Practical applications of biofluorescent particle counting in environmental monitoring investigations

A Prasad, P Villari, J Weber, J Hauschild… - PDA Journal of …, 2020 - journal.pda.org
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 …

Challenges Encountered in the Implementation of Bio-Fluorescent Particle Counting Systems as a Routine Microbial Monitoring Tool

A Scott, A Vanbroekhoven, C Joossen… - PDA Journal of …, 2023 - journal.pda.org
The transition from traditional growth-based microbial detection methods to continuous bio-
fluorescent particle counting methods represents a paradigm shift, because the results will …

A discussion on bio-fluorescent particle counters: summary of the process and environmental monitoring methods working group meeting with the FDA emerging …

A Scott, RY Forng, M Russ, G Dalmaso… - PDA Journal of …, 2021 - journal.pda.org
The Process and Environmental Monitoring Methods Working Group, composed of members
from industry and instrument manufacturers, met with the FDA Emerging Technology Team …

Continuous microbiological environmental monitoring for process understanding and reduced interventions in aseptic manufacturing

J Weber, J Hauschild, P Ijzerman-Boon… - PDA Journal of …, 2019 - journal.pda.org
This paper provides recommendations for quality oversight, manufacturing operations, and
industry perspective of regulatory expectations to enable aseptic facilities to move toward …

Future of biological aerosol detection

J Ho - Analytica Chimica Acta, 2002 - Elsevier
Biological aerosol detection in real time is an urgent civilian and military requirement. Such
detection capability will be useful in environmental monitoring, for example, in gathering …

[HTML][HTML] Application of Biofluorescent Particle Counters for Real-Time Bioburden Control in Aseptic Cleanroom Manufacturing

D Behrens, J Schaefer, CM Keck, FE Runkel - Applied Sciences, 2022 - mdpi.com
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 …

[PDF][PDF] Real-time counting of airborne particles and microorganisms: A new technological wave?

T Sandle - Clean Air Containment Rev, 2012 - researchgate.net
The methods for monitoring air in cleanroom environments: viable counting techniques
(settle plates and biological air samplers) and particle counters are long established …

Application of rapid microbiological methods for the risk assessment of controlled biopharmaceutical environments

T Sandle, C Leavy, H Jindal… - Journal of applied …, 2014 - academic.oup.com
Aims To assess the different operational states within a biopharmaceutical grade clean
room, using a rapid microbiological method. The method was a novel system, based on …

Evaluation of epifluorescence methods for quantifying bioaerosols in fine and coarse particulate air pollution

LWA Chen, M Zhang, T Liu, K Fortier, JC Chow… - Atmospheric …, 2019 - Elsevier
Despite being recognized as an important part of particulate matter (PM) air pollution and
health risk, bioaerosols have not been quantified as extensively as other PM components for …

[PDF][PDF] The implementation of rapid microbiological methods

MJ Miller - European Pharmaceutical Review, 2010 - rapidmicromethods.com
MICROBIOLOGY SERIES demonstrating that the technology is nondestructive and that
staining does not impact microbial viability. This may allow subsequent testing of the micro …