Flamma’s cGMP Chignolo site is FDA Registered and continues to upgrade and improve the facility in order to meet our customer’s demands. The facility is regularly inspected by regulatory agencies (FDA, Italian Ministry of Health- AIFA) as well as customers. Recent upgrades include the addition of a Validation lab, a High Containment lab (to handle genotoxic materials to OEB 4), and a Process Improvement/ Troubleshooting lab.
This cGMP production facility is monitored and coordinated by a computer assisted system.
Production capacity (total 120 m3)
Julia/Claudia – workshops
12 stainless steel reactors, from 1500 L to 6000 L
9 glass-lined reactors, from 1000 L to 8000 L
3 dryers (tray, paddle)
Jolie/Michelle – API production
3 stainless steel reactors, from 2500 L to 6000 L
3 glass-lined reactors, from 2500 L to 8000 L
2 Conic dryers 2.5 m3
Drying press filter 2.5 m2 and 1.5 m2
Pilot Plant – demo batches & low volume production
Do you want to learn more about the Chignolo site?
Download the Flamma Chignolo Brochure