title: Establishment of critical contamination risk locations ("hot spots") in environmental monitoring by means of three-dimensional airflow analysis and particulate evaluation.
abstract: A practical approach for the qualification of the surrounding environment of the critical area in aseptic processing has been developed. This method uses three-dimensional air velocity measurements combined with airborne particle monitoring. The analysis of the results obtained using the methods described in this article are beneficial in the selection of sample sites and frequencies and in refining personnel procedures and materials flow in aseptic processing. We propose that this improved qualification method can be widely applicable for both existing and new aseptic processing areas. This paper shows the results of one case study utilizing this method. The particle distribution map of a Grade B environment based upon extensive analysis was found to correspond to room airflow, as visualized by air vector mapping. The actual annual environmental monitoring data, which include airborne particles and microbes, as well as other microbial monitoring data, are also presented with respect to their relationship to the airflow pattern.
authors.affiliation: Fujisawa Pharmaceutical Co, Ltd, Pharmaceutical Science Laboratories, Osaka, Japan. hirohito_katayama@po.fujisawa.co.jp
authors.forename: Hirohito
authors.initials: H
authors.lastname: Katayama
authors.forename: Takashi
authors.initials: T
authors.lastname: Higo
authors.forename: Yuji
authors.initials: Y
authors.lastname: Tokunaga
authors.forename: Yukio
authors.initials: Y
authors.lastname: Hiyama
authors.forename: Kaoru
authors.initials: K
authors.lastname: Morikawa
mesh_terms: D000391:Air Microbiology / Q000592:standards*; D001207:Asepsis / Q000295:instrumentation / Q000379:methods* / Q000592:standards*; D004780:Environment, Controlled; D004866:Equipment Contamination / Q000517:prevention & control; D018570:Risk Assessment