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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 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

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 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

3

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.

4

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

5

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

6

Field evaluation of nanofilm detectors for measuring acidic particles in indoor and outdoor air.

Cohen BS, Heikkinen MS, Hazi Y, Gao H, Peters P, Lippmann M. Cohen BS, et al. Res Rep Health Eff Inst. 2004 Sep;(121):1-35; discussion 37-46. Res Rep Health Eff Inst. 2004. PMID: 15553489

7

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.

8

Removal of viable bioaerosol particles with a low-efficiency HVAC filter enhanced by continuous emission of unipolar air ions.

Huang R, Agranovski I, Pyankov O, Grinshpun S. Huang R, et al. Indoor Air. 2008 Apr;18(2):106-12. doi: 10.1111/j.1600-0668.2007.00512.x. Indoor Air. 2008. PMID: 18333990

9

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

10

Development and application of an aerosol screening model for size-resolved urban aerosols.

Stanier CO, Lee SR; HEI Health Review Committee. Stanier CO, et al. Res Rep Health Eff Inst. 2014 Jun;(179):3-79. Res Rep Health Eff Inst. 2014. PMID: 25145039

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