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Review ArticleReview

Holistic Considerations in Optimizing a Sterile Product Package to Ensure Container Closure Integrity

Fran L. Degrazio
PDA Journal of Pharmaceutical Science and Technology January 2018, 72 (1) 15-34; DOI: https://doi.org/10.5731/pdajpst.2017.007658
Fran L. Degrazio
West Pharmaceutical Services, Inc., 530 Herman O. West Drive, Exton, PA 19341
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  • For correspondence: fran.degrazio@westpharma.com
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Reference

  1. 1.↵
    United States Pharmacopeial Convention. <1207> Packaging Integrity Evaluation—Sterile Products.
  2. 2.↵
    ASTM D2240 Standard Test Method for Rubber Property—Durometer Hardness.
  3. 3.↵
    West Pharmaceutical Services Materials Development, Review of Historic Formulations, 2016.
  4. 4.↵
    1. Ward I. M.,
    2. Sweeney J.
    An Introduction to the Mechanical Properties of Solid Polymers, 2nd ed.; John Wiley & Sons: Hoboken, NJ, 2004.
  5. 5.↵
    1. Hiemenz P. C.,
    2. Lodge T. P.
    Polymer Chemistry, 2nd ed.; CRC Press: Boca Raton, FL, 2007.
  6. 6.↵
    1. Zeng Q,
    2. Zhao C.
    Critical Consideration in Time-Dependent Evaluation and Modeling for Rubber Stopper Seal Performance. Presented at the PDA Europe Parenteral Packaging Meeting, Barcelona, Spain, 2017.
  7. 7.↵
    United Seal & Rubber Co., Inc. Designing and Producing a High Performance Gasket or Seal. e-book, 2013.
  8. 8.↵
    1. Chose T.
    Live Science, June 4, 2013, Live Science Publication, Tia Chose, Senior Writer.
  9. 9.↵
    1. Dorison A.,
    2. Ludema K. C.
    Chapter 9. Lubricated Friction. In Mechanics and Chemistry In Lubrication, Dorison A., Ludema K. C., Eds.; Elsevier Science Publishers B. V.: Amsterdam, The Netherlands, 1985; Tribology Series Vol. 9, pp 178–197.
  10. 10.↵
    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.
    OpenUrlCrossRefPubMed
  11. 11.↵
    1. Thirumangalathu R.,
    2. Krishnan S.,
    3. Ricci M. S.,
    4. Brems D. N.,
    5. Randolph T. W.,
    6. Carpenter J. F.
    Silicone Oil- and Agitation-Induced Aggregation of a Monoclonal Antibody in Aqueous Solution. J. Pharm. Sci. 2009, 98 (9), 3167–3181.
    OpenUrlCrossRefPubMedWeb of Science
  12. 12.↵
    1. Rey L.,
    2. May J.
    1. DeGrazio F.
    Chapter 9. Closure and Container Considerations in Lyophilization. In Freeze-Drying Lyophilization of Pharmaceutical and Biological Products, 2nd ed.; Rey L., May J., Eds.; Informa Healthcare: New York, 2010; Vol. 137.
  13. 13.↵
    1. Vincent J.
    Chapter 1. Structural Biomaterials. In Basic Elasticity and Viscoelasticity, 3rd ed.; Princeton University Press: Princeton, NJ, 2012.
  14. 14.↵
    1. Morton D. K.,
    2. Lordi N. G.
    Quantitative and Mechanistic Measurements of Container/Closure Integrity: Viscoelastic Measurements of Elastomeric Closures. PDA J. Pharm. Sci. Technol. 1988, 42 (4), 57–61.
    OpenUrlAbstract/FREE Full Text
  15. 15.↵
    1. Davidson K.,
    2. Mangus J.
    Selecting and Verifying Integral Packaging Systems for Injectable Drug Products. Poster presented at the PDA Annual Meeting, Las Vegas, NV, 2015.
  16. 16.↵
    PDA Technical Report No. 76. Identification and Classification of Visible Nonconformities in Elastomeric Components and Aluminum Seals for Parenteral Packaging; PDA: Bethesda, MD, 2016.
  17. 17.↵
    1. Lam P.,
    2. Stern A.
    Visualization Techniques for Assessing Design Factors That Affect Interaction between Pharmaceutical Vials and Stoppers. PDA J. Pharm. Sci. Technol. 2010, 64 (2), 182–187.
    OpenUrlAbstract/FREE Full Text
  18. 18.↵
    1. Lysfjord J.
    1. Bogle F. W.,
    2. Asselta R. P.,
    3. Pepper L.
    Chapter 13. Crimp Sealing Parenteral Vials. In Practical Aseptic Processing: Fill Finish, Lysfjord J., Ed.; PDA and Davis Healthcare International Publishing: Bethesda, MD and River Grove, IL, respectively, 2009; Vol. 1, pp 261–273.
    OpenUrl
  19. 19.↵
    1. Mathaes R.,
    2. Mahler H. C.,
    3. Buettiker J. P.,
    4. Roehl H.,
    5. Lam P.,
    6. Brown H.,
    7. Luemkemann J.,
    8. Adler M.,
    9. Huwyler J.,
    10. Streubel A.,
    11. Mohl S.
    The Pharmaceutical Vial Capping Process: Container Closure Systems, Capping Equipment, Regulatory Framework, and Seal Quality Tests. Eur. J. Pharm. Biopharm. 2016, 99, 54–64.
    OpenUrlPubMed
  20. 20.↵
    1. Mathaes R.,
    2. Mahler H.,
    3. Roggo Y.,
    4. Ovadia R.,
    5. Lam P.,
    6. Stauch O.,
    7. Vogt M.,
    8. Roehl H.,
    9. Huwyler J.,
    10. Mohl S.,
    11. Streubel A.
    Impact of Vial Capping on Residual Seal Force and Container Closure Integrity. PDA J. Pharm. Sci. Technol. 2016, 70 (1), 12–29.
    OpenUrlAbstract/FREE Full Text
  21. 21.↵
    1. Asselta R.
    Parenteral Vial Sealing and Integrity Webinar. Genesis Packaging Technologies: Exton, PA; January 2017.
  22. 22.↵
    United States Pharmacopeia. <1207.1> Package Integrity Testing in the Product Life Cycle—Test Method Selection and Validation. United States Pharmacopeial Convention: Rockville, MD, 2016.
  23. 23.↵
    United States Pharmacopeia. <1207> Section 5. Product-Package Quality Requirements and the Maximum Allowable Leakage Limit. United States Pharmacopeial Convention: Rockville, MD, 2016.
  24. 24.↵
    1. Paskiet D.,
    2. Asselta R.
    Qualifying Integral Container Closure Systems. Presented at the PDA Annual Meeting, San Antonio, TX, 2014.
  25. 25.↵
    1. Morton D. K.,
    2. Lordi N. G.
    Residual Seal Force Measurements of Parenteral Vials. I. Methodology. PDA J. Pharm. Sci. Technol. 1988, 42 (1), 23–29.
    OpenUrlAbstract/FREE Full Text
  26. 26.↵
    1. Mathaes R.,
    2. Mahler H.,
    3. Roggo Y.,
    4. Huwyler J.,
    5. Eder J.,
    6. Fritsch K.,
    7. Posset T.,
    8. Mohl S.,
    9. Streubel A.
    Influence of Different Container Closure Systems and Capping Process Parameters on Product Quality and Container Closure Integrity in GMP Drug Product Manufacturing. PDA J. Pharm. Sci. Technol. 2016, 70 (2), 109–119.
    OpenUrlAbstract/FREE Full Text
  27. 27.↵
    FDA Guidance for Industry. Drug Stability Guidelines. Section C3. Temperature. December 9, 2008.
  28. 28.↵
    Fisher BioServices. Cold Chain Qualification: 5 Questions You Must Ask When Shipping Biologics, e-book, August 14, 2013.
  29. 29.
    1. Zuleger B.,
    2. Werner U.,
    3. Kort A.,
    4. Glowienka R.,
    5. Wehnes E.,
    6. Duncan D.
    Container/Closure Integrity Testing and the Identification of a Suitable Vial/Stopper Combination for Low-Temperature Storage at −80° C. PDA J. Pharm. Sci. Technol. 2012, 66 (5), 453–465.
    OpenUrlAbstract/FREE Full Text
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PDA Journal of Pharmaceutical Science and Technology: 72 (1)
PDA Journal of Pharmaceutical Science and Technology
Vol. 72, Issue 1
January/February 2018
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Holistic Considerations in Optimizing a Sterile Product Package to Ensure Container Closure Integrity
Fran L. Degrazio
PDA Journal of Pharmaceutical Science and Technology Jan 2018, 72 (1) 15-34; DOI: 10.5731/pdajpst.2017.007658

