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

Abstract

This paper describes the assessment of the BioVigilant® IMD-A™, a novel optical spectroscopy technology for the detection, sizing, and quantification of both viable and nonviable particles in real time. A comparative-study of a prototype design with conventional air sampling systems (the MAS-100™ and the CLiMET CI-450t) is presented. Studies have demonstrated that the BioVigilant IMD-A is capable of simultaneously and instantaneously enumerating both viable and nonviable particles in a variety of classified and uncontrolled environments. In general, the data for the IMD-A and the CLiMET followed a similar trend of increasing counts for both the ≥0.5 μm and the ≥5.0 μm nonviable particles when sampling progressed from the most controlled area (Grade A) to the least controlled area (a loading dock open to the outside of the facility). Zero viable particle counts were observed for both the IMD-A and the MAS when sampling the Grade A location. However, there was a trend for the IMD-A to detect significantly greater numbers of viable particles when monitoring all other sampling locations, especially those locations representing the least controlled environments. In addition, the IMD-A also detected, sized, and enumerated both viable and nonviable particles in a continuous sampling mode. The IMD-A technology's ability to provide real-time data may offer the industry an unprecedented advantage over growth-based bioaerosol samplers for monitoring the state of microbiological control in pharmaceutical manufacturing environments.