R&D > Labs

The strength of F.I.S. is not only a large production capacity, to that is added the on-site availability of state-of-the-art labs to support process chemistry and analytical development research applied to API process development and validation.

R&D F.I.S. facility is comprised by:

12 Sythetic chemistry labs equiped with 100 standard chemistry fumewoods and 12 walk-in fumewoods to run safely process development activites up to 500g scale and process optimization studies aimed at identify critical process parameters according to the Quality By Design principle applied to process validation of API

12 Analytical Labs equiped with 27 fumewoods and a considerable number of qualified analytical instruments (HPLC, GC, HS-GC, GS-MS, LC-MS, NMR)

2 Hydrogenation suites equiped 8 fumewoods and different size (0.5 – 3 liters) and material of constructions autoclaves that could operated up to 100 bar. The facility is also equiped with a 4 channels reaction screening HEL system

2 Suites for Process Hazard evaluation equiped with 8 fumewoods, 2 RC-1 calorimeters, 1 Phitec adiabatic calorimeter, 1 C-80 Calvet calorimeter, 1 Optimax system, 3 DSC, 2 TGA

1 Laboratory dedicate to biocatalysis development and implementation, including fermentation capabilities up to 100 liters volume

3 Kilolabs ISO8 classification for scale-up to 1.5Kg with hydrogenation capability up to 60 bar. Each suite is qualified and approved for GMP manufacturing of clinical batches and GMP seeds

1 Highly Potent API (HPAPI) laboratory equiped with 2 isolators with a containment level down to 50 ng/m3

1 Analytical Lab for HPAPI containment level down to 50 ng/m3 equiped with 6 HPLC, 2 GC, 2HS-GC, 1 IR, 1 UV

1 Analytical Lab for HPAPI containment level down to 0.1 µg/m3 equiped with 4 HPLC, 2 GC, 1 IR

2 Kilolabs for HPAPI classe ISO 8 isolators fior scale-up to 1.5Kg with a containment level down to 50 ng/m3

1 Kilolab for HPAPI with a containment level down to 0.1 µg/m3 for scale-up to1Kg