Idifarma’s facilities built in 2008 were specifically designed for the handling of highly potent substances such as cytotoxics and cytostatics.
We have dedicated rooms for these compounds in our formulation and analytical development laboratories, with 100% air renewal, in depression and with the necessary personal protective equipment and other measures in place in order to guarantee the safety of the operators. All the rooms in our GMP manufacturing plant are clean rooms EU-GMP class C (ISO 7, US FED STD 209E class 10000 equivalent).
Our GMP plant was conceived as a high containment area, so we are also fully capable of manufacturing highly potent drugs.
Before the start of any new development or manufacturing project, we carry out a thorough risk analysis for each active substance, ranking them into one of the five operational exposure levels or bands, as a measure of the concentration in micrograms per cubic meter:
In the risk analysis, we take into consideration the specific characteristics of our facilities and equipment, as well as the necessary personal protective equipment and the specific properties of the active substance.
As a general rule, Idifarma is able to work with substances in categories 1 to 4 (up to OEL of 0.1 µg/m3), which comprise the overwhelming majority of pharmaceutical active substances.