Residual Seal Force Testing: A Suitable Method for Seal Quality Determination of (High Potent) Parenterals

References

1. 1.↵
   1. Sacha G. A.,
   2. Saffell-Clemmer W.,
   3. Abram K.,
   4. Akers M. J.

   Practical Fundamentals of Glass, Rubber, and Plastic Sterile Packaging Systems. Pharm. Dev. Technol. 2010, 15 (1), 6–34.

   OpenUrlPubMed
2. 2.↵
   1. Mathaes R.,
   2. Mahler H. C.,
   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 (CCI) in GMP Drug Product Manufacturing. PDA J. Pharm. Sci. Technol. 2016, 70 (2), 109–119.

   OpenUrlAbstract/FREE Full Text
3. 3.↵
   1. Sharkey R. M.,
   2. Goldenberg D. M.

   Targeted Therapy of Cancer: New Prospects for Antibodies and Immunoconjugates. CA Cancer J. Clin. 2006, 56 (4), 226–243.

   OpenUrlCrossRefPubMedWeb of Science
4. 4.↵
   1. Rohrer T.

   Consideration for the Safe and Effective Manufacturing of Antibody Drug Conjugates. Chem. Oggi-Chem. Today, 2012, 30, 76–79.

   OpenUrl
5. 5.↵
   1. Wollowitz S.

   Managing High-Potency Active Pharmaceutical Ingredients-A Drug Sponsor's Guide. Drug Dev. Res. 2010, 71 (7), 420–428.

   OpenUrlCrossRef
6. 6.↵
   1. Luo Q.,
   2. Chung H. H.,
   3. Borths C.,
   4. Janson M.,
   5. Wen J.,
   6. Joubert M. K.,
   7. Wypych J.

   Structural Characterization of a Monoclonal Antibody-Maytansinoid Immunoconjugate. Anal. Chem. 2015, 88 (1), 695–702.

   OpenUrl
7. 7.↵
   1. Buecheler J. W.,
   2. Winzer M.,
   3. Tonillo J.,
   4. Weber C. A.,
   5. Gieseler H.

   Impact of Payload Hydrophobicity on Stability of Antibody-Drug-Conjugates. Mol. Pharm. 2018, 15 (7), 2656–2664.

   OpenUrl
8. 8.↵
   1. Mahler H.,
   2. Friess W.,
   3. Grauschopf U.,
   4. Kiese S.

   Protein Aggregation: Pathways, Induction Factors and Analysis. J. Pharm. Sci. 2009, 98 (9), 2909–2934.

   OpenUrlCrossRefPubMed
9. 9.↵
   1. Singh S. K.,
   2. Luisi D. L.,
   3. Pak R. H.

   Antibody-Drug Conjugates: Design, Formulation and Physicochemical Stability. Pharm. Res. 2015, 32 (11), 3541–3571.

   OpenUrl
10. 10.↵
    1. Daugherty A. L.,
    2. Mrsny R. J.

    Formulation and Delivery Issues for Monoclonal Antibody Therapeutics. Adv. Drug Deliv. Rev. 2006, 58 (5), 686–706.

    OpenUrlCrossRefPubMed
11. 11.↵
    1. Mac¡as A. E.,
    2. Munoz J. M.,
    3. Bruckner D. A.,
    4. Galvín A.,
    5. Rodr¡guez A. B.,
    6. Guerrero F. J.,
    7. Medina H.,
    8. Gallaga J. C.,
    9. Cortes G.

    Parenteral Infusions Bacterial Contamination in a Multi-institutional Survey in Mexico: Considerations for Nosocomial Mortality. American Journal of Infection Control, 1999, 27 (3), 285–290.

    OpenUrlCrossRefPubMedWeb of Science
12. 12.↵
    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
13. 13.↵
    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
14. 14.↵
    1. Kale N. S.,
    2. Kazi A.,
    3. Kale S. S.

    Drug prefilled non-reusable syringes as drug-device. World J. Pharm. Sci. 2015, 3 (10), 2095–2110.

    OpenUrl
15. 15.↵
    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
16. 16.↵
    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
17. 17.↵
    1. Morton D. K.

    Container/Closure Integrity of Parenteral Vials. PDA J. Pharm. Sci. Technol. 1987, 41 (5), 145–158.

    OpenUrlAbstract/FREE Full Text
18. 18.↵
    1. Morton D. K.,
    2. Lordi N. G.

    Residual Seal Force Measurement of Parenteral Vials. II. Elastomer Evaluation. PDA J. Pharm. Sci. Technol. 1988, 42 (2), 57–61.

    OpenUrlAbstract/FREE Full Text
19. 19.↵
    1. Ludwig J. D.,
    2. Nolan P. D.,
    3. Davis C. W.

    Automated Method for Determining Instron Residual Seal Force of Glass Vial/Rubber Closure Systems. PDA J. Pharm. Sci. Technol. 1993, 47 (5), 211–253.

    OpenUrlAbstract/FREE Full Text
20. 20.↵
    1. Ludwig J. D.,
    2. Davis C. W.

    Automated Method for Determining Instron Residual Seal Force of Glass Vial/Rubber Closure Systems Part II. 13 mm vials. PDA J. Pharm. Sci. Technol. 1995, 49 (5), 253–256.

    OpenUrlAbstract/FREE Full Text
21. 21.↵
    1. Mathaes R.,
    2. Mahler H. C.,
    3. Vorgrimler L.,
    4. Steinberg H.,
    5. Dreher S.,
    6. Roggo Y.,
    7. Nieto A.,
    8. Brown H.,
    9. Roehl H.,
    10. Adler M.,
    11. Luemkemann J.,
    12. Huwyler J.,
    13. Lam P.,
    14. Stauch O.,
    15. Mohl S.,
    16. Streubel A.

    The Pharmaceutical Capping Process-Correlation between Residual Seal Force, Torque Moment, and Flip-off Removal Force. PDA J. Pharm. Sci. Technol. 2016, 70 (3), 218–229.

    OpenUrlAbstract/FREE Full Text
22. 22.↵
    1. Corveleyn S.,
    2. De Smedt S.,
    3. Remon J. P.

    Moisture Absorption and Desorption of Different Rubber Lyophilisation Closures. Inter. J. Pharm. 1997, 159 (1), 57–65.

    OpenUrl