The Pharmaceutical Capping Process—Correlation between Residual Seal Force, Torque Moment, and Flip-off Removal Force

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. Bauer E.

   Pharmaceutical Packaging Handbook; Informa Health Care: Zug, Switzerland, 2009.
3. 3.↵
   1. Pikal M.,
   2. Dellerman K.,
   3. Roy M.

   Formulation and Stability of Freeze-Dried Proteins: Effects of Moisture and Oxygen on the Stability of Freeze-Dried Formulations of Human Growth Hormone. Dev. Biol. Stand. 1992, 74, 21–37, discussion 37–38.

   OpenUrlPubMed
4. 4.↵
   1. Akers M. K.,
   2. Larrimore D.,
   3. Guazzo D.

   Parenteral Quality Control: Sterility, Pyrogen, Particulate, and Package Integrity Testing; CRC Press: Boca Raton, FL, 2002.
5. 5.↵
   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. European Journal of Pharmaceutics and Biopharmaceutics. 2006, 99 (2), 54–64.
6. 6.↵
   1. Morton D. K.

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

   OpenUrlAbstract/FREE Full Text
7. 7.↵
   1. Guazzo D. M.

   Current Approaches in Leak Testing Pharmaceutical Packages. PDA J. Pharm. Sci. Technol. 1996, 50 (6), 378–385.

   OpenUrlFREE Full Text
8. 8.↵
   General Chapter <1207> Sterile Product Packaging—Integrity Evaluation. U.S. Pharmacopeia 37; U.S. Pharmacopeial Convention: Rockville, MD.
9. 9.↵
   1. Mathaes R.,
   2. Mahler H. C.,
   3. Roggo Y.,
   4. Ovadia R.,
   5. Lam P.,
   6. Stauch O.,
   7. Vogt O.,
   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. 2006, 70 (1), 12–29.

   OpenUrl
10. 10.↵
    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
11. 11.↵
    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
12. 12.↵
    1. Morton D. K.,
    2. Lordi N. G.

    Residual Seal Force Measurement of Parenteral Vials. I. Methodology. PDA J. Pharm. Sci. Technol. 1988, 42 (1), 23–29.

    OpenUrlAbstract/FREE Full Text
13. 13.↵
    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
14. 14.↵
    1. Mahler H. C.,
    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