenUrl

[127] Traeger R. K.,

[128] Castonguay T. T.

[129] 29.↵
Mazor E.,
Zilberman M.
Effect of Gamma-Irradiation Sterilization on the Physical and Mechanical Properties of a Hybrid Wound Dressing. Polym. Adv. Technol. 2017, 28 (1), 41–52.
OpenUrl

[130] Mazor E.,

[131] Zilberman M.

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Vapor-Phase Hydrogen Peroxide Uptake by Silicone Tubing and Primary Packaging Components during Protein Drug Product Aseptic Filling: Impact of Pretreatment and Sterilization Process

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