This experimental study examines the use of a real time viable particle counter in
pharmaceutical cleanroom operations under ISO class 8/Annex 1 Class C 'in …

The transition from traditional growth-based microbial detection methods to continuous bio-
fluorescent particle counting methods represents a paradigm shift, because the results will …

The Process and Environmental Monitoring Methods Working Group, composed of members
from industry and instrument manufacturers, met with the FDA Emerging Technology Team …

Investigations into environmental monitoring (EM) excursions can be prolonged and do not
always result in clear root causes or corrective and preventative actions. This article outlines …

In the aseptic manufacture of parenteral drug products and low bioburden, cell, and gene
therapy products, the control and monitoring of environmental-and personnel-associated …

Microbial contamination is an undesirable condition that occurs due to the presence of
microbes, including bacteria, viruses, fungi, and parasites. However, for the purpose of this …

Real-time onsite monitoring of indoor airborne microbes in a residential property in central
Tokyo was carried out in 2020 and 2021, following the onset of the COVID-19 pandemic. A …

Abstract The coronavirus disease 2019 (COVID-19) pandemic has reinforced the
longstanding concern that we are underprepared to respond to (re) emerging pathogens …

Despite the promise of biofluorescent particle counters (BFPCs) as an alternative and rapid
microbiological method and process analytical technology, their implementation thus far has …

Derry et al [1] are to be congratulated on their work concerning operating room (OR)
airborne contamination measurement using the Aerobiotix Illuvia device. The study, like …