Advanced Therapies Unit

The Advanced Therapies Unit has more than 150m2 located in basement -1 of Tower A of the Hospital Universitario y Politécnico La Fe, distributed in three independent production rooms, an area for cryopreservation and a quality control laboratory.

The execution and distribution of the spaces have been carried out according to the parameters established in the specific regulations for clean rooms, Annex 1 of the GMP EU standards, dedicated to the Manufacture of sterile medicines, which establishes the classification of these clean areas according to their degree of air cleanliness.

The space of the facilities is distributed as follows:

Three production rooms (grade B).
Three media and reagent preparation rooms (grade C) connected by double SAS for clean and dirty materials.
Quality control laboratory (grade C).
A cryogenization room for cell and tissue bank (grade C).
A storage room with an airlock for material entry (grade D).

All spaces are equipped with the necessary infrastructure to carry out the activities that take place in them (biosafety cabinets, microscope, centrifuges, balances, ph-meter, CO2 incubator, refrigerators, freezers, ultrafreezers, nitrogen tank, among others).

In addition, both the facilities and critical equipment are monitored 24 hours a day for follow-up and control of their conditions, ensuring that they are within the permitted and validated ranges at all times.