Aerosol Distribution in Filling Processes within Pharmaceutical Isolator Systems

Rubrik: Reinraum

(Treffer aus TechnoPharm, Nr. 01, Seite 28 (2013))

Lerch K | Rauschnabel J | Hinrichs J

Aerosol Distribution in Filling Processes within Pharmaceutical Isolator Systems / Rauschnabel et al. • Aerosol Distribution in Filling Processes · Lerch K, Rauschnabel J, Hinrichs J · Robert Bosch GmbH, Crailsheim und Institute of Food Science and Biotechnology 150e, Universität Hohenheim, Stuttgart
Pharmaceutical isolator pharmaceutical aeroso aerosol distribution return air system particles droplets Pharmaceutical isolator systems provide a sterile, cleanroom environment for aseptic fill / finish operations [ 1 ]. They assure product safety by separating personnel from the aseptic area of production. In the case of highly potent products, this separation also shields the operator from harmful contact with hazardous products, e. g. cytostatic formulations. Product aerosols can be generated by the filling process itself, leakage, spillage and breakup of primary packaging and can therefore result in a contamination of the process area. These product residues from aerosols, spills or splashes may ...