Designed and equipped for the manufacturing of solid oral dosage forms and specialized in high-activity substances (cytostatic, cytotoxic), it has ancillary areas for the proper management of materials intended for clinical trials of new drugs. All the rooms in our GMP manufacturing plant are clean rooms EU-GMP class C (ISO 7, US FED STD 209E class 10000 equivalent).
Equipment
- Spray Dryer GEA Niro Mobile Minor.
- Binder VLD56 secondary vacuum drying chamber
- Oystar Hüttlin Pilotmix 75T single-pot high shear mixer and dryer. Capacity: from 8 to 20 Kg per batch.
- Container mixer: 60 and 200 liters bins.
- Quadro Comill sieve.
- Fette 1200iC rotary tablet press, fully equipped for formulation development and manufacturing. EU-B and EU-D punches.
- Semi Automatic Tablet Counting Machine AC 2000 KBW Packaging.
- Metal detector.
- Fette Gratex deduster.
- Oystar Manesty XL Lab 01 tablet coater, with interchangeable perforated drums. Capacity: Up to 20 Kg per fraction.
- iW Series Weight Checking Series Model 60
- IMA Clinipack blister machine (Alu/Alu and thermoformed materials).
- Sepha press-out deblister.
- Bosch GKF 702 automatic capsule filling machine.
- Capsunorm 2000 manual capsule filler.
- Bottle filling: Semi Automatic Tablet Counting Machine AC 2000 KBW Packaging. and Kinex SA 2000 capping machine
- IN2 blister and carton printing equipment.
- Antares Vision Print&Check EVO-TE for serialization.
- Process control laboratory: Dr. Schleuniger tablet hardness tester, Erweka tablet disintegration tester, Erweka friability tester, Mettler Toledo moisture content determination equipment.