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Research ArticleResearch

Definition of Particle Visibility Threshold in Parenteral Drug Products—Towards Standardization of Visual Inspection Operator Qualification

Filip M. Fedorowicz, Andreas Zerr, Roman Mathaes, Matthias Eisele, Swen Maas and Atanas Koulov
PDA Journal of Pharmaceutical Science and Technology January 2025, 79 (1) 28-58; DOI: https://doi.org/10.5731/pdajpst.2024.012994
Filip M. Fedorowicz
1Clear Solutions Laboratories AG, Mattenstrasse 22, 4058 Basel, Switzerland; and
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Andreas Zerr
1Clear Solutions Laboratories AG, Mattenstrasse 22, 4058 Basel, Switzerland; and
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Roman Mathaes
1Clear Solutions Laboratories AG, Mattenstrasse 22, 4058 Basel, Switzerland; and
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Matthias Eisele
2Material Analytischer Service (M.A.S.) GmbH, Carl Mez Str. 73, D-79114 Freiburg im Breisgau, Germany
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Swen Maas
2Material Analytischer Service (M.A.S.) GmbH, Carl Mez Str. 73, D-79114 Freiburg im Breisgau, Germany
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Atanas Koulov
1Clear Solutions Laboratories AG, Mattenstrasse 22, 4058 Basel, Switzerland; and
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  • For correspondence: atanas.koulov@clearsolutions-labs.com
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References

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    U.S. Pharmacopeial Convention. General Chapter <790> Visible Particulates in Injections. USP—NF 2023, https://www/uspnf.com.
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    Monitoring of Visible Particles in Parenteral Products by Manual Visual Inspection - Reassessing Size Threshold and Other Particle Characteristics That Define Particle Visibility. J. Pharm. Sci. 2024, 113 (3), 616–624. https://doi.org/10.1016/j.xphs.2023.10.002.
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    1. Shabushnig J.,
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    , PDA Research: 2023 PDA Visual Inspection Survey; PDA: Bethesda, MD, 2023.
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    U.S. Pharmacopeial Convention. General Chapter <1790> Visual Inspection of Injections. USP—NF 2023, https://www/uspnf.com.
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    1. Bush T.,
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    Technical Report No. 85: Enhanced Test Methods for Visible Particle Detection and Enumeration on Elastomeric Closures and Glass Containers; Bethesda, MD, 2021.
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    Visible Particulate Matter Detection in LVIs., 2008.
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    Sensation and Perception, 8th ed.; Cengage Learning, 2009.
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    Research Progress of Automated Visual Surface Defect Detection for Industrial Metal Planar Materials. Sensors 2020, 20 (18), 5136. https://doi.org/10.3390/s20185136.
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    3D Reconstruction Methods and Quality Assessment for Visual Inspection of Welds. Autom. Constr. 2017, 79 49–58. https://doi.org/10.1016/j.autcon.2017.03.002.
    OpenUrl
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PDA Journal of Pharmaceutical Science and Technology: 79 (1)
PDA Journal of Pharmaceutical Science and Technology
Vol. 79, Issue 1
January/February 2025
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Definition of Particle Visibility Threshold in Parenteral Drug Products—Towards Standardization of Visual Inspection Operator Qualification
Filip M. Fedorowicz, Andreas Zerr, Roman Mathaes, Matthias Eisele, Swen Maas, Atanas Koulov
PDA Journal of Pharmaceutical Science and Technology Jan 2025, 79 (1) 28-58; DOI: 10.5731/pdajpst.2024.012994

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Definition of Particle Visibility Threshold in Parenteral Drug Products—Towards Standardization of Visual Inspection Operator Qualification
Filip M. Fedorowicz, Andreas Zerr, Roman Mathaes, Matthias Eisele, Swen Maas, Atanas Koulov
PDA Journal of Pharmaceutical Science and Technology Jan 2025, 79 (1) 28-58; DOI: 10.5731/pdajpst.2024.012994
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Keywords

  • visual inspection
  • Particle visibility limit
  • Visible particles
  • Threshold studies
  • Knapp test
  • Equivalent circular diameter

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