Skip to main content

Main menu

  • Home
  • Content
    • Current Issue
    • Past Issues
    • Accepted Articles
    • Email Alerts
    • RSS
    • Terms of Use
  • About PDA JPST
    • JPST Editors and Editorial Board
    • About/Vision/Mission
    • Paper of the Year
  • Author & Reviewer Resources
    • Author Resources / Submit
    • Reviewer Resources
  • JPST Access and Subscriptions
    • PDA Members
    • Institutional Subscriptions
    • Nonmember Access
  • Support
    • Join PDA
    • Contact
    • Feedback
    • Advertising
    • CiteTrack
  • .
    • Visit PDA
    • PDA Letter
    • Technical Reports
    • news uPDATe
    • Bookstore

User menu

  • Register
  • Subscribe
  • My alerts
  • Log in
  • My Cart

Search

  • Advanced search
PDA Journal of Pharmaceutical Science and Technology
  • .
    • Visit PDA
    • PDA Letter
    • Technical Reports
    • news uPDATe
    • Bookstore
  • Register
  • Subscribe
  • My alerts
  • Log in
  • My Cart
PDA Journal of Pharmaceutical Science and Technology

Advanced Search

  • Home
  • Content
    • Current Issue
    • Past Issues
    • Accepted Articles
    • Email Alerts
    • RSS
    • Terms of Use
  • About PDA JPST
    • JPST Editors and Editorial Board
    • About/Vision/Mission
    • Paper of the Year
  • Author & Reviewer Resources
    • Author Resources / Submit
    • Reviewer Resources
  • JPST Access and Subscriptions
    • PDA Members
    • Institutional Subscriptions
    • Nonmember Access
  • Support
    • Join PDA
    • Contact
    • Feedback
    • Advertising
    • CiteTrack
  • Follow pda on Twitter
  • Visit PDA on LinkedIn
  • Visit pda on Facebook
Research ArticleResearch

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

Jakob W. Buecheler, Joerg Luemkemann, Henning Gieseler, Silke Mohl and Alexander Streubel
PDA Journal of Pharmaceutical Science and Technology March 2019, 73 (2) 111-120; DOI: https://doi.org/10.5731/pdajpst.2018.008870
Jakob W. Buecheler
1Division of Pharmaceutics, Friedrich-Alexander Universität (FAU) Erlangen-Nürnberg, Erlangen, Germany;
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Joerg Luemkemann
2Pharmaceutical Development & Supplies, Pharma Technical Development Biologics EU, F. Hoffmann-La Roche Ltd., Basel, Switzerland; and
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Henning Gieseler
1Division of Pharmaceutics, Friedrich-Alexander Universität (FAU) Erlangen-Nürnberg, Erlangen, Germany;
3GILYOS GmbH, Friedrich-Bergius Ring 15, Wuerzburg, Germany.
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Silke Mohl
2Pharmaceutical Development & Supplies, Pharma Technical Development Biologics EU, F. Hoffmann-La Roche Ltd., Basel, Switzerland; and
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Alexander Streubel
2Pharmaceutical Development & Supplies, Pharma Technical Development Biologics EU, F. Hoffmann-La Roche Ltd., Basel, Switzerland; and
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
  • For correspondence: alexander.streubel@roche.com
  • Article
  • Figures & Data
  • References
  • Info & Metrics
  • PDF
Loading

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
PreviousNext
Back to top

In This Issue

PDA Journal of Pharmaceutical Science and Technology: 73 (2)
PDA Journal of Pharmaceutical Science and Technology
Vol. 73, Issue 2
March/April 2019
  • Table of Contents
  • Index by Author
Print
Download PDF
Article Alerts
Sign In to Email Alerts with your Email Address
Email Article

Thank you for your interest in spreading the word on PDA Journal of Pharmaceutical Science and Technology.

NOTE: We only request your email address so that the person you are recommending the page to knows that you wanted them to see it, and that it is not junk mail. We do not capture any email address.

Enter multiple addresses on separate lines or separate them with commas.
Residual Seal Force Testing: A Suitable Method for Seal Quality Determination of (High Potent) Parenterals
(Your Name) has sent you a message from PDA Journal of Pharmaceutical Science and Technology
(Your Name) thought you would like to see the PDA Journal of Pharmaceutical Science and Technology web site.
CAPTCHA
This question is for testing whether or not you are a human visitor and to prevent automated spam submissions.
1 + 2 =
Solve this simple math problem and enter the result. E.g. for 1+3, enter 4.
Citation Tools
Residual Seal Force Testing: A Suitable Method for Seal Quality Determination of (High Potent) Parenterals
Jakob W. Buecheler, Joerg Luemkemann, Henning Gieseler, Silke Mohl, Alexander Streubel
PDA Journal of Pharmaceutical Science and Technology Mar 2019, 73 (2) 111-120; DOI: 10.5731/pdajpst.2018.008870

Citation Manager Formats

  • BibTeX
  • Bookends
  • EasyBib
  • EndNote (tagged)
  • EndNote 8 (xml)
  • Medlars
  • Mendeley
  • Papers
  • RefWorks Tagged
  • Ref Manager
  • RIS
  • Zotero
Share
Residual Seal Force Testing: A Suitable Method for Seal Quality Determination of (High Potent) Parenterals
Jakob W. Buecheler, Joerg Luemkemann, Henning Gieseler, Silke Mohl, Alexander Streubel
PDA Journal of Pharmaceutical Science and Technology Mar 2019, 73 (2) 111-120; DOI: 10.5731/pdajpst.2018.008870
Reddit logo Twitter logo Facebook logo Mendeley logo
  • Tweet Widget
  • Facebook Like
  • Google Plus One

Jump to section

  • Article
    • Abstract
    • Introduction
    • Materials and Methods
    • Results and Discussion
    • Conclusion
    • Conflict of Interest Declaration
    • Acknowledgment
    • References
  • Figures & Data
  • Info & Metrics
  • References
  • PDF

Related Articles

  • No related articles found.
  • PubMed
  • Google Scholar

Cited By...

  • Long-Term Study of Container Closure Integrity of Rubber-Glass Vial Systems by Multiple Methods
  • Google Scholar

More in this TOC Section

  • Container Closure Integrity of Vial Primary Packaging Systems under Frozen Storage Conditions: A Case Study
  • Advances in Large Volume Subcutaneous Injections: A Pilot Tolerability Study of an Innovative Needle-Free Injection Platform
  • Quantification and Stability Impact Assessment of Drop Stresses in Biologic Drug Products
Show more Research

Similar Articles

Keywords

  • Capping
  • Residual seal force (RSF)
  • Process control
  • Seal quality
  • Vial

Readers

  • About
  • Table of Content Alerts/Other Alerts
  • Subscriptions
  • Terms of Use
  • Contact Editors

Author/Reviewer Information

  • Author Resources
  • Submit Manuscript
  • Reviewers
  • Contact Editors

Parenteral Drug Association, Inc.

  • About
  • Advertising/Sponsorships
  • Events
  • PDA Bookstore
  • Press Releases

© 2023 PDA Journal of Pharmaceutical Science and Technology ISSN: 1079-7440

Powered by HighWire