Evaluation of Container Closure System Integrity for Frozen Storage Drug Products

References

1. 1.↵
   1. Murphy B. M.,
   2. Swarts S.,
   3. Mueller B. M.,
   4. van der Geer P.,
   5. Manning M. C.,
   6. Fitchmun M. I.

   Protein instability following transport or storage on dry ice. Nature Methods 2013, 10 (4), 278–279.

   OpenUrlPubMed
2. 2.↵
   1. Jiang G.,
   2. Akers M.,
   3. Jain M.,
   4. Guo J.,
   5. Distler A.,
   6. Swift R.,
   7. Wadhwa M. V.,
   8. Jameel F.,
   9. Patro S.,
   10. Freund E.

   Mechanistic studies of glass vial breakage for frozen formulations. I. Vial breakage caused by crystallizable excipient mannitol. PDA J. Pharm. Sci. Technol. 2007, 61 (6), 441–451.

   OpenUrlAbstract/FREE Full Text
3. 3.↵
   1. Roff W. J.,
   2. Scott J. R.,
   3. Pacitti J.

   Handbook of Common Polymers, Fibers, Films, Plastics and Rubber; CRC Press: Cleveland, OH, 1971.
4. 4.↵
   1. Zuleger B.,
   2. Werner U.,
   3. Kort A.,
   4. et al

   . 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
5. 5.↵
   1. Taylor J.

   Recommendations on the control and monitoring of storage and transportation temperatures of medicinal products. The Pharmaceutical Journal 2001, 267 (28), 128–131.

   OpenUrl
6. 6.↵
   EudraLex, The Rules Governing Medicinal Products in the European Union, Volume 4, EU Guidelines to Good Manufacturing Practice, Medicinal Products for Human and Veterinary Use, Annex 1—Manufacture of Sterile Medicinal Products, European Commission.
7. 7.↵
   European Pharmacopoeia, 8^th ed., Section 5.1.1. Methods of Preparation of Sterile Products.
8. 8.↵
   U.S. Pharmacopoeia. USP <1207> Sterile Product Packaging—Integrity Evaluation. United States Pharmacopoeial Convention, Inc.: Rockville, MD, 2011.
9. 9.↵
   Guidance for Industry. Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products. U.S. Department of Health and Human Services Food and Drug Administration, 2008.
10. 10.↵
    1. Duncan D.,
    2. Asselta R.

    Correlating Vial Seal Tightness to Container Closure Integrity at Various Storage Temperatures. PDA Europe Parenteral Packaging Conference, Frankfurt, Germany, 2015.
11. 11.↵
    1. Duncan D.

    Container Closure Integrity of Sterile Vials During Deep Cold Storage. PDA/FDA Container Closure Components and Systems Workshop, Bethesda, United States, 2013.
12. 12.↵
    1. Asselta R.,
    2. Smith E. J.,
    3. Sunderland W. B.,
    4. Trappler E. H.

    Effect of Low Temperatures on Parenteral Vial Seal Integrity. PDA Annual Meeting, Las Vegas, United States, 2007.
13. 13.↵
    1. Mahler H. C.,
    2. Friess W.,
    3. Grauschoph U.,
    4. Kiese S.

    Protein aggregation: pathways, induction factors and analysis. J. Pharm. Sci. 2009, 98 (9), 2909–2934.

    OpenUrlCrossRefPubMed
14. 14.↵
    1. Pikal M. J.,
    2. Dellerman K.,
    3. Roy M. L.

    Formulation and stability of freeze-dried proteins: effects of moisture and oxygen on the stability of freeze-dried formulation of human growth hormone. Dev. Biol. Stand. 1992, 74, 21–38.

    OpenUrlPubMed
15. 15.↵
    1. Lei L.

    Advances in Container Closure Integrity Testing. In Sterile Product Development; Springer: New York, 2013; pp 315–329.
16. 16.↵
    1. Guazzo D. M.

    Selection and Application of Container Closure Integrity and Seal Quality Tests throughout the Parenteral Product Life Cycle. PDA/FDA Container Closure Components and Systems Workshop, Bethesda, United States, 2013.
17. 17.↵
    1. Carroll M. C.,
    2. Denny V. F.,
    3. Guazzo D. M.,
    4. Kaiser M. W.,
    5. Kirsch L. E.,
    6. Ludwig J. D.,
    7. Masover G. K.,
    8. May J. L.,
    9. Moldenhauer J. E.,
    10. Olsen J. I.,
    11. Polson T. M.,
    12. Wright G. E.

