Advanced Sensor Tech : SpectRx™ FFT-NIR, Speed & Hardness Test Game Changer

Ivy Lee

@IvyLeeSensorX

Marketing Director

@AmericanSensorX June, 2015

One of Advanced Sensor Tech : SpectRx™ FFT-NIR

Speed & Hardness Test Game Changer

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Advanced Sensor Tech Partnering In Fantastic SensorX

• Food&Drug Safety Modernization Cloud

• Smart MFG Platform

• Data Center System & Analytics • IoT

• sPhone

• SensorX Climate

• SiteSocial

Smart Engineering

Compact

SpectRx™

FFT-NIR

InspectRx® SpectRx™ FilleRx® OS

NanoMEMS

Sensor Network

Robot 3D Printer FFT

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3 InspectRx®: um Particle SpectRx™: Chemical Composition, 0.01% Concentration, 1 PPM Weight, 0.1% Sensitivity

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@SensorXClimate, Your 12.5 Milliseconds AQI

Wearable InspectRx®-SpectRx™-Nano Positioning & ID Chip Sensor--Environment

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Probe

Object

Fiber Optic Cables Detector

Spectrometer

Multi-online Process Apps—Pharma, Food, Polymer

Product Streams under 2, 80 Probes

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80 SpectRx™ Probes

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Redesigned for JNJ Stent

5 Analysis of Stents of Same Polymers with Different Active Concentrations

Stents of Different Polymers with Same Constant of Active Layer

Each Stent Includes Micro-composition of Drug Contents Deposited between Polymer Layers SpectRx ™-Stent Online Process

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Innovative Probe Awarded with FilleRx® 5 Milliseconds / Analyse/Probe

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Type1

Precision Concentration: 0.01% Weight: 25 PPM

Sensitivity: 0.1%

Penetrate 5 mm Depth

Prism 10 mm

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Lab App - Pharma, Food, Agri, Oil & Gas, Chemical

Samples on Turntable

Three Plug and Play Modules 1. Near Infrared Fiber Optic, Probe 2. InSb Detector • Analogue-to-digital Converter • Electromagnetic Interferometer

(100 + times data) • Digital Signal Processor 3. An Automated Indexer A PLC Sensors

Competitive: NIR Light Source Signal Transmission Reflected Signal Detection Data Analysis Process

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InspectRx®- SpectRx™ Better Foods Pricing, Nutrition

SpectRx™ FFT-NIR + InspectRx® Special Light Analyze • Fat/Protein/Moisture Contents • Infected Cysts, Parasites & Drug Residue

InspectRx® Measure • Fat/Protein Percentage • Protein Color Calculate • Area • Thickness • Volume • Weight • Accumulation • Price per weight

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World Fastest Speed:

Type1: 180 Analyses/Second/Probe

Type2: 80 Analyses/Second/Probe

Precision(Concentration): 0.01%

Precision(Weight):

Type1: 25 PPM

Type2: 1 PPM

Sensitivity: 0.1%

Wave Length: 830-2500nm

Spectra: Millions

Penetrate 5mm Depth

Real Time Production

Close-Loop System

Total Integration with Production Machine

Incoming Inspection and Verifications

In-process Inspection

Maintains Consistent Quality

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Frost & Sullivan Spectroscopy Inspection Tech Excellence IR-Based Vision System

9 Solid – Powder – Liquids – Semi-Solid – Gas

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Tech Advantage 1. Speed Time Dispersion and Time / Spatial Separation beyond Classical FFT(Fast Fourier Transform) Spectrometer

Classical advantages of FFT spectrometry over dispersive spectrometry:

• Multiplexing all wavelengths fall on the detector at all times

• Throughput the aperture vs resolution limitation is reduced

• Wavelength accuracy the internal laser ensures stability in ppm levels

SpectRx™ further superior:

It relies on time not spatial dispersion of the spectral information. This limits the number of moving components and provides a more reliable observation geometry. In practice, it is

• Higher spectral resolution.

• Larger bandwidth, more spectral channels

• Flexibility: because of the complete separation of spectral information (performed in the time domain) and spatial information (performed in the spatial domain),The spectral resolution can be instantly changed by computer. The field of view configuration can be changed in the field, simply by changing telescope modules.

