Kinetic Modeling of the Release of Ethylene Oxide from Sterilized Plastic Containers and its Interaction with Monoclonal Antibodies

References

1. 1.↵
   1. Ayoub K.,
   2. Harris L.,
   3. Thompson B.

   Determination of Low-Level Residual Ethylene Oxide by Using Solid-Phase Microextraction and Gas Chromatography. J. AOAC Int. 2002, 85 (6), 1205–1209.

   OpenUrlPubMed
2. 2.↵
   1. Sloey C..,
   2. Gleason C.,
   3. Phillips J.

   Determining the Delamination Propensity of Pharmaceutical Glass Vials Using a Direct Stress Method. PDA J. Pharm. Sci. Technol. 2013, 67 (1), 35–42.

   OpenUrlAbstract/FREE Full Text
3. 3.↵
   1. Reynolds G.,
   2. Paskiet D.

   Glass Delamination and Breakage. BioProcess Int. 2011, 9 (11).
4. 4.↵
   1. Jiang Y.,
   2. Nashed-Samuel Y.,
   3. Li C.,
   4. Liu W.,
   5. Pollastrini J.,
   6. Mallard D.,
   7. Wen Z. Q.,
   8. Fujimori K.,
   9. Pallitto M.,
   10. Donahue L.,
   11. Torraca G.,
   12. Vance A.,
   13. Mire-Sluis T.,
   14. Freund E.,
   15. Davis J.,
   16. Narhi L.

   Tungsten-Induced Protein Aggregation: Solution Behavior. J. Pharm. Sci. 2009, 98 (12), 4695–4710.

   OpenUrlCrossRefPubMed
5. 5.↵
   1. Carpenter J. F.,
   2. Randolph T. W.,
   3. Jiskoot W.,
   4. Crommelin D. J.,
   5. Middaugh C. R.,
   6. Winter G.,
   7. Fan Y. X.,
   8. Kirshner S.,
   9. Verthelyi D.,
   10. Kozlowski S.,
   11. Clouse K. A.,
   12. Swann P. G.,
   13. Rosenberg A.,
   14. Cherney B.

   Overlooking Subvisible Particles in Therapeutic Protein Products: Gaps That May Compromise Product Quality. J. Pharm. Sci. 2009, 98 (4), 1201–1205.

   OpenUrlCrossRefPubMed
6. 6.↵
   1. Qadry S. S.,
   2. Roshdy T. H.,
   3. Char H.,
   4. Terzo S. D.,
   5. Tarantino R.,
   6. Moschera J.

   Evaluation of CZ-Resin Vials for Rackaging Protein-Based Parenteral Formulations. Int. J. Pharm. 2003, 252 (1), 207–212.

   OpenUrlPubMed
7. 7.↵
   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
8. 8.↵
   1. Ansari I. A.,
   2. Datta A. K.

   An Overview of Sterilization Methods for Packaging Materials Used in Aseptic Packaging Systems. Food and Bioproducts Processing 2003, 81 (1), 57–65.

   OpenUrl
9. 9.↵
   1. Liang Y.,
   2. Lin X.

   Examination of Residual Ethylene Oxide on Disposable Syringes and Infusion Sets. Chinese Journal of Disinfection 1998, 15, 176.

   OpenUrl
10. 10.↵
    1. Fennell T. R.,
    2. MacNeela J. P.,
    3. Morris R. W.,
    4. Watson M.,
    5. Thompson C. L.,
    6. Bell D. A.

    Hemoglobin Adducts from Acrylonitrile and Ethylene Oxide in Cigarette Smokers: Effects of Glutathione S-Transferase T1-Null and M1-Null Genotypes. Cancer Epidemiology, Biomarkers & Prevention 2000, 9 (7), 705–712.

    OpenUrlAbstract/FREE Full Text
11. 11.↵
    1. Windmueller H. G.,
    2. Ackerman C. J.,
    3. Engel R. W.

    Reaction of Ethylene Oxide with Histidine, Methionine, and Cysteine. J. Biol. Chem. 1958, 234 (4), 895–899.

    OpenUrl
12. 12.↵
    1. Starbubk W. C.,
    2. Busch H.

    Hydroxyethylation of Amino Acids in Plasma Albumin with Ethylene Oxide. Biochim. Biophys. Acta 1963, 78 (4), 594–605.

    OpenUrlCrossRefPubMedWeb of Science
13. 13.↵
    1. Bolt H. M.,
    2. Peter H.,
    3. Fost U.

    Analysis of Macromolecular Ethylene Oxide Adducts. Int. Arch. Occup. Environ. Health 1988, 60 (3), 141–144.

    OpenUrlPubMed
14. 14.↵
    1. Grammer L. C.,
    2. Patterson R.

    IgE against Ethylene Oxide-Altered Human Serum Albumin (ETO-HSA) as an Etiologic Agent in Allergic Reactions of Hemodialysis Patients. Artif. Organs 1987, 11 (2), 97–99.

    OpenUrlPubMed
15. 15.↵
    1. Chen L.,
    2. Sloey C.,
    3. Zhang Z.,
    4. Bondarenko P. V.,
    5. Kim H.,
    6. Ren D.,
    7. Kanapuram S.

    Chemical Modifications of Therapeutic Proteins Induced by Residual Ethylene Oxide. J. Pharm. Sci. 2005, 104 (2), 731–739.

    OpenUrl
16. 16.↵
    1. Lucas A. D.,
    2. Merritt K.,
    3. Hitchins V. M.,
    4. Woods T. O.,
    5. McNamee S. G.,
    6. Lyle D. B.,
    7. Brown S. A.

    Residual Ethylene Oxide in Medical Devices and Device Material. J. Biomed. Mater. Res., B Appl. Biomater. 2003, 66 (2), 548–552.

    OpenUrlPubMed
17. 17.↵
    1. DiCicco M. P.,
    2. Lang B.,
    3. Harper T. I.

    Optimization of a Novel Headspace–Solid-Phase Microextraction–Gas Chromatographic Method by Means of a Doehlert Uniform Shell Design for the Analysis of Trace Level Ethylene Oxide Residuals in Sterilized Medical Devices. Biomed. Chrom. 2009, 23 (6), 647–657.

    OpenUrl
18. 18.↵
    1. Conway R. A.,
    2. Waggy G. T.,
    3. Spiegel M. H.,
    4. Berglund R. L.

    Environmental Fate and Effects of Ethylene Oxide. Environ. Sci. Technol. 1983, 17 (2), 107–112.

    OpenUrlPubMed
19. 19.↵
    1. Ross W. C. J.

    The Reactions of Certain Epoxides in Aqueous Solutions. J. Chem. Soc. 1950, 2257–2271.