A new paper of interest has been published: ‘Comparison of Different Fungal Agar for the Environmental Monitoring of Pharmaceutical-Grade Cleanrooms’. The paper has been written by Barbara Gebala and Tim Sandle.
The
abstract for the paper reads:
“In
relation to a growth in reported incidents of fungal contamination of
pharmaceutical products, there has been a developing interest by U.S. and U.K.
regulators concerning the risk of fungi. This paper describes a study undertaken
to examine the suitability of different commercially available mycological
agars for the environmental monitoring of pharmaceutical-grade cleanrooms. Five
agars were evaluated in relation to the detection of both numbers and different
species of fungi (yeasts and moulds). The objective was to determine if one
mycological medium is more suitable than another. Data was collected using different
sampling techniques (settle plates, active air samples, and contact plates)
from different locations within representative cleanrooms. Samples were taken
over a 3 month time period. The study results indicated that fungi are not
distributed evenly across cleanrooms and that that the prevalence of fungi
partly relates to the room design and operation. In relation to the different
agar types, the study indicated that Sabouraud dextrose agar was the most
effective at detecting the widest number of different types of isolates, and
that Sabouraud dextrose agar and malt extract agar were the most efficient in
terms of the numbers of recovered isolates. Other media, notably potato
dextrose agar, was relatively less effective.”
The reference is:
The reference is:
Comparison of Different Fungal Agar for the Environmental Monitoring of Pharmaceutical-Grade Cleanrooms
Barbara Gebala and Tim Sandle
PDA J. Pharm. Sci. Technol. 2013; 67:621-633
Posted by Tim Sandle
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