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Tech Advantage 2. Radiometric Accuracy Influenced by

1. Calibration Source Errors

Relative radiometric errors at 5000 cm-1, 2860 cm-1, and 2000 cm-1 (2 m, 3.5 m, and 5 m) due to the uncertainty of the calibration source temperature, assuming a blackbody relative temperature accuracy of 0.2% and an absolute accuracy of 1°. The maximum error is 5% for the coldest source (TS=373K) at the highest frequency(=2860cm-1). This is a very pessimistic value.

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2. Calibration Drift

InSb detectors exhibit much less variation of responsively with respect to temperature.

We typically use 2% as the relative radiometric accuracy due to drift, and assume that the corresponding time interval between characterisation and scene measurement is long enough to allow measurement.

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3.Spectrometer Intrinsic linearity

Detector Non-Linearity Error The saturation level is never reached because the feedback resistors used are high enough so that preamplifier saturation occurs before there is detector saturation. We therefore do not anticipate detector non-linearity problems in InSb detectors.

Channel Spectrum Error

A certain degree of wedging a parallel-face protective window would further reduce the channel spectrum but at the cost of introducing the phenomenon of ghost images. Spectral Aliasing Error

An optical filter provides both a sharp cut-off and very high attenuation outside the spectral range of interest. This method also reduces photon noise.

Tech Advantage 2. Radiometric Accuracy Influenced by

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Solid - Tablets-Capsules-Polymer

Diffused Reflectance Tablet Hardness Tablet Disintegration Tablet/Capsule Moisture Contents Tablet Friability Tablet Capsule Active Ingredients Tablet/Capsule Impurities Tablet Cracks Capsule Deterioration Tablet/Capsule Homogeneity

Sabrie Index (FDA Approved)

Non-destructive identification harness and disintegration by the InspectRx® & SpectRx™ correlation with the energy absorbed or reflected.

Widely used among scientists and physicists.

13 • The only automated system can detect hardness and disintegration without destroying • Achieved by applying neural network analysis using Sabrie’s Index.

Tech Advantage 3. IR-Based Vision System Analyze Physical & Chemical Properties

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Liquid - Gels – Ointments

• Transmission

• Liquid Composition

• Active Ingredients

• Homogeneity

• Impurities

• Air-Bubbles

• Oxygen

• Acidity

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Tech Advantage 3. IR-Based Vision System Analyze Physical & Chemical Properties

IR-Based Vision System

•InspectRx® vision inspects physical

properties.(U.S. Patent 5,679,954)

•SpectRx™ FFT-NIR analyzes organic and

inorganic properties.(5,900,634)

SpectRx™ FFT-NIR App in Brief

•Chemical Compositions

•Active Ingredients

•Impurities

•Concentration

•Homogeneity

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Windows-based data manipulation and processing module

• View, process, and organise data. It allows easy data and graphics exchange with other Windows applications such as spreadsheet and word processors.

• Data processing capabilities are fast and accurate. It includes a built-in programming language, Array Basic, so that advanced users can modify existing algorithms or create new ones for the individual requirements of specific experiments.

―C++/Visual Basic‖ Windows® based acquisition module—Research Acquire 1. Necessary functions: • Raw interferograms • Un calibrated spectra • Radiometric reference spectra using calibrated

sources • Calibrated spectra • FFTNIR or FFTIR-type data in transmission, such as

raw, reference, transmittance and absorbance spectra, which can be useful for quick diagnostics in such things as the measuring of stability, the transmission capacity of optical filters, and a general examination of the spectral content of the source observed.

2. A basic display system and a set of post-processing functions • Perform radiometric calibration, • Conversion to temperature units • Integration over programmable bands • Computation of theoretical Planck functions, addition,

subtraction, multiplication, and ratios.

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Tech Advantage 4. Software Philosophy

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Tech Advantage 5. Data Flow Outline Involved in Spectrometer

• The scan length is a function of resolution.

• All wavelengths are acquired simultaneously whatever the scan length is.

• SpectRx™ systems acquire double-sided interferograms.

• The sampling rate is a function of the scanning speed and of the number of samples per fringe or oversampling factor.

