Cytotoxic process plants require extra care in the design: each component of the plant has to be compliant with GMP regulations, therefore ensure protection for operators and for the surrounding environment. Indeed, cytotoxic drugs act by inhibiting or preventing the function of cells, stopping their replication or growth. They are primarily used to treat cancer and other diseases. This drug category is not able to generate action tightly targeted on tumoral cells and attack healthy cells too, thus it can produce side effects both to the patients and operators exposed.

The isolator so becomes a fundamental part of the plant: designed to handle liquid with cytotoxic compounds, it offers an effective barrier to protect operator, product and environment from hazards caused by uncontrolled diffusion of air-transported contaminants. At the same time, it avoids any biological interference of the environment on the product during its handling.

The plant can be subdivided into 5 blocks, corresponding to different phases of the process. 1: excipients production, that is salty solution and sucrose. 2: lipids production, extrusion and diafiltration systems, where the lipidic component of liposome, that will incorporate the drug, is produced. 3: API loading zone, where the active principle is loaded through isolator, operator can access to isolator via glove ports for his security. 4: heating and cooling systems, that shape the liposome in a way it can be the delivery system of the drug. 5: filtration group and sterile holding tank, to maintain the sterility of the final product.

The final product is then transferred to the filling line. 

The plant is thus composed of 2 Buffer tanks (2.000 L), 8 Process tanks, 4 Cytotoxic area for fixed tanks, TCM on skids and isolator.