Research ArticleTechnology/Application
Development and Qualification of Visible Particle Load Analysis Methods for Injectable Drug Product Primary Packaging Components
Robin Wagner, Peter Masatani, Dana GRACE, Gianpiero TORRACA, Stephanie Moore and David Semin
PDA Journal of Pharmaceutical Science and Technology March 2023, 77 (2) 99-114; DOI: https://doi.org/10.5731/pdajpst.2021.012710
Robin Wagner
1Amgen Inc., Thousand Oaks, CA
Peter Masatani
1Amgen Inc., Thousand Oaks, CA
Dana GRACE
1Amgen Inc., Thousand Oaks, CA
Gianpiero TORRACA
1Amgen Inc., Thousand Oaks, CA
Stephanie Moore
1Amgen Inc., Thousand Oaks, CA
David Semin
1Amgen Inc., Thousand Oaks, CA
References
- 1.↵
- Wang H.
- 2.↵U.S. Pharmacopeial Convention, General Chapter <1> Injections and Implanted Drug Product (Parenterals)—Product Quality Tests. In USP 42–NF 37, USP, Rockville, MD, 2019; pp 6339–6343.
- 3.↵Council of Europe, Parenteral Preparations, Monograph 0520. In European Pharmacopoeia (Ph. Eur.), 9th Edition, Council of Europe, Strasbourg, France, 2016; pp 871–873.
- 4.↵Ministry of Health Labour and Welfare of Japan, General Tests, Processes and Apparatus—6.06: Foreign Insoluble Matter Test for Injection. In The Japanese Pharmacopoeia, 17th Edition (English Version), MHLW: Tokyo, 2016; p 151.
- 5.↵
- Langille S. E.
- 6.↵U.S. Pharmacopeial Convention, General Chapter <787> Subvisible Particulate Matter in Therapeutic Protein Injections. In USP 40–NF 35, USP, Rockville, MD, 2017; pp 663–664.
- 7.↵U.S. Pharmacopeial Convention, General Chapter <788> Particulate Matter in Injections. In USP 40–NF 35, USP, Rockville, MD, 2017; pp 665–668.
- 8.↵U.S. Pharmacopeial Convention, General Chapter <1787> Measurement of Subvisible Particulate Matter in Therapeutic Protein Injections. In USP 40–NF 35, USP, Rockville, MD, 2017; pp 2149–2162.
- 9.↵U.S. Pharmacopeial Convention, General Chapter <1788> Particulate Matter in Injections and Ophthalmic Solutions. In USP 40–NF 35, USP, Rockville, MD, 2017; pp 2163–2172.
- 10.↵U.S. Pharmacopeial Convention, General Chapter <790> Visible Particulates in Injections. In USP 42–NF 37, USP, Rockville, MD, 2019; p 6947.
- 11.↵U.S. Pharmacopeial Convention, General Chapter <1790> Visual Inspection of Injections. In USP 41–NF 36, USP, Rockville, MD, 2018; pp 8066–8083.
- 12.↵
- Mathonet S.,
- Mahler H.-C.,
- Esswein S. T.,
- Mazaheri M.,
- Cash P. W.,
- Wuchner K.,
- Kallmeyer G.,
- Das T. K.,
- Finkler C.,
- Lennard A.
- 13.↵
- Rech J.,
- Fradkin A.,
- Krueger A.,
- Kraft C.,
- Paskiet D.
- 14.↵International Organization for Standardization, ISO 8871-3:2003 Elastomeric Parts for Parenterals and for Devices for Pharmaceutical Use—Part 3: Determination of Released-Particle Count. ISO: Geneva, Switzerland, 2003.
- 15.↵
- McPherson E.,
- Bingham C.,
- Carter D.,
- Toomey W.,
- Scofield M.,
- Pulvirenti R.
- 16.↵U.S. Pharmacopeial Convention, General Chapter <660> Containers—Glass. In USP 42–NF 37, USP, Rockville, MD, 2019; pp 6806–6811.
- 17.↵U.S. Pharmacopeial Convention, General Chapter <661> Plastic Packaging Systems and Their Materials of Construction. In USP 42–NF 37, USP, Rockville, MD, 2019; pp 6812–6818.
- 18.↵
- Johns J.,
- Golfetto P.,
- Bush T.,
- Fantozzi G.,
- Shabushnig J.,
- Perry A.,
- Degrazio F.,
- Streich D.,
- Miller J.,
- Soukiassian H.,
- Stanton A.,
- Watson R.
- 19.↵Parenteral Drug Association Inc. PDA Technical Report No. 85: Enhanced Test Methods for Visible Particle Detection and Enumeration on Elastomeric Closures and Glass Containers; Bethesda, MD, 2021.
- 20.↵
- Langille S. E.
- 21.↵
- Makwana S.,
- Basu B.,
- Makasana Y.,
- Dharamsi A.
- 22.↵Brandessence Market Research. Global Safety & Prefilled Syringe Market Size By Product Type (Retractable Safety Syringe, Non-Retractable Safety Syringe) By Application (Insulin, Others) By End User (Hospitals, Others) Analysis Report, Regional Outlook, Growth Potential, Competitive Market Share & Forecast, 2021 – 2027. https://brandessenceresearch.com/medical-device/safety-prefilled-syringes-market (accessed August 2, 2021).
In This Issue
PDA Journal of Pharmaceutical Science and Technology
Vol. 77, Issue 2
March/April 2023
Development and Qualification of Visible Particle Load Analysis Methods for Injectable Drug Product Primary Packaging Components
Robin Wagner, Peter Masatani, Dana GRACE, Gianpiero TORRACA, Stephanie Moore, David Semin
PDA Journal of Pharmaceutical Science and Technology Mar 2023, 77 (2) 99-114; DOI: 10.5731/pdajpst.2021.012710
Development and Qualification of Visible Particle Load Analysis Methods for Injectable Drug Product Primary Packaging Components
Robin Wagner, Peter Masatani, Dana GRACE, Gianpiero TORRACA, Stephanie Moore, David Semin
PDA Journal of Pharmaceutical Science and Technology Mar 2023, 77 (2) 99-114; DOI: 10.5731/pdajpst.2021.012710
Jump to section
Related Articles
- No related articles found.
Cited By...
- No citing articles found.