Low-power Portable Laser Spectroscopic Sensors for Atmospheric CO2 Monitoring
Tru Process
1. TruProcess Near Infrared Analyzer
Kurt Kortokrax
Thermo Scientific
Account Manager
Kurt.Kortokrax@thermofisher.com
2. Thermo Scientific TruProcess NIR Process Analyzer
Spectral Range 1600-2400 nm (6250-4100 cm-1)
Absolute Wavelength Accuracy +/- 0.1 nm
Internal software controlled wavelength standard for on-the-fly calibration and
Wavelength Calibration
qualification.
Measurement time <0.75 sec. per spectrum
Sampling Mode Non-Contact diffuse reflectance
Nominal working distance - 35 – 50 mm
Working Distance
Maximum recommended working distance - 100 mm
Sampling area 25 mm @ 50 mm working distance
Size 177 mm (l) x 127 mm (w) x 158 mm (h) standard configuration
Weight 2.95 kgs (6.5 lbs)
Aluminum, dust and waterproof, o-ring sealed enclosure with durable and
Enclosure & materials cleanable powder coated surface, stainless steel tri-clover fitting, and sapphire
isolation window.
A/D Converter 24 bit
Integrated MEMS accelerometer for dynamic blending applications
Position Trigger
Detector Single InGaAs w/2 stage cooling
Source Dual 5 watt tungsten NIR source
SpectralCode Plus™, SpectralCode Direct Command Set
Software included:
Operating Systems Windows XP, Vista or Windows 7
Ethernet, RS232 serial, USB, and wireless with router
Computer Interface
Operating Temp Range 0 to 35°C (non-condensing).
Storage Temp Range
-40 to +85°C
Batteries: 2 x 5AH 7.2 Lithium Ion (4.5 hour run-time)
Power
External Power: 7 – 14 Volt DC (2.5 amps max)
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3. TruProcess Near Infrared (NIR) Process Analyzer
• Non-Destructive: Non-contact diffuse reflectance measurement with programmable acquisition trigger
• Fast, accurate monitoring: Wireless communications with real-time data analysis and storage
• Customizable: TruProcess is compatible with Thermo Scientific Method Development software which
allows for both qualitative and quantitative applications including; drying, blending and moisture analysis
• Advanced Technology: Micro-electrical Mechanical (MEMS) technology transforms traditional NIR
technology into a process-line NIR sensor
Advantages of MEMS technology
• Smaller size and portability: Allows for quick deployment across
large process manufacturing environments
• Reliability: MEMS technology has no moving parts with proven
reliability
• Reproducibility for method transfer: Internal wavelength calibration
provides superior wavelength accuracy
• Speed: The MEMS engine has a scanning speed up to five
microseconds and blending rates up to 25 rpm
• Scalable from bench scale to full manufacturing scale
• Reduced deployment costs and long term cost of ownership
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4. TruProcess Analyzer Configuration
2 Light sources
with 2.5” tri-clover
connection for
easy installation on
blenders & dryers
Wireless “Wi-Fi”
antenna to transfer
Integrated Standard Real-time spectra to
external PC/station
materials for performing
background and PQ
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8. Near Infrared Spectroscopy
• The observation of how electromagnetic energy (Near Infrared) interacts
with a sample
• NIR light is all around us – It is the part of sunlight that carries the heat
• A simple quartz tungsten-halogen bulb is used as a source of NIR
• Many substances will interact with infrared light by absorbing at specific
frequencies that are unique to that material
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11. SpecralCode Plus Software
• “Real-time” acquisition of spectral data
• Standard pre-process functions (SNV, MSC, 1st ,2nd Deriv.
Normalization, etc.)
• Qualitative algorithms
• Standard Deviation (MBSD)
• PCA
• Quantitative algorithms:
• PLS1
• “Real-time” trending of multiple Qualitative and/or Quantitative
results
• Saving all results, spectra, etc.
