Successfully reported this slideshow.
We use your LinkedIn profile and activity data to personalize ads and to show you more relevant ads. You can change your ad preferences anytime.

Tru Process

1,388 views

Published on

  • Be the first to comment

  • Be the first to like this

Tru Process

  1. 1. TruProcess Near Infrared AnalyzerKurt KortokraxThermo ScientificAccount ManagerKurt.Kortokrax@thermofisher.com
  2. 2. Thermo Scientific TruProcess NIR Process AnalyzerSpectral Range 1600-2400 nm (6250-4100 cm-1)Absolute Wavelength Accuracy +/- 0.1 nm Internal software controlled wavelength standard for on-the-fly calibration andWavelength Calibration qualification.Measurement time <0.75 sec. per spectrumSampling Mode Non-Contact diffuse reflectance Nominal working distance - 35 – 50 mmWorking Distance Maximum recommended working distance - 100 mmSampling area 25 mm @ 50 mm working distanceSize 177 mm (l) x 127 mm (w) x 158 mm (h) standard configurationWeight 2.95 kgs (6.5 lbs) Aluminum, dust and waterproof, o-ring sealed enclosure with durable andEnclosure & 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 applicationsPosition TriggerDetector Single InGaAs w/2 stage coolingSource Dual 5 watt tungsten NIR source SpectralCode Plus™, SpectralCode Direct Command SetSoftware included:Operating Systems Windows XP, Vista or Windows 7 Ethernet, RS232 serial, USB, and wireless with routerComputer InterfaceOperating 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) 2 Polychromix 2
  3. 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 whichallows for both qualitative and quantitative applications including; drying, blending and moisture analysis• Advanced Technology: Micro-electrical Mechanical (MEMS) technology transforms traditional NIRtechnology 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 3Polychromix 3
  4. 4. TruProcess Analyzer Configuration 2 Light sources with 2.5” tri-clover connection foreasy 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 4 Polychromix 4
  5. 5. Technology- MEMS (Micro ElectroMechanical Systems) Unactuated: incident Actuated: programmable light reflected filtering at 1/4- wavelength displacement 5Polychromix 5
  6. 6. TruProcess Analyzer Configuration Hot-swappable batteries ports, rechargeable Li-Ion batteries for up to 5-6 hours of continuous operation DC power, RS232, USB, Ethernet connections 6Polychromix 6
  7. 7. Electromagnetic Spectrum Near Infrared is ~ 800-2500 nm region 1nm = 10-9 meters 7Polychromix 7
  8. 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 8 Polychromix 8
  9. 9. OvertonesExample: C-H OvertonesFirst Overtone3378 nm (C-H Stretch) * 1/2 = 1689 nmSecond Overtone3378 nm (C-H Stretch)* 1/3 = 1126 nm 9Polychromix 9
  10. 10. SpectralCode Plus Software
  11. 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 11Polychromix 11
  12. 12. SpecralCode Plus Software 12Polychromix 12
  13. 13. Triggering • Power Monitor Method • Optical power monitoring is good enough to detect onset of cascading material • Gravity Method • Fully software programmable MEMS Accelerometer 13Polychromix 13
  14. 14. Real-Time Prediction and Trending 14Polychromix 14
  15. 15. TruProcess Applications and Usage
  16. 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 16Polychromix 16
  17. 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 17Polychromix 17
  18. 18. Monitoring Blending and Drying Processes 18Polychromix 18
  19. 19. TruProcess Scalability 19Polychromix 19
  20. 20. Real-time Blend Uniformity by using TruProcess Analyzer 20Polychromix 20
  21. 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 # 21Polychromix 21
  22. 22. Full-spectrum PCA trending 0.4• PCA - 1 factor 0.3• Savitzky-Golay 1st Derivative 0.2• Use range 1976-2067 nm Score F1 0.1 0 -0.1 Suspected Acetaminophen -0.2 issue -0.3 0 50 100 150 200 250 300 350 22 Polychromix 22
  23. 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 23Polychromix 23
  24. 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 24Polychromix 24
  25. 25. Results 1.2 1.2 APAP APAP MCC MCC 1 1 MGST MGST 0.8 0.8 ConcentrationsConcentrations 0.6 0.6 0.4 0.4 0.2 0.2 0 0 -0.2 -0.2 0 50 100 150 200 250 300 0 50 100 150 200 250 300 Rotations Rotations Sensor 1 Sensor 2 25Polychromix 25
  26. 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. 26Polychromix 26
  27. 27. Real-time on-line Moisture Content by TruProcess™• Every 15 sec.• RMSEC - 0.17%• RMSECV - 0.17%:  - Reference validation results 27 Polychromix 27
  28. 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 28Polychromix 28
  29. 29. Qualification and Connection to ExternalSystems
  30. 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 30Polychromix 30
  31. 31. Regulatory Solution Performance Qualification and background spectra collection can be performed AUTOMATICALLY Shutter open Shutter closed 31Polychromix 31

×