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
Olivier Benoit
Sartorius Stedim Biotech, August Spindler Strasse 11, 37079 Goettingen, Germany
Dounia Kateb
Sartorius Stedim Biotech, August Spindler Strasse 11, 37079 Goettingen, Germany
Dany Laruelle
Sartorius Stedim Biotech, August Spindler Strasse 11, 37079 Goettingen, Germany

References
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- 2.↵U.S. Pharmacopeial Convention, General Chapter <790> Visible Particulates in Injections. In USP 43—NF 38, USP: Rockville, MD, 2020; p 7021.
- 3.↵U.S. Pharmacopeial Convention, General Chapter <1790> Visual Inspection of Injections. In USP 43—NF 38, USP: Rockville, MD, 2020; p 8587.
- 4.↵Bio-Process Systems Alliance. 2020 Recommendations for Testing, Evaluation, and Control of Particulates from Single-Use Process Equipment. BPSA, 2020.
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- Wormuth K.,
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- 6.↵
- Aldrich D. S.,
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- Shabushnig J. G.
In This Issue
PDA Journal of Pharmaceutical Science and Technology
Vol. 75, Issue 4
July/August 2021
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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