• The maximum observable spectral range is determined by the oversampling factor. In the SpectRx™ the oversampling factor can be 1 (no oversampling) or 2, this provides for spectral ranges of 0 to 7899 cm-1 and 15798cm-1 respectively.

• Each data point is stored as a 16-bit number. Coherent addition or signal averaging is done with 32 bit numbers.

• The maximum number of interferograms, which can be recorded in kinetic mode, depends on the size of the DRAM buffer. This is 4 MB (expandable to 64 MB) in the case of the SpectRx™ 100, and 64 MB in the SpectRx™ 200.

• The required scanning speed is dictated by how fast an event is to be resolved; it is limited by the ADC speed, the detector response time, and the throughput of the electronics, including the communication links. It is 1 cm/s in the SpectRx™ 100 and 25 cm/s in the SpectRx™ 200.

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Tech Advantage 6. Sensitivity: 0.1% Signal / Peak Noise Amplitude = 3

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Really Simple Syndication

Scene Radiation

Detector Irradiance

Detector Current

Photon Noise Johnson Noise

Jitter Noise

ADC Noise

Dark Noise

Noise Equivalent Spectral Radiance

Signal to Noise Ratio

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Tech Advantage 7. One of World Largest Spectral Database (Millions)

Comparing to stored ―gold standard sample‖ It can enter the verification and validation to maintain quality and consistency.

In case of unknown composition

A 95% chance of unknown composition can be found through millions of spectral diagram ( local database), unless the composition of signal to noise ratio is too small.

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Input – Use Spectra as Input Layer - Data

Output

Input

Hidden Layers

Input Layers

Output Layers

Output – Such As Active Ingredients by Weight

Tech Advantage 8. SensorX Neural Network Analysis

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SpectRx™ Software Programming Guide

Run Manual Mode 1. Set sample standard

• In case of known conditions as P12-

P13, for instance, ① Hardness, disintegration, sabrie index ② Weight : chemical compositions, active

ingredients ③ Content : air humidity, sample moisture

• In case of unknown composition, 95%

can be found in local database. 2. Set upper & lower control limits on production screen 3.Set spectroscopic methods.

Run Auto Mode

1. Accept – Reject - Quarantined An acceptable product must fall between upper & lower control limits

2. Data Storage, implementation, validation

Training and Development

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21 21 21 21 Auto Mode / Manual Mode Chemical Composition Spectrum Deviation

Set as (Golden) Standard

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22 22 Active Ingredients Weight and Spectrum Deviation Air Humidity, Product Moisture Content

Set as (Golden) Standard

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Sabrie Index, Hardness, Disintegration and Spectrum Deviation 23

Set as (Golden) Standard

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An Acceptable Product Must Fall Between Upper & Lower Control Limits

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Data Storage & Implement & Validation Experience Lab-Precision, Online Production-Speed in Large Corps

• UI (Production) Monitor Interface(MI)

Operator/Supervisor/Admin

Interface(OI)

Global Program Parameters

Interface (PI)

• FDA Compliance Package ( Data Storage & Implement) • Data Security (Massive,

Permanent Electronic Document / Image Classification & Records)

• Global Sites Network

• Servers

25 Currently, 50% of global production data are inactive.

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Tech Advantage 9. SpectRx ™ FFT – NIR Spectroscopic Methods

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Emission Spectroscopy Fluorescence

Light Source Measurement

Reflection Absorbancy

Infrared Spectroscopy

UV spectroscopy

Laser Spectroscopy

Transmission

Every sample has its own specific spectral ―fingerprint.‖ Unlike other analytical procedures, the samples do not need time-consuming preparation.

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Emission Spectroscopy Fluorescence In Biology, Materials, Production Oversight

Measure an excitation spectrum,

• The fluorescent sample is illuminated with different wavelengths one after another.

• The intensity of the fluorescent radiation is measured at a fixed wavelength.

• The intensity measured at this wavelength is applied at the excitation wavelength.

Measure an emission spectrum,

• with a fixed wavelength.

• The sample emits fluorescent radiation over a wide range of wavelengths.

• The intensity emitted is applied at

the particular emission wavelength.

27 Light source measurement is commonly used in emission spectroscopy area.

UV Spectroscopy is primarily executed as absorption and fluorescence spectroscopy.

