Toxicological evaluation of some active and inactive materials according to the ventilation conditions variation during the manufacturing in non sterile pharmaceutical industry

The purpose of this thesis is to study the effect of air changes on particle number in pharmaceutical production facilities during production stage of non-sterile dosage forms. After those particle count measurements, a comparison of particle number with permitted daily exposure limit (PDE) and occupational exposure limit (OEL) was carried out. It was found that high particle concentration of the measured materials was detected in the environment of the manufacturing area . As a conclusion it is the first study to measure particle count during the operation phase of non-sterile pharmaceutical dosage forms production area. It was concluded that this type of measurements should be included by international guidelines and an extra care needed for each case for the manufacturing conditions to protect workers.