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Research ArticleTechnology/Application

Comparative Delamination Study to Demonstrate the Impact of Container Quality and Nature of Buffer System

Uwe Rothhaar, Michaela Klause and Bernhard Hladik
PDA Journal of Pharmaceutical Science and Technology November 2016, 70 (6) 560-567; DOI: https://doi.org/10.5731/pdajpst.2016.006577
Uwe Rothhaar
1SCHOTT pharma services and
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Michaela Klause
1SCHOTT pharma services and
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Bernhard Hladik
2SCHOTT Pharmaceutical Packaging, SCHOTT AG, Hattenbergstrasse 10, 55122 Mainz, Germany
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  • For correspondence: bernhard.hladik@schott.com
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Reference

  1. 1.↵
    USP <1660> Evaluation of the Inner Surface Durability of Glass Containers, USP 38-NF 33, effective Dec. 1, 2015.
  2. 2.↵
    1. Iacocca R. G.,
    2. Toltl N.,
    3. Allgeier M.,
    4. Bustard B.,
    5. Dong X.,
    6. Hofer J.,
    7. Peoples S.,
    8. Shelbourn T.
    Factors Affecting the Chemical Durability of Glass Used in the Pharmaceutical Industry. AAPS PharmSciTech 2010, 11 (3), 1340–1349.
    OpenUrlPubMed
  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. Guardagnino E.,
    2. Zuccato D.
    Delamination Propensity of Pharmaceutical Glass Containers by Accelerated Testing with Different Extraction Media. PDA J. Pharm. Sci. Technol. 2012, 66 (1), 116–125.
    OpenUrlAbstract/FREE Full Text
  5. 5.↵
    1. Haines D.,
    2. Scheumann V.,
    3. Rothhaar U.
    Glass Flakes, Pre-Testing Stops a Big Problem before It Even Starts. Contract Pharma, 2013, June, 2–7.
  6. 6.↵
    1. Ennis R. D.,
    2. Pritchard R.,
    3. Nakamura C.,
    4. Coulon M.,
    5. Yang T.,
    6. Visor G. C.,
    7. Lee W. A.
    Glass Vials for Small Volume Parenterals: Influence of Drug and Manufacturing Process on Glass Delamination. Pharm. Dev. Technol. 2001, 6 (3), 393–405.
    OpenUrlPubMed
  7. 7.↵
    1. Rupertus V.,
    2. Hladik B.,
    3. Rothhaar U.,
    4. Scheumann V.
    A Quick Test To Monitor the Delamination Propensity of Glass Containers. PDA J. Pharm. Sci. Technol. 2014, 68 (4), 373–380.
    OpenUrlAbstract/FREE Full Text
  8. 8.↵
    1. Swift R.
    , Vial Delamination and Syringe Breakage in Biopharmaceutical Products, PDA Universe of Pre-Filled Syringes 2011.
  9. 9.↵
    USP <790> Visible Particulates in Injections, USP 38-NF 33, effective Dec. 1, 2015.
  10. 10.↵
    SCHOTT AG brochure Fiolax. www.schott.com/tubing/english/download/schott-tubing_brochure_fiolax_english.pdf, 2015.
  11. 11.↵
    1. Ogawa T.,
    2. Miyajima M.,
    3. Nishimoto N.,
    4. Minami H.,
    5. Terada K.
    Comparisons of Aluminum and Silica Elution from Various Glass Vials. Chem. Pharm. Bull (Tokyo) 2016, 64 (2), 150–160.
    OpenUrl
  12. 12.↵
    1. Bacon F. R,
    2. Raggon F. C.
    Promotion of attack on glass and silica by citrate and other anions in neutral solution. J. Am. Cer. Soc. 1959, 42 (4), 199–205.
    OpenUrl
  13. 13.↵
    1. Ogawa T.,
    2. Miyajima M.,
    3. Wakiyama N.,
    4. Teradab K.
    Effects of Phosphate Buffer in Parenteral Drugs on Particle Formation from Glass Vials. Chem. Pharm. Bull. 2013, 61 (5), 539–545.
    OpenUrlPubMed
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PDA Journal of Pharmaceutical Science and Technology: 70 (6)
PDA Journal of Pharmaceutical Science and Technology
Vol. 70, Issue 6
November/December 2016
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Comparative Delamination Study to Demonstrate the Impact of Container Quality and Nature of Buffer System
Uwe Rothhaar, Michaela Klause, Bernhard Hladik
PDA Journal of Pharmaceutical Science and Technology Nov 2016, 70 (6) 560-567; DOI: 10.5731/pdajpst.2016.006577

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Comparative Delamination Study to Demonstrate the Impact of Container Quality and Nature of Buffer System
Uwe Rothhaar, Michaela Klause, Bernhard Hladik
PDA Journal of Pharmaceutical Science and Technology Nov 2016, 70 (6) 560-567; DOI: 10.5731/pdajpst.2016.006577
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Keywords

  • Glass delamination
  • USP <1660> Delamination Testing
  • Delamination Control

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