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
Andreas Zerr
1Clear Solutions Laboratories AG, Mattenstrasse 22, 4058 Basel, Switzerland; and
Roman Mathaes
1Clear Solutions Laboratories AG, Mattenstrasse 22, 4058 Basel, Switzerland; and
Matthias Eisele
2Material Analytischer Service (M.A.S.) GmbH, Carl Mez Str. 73, D-79114 Freiburg im Breisgau, Germany
Swen Maas
2Material Analytischer Service (M.A.S.) GmbH, Carl Mez Str. 73, D-79114 Freiburg im Breisgau, Germany
Atanas Koulov
1Clear Solutions Laboratories AG, Mattenstrasse 22, 4058 Basel, Switzerland; and

References
- 1.↵U.S. Pharmacopeial Convention. General Chapter <790> Visible Particulates in Injections. USP—NF 2023, https://www/uspnf.com.
- 2.↵Council of Europe, Particulate Contamination: Visible Particles, Chapter 2.9.20. In European Pharmacopoeia (Ph. Eur.), 6th Edition, Council of Europe: Strasbourg, France, 2008.
- 3.↵Ministry of Health Labour and Welfare of Japan, Tests for Preparations—6.06: Foreign Insoluble Matter Test for Injections. In The Japanese Pharmacopoeia, 17th Edition (English Version), MHLW: Tokyo, 2016.
- 4.↵
- Knapp J. Z.,
- Kushner H. K.
- 5.↵
- Mazaheri M.,
- Saggu M.,
- Wuchner K.,
- Koulov A. V.,
- Nikels F.,
- Chalus P.,
- Das T. K.,
- Cash P. W.,
- Finkler C.,
- Levitskaya-Seaman S. V.,
- Case J.,
- Parsons J.,
- Gonzalez K.
- 6.↵
- Mathonet S.,
- Mahler H.-C.,
- Esswein S. T.,
- Mazaheri M.,
- Cash P. W.,
- Wuchner K.,
- Kallmeyer G.,
- Das T. K.,
- Finkler C.,
- Lennard A.
- 7.↵
- Melchore J. A.,
- Berdovich D.
- 8.↵
- Shabushnig J.,
- Miller R.,
- Watson R
- 9.↵U.S. Pharmacopeial Convention. General Chapter <1790> Visual Inspection of Injections. USP—NF 2023, https://www/uspnf.com.
- 10.↵
- Bush T.,
- Ayres J.,
- Begat C.,
- Burazer A.,
- DeGrazio F.,
- Flynn C.,
- Harianawala A.,
- Kinsey P.,
- Miller J.,
- Perry A.,
- Shabushnig J.,
- Song X.,
- Soukiassian H.,
- Spasoff A.,
- Stanton A.,
- Streich D.,
- Watson R.
- 11.↵
- Shabushnig J.,
- Melchore J. A.,
- Geiger M.,
- Chrai S.,
- Gerger M. E.
- 12.↵
- Dunham A.
- 13.↵
- Goldstein E. B.
- 14.↵
- Fang X.,
- Luo Q.,
- Zhou B.,
- Li C.,
- Tian L.
- 15.↵
- Rodríguez-Gonzálvez P.,
- Rodríguez-Martín M.,
- Ramos L. F.,
- González-Aguilera D.
In This Issue
PDA Journal of Pharmaceutical Science and Technology
Vol. 79, Issue 1
January/February 2025
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
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
Jump to section
Related Articles
- No related articles found.
Cited By...
- No citing articles found.