ConsiGma TM, a platform for continuous processing GEA Pharma Systems Where Inspiration meets Technology GEA Process Engineering / GEA Pharma Systems
ConsiGma TM R&D and Manufacturing platform ConsiGma TM = Continuous solid dosage manufacturing targeting 6 sigma Direct compression Melt extrusion Raw materials Roller Compaction Coated tablets Wet granulation Hot melt granulation GEA Pharma Systems NV Collette
ConsiGma TM R&D and Manufacturing platform ConsiGma TM = Continuous solid dosage manufacturing targeting 6 sigma Direct compression Melt extrusion Raw materials Roller Compaction Coated tablets Wet granulation Hot melt granulation More data from less product Rapid deployment / later investment Zero scale up Flexible batch size Skid mounted rapid deployment Rapid deployment / later investment Development New Product Launch Growth New markets Line extension Cost cutting 1-5 kg tests 30-600 t/year 1500 t/year 3 GEA Pharma Systems NV Collette
ConsiGma TM R&D and Manufacturing platform ConsiGma TM = Continuous solid dosage manufacturing targeting 6 sigma 25 50 Raw materials 100 Coated tablets 200 1 More data from less product Rapid deployment / later investment Zero scale up Flexible batch size Skid mounted rapid deployment Rapid deployment / later investment Development New Product Launch Growth New markets Line extension Cost cutting 1-5 kg tests 30-600 t/year 1500 t/year 4 GEA Pharma Systems NV Collette
ConsiGma TM R&D and Manufacturing platform ConsiGma TM = Continuous solid dosage manufacturing targeting 6 sigma Process times Material in process Raw materials PAT tools Control loops Product keys Coated tablets More data from less product Rapid deployment / later investment Zero scale up Flexible batch size Skid mounted rapid deployment Rapid deployment / later investment Development New Product Launch Growth New markets Line extension Cost cutting 1-5 kg tests 30-600 t/year 1500 t/year 5 GEA Pharma Systems NV Collette
ConsiGma TM case 1: Big volume ConsiGma TM 100 Raw materials Int. Phase: 100 kg/h Ext. Phase: 30 kg/h Coating: 3% Total: 133 kg/h Capacity: 333.000 tabs/h Footprint 48 m 2 Dispensing Blending Wet granulation Drying Calibration Ext. Phase blending Lubricant blending Compression Coating Coated tablets GEA Pharma Systems NV Collette
Conventional high efficient production area 64m 2 300L 190m 2 74m 2 40m 2 100m 2 1200L 55m 2 36m 2 40m 2 30m 2 30m 2 30m 2 Tablets / year: 1,5 Bn Dispensing 90 10% Blending 80 9% Granulation suit 300L 64 7% Granulation suit 1200L 100 11% Compression 130 15% Storage area 150 17% Corridor 190 21% Cleaning area 55 6% IPC Laboratory 25 3% Total area 884 100% GEA Pharma Systems / GEA Process Engineering
ConsiGma TM case 2: High value products ConsiGma TM 25 Raw materials Int. Phase: 25 kg/h Ext. Phase: 8 kg/h Total: 33 kg/h Solvent abatement AHU Dispensing Blending Capacity 164.000 tabs/h Footprint 36 m2 2900 Wet granulation Drying Calibration Ext. Phase blending Lubricant blending 3500 Compression H =3200 3540 5240 Tablets GEA Pharma Systems NV Collette
Current reference drivers Who ConsiGma TM? FDA - EMA 80% Local regulated 20% Only new formulations 70% Existing & new 30% Batch c75% Continuous RTR c25% High Potent 70% Non Potent 30% 9 GEA Pharma Systems / GEA Process Engineering
ConsiGma TM : how does it work? Exipient Exipient API Gran. liquid Ext.Phase 1 Ext.Phase 2 Coating liquid Lubricant Preblend Granule Tablet Powder feed Blending Granulation Drying Milling Ext. Phase Lubricant Compression Coating GEA Pharma Systems / GEA Process Engineering
ConsiGma TM : How does it work? GEA Pharma Systems / GEA Process Engineering
ConsiGma : How does it work? GEA tabletpress with constant dwelltime & Exchangeable Compression Module Modul S 12 Text über "Einfügen Kopf- u. Fußzeile" einfügen GEA Pharma Systems / GEA Process Engineering
ConsiGma TM : How does it work? GEA Pharma Systems / GEA Process Engineering
ConsiGma Tablet Coater GEA Pharma Systems / GEA Process Engineering
ConsiGma Tablet Coater working Principles Machine without front cover Charging plugs of 1,5 kg or 3 kg (wider drum) Fast and Accurate coating in 6 minutes Discharging Overall capacity small wheel (80 mm) 15 kg/hr, wider wheel (160 mm) 30 kg/hr GEA Pharma Systems / GEA Process Engineering
ConsiGma Tablet Coater working Principles 16 GEA Pharma Systems / GEA Process Engineering
ConsiGma TM Process Control Strategy 3 4 2 6 1. Lighthouse Probe NIR for LOD 2. Malvern Insitec PSD 3. Xoptix PSD / Lasentec FBRM PSD 4. Lighthouse Probe NIR for Blend Homogenity 5. Bruker Tandem for CU tablets 6. Kaiser Optics Raman for Coating quality 7. Bruker or Foss for Identity 5 1 1 Basic PAT measurement 1. Powder Feed Factor(s) 2. Liquid addition (mass & density) 3. Torque measurement 4. Product Temperature/drying curves 5. Air inlet/outlet temperature 6. Differential Pressure over filter 7. rh dryer outlet 8. Mill temperature 9. Compression force 10. GEA Pharma Systems NV Collette
ConsiGma TM : How does it work? - PAT GEA Pharma Systems / GEA Process Engineering
ConsiGma TM : Efficient R&D Granulation Unit Development Mode: variation of parameters GEA Pharma Systems NV Collette
ConsiGma TM : Efficient R&D Drying Unit Development Mode : variation of parameters (1) GEA Pharma Systems NV Collette
ConsiGma TM : Efficient R&D Drying Unit Development Mode : variation of parameters (2) GEA Pharma Systems NV Collette
ConsiGma TM : Efficient R&D GEA Pharma Systems / GEA Process Engineering
Savings in R&D: ICH Q8/Q9 - QbD to calculation sheet GEA Pharma Systems / GEA Process Engineering
ConsiGma TM Direct Compression GEA Pharma Systems NV Collette
ConsiGma TM Direct Compression : Process Flow Diagram GEA Pharma Systems NV Collette
Flexibility in process: Direct Compression GEA Pharma Systems NV Collette
Flexibility in process: Dry Granulation GEA Pharma Systems NV Collette
Flexibility in process: Wet granulation GEA Pharma Systems NV Collette
J&J case study: the factory of the future GEA Pharma Systems / GEA Process Engineering
J&J case study: the factory of the future Figure 3: the measured CQA s during a 16 hours run (weight, thickness and content uniformity), extracted from SIPAT GEA Pharma Systems / GEA Process Engineering
ConsiGma, a diamond with many facets GEA Pharma Systems / GEA Process Engineering