ConsiGma TM, a platform for continuous processing

Transcription

1 ConsiGma TM, a platform for continuous processing GEA Pharma Systems Where Inspiration meets Technology GEA Process Engineering / GEA Pharma Systems

2 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

3 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 t/year 1500 t/year 3 GEA Pharma Systems NV Collette

4 ConsiGma TM R&D and Manufacturing platform ConsiGma TM = Continuous solid dosage manufacturing targeting 6 sigma Raw materials 100 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 t/year 1500 t/year 4 GEA Pharma Systems NV Collette

5 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 t/year 1500 t/year 5 GEA Pharma Systems NV Collette

6 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: 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

7 Conventional high efficient production area 64m 2 300L 190m 2 74m 2 40m 2 100m L 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 % Compression % Storage area % Corridor % Cleaning area 55 6% IPC Laboratory 25 3% Total area % GEA Pharma Systems / GEA Process Engineering

8 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 tabs/h Footprint 36 m Wet granulation Drying Calibration Ext. Phase blending Lubricant blending 3500 Compression H = Tablets GEA Pharma Systems NV Collette

9 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

10 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

11 ConsiGma TM : How does it work? GEA Pharma Systems / GEA Process Engineering

12 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

13 ConsiGma TM : How does it work? GEA Pharma Systems / GEA Process Engineering

14 ConsiGma Tablet Coater GEA Pharma Systems / GEA Process Engineering

15 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

16 ConsiGma Tablet Coater working Principles 16 GEA Pharma Systems / GEA Process Engineering

17 ConsiGma TM Process Control Strategy 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 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

18 ConsiGma TM : How does it work? - PAT GEA Pharma Systems / GEA Process Engineering

19 ConsiGma TM : Efficient R&D Granulation Unit Development Mode: variation of parameters GEA Pharma Systems NV Collette

20 ConsiGma TM : Efficient R&D Drying Unit Development Mode : variation of parameters (1) GEA Pharma Systems NV Collette

21 ConsiGma TM : Efficient R&D Drying Unit Development Mode : variation of parameters (2) GEA Pharma Systems NV Collette

22 ConsiGma TM : Efficient R&D GEA Pharma Systems / GEA Process Engineering

23 Savings in R&D: ICH Q8/Q9 - QbD to calculation sheet GEA Pharma Systems / GEA Process Engineering

24 ConsiGma TM Direct Compression GEA Pharma Systems NV Collette

25 ConsiGma TM Direct Compression : Process Flow Diagram GEA Pharma Systems NV Collette

26 Flexibility in process: Direct Compression GEA Pharma Systems NV Collette

27 Flexibility in process: Dry Granulation GEA Pharma Systems NV Collette

28 Flexibility in process: Wet granulation GEA Pharma Systems NV Collette

29 J&J case study: the factory of the future GEA Pharma Systems / GEA Process Engineering

30 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

31 ConsiGma, a diamond with many facets GEA Pharma Systems / GEA Process Engineering