Concepedia

Sterile Process Validation

Sterile Process Validation is a formal methodology within the domain of concurrent validation that establishes the effectiveness and reliability of sterilization procedures in real-time operational environments to ensure consistent production of sterile products in compliance with regulatory and quality standards.

10

Publications

218

Citations

62

Authors

21

Institutions

Publications per year

2017–2026

3

Parents

Publications

10

Comparison of automated culture systems with a CFR/USP-compliant method for sterility testing of cell-therapy products

Hanh Khuu, Frida Stock, M. McGann et al. · Cytotherapy · 2004 · 38 citations

, , +14

Importance of ultrasonication conditions in recovery of microbial contamination from material surfaces

David K. Jeng, Li Lin, L. V. Hervey · Journal of Applied Bacteriology · 1990 · 34 citations

, , +17

ESGE/ESGENA guideline for process validation and routine testing for reprocessing endoscopes in washer-disinfectors, according to the European Standard prEN ISO 15883 parts 1, 4 and 5

Ulrike Beilenhoff, Christiane Neumann, Holger Biering et al. · Endoscopy · 2007 · 32 citations · Full text

, , +17

Cleaning and Sterilization of Used Cardiac Implantable Electronic Devices With Process Validation

Thomas Crawford, Craig Allmendinger, Jay Snell et al. · JACC. Clinical electrophysiology · 2017 · 25 citations

, , +14

Evaluation of a sterile filtration process for viral vaccines using a model nanoparticle suspension

Neil W. Taylor, Wanli Ma, Adam Kristopeit et al. · Biotechnology and Bioengineering · 2020 · 23 citations

, , +14

1–5 of 10

Authors

62

  1. GS
    George Samson

    Relief International, United States

    1 publications · 25 citations

    1

    h-index

  2. HB
    Holger Biering

    Institut Arnault Tzanck, France

    1 publications · 32 citations

    1

    h-index

  3. NW
    Neil W. Taylor

    National Center for Agricultural Utilization Research, United States

    1 publications · 23 citations

    1

    h-index

  4. BW
    Brad Wasserman

    Yale University, United States

    1 publications · 25 citations

    1

    h-index

  5. SL
    Sandra Lach Arlinghaus

    MAKScientific (United States), United States

    1 publications · 25 citations

    1

    h-index

1–5 of 62

Institutions

21

  1. United States Military Academy

    West Point, United States

    2 h-index

    7 publications

    153 citations

  2. National Institutes of Health Clinical Center

    Bethesda, United States

    1 h-index

    2 publications

    76 citations

  3. Bon Secours Heart & Vascular Institute

    Richmond, United States

    1 h-index

    11 publications

    275 citations

  4. Texas Tech University

    Lubbock, United States

    1 h-index

    1 publications

    13 citations

  5. MAKScientific (United States)

    Burlington, United States

    1 h-index

    2 publications

    50 citations

  6. Texas Tech University Health Sciences Center

    Lubbock, United States

    1 h-index

    2 publications

    26 citations

  7. National Institutes of Health

    Bethesda, United States

    1 h-index

    5 publications

    190 citations

  8. Children's Medical Center

    Dallas, United States

    1 h-index

    1 publications

    13 citations

1–8 of 21

Venues

  1. Endoscopy

    1 publications · 32 citations

    1

    h-index

  2. AORN Journal

    1 publications · 12 citations

    1

    h-index

  3. Journal of Applied Bacteriology

    1 publications · 34 citations

    1

    h-index

  4. JACC. Clinical electrophysiology

    1 publications · 25 citations

    1

    h-index

  5. American Journal of Health-System Pharmacy

    AJHP · 1 publications · 13 citations

    1

    h-index

1–5