• Adjust triggering time delay based on blender fill
• Off-line models testing capability
• Process interfaces to PLCs using Ethernet connection
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13. Triggering
• Power Monitor Method
• Optical power monitoring is good enough to detect onset of cascading
material
• Gravity Method
• Fully software programmable MEMS Accelerometer
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16. Process Analytical Technology and NIR
• Real time monitoring and control of process parameters and
material performance attributes
• NIR devices well suited for at-line, in-line and on-line measurements
• Rapid determination of physical and chemical properties of
raw materials, intermediates and final dosage forms
• Chemometric analysis from data acquisition to statistical process control
• Multivariate analysis for quantitative assessment
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17. At point-of-use application in Pharmaceutical Manufacturing
Receiving 100% verification of receivables.
warehouse:
Detection of common contaminants.
Quantification of ingredient moisture content.
Dispensing: 100% Final verification of ingredients.
In process: Reaction completion
Determination of moisture content
Solvent exchange monitoring
Finished Product: Determination of ingredient ratios.
Content uniformity.
Thickness of tablet film coatings.
Packaging: Verification of packaging polymers.
Determination of polymer thickness.
Clinical trial: Spot verification of placebo and active doses.
Post-production: Degradation analysis of retained samples.
Counterfeit products evaluation
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21. Real-time Blend Uniformity by using TruProcess Analyzer
• Standard deviations 1 kg Lac Added
calculation 1 kg APAP Added 60 g MgS Added
• Lac/APAP Scores are 1.1 0.3
calculated using the 0.9
difference between 0.25
Score: 1=pure component
0.7
pure Lac and APAP
0.2
0.5
• MgS scores are 0.3 0.15 Lac
calculated using the MgS
0.1
difference between Blending 0.1
Stdev - Lac
Stdev - MgS
MgS and the Lac/APAP -0.1 Good
blend. -0.3
0.05
-0.5 0
0 100 200 300 400 500 600 700
Measurement #
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23. Trending
• Spectral difference model
5-point symmetric stdev
• Savitzky-Golay 1st Derivative
15-point historic stdev
• Normalize Range “PLS” prediction
• Trending is similar to other 1.05 0.05
methods, but some quantitative 0.045
information is present. 0.95 0.04
0.035
0.85 0.03
0.025
• Recommendation: 0.75 0.02
• Follow standard deviation until it 0.015
0.65 0.01
falls below target value 0.005
• Follow quantitative value until if 0.55 0
0 50 100 150 200 250 300 350
falls below target value
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24. Real-time API Blending by using 2 TruProcess Analyzers
• 3.5 Quart Stainless steel
V-Blender
• 8 compounds
formulation
• Spectra were collected
with Gravity sensor
- 1 scan every rotation
- 22 rotation per minute
• Modeling done using
PLS
• RMSNV (Root Mean
Square to the Nominal
Value) was uses to
monitor blend
homogeneity
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26. Real-time on-line Moisture content by TruProcess
• Analyzer communicates with external PC via
standard wireless (Wi-Fi) Ethernet connection
• TruProcess NIR Analyzer was installed on viewing
window of Glatt FBD without any dryer
modification.
• Standard tri-clover connection was used, allowing
to relocate analyzer easily without any tools.
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27. Real-time on-line Moisture Content by TruProcess™
• Every 15 sec.
• RMSEC - 0.17%
• RMSECV - 0.17%:
- Reference validation results
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28. Real-time moisture prediction
Reference validation results
3:20pm 3:50pm 4:20pm 4:50pm 5:10pm
Time (July 27, 2010)
Prediction was performed for first 3 hours of 9 hours of granulation/drying process using
previously created Quantitative PLS1 calibration/model
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30. Regulatory Solution
IQ OQ PQ RESULTS
Installation Operational Performance
Qualification Qualification Qualification Data
Methods
LCD Display
Archive
Qualification Traceable USP 1119 LIMS
Procedures Standards Protocol
PLCs or DCS
Method
Development
Traceable Standards
USP 1119 Qualification
Protocol
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31. Regulatory Solution
Performance Qualification and
background spectra collection
can be performed
AUTOMATICALLY
Shutter open Shutter closed
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