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Definition of particle visibility threshold in parenteral drug products - towards standardization of visual inspection operator qualification

Filip Fedorowicz, Andreas Zerr, Roman Mathaes, Matthias Eisele, Swen Maas and Atanas Koulov
PDA Journal of Pharmaceutical Science and Technology December 2024, pdajpst.2024.012994; DOI: https://doi.org/10.5731/pdajpst.2024.012994
Filip Fedorowicz
1 Clear Solutions Laboratories AG;
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Andreas Zerr
1 Clear Solutions Laboratories AG;
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Roman Mathaes
1 Clear Solutions Laboratories AG;
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Matthias Eisele
2 Material Analytischer Service (M.A.S.) GmbH
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  • For correspondence: eneiselee@gmx.de
Swen Maas
2 Material Analytischer Service (M.A.S.) GmbH
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  • For correspondence: mas@ma-service.de
Atanas Koulov
1 Clear Solutions Laboratories AG;
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Article Information

pdajpst.2024.012994
DOI 
https://doi.org/10.5731/pdajpst.2024.012994
PubMed 
39730203

Published By 
Parenteral Drug Association (PDA)
Print ISSN 
1079-7440
Online ISSN 
1948-2124
History 
  • Received June 24, 2024
  • Accepted December 17, 2024
  • Published online December 27, 2024.

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  • You are currently viewing a previous version of this article (December 27, 2024 - 10:20).
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Copyright & Usage 
Copyright © 2024, Parenteral Drug Association

Author Information

  1. Filip Fedorowicz1 (filip.fedorowicz@clearsolutions-labs.com),
  2. Andreas Zerr1 (andreas.zerr@clearsolutions-labs.com),
  3. Roman Mathaes1 (roman.mathaes@clearsolutions-labs.com),
  4. Matthias Eisele2 (eneiselee@gmx.de),
  5. Swen Maas2 (mas@ma-service.de) and
  6. Atanas Koulov1,3 (atanas.koulov@clearsolutions-labs.com)
  1. 1 Clear Solutions Laboratories AG;
  2. 2 Material Analytischer Service (M.A.S.) GmbH
  1. ↵* Corresponding author; email: atanas.koulov@clearsolutions-labs.com

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PDA Journal of Pharmaceutical Science and Technology: 79 (3)
PDA Journal of Pharmaceutical Science and Technology
Vol. 79, Issue 3
May/June 2025
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Definition of particle visibility threshold in parenteral drug products - towards standardization of visual inspection operator qualification
Filip Fedorowicz, Andreas Zerr, Roman Mathaes, Matthias Eisele, Swen Maas, Atanas Koulov
PDA Journal of Pharmaceutical Science and Technology Dec 2024, pdajpst.2024.012994; DOI: 10.5731/pdajpst.2024.012994
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Keywords

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

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Definition of particle visibility threshold in parenteral drug products - towards standardization of visual inspection operator qualification
Filip Fedorowicz, Andreas Zerr, Roman Mathaes, Matthias Eisele, Swen Maas, Atanas Koulov
PDA Journal of Pharmaceutical Science and Technology Dec 2024, pdajpst.2024.012994; DOI: 10.5731/pdajpst.2024.012994

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