Maximizing Cleanroom Efficiency with Instant Microbial Detection

1. Presentation to National Air Filtration Association Particle Counting in Non-Cleanrooms Instantaneous Microbial Detection What’s In It For You • JP Jiang, PhD, Chief Technology Officer • Chuck Bolotin, VP, Sales 9-24-05

2. Agenda • About BioVigilant Laboratories • Particle Counting in Non-Cleanrooms • How Microbial Contamination Testing is Done Now • What is “Instantaneous Microbial Detection”? • How IMD Differs from How It’s Done Now • Industry Applications for IMD • IAQ Consulting • Military and Homeland Security • Pharmaceutical Manufacturing • Medical Device Manufacturing • Personal Care • Food Processing • Healthcare • “Sick Buildings” • Joint Business Opportunities

3. About BioVigilant Laboratories Mission Statement Apply our scientific capabilities in the service of our customers’ needs. • Headquarters in world famous “Optics Valley”, Tucson, Arizona • Highly skilled researchers, scientists, engineers -- 12 patents issued, 7 pending • Initial focus was homeland security • Novel application of Mie Scattering • Only company to combine simultaneous determination of inert or biological • Currently applying technology to commercial markets • Strong management team • Experienced: average of 23+ years per person in successful tech development and deployment • Multi-disciplinary: optical physics, software development, mechanical engineering, bio-sciences, medical, manufacturing, semiconductor, government.

4. Particle Counting in Non-Cleanrooms Q: What is the primary problem using a conventional particle counter in a non-cleanroom environment? A: The device is easily overwhelmed by the quantity of particles. BioVigilant’s detector was designed to work in a non-cleanroom environment. • Not overwhelmed by quantity of particles • Continuous monitoring design enables trending Applications: • QA in filter manufacturing • Part of air filtration system in buildings • Monitor emissions in “dirty” environment

5. How Microbial Contamination Testing is Done Now Traditional Methods • Plate culture of viable cells • Antibody immunoassay “Rapid Methods” • Plate scanning cytometer • Flow cytometer • PCR

6. What is “Instantaneous Microbial Detection”? Instantaneous Microbial Detection (or “IMD”)n.The process that provides immediate and continuous quantification of microbes present in a specified volume of air or liquid. <BioVigilant

7. Relevant Particle Size Range Color Guide = biological = inert pollen = virus bacteria mold bio-agent dust smog Virus 0.2mm 0.5mm 1mm 5mm 50mm Particle size

8. What is “Instantaneous Microbial Detection”? Can do: • Single particle detection, size and count • Resolution to +/- 0.25 micron; highly accurate sizing • Simultaneously and in real time determine if each individual particle is inert or biological • Broad range of microbial detection • No need for reagent Cannot do: • Detect viruses • Identify genus

9. What is “Instantaneous Microbial Detection”? Scientific Principle • Microbes (bacteria, fungi) contain metabolites, which emit fluorescence under UV illumination. Intrinsic fluorescence emission is used as the marker for microbes. • Deterministic single particle sizing / fluorescence measurements provide ability to differentiate pollens and smoke from bacteria. • Methodology eliminates the need of reagent dye labeling and achieves instantaneous detection.

10. Fluorescence Excitation Spectra (J.K. Li, et al,Biotechnol. Prog. Vol. 7, 21, 1991) Relative Fluorescence Intensity (AFU) Relative Fluorescence Intensity (AFU) NAD(P)H Riboflavin 300 320 340 360 380 400 300 320 340 360 380 400 Wavelength (nm) Wavelength (nm)

11. Fluorescence Emission Spectra (Hill et al, Field Ana. Chem. & Tech, 3(4-5), 221,1999)

12. What is “Instantaneous Microbial Detection”? • Instantaneous Microbial Detector • Key features: • High resolution particle counter • Integration of BioVigilant’s patented single path technology • Individual particle analysis • 0.5 – 20 μm range (high resolution) • Simultaneous fluorescence detection • Single wavelength UV laser source • Targeting major metabolites • Technical background • Leverage bio-defense sensor technology • Advent of UV laser sources Model IMD-A

13. Continuous, Simultaneous & Instantaneous Microbial Detection Display of Microbe-free Air (Yellow bars are inert particles.)

14. Continuous, Simultaneous & Instantaneous Microbial Detection Display of Dispersed Baker’s Yeast (Saccharomyces Cerevisiae) (Yellow bars are inert particles. Red bars are microbe counts.)

15. How IMD Differs from How It’s Done Now Instantaneous vs. 1 – 9 days • Information for bio-terror attack is time sensitive • Throw out less production • Fewer planned halts in production • Unplanned halts in production • Easier to remediate and verify remediation • Value as sales tool to demonstrate contamination and remediation Continuous monitoring and real-time feedback vs. episodic testing and time-delayed feedback • Able to trend, spot anomalies / problems earlier • Lowers chances of contamination • Throw out less production

16. Industry Applications for IMD • IAQ Consulting • As a sales tool to show what work needs to be done • As a sales tool to verify that remediation worked • Military and Homeland Security • Trigger device against bio-terror attack • HVAC • In the open • Pharmaceutical Manufacturing • FDA regulations • Internal requirements • Reputation • Legal exposure • Recalls • Replace much of: settle plates, particle detectors, rapid methods devices • Significant, quantifiable, understood, urgent need

17. Industry Applications for IMD • Medical device manufacturing • Similar requirements to pharmaceutical manufacturing • Personal care (cosmetics) • Significant internal requirements • Food processing • Limited but valuable in certain areas, no strict regulatory requirements • Hospitals • Hospital Acquired Illnesses • Legal exposure • “Sick Buildings” • Commercial • Government • Schools

18. Joint Business Opportunities Internal use as sales and process tool Distribution Licensing ?