Concepedia

Container Integrity Testing

Container Integrity Testing is a methodological framework within pharmaceutical science that systematically evaluates the hermetic seal and structural soundness of drug product containers to ensure aseptic maintenance and prevent microbial ingress during storage and distribution.

22

Publications

380

Citations

111

Authors

43

Institutions

Publications per year

2017–2026

4

Parents

Publications

22

Container/Closure Integrity Testing and the Identification of a Suitable Vial/Stopper Combination for Low-Temperature Storage at -80  C

B. Zuleger, A. Kort, R. Glowienka et al. · PDA Journal of Pharmaceutical Science and Technology · 2012 · 28 citations

, , +14

Container Closure Integrity Testing—Practical Aspects and Approaches in the Pharmaceutical Industry

Helen Brown, Hanns‐Christian Mahler, James Mellman et al. · PDA Journal of Pharmaceutical Science and Technology · 2016 · 27 citations

, , +17

Pharmaceutical container/closure integrity. I: Mass spectrometry-based helium leak rate detection for rubber-stoppered glass vials.

Lee E. Kirsch, Lida Nguyen, Craig S. Moeckly · PubMed · 1997 · 26 citations

, , +13

Development of a dye ingress method to assess container-closure integrity: correlation to microbial ingress.

Lance Burrell, M W Carver, G E DeMuth et al. · PubMed · 2006 · 24 citations

, , +16

Impact of Vial Capping on Residual Seal Force and Container Closure Integrity

Roman Mathaes, Hanns‐Christian Mahler, Yves Roggo et al. · PDA Journal of Pharmaceutical Science and Technology · 2016 · 22 citations

, , +13

1–5 of 22

Authors

111

  1. HM
    Hanns‐Christian Mahler

    Roche (Switzerland), Switzerland

    4 publications · 81 citations

    4

    h-index

  2. RM
    Roman Mathaes

    Lonza (Switzerland), Switzerland

    3 publications · 66 citations

    3

    h-index

  3. HR
    Holger Roehl

    Roche (Switzerland), Switzerland

    3 publications · 64 citations

    3

    h-index

  4. HB
    Helen Brown

    Curtin University, Australia

    2 publications · 42 citations

    2

    h-index

  5. RO
    Robert Ovadia

    Pharmaceutical Product Development (United States), United States

    2 publications · 39 citations

    2

    h-index

1–5 of 111

Institutions

43

  1. Lonza (Switzerland)

    Basel, Switzerland

    4 h-index

    11 publications

    215 citations

  2. Roche (Switzerland)

    Basel, Switzerland

    3 h-index

    18 publications

    379 citations

  3. United States Food and Drug Administration

    Silver Spring, United States

    2 h-index

    6 publications

    106 citations

  4. Pharmaceutical Product Development (United States)

    Wilmington, United States

    2 h-index

    7 publications

    134 citations

  5. University of Iowa

    Iowa City, United States

    2 h-index

    2 publications

    40 citations

  6. Baxter (United States)

    Deerfield, United States

    2 h-index

    5 publications

    57 citations

  7. Boehringer Ingelheim (Germany)

    Ingelheim, Germany

    1 h-index

    1 publications

    17 citations

  8. Shanghai Institute of Pharmaceutical Industry

    Shanghai, China

    1 h-index

    3 publications

    36 citations

1–8 of 43

Venues

  1. 9

    h-index

  2. PubMed

    Repository · 5 publications · 89 citations

    5

    h-index

  3. International Journal of Pharmaceutics

    2 publications · 22 citations

    2

    h-index

  4. 1

    h-index

  5. Scanning

    1 publications · 13 citations

    1

    h-index

1–5