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
Agenda
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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
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IAQ Consulting
Military and Homeland Security
Pharmaceutical Manufacturing
Medical Device Manufacturing
Personal Care
Food Processing
Healthcare
“Sick Buildings”
• Joint Business Opportunities
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.
Particle Counting in Non-Cleanrooms
Q:
A:
What is the primary problem using a conventional
particle counter in a non-cleanroom environment?
The device is easily overwhelmed by the quantity of
particles.
BioVigilant’s detector was designed to work in a noncleanroom 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
How Microbial Contamination Testing is Done
Now
Traditional Methods
• Plate culture of viable cells
• Antibody immunoassay
“Rapid Methods”
• Plate scanning cytometer
• Flow cytometer
• PCR
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
Relevant Particle Size Range
Color Guide
= biological
= inert
= virus
pollen
bacteria
mold
bio-agent
dust
smog
Virus
0.2mm 0.5mm
1mm
5mm
50mm
Particle size
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
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.
Fluorescence Excitation Spectra
Metabolite
Excitation Wavelength Peak / (Range)
Tryptophan
270 nm (220 nm – 300 nm)
NADH
340 nm (300 nm – 410 nm)
Riboflavin
400 nm (320 nm – 420 nm)
NAD(P)H
300
320
340
360
Wavelength (nm)
380
400
Relative Fluorescence Intensity (AFU)
Relative Fluorescence Intensity (AFU)
(J.K. Li, et al, Biotechnol. Prog. Vol. 7, 21, 1991)
Riboflavin
300
320
340
360
380
Wavelength (nm)
400
Fluorescence Emission Spectra
(Hill et al, Field Ana. Chem. & Tech, 3(4-5), 221,1999)
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)
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•Simultaneous fluorescence detection
Single wavelength UV laser source
– Targeting major metabolites
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•Technical background
Leverage bio-defense sensor technology
– Advent of UV laser sources
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Model IMD-A
Continuous, Simultaneous & Instantaneous Microbial
Detection
Display of
Microbe-free Air
(Yellow bars are
inert particles.)
Continuous, Simultaneous & Instantaneous Microbial
Detection
Display of
Dispersed Baker’s
Yeast
(Saccharomyces
Cerevisiae)
(Yellow bars are
inert particles. Red
bars are microbe
counts.)
How IMD Differs from How It’s Done Now
Instantaneous vs. 1 – 9 days
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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
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
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
Joint Business Opportunities
Internal use as sales and process tool
Distribution
Licensing
?