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Research ArticleResearch

Challenges in the Manual Visual Inspection of the Interior Surfaces of Single-Use Systems for the Presence of Particulate Matter

Klaus Wormuth, Olivier Benoit, Dounia Kateb and Dany Laruelle
PDA Journal of Pharmaceutical Science and Technology July 2021, 75 (4) 332-340; DOI: https://doi.org/10.5731/pdajpst.2020.012211
Klaus Wormuth
Sartorius Stedim Biotech, August Spindler Strasse 11, 37079 Goettingen, Germany
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  • For correspondence: klaus.wormuth@sartorius.com
Olivier Benoit
Sartorius Stedim Biotech, August Spindler Strasse 11, 37079 Goettingen, Germany
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Dounia Kateb
Sartorius Stedim Biotech, August Spindler Strasse 11, 37079 Goettingen, Germany
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Dany Laruelle
Sartorius Stedim Biotech, August Spindler Strasse 11, 37079 Goettingen, Germany
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References

  1. 1.↵
    1. Knapp J. Z.,
    2. Barber T. A.,
    3. Lieberman A.
    1. Knapp J. Z.,
    2. Abramson L. R.
    Evaluation and Validation of Nondestructive Particle Inspection Methods and Systems. In Liquid- and Surface-Borne Particle Measurement Handbook; Knapp J. Z., Barber T. A., Lieberman A., Eds.; Marcel Dekker: New York, 1996; pp 295–450.
  2. 2.↵
    U.S. Pharmacopeial Convention, General Chapter <790> Visible Particulates in Injections. In USP 43—NF 38, USP: Rockville, MD, 2020; p 7021.
  3. 3.↵
    U.S. Pharmacopeial Convention, General Chapter <1790> Visual Inspection of Injections. In USP 43—NF 38, USP: Rockville, MD, 2020; p 8587.
  4. 4.↵
    Bio-Process Systems Alliance. 2020 Recommendations for Testing, Evaluation, and Control of Particulates from Single-Use Process Equipment. BPSA, 2020.
  5. 5.↵
    1. Wormuth K.,
    2. Gauthier M.,
    3. Labedan M.,
    4. Cantin V.,
    5. Gaston F.,
    6. Thaust M.,
    7. Montenay N.,
    8. Barbaroux M.
    Visible Particulate Matter in Single-Use Bags: from Measurement to Prevention. BioProcess Int. 2019, 17 (4), 50.
    OpenUrl
  6. 6.↵
    1. Aldrich D. S.,
    2. Cherris R. T.,
    3. Shabushnig J. G.
    Visual Inspection and Particulate Control; Davis Healthcare International Publishing: Bethesda, MD, 2016; pp 121–204.
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PDA Journal of Pharmaceutical Science and Technology: 75 (4)
PDA Journal of Pharmaceutical Science and Technology
Vol. 75, Issue 4
July/August 2021
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Challenges in the Manual Visual Inspection of the Interior Surfaces of Single-Use Systems for the Presence of Particulate Matter
Klaus Wormuth, Olivier Benoit, Dounia Kateb, Dany Laruelle
PDA Journal of Pharmaceutical Science and Technology Jul 2021, 75 (4) 332-340; DOI: 10.5731/pdajpst.2020.012211

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Challenges in the Manual Visual Inspection of the Interior Surfaces of Single-Use Systems for the Presence of Particulate Matter
Klaus Wormuth, Olivier Benoit, Dounia Kateb, Dany Laruelle
PDA Journal of Pharmaceutical Science and Technology Jul 2021, 75 (4) 332-340; DOI: 10.5731/pdajpst.2020.012211
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Keywords

  • Single-use systems
  • visual inspection
  • Particulate matter
  • Probability of detection
  • Method development
  • Method validation

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