Steinkrauss M., Huxol E., Kubainsky C., Suter G., 2016, Safety Issue with Flammable Solvents in Pharmaceutical Production, Chemical Engineering Transactions, 48, 385-390.
In the pharmaceutical production are isolators in use to handle open highly active pharmaceutical compounds. The isolators are the safety barrier to avoid inhalation or skin contact with the highly active substances. From time to time the isolators must be cleaned and disinfected due to GMP and microbiological requirements. Often flammable solvents like ethanol are used for this purpose. Contrary to Deconex® and others, flammable solvents dry without leaving any residue behind. Disinfection is carried out by spraying, wiping or bathing most parts of the equipment, the plant and the room. By spraying flammable solvents, formation of an explosive atmosphere is possible. Swissi simulates evaporation of flammable solvent in an self build isolator under different conditions by spraying the solvent. Normally the equipment and ventilation of an isolator is not designed to prevent explosive atmosphere. Some ignition sources are present every time. Typical electronic equipment like ultrasonic baths and balances but also the electrical installations of the room itself, hot surfaces, mechanical sparks and electrostatic discharges could ignite this atmosphere and endanger people and plant. Some events of exploded isolators are known. Low ventilation can also easily lead to inhalation high above the accepted exposure limits when the isolator is open to the room or exchanges air with it. The experiments will show how the air exchange can be optimized or disinfection can be further optimized, so that an explosive atmosphere can be excluded.