    PDA Technical Information Bulletin No. 4. Aspects of container/closure integrity. PDA J. Pharm. Sci. Technol. 1998, 52 (2), 1–48.

    OpenUrlPubMed
18. 18.↵
    Technical Report No. 27. Pharmaceutical Package Integrity PDA J. Pharm. Sci. Technol. 1998, 52.
19. 19.↵
    1. Morrical B. D.,
    2. Goverde M.,
    3. Grausse J.,
    4. Gerwig T.,
    5. Vorgrimler L.,
    6. Morgen R.,
    7. Buettiker J.-P.

    Leak testing in parenteral packaging: establishment of direct correlation between helium leak rate measurements and microbial ingress for two different leak types. PDA J. Pharm. Sci. Technol. 2007, 61 (4), 226–236.

    OpenUrlAbstract/FREE Full Text
20. 20.↵
    1. Cook I. A.,
    2. Ward K. R.

    Headspace moisture mapping and the information that can be gained about freeze-dried materials and processes. PDA J. Pharm. Sci. Technol. 2011, 65 (5), 457–467.

    OpenUrlAbstract/FREE Full Text
21. 21.↵
    1. Lin T. P.,
    2. Hsu C. C.,
    3. Kabakoff B. D.,
    4. Patapoff T. W.

    Application of frequency-modulated spectroscopy in vacuum seal integrity testing of lyophilized biological products. PDA J. Pharm. Sci. Technol. 2004, 58 (2), 106–115.

    OpenUrlAbstract/FREE Full Text
22. 22.↵
    1. Cummings P.,
    2. Jacobs B.

    Testing Closure Integrity at Low Temperatures. West Pharmaceutical. Web: Contract Pharma on 1 April 2014 http://www.contractpharma.com/issues/2014-04-01/view_features/testing-closure-integrity-at-low-temperatures/
23. 23.↵
    1. Srivastava S. P.,
    2. Pandarkar S. P.,
    3. Unni T. G.,
    4. Sinha A. K.,
    5. Mahajan K.,
    6. Suthar R. L.

    Leak Testing of Cryogenic Components—Problems and Solutions. International Symposium on “Vacuum Science and Technology”, J. Phy. Conference Series 2008, 114, 012059.
24. 24.↵
    1. Nieto A.,
    2. Roehl H.,
    3. Brown H.,
    4. Adler M.,
    5. Mahler H. C.

    Artificial leaks in container closure integrity testing: nonlinear finite element simulation of aperture size originated by a copper wire sandwiched between the stopper and the glass vial. PDA J. Pharm. Sci. Technol. 2016
25. 25.↵
    1. Hindelang F,
    2. Zurbach R.,
    3. Roggo Y.

    Micro computer tomography for medical device and pharmaceutical packaging analysis. J. Pharm. Biomed. Anal. 2015, 108, 38–48.

    OpenUrlPubMed
26. 26.↵
    1. Nema S.,
    2. Ludwig J. D.

    1. Smith E. J.,
    2. Nash R. J.

    Elastomeric Closures for Parenterals. In Pharmaceutical Dosage Forms: Parenteral Medications, 3rd ed.; Nema S., Ludwig J. D., Eds.; Informa Healthcare: London, 2009; pp 324–357.
27. 27.↵
    1. Jaunich M.,
    2. Wolff D.,
    3. Stark W.

    Investigating Low Temperature Properties of Rubber Seals. WM2013 Conference, Phoenix, AZ, 2013.
28. 28.↵
    McGrosky, Dale T. Physical Properties of Rubber. Technical paper. Satori Seal Co., 2014.
29. 29.↵
    European public assessment reports (EPAR) website, July 2015 http://www.ema.europa.eu
30. 30.↵
    Centers for Disease Control and Prevention. Epidemiology and Prevention of Vaccine-Preventable Diseases. In The Pink Book: Course Textbook, 13th ed.; 2015.
31. 31.
    1. Zapfe K.

    Leak Detection. Deutsches Elektronen-Synchrotron DESY, Hamburg, Germany. Technical Note 2007-03.
32. 32.
    1. Mackenzie F. T.,
    2. Mackenzie J. A.

    Our Changing Planet; Prentice-Hall: Upper Saddle River, NJ; 1995, pp 288–307.