Evaluation of Container Closure System Integrity for Storage of Frozen Drug Products: Impact of Capping Force and Transportation

Reference

1. 1.↵
   1. Nieto A.,
   2. Roehl H.,
   3. Brown H.,
   4. Nikoloff J.,
   5. Adler M.,
   6. Mahler H.-C.

   Evaluation of Container Closure System Integrity for Frozen Storage Drug Products. PDA J. Pharm. Sci. Technol. 2016, 70 (2), 120–133.

   OpenUrlAbstract/FREE Full Text
2. 2.↵
   1. Brown H.,
   2. Mahler H.-C.,
   3. Mellmann 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
3. 3.↵
   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
4. 4.↵
   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
5. 5.↵
   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.
6. 6.↵
   1. Rey L.,
   2. May J. C.

   Freeze Drying/Lyophilization of Pharmaceutical and Biological Products, 3rd ed.; Informa Healthcare: London, UK, 2010; p. 402.
7. 7.↵
   1. Asselta R.,
   2. Smith E.,
   3. Sunderland W.,
   4. Trapper E.

   Effect of Low Temperatures on Parenteral Vial Seal Integrity. Presented at the PDA Annual Meeting, 2007.
8. 8.↵
   1. Duncan D.,
   2. Asselta R.

   Correlating Vial Seal Tightness to Container Closure Integrity at Various Storage Temperatures. Presented at the PDA Europe Parenteral Packaging Conference, Frankfurt, Germany, 2015.
9. 9.↵
   1. Nieto A.,
   2. Roehl H.,
   3. Adler M.,
   4. Mohl S.

   Sealing Behavior of Container Closure Systems under Frozen Storage Conditions: Nonlinear Finite Element Simulation of Serum Rubber Stoppers. PDA J. Pharm. Sci. Technol. 2018, 72 (4), 367–381.

   OpenUrlAbstract/FREE Full Text
10. 10.↵
    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.

    Critical Process Parameters of Capping Equipment used in GMP DP Manufacturing. PDA J. Pharm. Sci. Technol. DOI:10.5731/pdajpst.2015.005918. Published Online: Jan 21, 2016.

    OpenUrlAbstract/FREE Full Text
11. 11.↵
    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
12. 12.↵
    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
13. 13.
    ASTM 7386. Standard Practice for Performance Testing of Packages for Single Parcel Delivery Systems.
14. 14.↵
    1. Lam P.,
    2. Stern A.

    Visualization Techniques for Assessing Design Factors That Affect the Interaction between Pharmaceutical Vials and Stoppers. PDA J. Pharm. Sci. Tech. 2010, 64, 182–187.

    OpenUrl