RT Journal Article
SR Electronic
T1 Environmental Monitoring: A Correlation Study Between Viable and Nonviable Particles in Clean Rooms
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 45
OP 53
VO 58
IS 1
A1 De Abreu, Catherine Simões
A1 de Jesus Andreoli Pinto, Terezinha
A1 De Oliveira, Débora Cristina
YR 2004
UL http://journal.pda.org/content/58/1/45.abstract
AB This article describes an environmental monitoring data study for clean rooms. Two parameters were compared in order to investigate the possibility of correlation between them: (1) total airborne nonviable (0.5 and 5 μm) and viable (CFU) particulates, and (2) surface contamination (Rodac®). The investigation took into account A, B, and C classified areas, in operational moment or status, which involved “at rest” (just equipment working) and “dynamic” (equipment and operators working) conditions. Available data in the literature indicates that the parameters are not particularly dependent upon the layout or classification of areas, but rather on the use of the areas and operator behaviour. Our results showed a correlation around 0.6 between different sampling places for nonviable 0.5- and 5-μm particles. There was no correlation between nonviable 0.5- and 5-μm particles in places with laminar flow.