BlendAlyser - Turnkey system for online monitoring of blending processes

1. BlendAlyser - Turnkey system for online monitoring of blending processes

2. Table of content • Introduction • Definition „Blending process“ • BlendAlyser - Process monitoring • BlendAlyser - Design and technical specification

3. 1. Analytical Measuring Optics • application specific measurement systems • optical sensors • spectroscopic modules and components • partner in optical measurements for chemical or biological parameters • technological know how, high tech products and additional services

4. Your qualified partner in laboratory and process technologies • Development and fabrication of optical measuring systems • Services, such as • test measurements • instrument demonstrations • trainings • individual advisory services Do not hesitate to ask us if any questions shall come up!

5. Components for optical spectroscopy: • UV/VIS and NIR spectrometers • Light sources • Probes and sample holders • User and analyzer software • Fiber optic probes and fiber optics If you want to set up your own measurement system just ask us and benefit from our knowledge!

6. Optical sensors for determining chemical and physical parameters: • Fiber optical Oxygen sensors for measurements in liquids and gases • CO2- and CH4-Sensors for monitoring fermentation processes • Temperature measurement in electromagnetic fields

7. Compact analyzer for online monitoring of blending processes BlendAlyser - latest development for contact-free online monitoring of powder blending processes. This instrument is well tailored for the needs of pharmaceutical industries and research establishments.

8. 2. Definition: Blending process Definition: Blending (process engineering): Main aim of the blending process is the production of a blend whose sample reflects exactly, or at least by pre-defined accuracy, the ratio of the added base materials. Pharmaceutical industry – solid blend of agent (API) and several additives (up to 10)

9. Main goal of blending processes in pharmaceutical industries: Tablet production which requires identical ingredients and homogenous distribution of the active pharmaceutical ingredient (API) as well as additives.

10. Principle of tablet production Active substance synthesis Blending and Granulation Compression Coating Package

11. Schematic blender design Active Pharmaceutical Ingredient (API) Excipients Measurement window to which the BlendAlyser is mounted

12. Problems which may arise during blending processes • inhomogeneity in material blends • deblending due to exceeded blending times • increased time and cost consumption due to exceeded blending times • general failures Solutions: Sampling at the blender  offline lab analysis of material mixture (e.g. by HPLC) Online process monitoring enabling the moving blender is no longer necessary, online blend analysis, immediate results

13. 3. Process monitoring with the BlendAlyser • Features • solid end point detection of blending processes • avoids deblending • online analysis of blending and production processes • quantitative analysis of different ingredients

14. BlendAlyser Connection via 4“ standard flange using a flange fastener Blender system The measuring instrument is directly mounted to the blender. Measurement is performed online.

15. Advantages: • optimized production processes • improved process knowledge • expensive and time consuming laboratory analysis are no longer • necessary • improved quality assurance • time and cost savings • real-time analysis

16. Online monitoring of end point detections via NIR spectra Absorbance in AU Wavelength in nm

17. Online monitoring of end point detections via NIR spectra Absorbance in AU Wavelength in nm

18. Absorbance in AU Online monitoring of end point detections via NIR spectra Wavelength in nm

19. Absorbance in AU Online monitoring of end point detections via NIR spectra Wavelength in nm

20. Absorbance in AU Online monitoring of end point detections via NIR spectra Wavelength in nm

21. Blend process‘ end point – homogeneous blend Absorbance in AU Beginning of the blend process Online monitoring of end point detections via NIR spectra Wavelength in nm

22. Different ways for determining homogeneity • monitoring of standard deviations within a certain spectral • range (e.g. Moving Block StdDev I) • absorbance monitoring at significant peaks • quantitative analysis (e.g. concentration determination • using PLSR) • PCA (Principal Component Analysis)

23. Homogeneous blend Previous blending time End point detection via Moving Block Standard Deviation I of absorbance at selected wavelength ranges

24. End point detection by absorbance determination at signification peaks Homogeneous blend Addition of magnesium stearate in order to improve miscibility

25. End point detection by measuring API’s concentration variations – determination of chemometric calibration Homogeneous blend

26. End point detection via PCA (Principal Component Analysis) Homogeneous blend till addition of magnesium stearate after addition of magnesium stearate

27. 4. BlendAlyser Setup Compact IP65 stainless steel housing with Weight: 6.5 kg / 14.3 lb Dimensions: 230 x 210 x 150 mm / 9 x 8.5 x 6 inch

28. Detector1 Etalon Detector2 Tunable Source Sample Interface Beamsplitter Beamsplitter Detector3 Setup of Tunable Laser Systems WARM® design - Wavelength and Amplitude Reference Module

29. Integrated angle sensor for measurement trigger • BlendAlyser contains a MEMS based 3 axis • angle sensor system. • (360°, normalized to instrument axis) • optimum trigger angle e.g. at 180° +/- 35° • user configurable by software • one single measurement • at every blender revolution • alternatively, triggering is possible • by digital I/O (5-24VDC)

30. BlendAlyser – Technical Specifications

31. Further Technical Specifications

32. Product features Flat anodized aluminium heat sink for GmP compliance, IP65 stainless steel housing • 2 orthogonal antennas • (antenna diversity) for increased • connections stability • 802.11 b/g wireless ethernet Status LED’s

33. Status LED Status LED with control function: • System status • Battery status • Trigger status • Network status

34. Safe and easy battery replacement Battery slot for easy replacement • hot swappable battery change due to back-up storage battery • battery powered up to 3hrs working time

35. Power Plug Power plug (internal battery charger) or Power supply by slit rings

36. Easy adjustment to different blending systems Modular process interface, can be customised to fulfil specific implementation needs standard: 4“ hygienic clamp, 18mm working distance Installation on lab and process blenders!

37. Hidden service plugs Service plug for direct connection to - monitor - keyboard / mouse - USB

38. Fewest service needs Fewest service needs due to • no moving parts • no serviceable parts • expected TL-source life time ~20 years

39. Highlights of the BlendAlyser • High resolution spectrometer based on MEMS technology • Programmable 3D orientation sensor as trigger • Battery powered up to 3hrs working time • Battery hot swappable • Compact all-in-one system • Internal embedded PC for data safety • WLAN communication (IEEE 802.11 b/g) • Smooth surfaces, cGMP compliant • Validated software (IQ/OQ/PQ-documentation)

40. Data flow diagram BlendAlyser NovaPAC NovaMath Spectra Method Results files Events / Log data server Chemometrician desk ( LAN ) Methods Models Spectra Results Events / Log NovaMath Workstation Server