consigmatm, a platform for continuous processing · consigmatm, a platform for continuous...
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GEA Process Engineering / GEA Pharma Systems
GEA Pharma Systems
ConsiGmaTM, a platform for continuous processing
Where Inspiration meets Technology
GEA Pharma Systems NV Collette
ConsiGmaTM = Continuous solid dosage manufacturing targeting 6 sigma
ConsiGmaTM R&D and Manufacturing platform
Roller Compaction
Wet granulation
Direct compression
Hot melt granulation
Melt extrusion
Raw materials Coated tablets
GEA Pharma Systems NV Collette 3
ConsiGmaTM = Continuous solid dosage manufacturing targeting 6 sigma
More data from less product
Rapid deployment / later investment
Flexible batch size Zero scale up Skid mounted rapid deployment
1- 5 kg tests 30 - 600 t/year
Rapid deployment / later investment
1500 t/year
Development New Product Launch Growth Line extension Cost cutting New markets
ConsiGmaTM R&D and Manufacturing platform
Roller Compaction
Wet granulation
Direct compression
Hot melt granulation
Melt extrusion
Raw materials Coated tablets
GEA Pharma Systems NV Collette 4
ConsiGmaTM = Continuous solid dosage manufacturing targeting 6 sigma
More data from less product
Rapid deployment / later investment
Flexible batch size Zero scale up Skid mounted rapid deployment
1- 5 kg tests 30 - 600 t/year
Rapid deployment / later investment
1500 t/year
Development New Product Launch Growth Line extension Cost cutting New markets
ConsiGmaTM R&D and Manufacturing platform
100
200
25
1
50
Raw materials Coated tablets
GEA Pharma Systems NV Collette 5
ConsiGmaTM = Continuous solid dosage manufacturing targeting 6 sigma
More data from less product
Rapid deployment / later investment
Flexible batch size Zero scale up Skid mounted rapid deployment
1- 5 kg tests 30 - 600 t/year
Rapid deployment / later investment
1500 t/year
Development New Product Launch Growth Line extension Cost cutting New markets
ConsiGmaTM R&D and Manufacturing platform
Process timesMaterial in process
PAT tools Control loopsProduct keys
Raw materials Coated tablets
GEA Pharma Systems NV Collette
ConsiGmaTM case 1: Big volume
Coated tablets
Raw materials
Int. Phase: 100 kg/hExt. Phase: 30 kg/hCoating: 3% Total: 133 kg/h
Capacity: 333.000 tabs/hFootprint 48 m2
Ext. Phase blending
Calibration
Drying
Wet granulation
Blending
Dispensing
Lubricant blending
Compression
Coating
ConsiGmaTM 100
GEA Pharma Systems / GEA Process Engineering
100m2
30m230m230m2
64m2
74m2
40m236m2
190m2
40m2
55m2
Conventional high efficient production area
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%
Tablets / year: 1,5 Bn
300L1200L
GEA Pharma Systems NV Collette
ConsiGmaTM case 2: High value products
Tablets
Raw materials
Int. Phase: 25 kg/hExt. Phase: 8 kg/hTotal: 33 kg/h
Capacity 164.000 tabs/hFootprint 36 m2
Ext. Phase blending
Calibration
Drying
Wet granulation
Blending
Dispensing
Lubricant blending
Compression
52403540
3500
2900
H =3200
ConsiGmaTM 25Solvent abatement
AHU
GEA Pharma Systems / GEA Process Engineering9
Current reference drivers
Who ConsiGmaTM?
High Potent70%
Continuous – RTRc25%
Only new formulations70%
Existing & new30%
Non Potent30%
Batchc75%
FDA - EMA80%
Local regulated20%
GEA Pharma Systems / GEA Process Engineering
ConsiGmaTM: how does it work?
Ext.Phase 2Ext.Phase 1 Coating liquidGran. liquidAPIExipientExipient
Preblend Granule Tablet
Powder feedBlending
GranulationDrying
MillingExt. PhaseLubricant
Compression Coating
Lubricant
GEA Pharma Systems / GEA Process Engineering
ConsiGmaTM: How does it work?
GEA Pharma Systems / GEA Process Engineering12 Text über "Einfügen Kopf- u. Fußzeile" einfügen
GEA tabletpress with constant dwelltime& Exchangeable Compression Module
ConsiGma™ : How does it work?
Modul S
GEA Pharma Systems / GEA Process Engineering
ConsiGmaTM: How does it work?
GEA Pharma Systems / GEA Process Engineering
ConsiGma™ Tablet Coater
GEA Pharma Systems / GEA Process Engineering
Machine without front cover
ConsiGma™ Tablet Coater working Principles
• 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 NV Collette
ConsiGmaTM Process Control Strategy
4
Basic PAT measurement1. Powder Feed Factor(s)2. Liquid addition (mass & density)3. Torque measurement4. Product Temperature/drying curves5. Air inlet/outlet temperature6. Differential Pressure over filter7. rH dryer outlet 8. Mill temperature9. Compression force10.…
5
3
1
2
1
1. Lighthouse Probe™ NIR for LOD2. Malvern Insitec PSD3. Xoptix PSD / Lasentec FBRM PSD4. Lighthouse Probe™ NIR for Blend Homogenity5. Bruker Tandem for CU tablets6. Kaiser Optics Raman for Coating quality7. Bruker or Foss for Identity
6
GEA Pharma Systems / GEA Process Engineering
ConsiGmaTM: How does it work? - PAT
GEA Pharma Systems NV Collette
• Granulation Unit – Development Mode: variation of parameters
ConsiGmaTM: Efficient R&D
GEA Pharma Systems NV Collette
ConsiGmaTM: Efficient R&D
• Drying Unit– Development Mode : variation of parameters (1)
GEA Pharma Systems NV Collette
ConsiGmaTM: Efficient R&D
• Drying Unit– Development Mode : variation of parameters (2)
GEA Pharma Systems / GEA Process Engineering
ConsiGmaTM: Efficient R&D
GEA Pharma Systems / GEA Process Engineering
Savings in R&D: ICH Q8/Q9 - QbD
to calculation sheet
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ConsiGmaTM Direct Compression
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ConsiGmaTM Direct Compression : Process Flow Diagram
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Flexibility in process: Direct Compression
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Flexibility in process: Dry Granulation
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Flexibility in process: Wet granulation
GEA Pharma Systems / GEA Process Engineering
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