RT Journal Article
SR Electronic
T1 Establishment of Critical Contamination Risk Locations (“Hot Spots”) in Environmental Monitoring by Means of Three-Dimensional Airflow Analysis and Particulate Evaluation
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 49
OP 63
VO 59
IS 1
A1 Katayama, Hirohito
A1 Higo, Takashi
A1 Tokunaga, Yuji
A1 Hiyama, Yukio
A1 Morikawa, Kaoru
YR 2005
UL http://journal.pda.org/content/59/1/49.abstract
AB 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.