Concepedia

Sterile Process Controls

Sterile Process Controls is a quality system regulation framework that specifies the controlled conditions and procedures necessary to ensure the sterility of medical devices and pharmaceutical products during manufacturing, distinguishing it from general process controls by its focus on eliminating viable microorganisms to meet defined sterility assurance levels.

19

Publications

589

Citations

45

Authors

25

Institutions

Publications per year

2017–2026

4

Parents

Publications

19

Development, parallelization, and automation of a gas‐inducing milliliter‐scale bioreactor for high‐throughput bioprocess design (HTBD)

Robert Puskeiler, Klaus Kaufmann, Dirk Weuster‐Botz · Biotechnology and Bioengineering · 2005 · 168 citations · Full text

, , +17

ASHP guidelines on quality assurance for pharmacy-prepared sterile products. American Society of Health System Pharmacists

American Journal of Health-System Pharmacy · 2000 · 80 citations · Full text

, , +12

[Survey on the control of sterility of biological substances and pharmaceutical preparations].

J Desbordes, Bonnel Ph · PubMed · 1966 · 54 citations

, , +14

Modeling and adaptive control for batch sterilization

Antonio A. Alonso, Julio R. Banga, Ricardo I. Pérez‐Martín · Computers & Chemical Engineering · 1998 · 50 citations · Full text

, , +14

General sampling system for sterile monitoring of biological processes

H. Håkanson, Mats Nilsson, Bo Mattìasson · Analytica Chimica Acta · 1991 · 27 citations

, , +15

1–5 of 19

Authors

45

  1. JA
    James Agalloco

    Applied Research Associates (United States), United States

    2 publications · 24 citations

    2

    h-index

  2. BG
    Bernhard Gallnböck-Wagner

    1 publications · 11 citations

    1

    h-index

  3. HH
    H. Håkanson

    Lund University, Sweden

    1 publications · 27 citations

    1

    h-index

  4. JD
    J Desbordes

    Hôtel-Dieu de Paris, France

    1 publications · 54 citations

    1

    h-index

  5. TL
    Thomas Ley

    Roche (United States), United States

    1 publications · 26 citations

    1

    h-index

1–5 of 45

Institutions

25

  1. Baylor University

    Waco, United States

    1 h-index

    1 publications

    15 citations

  2. Lund University

    Lund, Sweden

    1 h-index

    3 publications

    81 citations

  3. CS Diagnostics

    Neuss, Germany

    1 h-index

    3 publications

    78 citations

  4. University of Leeds

    Leeds, United Kingdom

    1 h-index

    2 publications

    34 citations

  5. Baylor College of Medicine

    Houston, United States

    1 h-index

    1 publications

    15 citations

  6. Affiliated Hospital of Nantong University

    Nantong, China

    1 h-index

    3 publications

    66 citations

  7. The Bristol-Myers Squibb Children's Hospital

    New Brunswick, United States

    1 h-index

    1 publications

    12 citations

  8. Sartorius (Germany)

    Göttingen, Germany

    1 h-index

    1 publications

    12 citations

1–8 of 25

Venues

  1. PubMed

    Repository · 4 publications · 90 citations

    4

    h-index

  2. Journal of Food Engineering

    2 publications · 31 citations

    2

    h-index

  3. Computers & Chemical Engineering

    2 publications · 76 citations

    2

    h-index

  4. Journal of Pharmacy and Pharmacology

    JPP · 1 publications · 12 citations

    1

    h-index

  5. Advances in Contraception

    1 publications · 12 citations

    1

    h-index

1–5