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Presentation MicroNIR by Emiliano Genorini Nov 14th Rijksmuseum
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Title: Critical attributes process monitoring by NIR; from pharma to AFF
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Presentation MicroNIR by Emiliano Genorini Nov 14th Rijksmuseum
1.
1© 2016 Viavi
Solutions Inc.www.viavisolutions.com Critical attributes process monitoring by NIR Amsterdam (NL), November 14th 2019 Emiliano Genorini MicroNIR Americas and EMEA Account Manager +39 039 9300225 (office) | +39 337 1362987 (mobile) Via Cernuschi, 8 | 20900, Monza (MB) - Italy
2.
2© 2016 Viavi
Solutions Inc.www.viavisolutions.com 2© 2016 Viavi Solutions Inc.www.viavisolutions.com Company profile
3.
3© 2016 Viavi
Solutions Inc.www.viavisolutions.com Company Profile - Viavi Solutions
4.
4© 2016 Viavi
Solutions Inc.www.viavisolutions.com 4© 2016 Viavi Solutions Inc.www.viavisolutions.com Our vision
5.
5© 2016 Viavi
Solutions Inc.www.viavisolutions.com MicroNIR - Our vision
6.
6© 2016 Viavi
Solutions Inc.www.viavisolutions.com MicroNIR - Our vision
7.
MicroNIR - Our
vision
8.
8© 2016 Viavi
Solutions Inc.www.viavisolutions.com 8© 2016 Viavi Solutions Inc.www.viavisolutions.com Liner Variable Filter
9.
9© 2016 Viavi
Solutions Inc.www.viavisolutions.com Product line - LVF • Small size allow special applications • No moving parts: - no misalignments - stability over long time - 100% transferability between units • No fiber optics: - no possibility to break it - no ageing - insensible to temperature fluctuation • Small distance → high energy and S/N → from traditional benchtop to sensor
10.
10© 2016 Viavi
Solutions Inc.www.viavisolutions.com 10© 2016 Viavi Solutions Inc.www.viavisolutions.com Process Analytical Technology
11.
11© 2016 Viavi
Solutions Inc.www.viavisolutions.com MicroNIR - PAT
12.
12© 2016 Viavi
Solutions Inc.www.viavisolutions.com MicroNIR - PAT
13.
13© 2016 Viavi
Solutions Inc.www.viavisolutions.com 13© 2016 Viavi Solutions Inc.www.viavisolutions.com High Shear Mixer
14.
14© 2016 Viavi
Solutions Inc.www.viavisolutions.com FluidBed Dryer HighShear Granualtor MicroNIR - Granulation and Drying Multi steps process Mixing Granulation Discharging Wet mass calibration Drying Cooling Calibration Discharging HighShearGranualtor Single step Process I Mixing Granulation Drying Cooling Calibration Discharging FluidBedGranulator Single step Process II Mixing GranulationDrying Drying Cooling Calibration Discharging
15.
15© 2016 Viavi
Solutions Inc.www.viavisolutions.com MicroNIR - Granulation and Drying On line monitoring • Impeller torque for granualtion end point • INOUT air temperature for drying end point • INOUT air humidity for drying end point Pros • Real time online measurement • No sampling required Cons • Physical measurement • Indirect analysis of particle size and moisture content At line monitoring • Particle Size Analyzer for granualtion end point • Karl Fischer or Loss on Drying (LOD) for drying end point Pros • Direct analysis of Particle Size andor moisture • Chemical measurement Cons • Sampling required • Lab measurement • Long time compared to process duration (start) and final
16.
16© 2016 Viavi
Solutions Inc.www.viavisolutions.com MicroNIR - High Shear MixerInstallation IMA device with MicroNIR PAT U mounted on VIAVI welded flange
17.
17© 2016 Viavi
Solutions Inc.www.viavisolutions.com MicroNIR - High Shear MixerPreprocessed Spectra Liquid bridgeSolid bridgeSnowball Spectra 1der+SNV
18.
18© 2016 Viavi
Solutions Inc.www.viavisolutions.com MicroNIR - High Shear Mixer - MBSD Dry Mixing Wetting (Primary Granulation) Massing (Secondary Granualtion) ■ Impeller Torque ■ MBSD ■ MBM
19.
19© 2016 Viavi
Solutions Inc.www.viavisolutions.com 19© 2016 Viavi Solutions Inc.www.viavisolutions.com Fluid Bed Dryer
20.
20© 2016 Viavi
Solutions Inc.www.viavisolutions.com MicroNIR - Fluid Bed Granulation - Spectra • Collected datas are correlatd to physical variables like Moisture and Particle Size Distribution • It is necessary to collect physical datas manually to build a calibration curve. • The Partial Least Square method is used to calculate the correlation grade, represented by R2, the closer is to 1, the better the correlation is
21.
