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
- 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. Maximum capacity of 60 Kg per batch with direct compression processes or wet granulation processes (blending up to 3 fractions of 20 Kg in a single batch).
- Fette 1200iC rotary tablet press, fully equipped for formulation development and manufacturing. EU-B and EU-D punches.
- Oystar Manesty XL Lab 01 tablet coater, with interchangeable perforated drums. Capacity: Up to 20 Kg per fraction.
- Spray Dryer GEA Niro Mobile Minor.
- Bosch GKF 702 automatic capsule filling machine.
- IMA Clinipack blister machine (Alu/Alu and thermoformed materials).
- Quadro Comill sieve.
- Capsunorm 2000 manual capsule filler.
- Bottle filling: KBW AC2000 tablet counter and Kinex SA 2000 capping machine.
- Sepha press-out deblister.
- Fette Gratex deduster.
- IN2 blister and carton printing equipment.
- Antares Vision Print&Check EVO-TE for serialization.
- Metal detector.
- Process control laboratory: Dr. Schleuniger tablet hardness tester, Erweka tablet disintegration tester, Erweka friability tester, Mettler Toledo moisture content determination equipment.