AAAR 34th Annual Conference
October 12 - October 16, 2015
Hyatt Regency
Minneapolis, Minnesota, USA
Abstract View
Real-time Monitoring of Total and Biologically Viable Aerosol Particles in Cleanroom Environments
Boaz Granot, PETER HAIRSTON, Darrick Niccum, TSI Inc
Abstract Number: 172 Working Group: Bioaerosols
Abstract Manufacturing of injectable pharmaceuticals, biologic therapeutics, and medical devices must be done in controlled clean areas that are practically free of viable airborne bacteria, and that have low total particle concentrations. Viable and total particle concentration limits in these areas are dictated by regulatory standards created by the U.S. Pharmacopeia (USP) and International Standards Organization (ISO) and similar organizations. These standards set concentration limits that are aligned with the criticality of the process, and include requirements for aerosol monitoring to confirm that the environment is safe for performing the designed tasks. This presentation provides representative results from aerosol measurements in several clean room environments. The data were acquired in real-time with a TSI BioTrak(tm) instrument that samples air at 28.3 L/min and simultaneously measures the optical size and concentration of particles from 0.5 to 25 micrometers, and the size and concentration of viable biological particles from 2.0 to 10 micrometers based on ultraviolet induced fluorescence. In addition, the instrument collects particles from the sampled air onto a gelatin filter for subsequent incubation, growth, and identification of bacterial species. The data show that viable particles tend to arrive in short duration bursts that may not be correlated with the short term total particle concentration. This demonstrates that continuous, real-time total and viable particle monitoring is a useful method to assure clean room quality, to enable quick reaction to contamination events, and to support identification of any contamination sources.