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Light Source Measurement In Physiological Criteria Evaluation

Calibration source errors, the first type of three errors influence radiometric accuracy(P8), are deviations in the production of a perfect calibration source. These errors include the accuracy of blackbody temperature and the accuracy of its emissivity over the operational spectral range.

28 Light source measurement is commonly used in emission spectroscopy area.

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Laser Spectroscopy As Light Source

The laser is used

• A light source for excitation

• Illuminating the sample for absorption measurement.

• If the sample is excited by the laser, the sample itself begins to emit radiation. The spectrometer records the radiation at a right angle to the direction of the radiation excitations.

• If the sample absorbs the laser beam, the sample is placed between the laser and the spectrometer.

29 Light source measurement is commonly used in emission spectroscopy area.

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Absorbance For Materials In Water and Gas

Measure monochromatic radiation For materials in water solution or gas, optical density is directly proportional to the concentration of the material.

Measure cloudy samples

• A sensible choice of reference measurements must be made.

• Both absorption and reflection measurement values change as a result of the dispersion of the radiation. In order to get real spectra, the reference measurements in the observed wavelength range must be transparent but display a comparable dispersion.

30 UV Spectroscopy is primarily executed as absorption and fluorescence spectroscopy.

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Reflection

The sample reflects the radiation diffusely; the directly reflected radiation is coupled out through the gloss trap. Only the diffuse reflection is coupled into the optical fiber.

The reference measurement is measured against a comparable strongly diffuse reflecting white reference standard (Spectralon).

The spectrometer is reset to reflection measurement. The reflectance from the wavelength can be read off on the spectrometer

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Transmission

1.The spectrometer is set to absorption. • First, the radiation intensity and

special diffusion of the light source are measured. This reading is the reference measurement.

• The sample is then fixed into the holder.

2.Set to transmission • A spectrum is then taken.

• • Depending on the setting, the

transmission can be displayed as a percentage or transmittance from the wavelength.

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Infrared Spectroscopy in Organic Materials UV Spectroscopy in Drinking Water

They are separate fields, places special demands on the spectrometer.

IR spectroscopy has become extremely important because the molecular vibrations have an effect on the spectrum in infrared. Nearly all organic materials exhibit specific absorptions in the near infrared.

33 UV Spectroscopy is primarily executed as absorption and fluorescence spectroscopy.

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Sample SpectRx™ Customers

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1. Pfizer 2. Johnson & Johnson 3. Bayer 4. Hoffmann–La Roche 5. Novartis 6. GlaxoSmithKline 7. Sanofi-Aventis 8. AstraZeneca 9. Abbott Laboratories 10. Merck & Co. 11. Bristol-Myers Squibb 12. Eli Lilly and Company 13. Boehringer Ingelheim 14. Takeda

Pharmaceuticals

15. Amgen 16. Genentech 17. Baxter International 18. Teva Pharma 19. Astellas Pharma 20. Daiichi Sankyo 21. Novo Nordisk 22. Procter & Gamble 23. Eisai 24. Merck KgaA 25. Alcon 26. SINOPHARM 27. Akzo Nobel 28. UCB

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42. Mitsubishi Pharma 43. Shire 44. Cephalon 45. Dainippon Sumitomo 46. Kyowa Hakko Kogyo 47. Shionogi 48. Mylan Laboratories 49. H. Lundbeck

Sample SpectRx™ Customers

29. Nycomed 30. Forest Laboratories 31. Solvay 32. Genzyme 33. Allergan 34. Gilead Sciences 35. CSL 36. Chugai Pharma 37. Biogen Idec 38. Bausch & Lomb 39. Taiho Pharma 40. King harmaceuticals 41. Watson Pharma

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American SensoRx, Inc. USA The SpectRx™ FFT-NIR Technology

Advanced Sensor Technology

Ms. Ivy Lee

Online Marketing & Finance Director

31 North Monroe Street

Ridgewood, New Jersey, 07450 USA in: [email protected] WeChat / t: @IvyLeeSensorX Tel: 001 201 447 8999 Fax: 001 201 447 8998 Linkedln Company Page https://plus.google.com/+IvyLee/posts www.facebook.com/SmartSensorX

www.AmericanSensoRx.com