- Key technologies & expertise
- R&D Labs
- Manufacturing Plant
- Security of supply
- Quality control
- Project Management
Our Pilot Plant is an independent, small scale FDA approved production facility counting more than 25 reactors and vessels from 50 to 650 L for a total of 6 m3 of capacity.
3 different and fully segregated clean zones for final APIs processing are enabling 3 parallel projects running independently. Pilot Plant operations are designed and maintained in an exactly same standard as production environment at target commercial scale which ensures a smooth process transfer at larger scale (same quality, EHS standards, format for Batch records and SOP’s are applied as for production areas).
This facility runs 24h/day and 7 days/week and giving its capacity and flexibility is used for both scale-up studies to prove process robustness and also routine manufacturing of relatively small volume commercial API.
Dissolutors: 500 dm3 SS, 250 dm3 GL and 100 dm3 GL
Crystallizers: 100 dm3 GL, 250 dm3 GL and 500 dm3 GL.
Clean zone with vertical axe SS centrifuge and movable closed pressure nutshe-filter.
Discharge of nutshe-fitler.
Micronizer (Jet Mill) 5 cm diameter.