Some observations on airborne particles in the critical areas of a blow-fill-seal machine

Regulatory authorities set requirements on factors such as maximum allowed airborne particle concentrations in critical areas and the surrounded environment. An important issue when producing sterile drugs by aseptic processing with blow-fill-seal technology is to achieve Class 100 (ISO Class 5) in the critical area. To meet these requirements high efficiency particulate air (HEPA)-filtered airflow is used to dilute and remove airborne particles. The required airflow is dependent on the quantity of generated particles. The purpose of this paper is to present the measures taken to reduce airborne particle concentrations at critical areas of a blow-fill-seal machine. The methods being used in the experimental studies are smoke visualization and particle measurements. The results show that particle concentrations can be reduced by minor changes of process variables. By changing the process variables, particle concentrations--number of particles (> or = 0.5 microm) per cubic foot--in the shroud (filling zone), extrusion zone, and the filling room were approximately reduced as follows: approximately 90% in the shroud (filling zone), approximately 90% in the extrusion zone, and approximately 40-60% in the filling room. It should be noted that the presented results are limited to one type of blow-fill-seal machine and this paper is a continuation of an earlier published paper by the authors in the PDA