Environmental monitoring: a correlation study between viable and nonviable particles in clean rooms

CS De Abreu, TJA Pinto… - PDA Journal of …, 2004 - journal.pda.org
This article describes an environmental monitoring data study for clean rooms. Two
parameters were compared in order to investigate the possibility of correlation between …

Moving towards a (microbiological) environmental monitoring programme that can be used to release aseptically produced pharmaceuticals: a hypothesis, a practical …

R Hertroys, PAM Van Vught… - PDA Journal of …, 1997 - journal.pda.org
We present, in detail, the (microbiological) environmental monitoring programme for
cleanrooms that is in use at the RIVM†. The parameters that are measured are: Total …

Comparative study of airborne viable particles assessment methods in microbiological environmental monitoring

G Temprano, D Garrido, M D'Aquino - PDA Journal of …, 2004 - journal.pda.org
A comparative study was done among available assessment methods to measure airborne
viable particles in controlled rooms. Active methods were compared (sieve/nozzle impactor …

Hazard analyses of airborne contamination in clean rooms—application of a method for limitation of risks

B Ljungqvist, B Reinmüller - PDA Journal of Pharmaceutical …, 1995 - journal.pda.org
Hazard Analyses and establishing of Critical Control Points (HACCP) using a method with
Limitation of Risks, known as the LR Method are described. This method has a concept …

Airborne viable particles and total number of airborne particles: comparative studies of active air sampling

B Ljungqvist, B Reinmüller - PDA Journal of Pharmaceutical …, 2000 - journal.pda.org
This paper presents results from a comparative study of different impaction air samplers
under simulated operational conditions in a controlled environment. Furthermore …

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 …

[HTML][HTML] Calculating and understanding particulate contamination risk

M Haag - Pharmaceutical Technology Europe, 2011 - pharmtech.com
Ambient particles, potentially carrying microbial contaminants (viable particles), and
nonviable particles can spread from surfaces to the surrounding air volume of a proposed …

Human contamination control in a clean room

S Vidali - Microchemical journal, 1992 - Elsevier
By means of sophisticated analytical techniques, accurate research results can be obtained
even when concentration values are very low. Work must be performed in a contamination …

[PDF][PDF] Environmental monitoring programme in the cell therapy facility of a research centre: preliminary investigation

G Ottria, M Dallera, O Aresu, MA Manniello… - Journal of preventive …, 2010 - researchgate.net
Introduction. Recent discoveries in cell therapy research present new opportunities for
cellular products to be used to treat severe, and as yet incurable, diseases. It is therefore …

Interaction between air movements and the dispersion of contaminants: clean zones with unidirectional air flow

B Ljungqvist, B Reinmüller - PDA Journal of Pharmaceutical …, 1993 - journal.pda.org
The purpose of this presentation is to describe the theoretical relations for the dispersal of
airborne contaminants and to illustrate the validity of these equations occuring during factual …