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Holistic Considerations in Optimizing a Sterile Product Package to Ensure Container Closure Integrity
Fran L. Degrazio
PDA Journal of Pharmaceutical Science and Technology Jan 2018, 72 (1) 15-34; DOI: 10.5731/pdajpst.2017.007658
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Cited By...

  • A Vial Container Closure System Performance Optimization Case Study Using Comprehensive Dimensional Stack-Up Analyses
  • Quantifying the Vial-Capping Process: Reexamination Using Micro-Computed Tomography
  • Long-Term Study of Container Closure Integrity of Rubber-Glass Vial Systems by Multiple Methods
  • Time Temperature Superposition Evaluation and Modeling for Container Closure System's Seal Performance at Low Temperatures
  • Balancing Container Closure Integrity and Aesthetics for a Robust Aseptic or Sterile Vial Packaging System
  • Time-Dependent Testing Evaluation and Modeling for Rubber Stopper Seal Performance
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More in this TOC Section

  • Focus on biorburden culture media and Medical Devices
  • Using Analytical Platform Technologies to Support Accelerated Product Development—Concept Review and Case Study
  • Evaluating Nitrosamines from Elastomers in Pharmaceutical Primary Packaging
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Keywords

  • CCI
  • Container closure integrity
  • Integral System
  • Leak rate
  • Vial system
  • Leakage sealing optimization
  • Seal Integrity
  • Residual Seal Force

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