Best Practices to Quantify and Identify Particulate Matter on the Interior Surfaces of Single-Use Systems

References

1. 1.↵
   1. Langille S. E.

   Particulate Matter in Injectable Drug Products. PDA J. Pharm. Sci. Technol. 2013, 67 (3), 186–200.

   OpenUrlAbstract/FREE Full Text
2. 2.↵
   Parenteral Drug Association Inc. Technical Report No. 79: Particulate Matter Control in Difficult to Inspect Parenterals; Bethesda, MD, 2018.
3. 3.↵
   1. Aldrich D. S.,
   2. Cherris R. T.,
   3. Shabushnig J. G.

   Visual Inspection and Particulate Control,: Davis Healthcare International Publishing, LLC: River Grove, IL, 2016; pp 121–318.
4. 4.↵
   Bio-Process Systems Alliance. 2020 Recommendations for Testing, Evaluation, and Control of Particulates from Single-Use Process Equipment; BPSA, 2020.
5. 5.↵
   1. Wormuth K.,
   2. Benoit O.,
   3. Kateb D.,
   4. Laruelle D.

   Challenges in the Manual Visual Inspection of the Interior Surfaces of Single-Use Systems for the Presence of Particulate Matter. PDA J. Pharm. Sci. Technol. 2021, 75 (4), 332–340.

   OpenUrlAbstract/FREE Full Text
6. 6.↵
   U.S. Pharmacopeial Convention, General Chapter <788> Particulate Matter in Injections. In USP 42–NF 37. USP: Rockville, MD, 2019.
7. 7.↵
   1. Barber T. A.

   Control of Particulate Contamination in Healthcare Manufacturing, CRC Press: Boca Raton, FL, 1999; pp 275–318.
8. 8.↵
   U.S. Pharmacopeial Convention, General Chapter <1788.1> Light Obscuration Method for the Determination of Subvisible Particulate Matter. In USP 42–NF 37. USP: Rockville, MD, 2019.
9. 9.↵
   ASTM International, ASTM E3230-20(2020) Standard Practice for Extraction of Particulate Matter from the Surfaces of Single-Use Components and Assemblies Designed for Use in Biopharmaceutical Manufacturing, ASTM: West Conshohocken, PA, 2020.
10. 10.↵
    1. Carlton R. A.

    Pharmaceutical Microscopy, Springer: New York, NY, 2011; pp 131–156.
11. 11.↵
    International Organization for Standardization. ISO 16232:2018 Road Vehicles—Cleanliness of Components and Systems; ISO: Geneva, Switzerland, 2018.
12. 12.↵
    U.S. Pharmacopeial Convention, General Chapter <1788.2> Membrane Microscope Method for the Determination of Subvisible Particulate Matter. In USP 42–NF 37. USP: Rockville, MD, 2019.
13. 13.↵
    U.S. Pharmacopeial Convention, General Chapter <1788.3> Flow Imaging Method for the Determination of Subvisible Particulate Matter. In USP 42–NF 37. USP: Rockville, MD, 2019.
14. 14.↵
    ASTM International. ASTM E3060-16(2016) Standard Guide for Subvisible Particle Measurement in Biopharmaceutical Manufacturing using Dynamic (Flow) Imaging Microscopy, ASTM: West Conshohocken, PA, 2016.