ConsiGmaTM, a platform for continuous processing · ConsiGmaTM, a platform for continuous...

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


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


1500 t/year

Development New Product Launch Growth Line extension Cost cutting New markets


Roller Compaction

Wet granulation

Direct compression

Hot melt granulation

Melt extrusion









1500 t/year



100

200

25

1

50









1500 t/year



Process timesMaterial in process

PAT tools Control loopsProduct keys



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


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%


ConsiGmaTM: how does it work?

Ext.Phase 2Ext.Phase 1 Coating liquidGran. liquidAPIExipientExipient

Preblend Granule Tablet

Powder feedBlending

GranulationDrying

MillingExt. PhaseLubricant

Compression Coating

Lubricant


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


ConsiGmaTM: How does it work?


ConsiGma™ Tablet Coater


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


ConsiGma™ Tablet Coater working Principles

16


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


ConsiGmaTM: How does it work? - PAT


• Granulation Unit – Development Mode: variation of parameters

ConsiGmaTM: Efficient R&D



• Drying Unit– Development Mode : variation of parameters (1)



• Drying Unit– Development Mode : variation of parameters (2)


Savings in R&D: ICH Q8/Q9 - QbD

to calculation sheet


ConsiGmaTM Direct Compression


ConsiGmaTM Direct Compression : Process Flow Diagram


Flexibility in process: Direct Compression


Flexibility in process: Dry Granulation


Flexibility in process: Wet granulation


J&J case study: the factory of the future


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®


ConsiGma, a diamond with many facets

ConsiGmaTM, a platform for continuous processing · ConsiGmaTM, a platform for continuous...

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