RT Journal Article
SR Electronic
T1 Practical applications of bio-fluorescent particle counting in Environmental Monitoring investigations
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP pdajpst.2019.009969
DO 10.5731/pdajpst.2019.009969
A1 Prasad, Aditya
A1 Villari, Philip
A1 Henry, Robert 'Bo'
A1 Weber, Jeffrey
A1 Hauschild, James
A1 Yan, Lisa
A1 Horsch, Jeff
A1 Shereefa, Shebeer
A1 Rau, Jan Eric
A1 Milling, Annett
A1 Bolden, Jay S
A1 Plourde, Lucile
A1 Claassen, Marja
A1 IJzerman-Boon, Pieta
A1 Forng, Ren-Yo
A1 Portmann, Roland
A1 Urwyler, Simon
A1 Dassu, Dawood
YR 2019
UL http://journal.pda.org/content/early/2019/12/13/pdajpst.2019.009969.abstract
AB Investigations into environmental monitoring (EM) excursions can be prolonged and do not always result in clear root causes or CAPAs. This paper outlines how bio-fluorescent particle counting (BFPC) can be used in investigations to eliminate the inherent delays of culture-based methods. The application for investigations supplements routine EM; acting as a risk reduction tool enabling real-time detection of viable microorganisms in air samples − supporting root cause analysis and remedial actions. The paper includes guidance on how to use the technology, a real case study involving a mold excursion, and examples of business benefits achieved by various companies.