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Research ArticleResearch

Evaluation of Extreme Depyrogenation Conditions on the Surface Hydrolytic Resistance of Glass Containers for Pharmaceutical Use

Massimo Guglielmi, Satoshi Arai, Peggy Georges, Amy Meysner, Peter Otton, Serena Panighello, Volker Rupertus, Jingwei Zhang and Daniele Zuccato
PDA Journal of Pharmaceutical Science and Technology March 2025, 79 (2) 170-177; DOI: https://doi.org/10.5731/pdajpst.2024.012972
Massimo Guglielmi
1Dipartimento di Ingegneria Industriale, University of Padova, Via Marzolo 9, 35135 Padova, Italy;
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  • For correspondence: massimo.guglielmi@unipd.it
Satoshi Arai
2Nippon Electric Glass Co., Ltd. Otsu Plant, 7-1, Seiran 2-chome, Otsu, Shiga 520-8639 Japan;
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Peggy Georges
3Corning European Technology Center, 7 Bis Av. de Valvins, 77210 Avon, France;
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Amy Meysner
4Glass Technology Services Ltd, 9 Churchill Way, Chapeltown, Sheffield, South Yorkshire, S35 2PY, United Kingdom;
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Peter Otton
5Nipro Pharma Packaging Americas Corporation, 1200 N. Tenth Street, Millville, NJ 08332;
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Serena Panighello
6Stevanato Group, EMEA TEC Analytics, Via Molinella, 17, 35017 Piombino Dese (PD), Italy;
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Volker Rupertus
7SCHOTT Pharma AG & Co. KGaA, Hattenbergstr. 10, 55122 Mainz, Germany; and
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Jingwei Zhang
8SGD group, Rue Eolis – Pôle d’Activités Bresle Maritime, 80880 Saint Quentin La Motte Croix au Bailly, France
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Daniele Zuccato
7SCHOTT Pharma AG & Co. KGaA, Hattenbergstr. 10, 55122 Mainz, Germany; and
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References

  1. 1.↵
    U.S. Pharmacopeial Convention, General Chapter <1228> Depyrogenation. In USP 40—NF 35, USP: Rockville, MD, 2016.
  2. 2.↵
    Council of Europe, Depyrogenation of Items for Parenteral Preparations, Chapter 5.1.12. In European Pharmacopoeia (Ph. Eur.), Supplement 10.4, Council of Europe: Strasbourg, France, 2021.
  3. 3.↵
    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
  4. 4.↵
    1. Ditter D.,
    2. Mahler H.-C.,
    3. Gohlke L.,
    4. Nieto A.,
    5. Roehl H.,
    6. Huwyler J.,
    7. Wahl M.,
    8. Allmendinger A.
    Impact of Vial Washing and Depyrogenation on Surface Properties and Delamination Risk of Glass Vials. Pharm. Res. 2018, 35 (7), 146.
    OpenUrlPubMed
  5. 5.↵
    1. Cerdan-Diaz J.,
    2. Choju K.,
    3. Flynn C. R.,
    4. Gavioli F.,
    5. Iacocca R.,
    6. Meysner A.,
    7. Pfeifer J.,
    8. Roehl H.,
    9. Rupertus V.,
    10. Scarpa M.,
    11. Sun H.,
    12. Zhang J.,
    13. Zuccato D.,
    14. Guglielmi M.
    PDA J. Pharm. Sci. Technol. 2018, 72 (6), 553–565.
    OpenUrlAbstract/FREE Full Text
  6. 6.↵
    1. Guglielmi M.,
    2. Bessegato N.,
    3. Cerdan-Diaz J.,
    4. Choju K.,
    5. Lisman D.,
    6. Flynn C. R.,
    7. Guadagnino E.,
    8. Meysner A.,
    9. Pfeifer J.,
    10. Roehl H.,
    11. Rupertus V.,
    12. Scarpa M.,
    13. Sun H.,
    14. Zhang J.,
    15. Zuccato D.
    Laboratory Intercomparison for the Evaluation of the Delamination Propensity of Glass Containers for Pharmaceutical Use. Int. J. Appl. Glass Sci. 2021, 12 (1), 135–144.
    OpenUrl
  7. 7.↵
    1. Satapathy S.,
    2. Tavares J.,
    3. Bhateja V.,
    4. Mohanty J.
    1. Vinutha H. P.,
    2. Poornima B.,
    3. Sagar B. M.
    Detection of Outliers Using Interquartile Range Technique from Intrusion Dataset. In Information and Decision Sciences; Satapathy S., Tavares J., Bhateja V., Mohanty J., Eds.; Advances in Intelligent Systems and Computing, Vol 701; Springer: Singapore, 2018.
  8. 8.↵
    1. Rothhaar U.,
    2. Klause M.,
    3. Hladik B.
    Comparative Delamination Study to Demonstrate the Impact of Container Quality and Nature of Buffer System. PDA J. Pharm. Sci. Technol. 2016, 70 (6), 560–567.
    OpenUrlAbstract/FREE Full Text
  9. 9.↵
    1. Banerjee J.,
    2. Bojan V.,
    3. Pantano C. G.,
    4. Kim S. H.
    Effect of Heat Treatment on the Surface Chemical Structure of Glass: Oxygen Speciation from In Situ XPS Analysis. J. Am. Ceram. Soc. 2018, 101 (2), 644–656.
    OpenUrl
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PDA Journal of Pharmaceutical Science and Technology: 79 (2)
PDA Journal of Pharmaceutical Science and Technology
Vol. 79, Issue 2
March/April 2025
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Evaluation of Extreme Depyrogenation Conditions on the Surface Hydrolytic Resistance of Glass Containers for Pharmaceutical Use
Massimo Guglielmi, Satoshi Arai, Peggy Georges, Amy Meysner, Peter Otton, Serena Panighello, Volker Rupertus, Jingwei Zhang, Daniele Zuccato
PDA Journal of Pharmaceutical Science and Technology Mar 2025, 79 (2) 170-177; DOI: 10.5731/pdajpst.2024.012972

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Evaluation of Extreme Depyrogenation Conditions on the Surface Hydrolytic Resistance of Glass Containers for Pharmaceutical Use
Massimo Guglielmi, Satoshi Arai, Peggy Georges, Amy Meysner, Peter Otton, Serena Panighello, Volker Rupertus, Jingwei Zhang, Daniele Zuccato
PDA Journal of Pharmaceutical Science and Technology Mar 2025, 79 (2) 170-177; DOI: 10.5731/pdajpst.2024.012972
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Keywords

  • Glass vials
  • Depyrogenation
  • ICP-OES
  • Round-robin test
  • Type I borosilicate glass
  • Hydrolytic resistance

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