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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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Article Information

vol. 79 no. 1 28-58
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 
  • Published online March 3, 2025.

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  • previous version (December 27, 2024 - 10:20).
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© PDA, Inc. 2025

Author Information

  1. Filip M. Fedorowicz1,
  2. Andreas Zerr1,
  3. Roman Mathaes1,
  4. Matthias Eisele2,
  5. Swen Maas2 and
  6. Atanas Koulov1,*
  1. 1Clear Solutions Laboratories AG, Mattenstrasse 22, 4058 Basel, Switzerland; and
  2. 2Material Analytischer Service (M.A.S.) GmbH, Carl Mez Str. 73, D-79114 Freiburg im Breisgau, Germany
  1. ↵*Corresponding Author: Clear Solutions Laboratories AG, Mattenstrasse 22, 4058 Basel, Switzerland; E-mail: atanas.koulov@clearsolutions-labs.com
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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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Keywords

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

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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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