A Multicompany Survey Study for Helium Leak Container Closure Integrity Test

References

1. 1.↵
   1. Brown H.,
   2. Mahler H.-C.,
   3. Mellman J.,
   4. Nieto A.,
   5. Wagner D.,
   6. Schaar M.,
   7. Mathaes R.,
   8. Kossinna J.,
   9. Schmitting F.,
   10. Dreher S.,
   11. Roehl H.,
   12. Hemminger M.,
   13. Wuchner K.

   Container Closure Integrity Testing—Practical Aspects and Approaches in the Pharmaceutical Industry. PDA J. Pharm. Sci. Technol. 2017, 71 (2), 147–162.

   OpenUrlAbstract/FREE Full Text
2. 2.↵
   1. Ewan S.,
   2. Jiang M.,
   3. Stevenson C.,
   4. Henderson O.,
   5. Klohr S.,
   6. Wessel M.,
   7. Mehta P.,
   8. Adler S.,
   9. Lake C.,
   10. Walsh J.,
   11. Polomene T.,
   12. Everaert V.

   White Paper: Container Closure Integrity Control versus Integrity Testing during Routine Manufacturing. PDA J. Pharm. Sci. Technol. 2015, 69 (3), 461–465.

   OpenUrlFREE Full Text
3. 3.↵
   1. Kirsch L. E.,
   2. Nguyen L.,
   3. Moeckly C. S.,
   4. Gerth R.

   Pharmaceutical Container/Closure Integrity II: The Relationship between Microbial Ingress and Helium Leak Rates in Rubber-Stoppered Glass Vials. PDA J. Pharm. Sci. Technol. 1997, 51 (5), 195–202.

   OpenUrlAbstract/FREE Full Text
4. 4.↵
   U.S. Pharmacopeial Convention, General Chapter <1207.1> Package Integrity Testing in the Product Life Cycle—Test Method Selection and Validation. In USP 42 —NF 37, USP: Rockville, MD, 2019.
5. 5.↵
   1. Morrical B. D.,
   2. Goverde M.,
   3. Grausse J.,
   4. Gerwig T.,
   5. Vorgrimler L.,
   6. Morgen R.,
   7. Büttiker 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
6. 6.↵
   1. Peláez S. S.,
   2. Mahler H.-C.,
   3. Herdlitschka C.,
   4. Wertli T.,
   5. Kahl M.,
   6. Koulov A.,
   7. Matter A.,
   8. Singh S. K.,
   9. Widmer M.,
   10. Germershaus O.,
   11. Mathaes R.

   Comparing Physical Container Closure Integrity Test Methods and Artificial Leak Methodologies. PDA J. Pharm. Sci. Technol. 2019, 73 (3), 220–234.

   OpenUrlAbstract/FREE Full Text
7. 7.↵
   1. Peláez S. S.,
   2. Mahler H.-C.,
   3. Matter A.,
   4. Koulov A.,
   5. Singh S. K.,
   6. Germershaus O.,
   7. Mathaes R.

   Container Closure Integrity Testing of Prefilled Syringes. J. Pharm. Sci. 2018, 107 (8), 2091–2097.

   OpenUrlPubMed
8. 8.↵
   1. Kirsch L. E.,
   2. Nguyen L.,
   3. Moeckly C.

   Pharmaceutical Container/Closure Integrity I: Mass Spectrometry-Based Helium Leak Rate Detection for Rubber-Stoppered Glass Vials. PDA J. Pharm. Sci. Technol. 1997, 51 (5), 187–194.

   OpenUrlAbstract/FREE Full Text
9. 9.↵
   1. Wolf H.,
   2. Stauffer T.,
   3. Chen S.-C.,
   4. Lee Y.,
   5. Forster R.,
   6. Ludzinski M.,
   7. Kamat M.,
   8. Godorov P.,
   9. Guazzo D. M.

   Vacuum Decay Container/Closure Integrity Testing Technology. Part 1. ASTM F2338-09 Precision and Bias Studies. PDA J. Pharm. Sci. Technol. 2009, 63 (5), 472–488.

   OpenUrlAbstract/FREE Full Text
10. 10.↵
    1. Victor K. G.,
    2. Levac L.,
    3. Timmins M.,
    4. Veale J.

    Method Development for Container Closure Integrity Evaluation via Headspace Gas Ingress by Using Frequency Modulation Spectroscopy. PDA J. Pharm. Sci. Technol. 2017, 71 (6), 429–453.

    OpenUrlAbstract/FREE Full Text
11. 11.↵
    1. Keller S.,
    2. Marcy J.,
    3. Blakistone B.,
    4. Hackney C.,
    5. Carter W. H.,
    6. Lacy G.

    Application of Fluid Modeling to Determine Threshold Leak Size for Liquid Foods. J. Food Prot. 2003, 66 (7), 1260–1268.

    OpenUrlPubMed
12. 12.↵
    1. Zeng Q.

    A New Integrated Modeling Approach with Case Studies for Gas Transmission of Container Closure Headspace. PDA J. Pharm. Sci. Technol. 2021, 75 (5), 394–406.

    OpenUrlAbstract/FREE Full Text
13. 13.↵
    1. Mathaes R.,
    2. Mahler H.-C.,
    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
14. 14.↵
    1. Burrell L. S.,
    2. Carver M. W.,
    3. DeMuth G. E.,
    4. Lambert W. J.

    Development of a Dye Ingress Method to Assess Container-Closure Integrity: correlation to Microbial Ingress. PDA J. Pharm. Sci. Technol. 2000, 54 (6), 449–455.

    OpenUrlAbstract/FREE Full Text
15. 15.↵
    1. Keller S.,
    2. Marcy J.,
    3. Blakistone B.,
    4. Hackney C.,
    5. Carter W. H.,
    6. Lacy G.

    Effect of Microorganism Characteristics on Leak Size Critical to Predicting Package Sterility. J. Food Prot. 2003, 66 (9), 1716–1719.

    OpenUrlPubMed
16. 16.↵
    1. Keller S.

    Determination of the Leak Size Critical to Package Sterility Maintenance. Ph.D. Dissertation, Virginia Polytechnic Institute and State University: Blacksburg, VA, 1998.
17. 17.↵
    1. Gibney M. J.

    Predicting Package Defects: Quantification of Critical Leak Size. M.S. Thesis, Virginia Polytechnic Institute and State University: Blacksburg, VA, 2000.
18. 18.↵
    1. Ravishankar S.,
    2. Maks N. D.,
    3. Teo A. Y.-L.,
    4. Strassheim H. E.,
    5. Pascall M. A.

    Minimum Leak Size Determination, under Laboratory and Commercial Conditions, for Bacterial Entry into Polymeric Trays Used for Shelf-Stable Food Packaging. J. Food Prot. 2005, 68 (11), 2376–2382.

    OpenUrlPubMed
19. 19.↵
    1. Meltzer T. H.,
    2. Jornitz M. W.

    The Sterilizing Filter and Its Pore Size Rating. Am. Pharm. Rev. 2003, 6 (3), 44–52.

    OpenUrl