Concepedia

Sterilization Qualification

Sterilization Qualification is a formal validation process, within the broader category of facility qualification and sterility assurance, that establishes documented evidence through predefined protocols and scientific rationale that a sterilization method consistently achieves the required microbial lethality to ensure product sterility in compliance with regulatory standards.

6

Publications

127

Citations

27

Authors

9

Institutions

Publications per year

2017–2026

1

Parents

Publications

6

Plasma Sterilization: What are the Conditions to Meet this Claim?

Thomas von Woedtke, Axel Krämer, Klaus‐Dieter Weltmann · Plasma Processes and Polymers · 2008 · 58 citations · Full text

, , +16

Sterility testing of minimally manipulated cord blood products: validation of growth‐based automated culture systems

Salem Akel, Joan Lorenz, Donna Regan · Transfusion · 2013 · 16 citations

, , +17

An Overview of the Validation Approach for Moist Heat Sterilization, Part II

Etheresia Pretorius, R. Gochin, R. Chapoullie et al. · Pharmaceutical technology · 2002 · 14 citations

, , +17

Qualification of a rapid readout biological indicator with moist heat sterilization.

Patrick J. McCormick, Catherine Finocchario, Robert Manchester et al. · PubMed · 2003 · 14 citations

, , +17

False positive results of Bowie and Dick type test used for hospital steam sterilizer with slower come-up ramps: A case study

Paulo Roberto Laranjeira, Jeane Aparecida Gonzalez Bronzatti, Camila Quartim de Moraes Bruna et al. · PLoS ONE · 2020 · 13 citations · Full text

, , +16

1–5 of 6

Authors

27

  1. RM
    Robert Manchester

    Bausch & Lomb (France), France

    1 publications · 14 citations

    1

    h-index

  2. TD
    Trabue D. Bryans

    WellStar Kennestone Hospital, United States

    1 publications · 12 citations

    1

    h-index

  3. PR
    Paulo Roberto Laranjeira

    Cardinal Health (United States), United States

    1 publications · 13 citations

    1

    h-index

  4. KD
    Kimbrell Darnell

    Medical Protective, United States

    1 publications · 12 citations

    1

    h-index

  5. JM
    Joyce M. Hansen

    Johnson & Johnson (United States), United States

    1 publications · 12 citations

    1

    h-index

1–5 of 27

Institutions

9

  1. Leibniz Institute for Plasma Science and Technology

    Greifswald, Germany

    1 h-index

    2 publications

    116 citations

  2. Medical Protective

    Fort Wayne, United States

    1 h-index

    1 publications

    12 citations

  3. Universität Greifswald

    Greifswald, Germany

    1 h-index

    1 publications

    58 citations

  4. Cardinal Glennon Children’s Medical Center

    St Louis, United States

    1 h-index

    3 publications

    48 citations

  5. Leibniz Association

    Berlin, Germany

    1 h-index

    2 publications

    116 citations

  6. Universidade de São Paulo

    São Paulo, Brazil

    1 h-index

    4 publications

    52 citations

  7. Cardinal Health (United States)

    Dublin, United States

    1 h-index

    1 publications

    13 citations

  8. Getinge (United States)

    Wayne, United States

    1 h-index

    1 publications

    13 citations

1–8 of 9

Venues

  1. Pharmaceutical technology

    1 publications · 14 citations

    1

    h-index

  2. PubMed

    Repository · 1 publications · 14 citations

    1

    h-index

  3. Transfusion

    1 publications · 16 citations

    1

    h-index

  4. PLoS ONE

    1 publications · 13 citations

    1

    h-index

  5. Plasma Processes and Polymers

    1 publications · 58 citations

    1

    h-index

1–5