Culturable microbiological profile of a non-sterile drugs pharmaceutical production environment
Braz. J. Pharm. Sci. (Online)
; 60: e23664, 2024. tab, graf
Article
in English
| LILACS
| ID: biblio-1533992
Responsible library:
BR40.1
Localization: BR40.1
ABSTRACT
Abstract For places where non-sterile drug production occurs, regulatory bodies recommend monitoring of the environmental bioburden. This procedure provides information regarding possible microbiological risks to which the products may be exposed, so that subsequent action measures may be implemented. The aim of the present work was to quantify and characterize the microorganisms present in Grade D (ISO 8) cleanrooms of a Brazilian pharmaceutical industry, identifying any possible seasonal climatic influences on these environments. Sampling was performed by surface and air monitoring, over 12 months during the year 2019, in rooms that were in operation. For both sampling methods, no statistically significant differences in bacteria and fungi counts were found between months or seasonal periods. Microorganisms that presented higher incidence included Staphylococcus epidermidis (15%) and Micrococcus spp. (13%), common to the human microbiota, and the fungi Cladosporium sp. (23%) and Penicillium sp. (21%), typical of the external environment. The results showed that microbial contamination in the Grade D cleanrooms was within the permissible maximum levels and remained similar throughout the year. Microbiological quality control in the clean areas of the pharmaceutical industry investigated was considered effective, with regular maintenance being necessary to keep bioburden levels controlled.
Full text:
Available
Collection:
International databases
Health context:
SDG3 - Health and Well-Being
Health problem:
Target 3.9: Reduce the amount of deaths produced by dangerous chemicals and the pollution of the air, water and soil
Database:
LILACS
Main subject:
Bacteria
/
Environmental Monitoring
Language:
English
Journal:
Braz. J. Pharm. Sci. (Online)
Journal subject:
Farmacologia
/
Teraputica
/
Toxicologia
Year:
2024
Document type:
Article
Affiliation country:
Brazil
Institution/Affiliation country:
Universidade Estadual de Campinas/BR