Pilot Scale & Transfer

Last Updated on Donnerstag, 7 April 2016 11:15 Written by admin Samstag, 8 Dezember 2012 02:47

The manufacturing services for Development and Pilot Scale of solid dosage forms are operating in full GMP compliant mode and include:

1. Solid dosage forms with actives having an OEL > 10 µg/m3

• High shear mixing and wet granulation with tray- and fluid bed drying
Batch sizes 8 to 12 kg

• Fluid bed wet granulation with tray- and fluid bed drying
Batch sizes 2 to 15 kg

• Direct compression process
Batch sizes 1 to 15 kg

• Simulation of dry compaction (Roller compaction)
Batch sizes 1 to 15 kg

• Tabletting with instrumented rotary tabletting machines

• Aqueous coating
Batch sizes 8 to 12 kg

• Filling of hard gelatine capsules
Batch sizes 2 to 15 kg. 100 % weight control of filled capsules

Blister and bottle packaging see production unit.

 

2. Solid dosage forms with actives having an OEL < 10 µg/m3 (cytotoxics, high potent, others)

• High shear mixing and wet granulation with fluid bed drying
Batch sizes 0,5 to 1,5 kg; 8 to 15 kg

• Direct compression process
Batch sizes 0,3 to 1 kg; 4 to 25 kg

• Tabletting using Luxner Minitab (1000 – 6000 tbl/hrs) or Korsch XL 100 (60.000 tbl/hrs)

• Aqueous coating
Batch sizes 0,5 to 4 kg; 8 to 12 kg; 40 to 70 kg

• Filling of hard gelatine and HPMC capsules using In-Cap XL (up to 3000 caps/hr)
All equipment and processes are designed similar to the solid dosage form production units to ensure a fast and reliable product transfer.

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