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1

Evaluation of the BioVigilant IMD-A, a novel optical spectroscopy technology for the continuous and real-time environmental monitoring of viable and nonviable particles. Part II. Case studies in environmental monitoring during aseptic filling, intervention assessments, and glove integrity testing in manufacturing isolators.

Miller MJ, Walsh MR, Shrake JL, Dukes RE, Hill DB. Miller MJ, et al. PDA J Pharm Sci Technol. 2009 May-Jun;63(3):259-83. PDA J Pharm Sci Technol. 2009. PMID: 20069799

2

Evaluation of the BioVigilant IMD-A, a novel optical spectroscopy technology for the continuous and real-time environmental monitoring of viable and nonviable particles. Part I. Review of the technology and comparative studies with conventional methods.

Miller MJ, Lindsay H, Valverde-Ventura R, O'Conner MJ. Miller MJ, et al. PDA J Pharm Sci Technol. 2009 May-Jun;63(3):245-58. PDA J Pharm Sci Technol. 2009. PMID: 20069798

3

Continuous microbiological air monitoring for aseptic filling lines.

Scherwing C, Golin F, Guenec O, Pflanz K, Dalmaso G, Bini M, Andone F. Scherwing C, et al. PDA J Pharm Sci Technol. 2007 Mar-Apr;61(2):102-9. PDA J Pharm Sci Technol. 2007. PMID: 17479718

4

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

5

Application of rapid microbiological methods for the risk assessment of controlled biopharmaceutical environments.

Sandle T, Leavy C, Jindal H, Rhodes R. Sandle T, et al. J Appl Microbiol. 2014 Jun;116(6):1495-505. doi: 10.1111/jam.12487. Epub 2014 Mar 21. J Appl Microbiol. 2014. PMID: 24575809 Free article.

6

Continuous microbiological air monitoring for aseptic filling lines.

Ginsbury K. Ginsbury K. PDA J Pharm Sci Technol. 2007 Jul-Aug;61(4):225. PDA J Pharm Sci Technol. 2007. PMID: 17933205 No abstract available.

7

Investigation of the detection ability of an intrinsic fluorescence-based bioaerosol detection system for heat-stressed bacteria.

Irie K, Scott A, Hasegawa N. Irie K, et al. PDA J Pharm Sci Technol. 2014 Sep-Oct;68(5):478-93. doi: 10.5731/pdajpst.2014.01000. PDA J Pharm Sci Technol. 2014. PMID: 25336419

8

Some observations on airborne particles in the critical areas of a blow-fill-seal machine.

Sundström S, Ljungqvist B, Reinmüller B. Sundström S, et al. PDA J Pharm Sci Technol. 2009 Jan-Feb;63(1):71-80. PDA J Pharm Sci Technol. 2009. PMID: 19455943

9

How risky are pinholes in gloves? A rational appeal for the integrity of gloves for isolators.

Gessler A, Stärk A, Sigwarth V, Moirandat C. Gessler A, et al. PDA J Pharm Sci Technol. 2011 May-Jun;65(3):227-41. doi: 10.5731/pdajpst.2011.00716. PDA J Pharm Sci Technol. 2011. PMID: 22293234 Review.

10

Media-fill simulation tests in manual and robotic aseptic preparation of injection solutions in syringes.

Krämer I, Federici M, Kaiser V, Thiesen J. Krämer I, et al. J Oncol Pharm Pract. 2016 Apr;22(2):195-204. doi: 10.1177/1078155214565123. Epub 2014 Dec 30. J Oncol Pharm Pract. 2016. PMID: 25549919

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