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1

Visible Particulate Contamination Control for Injectable Products: A Life-Cycle Approach.

Langille SE. Langille SE. PDA J Pharm Sci Technol. 2020 May-Jun;74(3):359-366. doi: 10.5731/pdajpst.2019.010462. Epub 2019 Nov 15. PDA J Pharm Sci Technol. 2020. PMID: 31732691

2

Considerations for design and use of container challenge sets for qualification and validation of visible particulate inspection.

Melchore JA, Berdovich D. Melchore JA, et al. PDA J Pharm Sci Technol. 2012 May-Jun;66(3):273-84. doi: 10.5731/pdajpst.2012.00862. PDA J Pharm Sci Technol. 2012. PMID: 22634593

3

A Biopharmaceutical Industry Perspective on the Control of Visible Particles in Biotechnology-Derived Injectable Drug Products.

Mathonet S, Mahler HC, Esswein ST, Mazaheri M, Cash PW, Wuchner K, Kallmeyer G, Das TK, Finkler C, Lennard A. Mathonet S, et al. PDA J Pharm Sci Technol. 2016 Jul-Aug;70(4):392-408. doi: 10.5731/pdajpst.2015.006189. Epub 2016 Apr 18. PDA J Pharm Sci Technol. 2016. PMID: 27091885 Review.

4

Achieving "Zero" Defects for Visible Particles in Injectables.

Johns J, Golfetto P, Bush T, Fantozzi G, Shabushnig J, Perry A, Degrazio F, Streich D, Miller J, Soukiassian H, Stanton A, Watson R. Johns J, et al. PDA J Pharm Sci Technol. 2018 Nov-Dec;72(6):640-650. doi: 10.5731/pdajpst.2018.009027. Epub 2018 Sep 19. PDA J Pharm Sci Technol. 2018. PMID: 30232141

5

Particulate matter in injectable drug products.

Langille SE. Langille SE. PDA J Pharm Sci Technol. 2013 May-Jun;67(3):186-200. doi: 10.5731/pdajpst.2013.00922. PDA J Pharm Sci Technol. 2013. PMID: 23752747

6

The need for new control strategies for particulate matter in parenterals.

Poms J, Sacher S, Nixdorf M, Dekner M, Wallner-Mang S, Janssen I, Khinast JG, Schennach R. Poms J, et al. Pharm Dev Technol. 2019 Jul;24(6):739-750. doi: 10.1080/10837450.2019.1585449. Epub 2019 Apr 3. Pharm Dev Technol. 2019. PMID: 30821571

7

Points to Consider: Best Practices to Identify Particle Entry Routes along the Manufacturing Process for Parenteral Formulations.

Anger S, Begat C, Crnko V, Fantozzi G, Farach W, Fitzpatrick S, Gallagher B, Huelsmann S, Kinsey P, Langlade V, Lefevre G, Legendre E, McLean K, Miller J, Patel R, Perry A, Soukiassian H, Stanton A, Streich D, Timmons C, Vaneylen D, van Hoose T, Wildling L, Windover M. Anger S, et al. PDA J Pharm Sci Technol. 2019 Nov-Dec;73(6):635-647. doi: 10.5731/pdajpst.2019.010645. Epub 2019 Aug 16. PDA J Pharm Sci Technol. 2019. PMID: 31420504

8

Particulate Generation Mechanisms during Bulk Filling and Mitigation via New Glass Vial.

Timmons CL, Liu CY, Merkle S. Timmons CL, et al. PDA J Pharm Sci Technol. 2017 Sep-Oct;71(5):379-392. doi: 10.5731/pdajpst.2017.007724. Epub 2017 May 15. PDA J Pharm Sci Technol. 2017. PMID: 28512178

9

Container Closure Integrity Testing-Practical Aspects and Approaches in the Pharmaceutical Industry.

Brown H, Mahler HC, Mellman J, Nieto A, Wagner D, Schaar M, Mathaes R, Kossinna J, Schmitting F, Dreher S, Roehl H, Hemminger M, Wuchner K. Brown H, et al. PDA J Pharm Sci Technol. 2017 Mar-Apr;71(2):147-162. doi: 10.5731/pdajpst.2016.006999. Epub 2016 Oct 27. PDA J Pharm Sci Technol. 2017. PMID: 27789803

10

USP perspectives on particle contamination of injectable products.

Gallelli JF, Groves MJ. Gallelli JF, et al. J Parenter Sci Technol. 1993 Nov-Dec;47(6):289-92. J Parenter Sci Technol. 1993. PMID: 8120733

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