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1

Environmental and Personnel Monitoring Programs-A Risk-Based Case Study of Cutibacterium acnes.

Tidswel EC, Boone K. Tidswel EC, et al. PDA J Pharm Sci Technol. 2020 Jul-Aug;74(4):408-422. doi: 10.5731/pdajpst.2019.010975. Epub 2020 Feb 14. PDA J Pharm Sci Technol. 2020. PMID: 32060223 Review.

2

Continuous and Effective Microbiological Air Monitoring in Critical Environments: A Comparison of Analytical Methodologies.

Dalmaso G, Campanella A, Lazzeri P. Dalmaso G, et al. PDA J Pharm Sci Technol. 2020 Jul-Aug;74(4):446-455. doi: 10.5731/pdajpst.2019.010181. Epub 2020 Feb 14. PDA J Pharm Sci Technol. 2020. PMID: 32060221

3

Revision of Viable Environmental Monitoring in a Development Pilot Plant Based on Quality Risk Assessment: A Case Study.

Ziegler I, Borbély-Jakab J, Sugó L, Kovács RJ. Ziegler I, et al. PDA J Pharm Sci Technol. 2017 May-Jun;71(3):234-244. doi: 10.5731/pdajpst.2016.007096. Epub 2017 Jan 15. PDA J Pharm Sci Technol. 2017. PMID: 28089966

4

Comparison of different incubation conditions for microbiological environmental monitoring.

Gordon O, Berchtold M, Staerk A, Roesti D. Gordon O, et al. PDA J Pharm Sci Technol. 2014 Sep-Oct;68(5):394-406. doi: 10.5731/pdajpst.2014.00994. PDA J Pharm Sci Technol. 2014. PMID: 25336415

5

Quantitative Microbial Risk Assessment of Pharmaceutical Products.

Eissa ME. Eissa ME. PDA J Pharm Sci Technol. 2017 May-Jun;71(3):245-251. doi: 10.5731/pdajpst.2016.007047. Epub 2016 Dec 14. PDA J Pharm Sci Technol. 2017. PMID: 27974628

6

Validation of Milliflex^® Quantum for Bioburden Testing of Pharmaceutical Products.

Gordon O, Goverde M, Staerk A, Roesti D. Gordon O, et al. PDA J Pharm Sci Technol. 2017 May-Jun;71(3):206-224. doi: 10.5731/pdajpst.2016.007450. Epub 2017 Feb 14. PDA J Pharm Sci Technol. 2017. PMID: 28196917

7

Microbial identification strategies in the pharmaceutical industry.

Cundell AM. Cundell AM. PDA J Pharm Sci Technol. 2006 Mar-Apr;60(2):111-23. PDA J Pharm Sci Technol. 2006. PMID: 16696194

8

Continuous Microbiological Environmental Monitoring for Process Understanding and Reduced Interventions in Aseptic Manufacturing.

Weber J, Hauschild J, Ijzerman-Boon P, Forng RY, Horsch J, Yan L, Prasad A, Henry RB, Claassen M, Villari P, Shereefa S, Wyatt J, Bolden JS, Pycke JT, Dassu D. Weber J, et al. PDA J Pharm Sci Technol. 2019 Mar-Apr;73(2):121-134. doi: 10.5731/pdajpst.2018.008722. Epub 2018 Oct 25. PDA J Pharm Sci Technol. 2019. PMID: 30361285

9

Contamination Control.

Akers MJ. Akers MJ. Int J Pharm Compd. 2015 May-Jun;19(3):232-8. Int J Pharm Compd. 2015. PMID: 26714364

10

Validation Study of Rapid Assays of Bioburden, Endotoxins and Other Contamination.

Shintani H. Shintani H. Biocontrol Sci. 2016;21(2):63-72. doi: 10.4265/bio.21.63. Biocontrol Sci. 2016. PMID: 27350424 Free article. Review.

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