21© 2016 Viavi
Solutions Inc.www.viavisolutions.com MicroNIR - Fluid Bed Granulation - LOD 0.00 2.00 4.00 6.00 8.00 10.00 12.00 -15 5 25 45 65 85 105 125 145 165 LOD(%) Sample Number LOD Predicted Vs Real Predicted LOD Real LOD
22.
22© 2016 Viavi
Solutions Inc.www.viavisolutions.com MicroNIR - Fluid Bed Granulation - D50 0.00 50.00 100.00 150.00 200.00 250.00 300.00 350.00 400.00 450.00 500.00 0 20 40 60 80 100 120 140 160 180 200 D50(µm) Sample Number d50 Predicted Vs Real Real D50 Predicted D50
23.
23© 2016 Viavi
Solutions Inc.www.viavisolutions.com 23© 2016 Viavi Solutions Inc.www.viavisolutions.com Blending
24.
24© 2016 Viavi
Solutions Inc.www.viavisolutions.com MicroNIR - Blending - Theft Sampling • Labor intensive • Expensive • Poor reproducibility • Blender must be stopped • Perturbation of blending • Long time to have feed back • Contributes to sample non-uniformity • Cross contamination • Using of solvents • Potential for exposure of operators to high potency API
25.
25© 2016 Viavi
Solutions Inc.www.viavisolutions.com MicroNIR - Blending - Theft Sampling • Sampling errors 10-50 times greater than analytical errors! • Non-reproducible, therefore cannot be corrected for statistically • QbD requires isolation of the greatest source of variability (sample thief) Sample thieves de-mix powder beds resulting in heterogeneity increase
26.
26© 2016 Viavi
Solutions Inc.www.viavisolutions.com • Blending homogeneity is not content uniformity API % • Question is not how much API you have but if it has been blended → if you want to know how much is the API you weigh the API before mixing (more accurate) Make PLS working and validate it from 0 to 100% of API is very challenging: - Calibration deployed at line are not valid at line - How can you build this on line? If you make spiking of API at line you could have a reasonable number but it is hard to validate - If you withdraw a sample you damage you blending • Building a PLS requires to validate the method and register (documentation cost that is 100x the cost of HPLC) • It is only for valid for production not for R&D
27.
27© 2016 Viavi
Solutions Inc.www.viavisolutions.com MicroNIR - Blending • Rotation Time • API concentration • Excipients • Particle Size • Blender Capacity • Rotation Rate • Fill level • Loading Method (symmetric vs. asymmetric)
28.
28© 2016 Viavi
Solutions Inc.www.viavisolutions.com MicroNIR - Blending
29.
29© 2016 Viavi
Solutions Inc.www.viavisolutions.com MicroNIR - Blending 0 0.02 0.04 0.06 0.08 0.1 0 25 50 75 100 125 150 175 200 Problem Blend Model Blend
30.
30© 2016 Viavi
Solutions Inc.www.viavisolutions.com MicroNIR - Blending 0 0.01 0.02 0.03 0.04 0.05 0.06 0.07 0.08 0.09 0.1 0 5 10 15 20 25 30 35 40 Rotation Number 5 Liter Bin 10 Liter Bin 40 Liter Bin 0 0.01 0.02 0.03 0.04 0.05 0.06 0.07 0.08 0.09 0.1 0 5 10 15 20 25 30 35 40 Rotation Number 15 rpm 25 rpm 32 rpm 0 0.01 0.02 0.03 0.04 0.05 0.06 0.07 0.08 0.09 0.1 0 10 20 30 40 50 60 70 80 60% Filll 75% Filll 90% Filll 0 0.01 0.02 0.03 0.04 0.05 0.06 0.07 0.08 0.09 0.1 0 5 10 15 20 25 30 35 40 Rotation Number Active Layered - Centered Active Spot - Off Center
31.
31© 2016 Viavi
Solutions Inc.www.viavisolutions.com 31© 2016 Viavi Solutions Inc.www.viavisolutions.com Tableting
32.
32© 2016 Viavi
Solutions Inc.www.viavisolutions.com MicroNIR - Feed frame
33.
33© 2016 Viavi
Solutions Inc.www.viavisolutions.com MicroNIR - Feed frame Talc
34.
34© 2016 Viavi
Solutions Inc.www.viavisolutions.com MicroNIR - Feed frame Talc 1% Talc 3% Talc 5%
35.
35© 2016 Viavi
Solutions Inc.www.viavisolutions.com www.viavisolutions.com
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