The production area includes two distinct sections:
High Containment and Chemical Plant
- The High Containment Area is segregated from the Chemical plant and is divided in suites completely independent.
- The suites are dedicated to manufacturing of APIs intended for human use. A single project can be carried out in each suite.
- Development work is carried out in separate labs, also equipped with glove boxes, but intended for non GMP work.
Our approach to high containment is to isolate in glove box any manipulation of powders, as dissolution, filtration, sieving, drying and packaging.
The reactors workcenter is connected to the glove box by means of fixed piping in a closed-cycle system. The volumes rank from 50 to 250L reactors. The batch size can vary from 0.5 to 4.0 kg.
Remote control of the reactions ensures additional safety and accurate monitoring of the reaction parameters.
- Because of the high activity of the compounds, limits for cleaning are very demanding (normally LT 0.01 micrograms per squared cm).
Isolation of solids is carried out by Buchner filters in the smaller suites, (0.5 to 2 kg) while there is a 0.06 m2 filter drier inside a glove box for larger batches (4-5 kg). There are several different columns for chromatographic purification. The largest can hold 48 kg silica/resin.