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2015, Number 1

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Rev Cubana Farm 2015; 49 (1)

Evaluation of the environmental microbiological burden in vaccine production and control areas

Bottale AJ, Riera LM, Rabinovitch L

Language: Spanish
References: 22
Page: 47-60
PDF size: 354.38 Kb.


ABSTRACT

Objectives: the objective of this study was to support microbiological quality assurance in a vaccine production plant through identification of environmental microbiological charge and its behavior with routine disinfectants.
Methods: the existing flora of each classified area was studied. Air samples taken by volumetric and plate sedimentation methods were analyzed. Surfaces and the gown of the staff were assessed by contact method. Genera and species were identified, thus setting a Group of Indicator Microorganisms made up of microorganisms that were isolated at a rate greater than 5% for each facility.
Results: animal Facility: Staphylococcus spp (50 %), Aerococcus spp (21%), Micrococcus spp (10%), Bacillus spp and related genera (6%); Normal Tissue Culture Laboratory: Staphylococcus spp (48%), Micrococcus spp (34%), Bacillus spp and related genera (13%); Quality Control Laboratory: Staphylococcus spp (50%), Micrococcus spp (27%), Kocuria spp (9%), Bacillus spp and related genera (7%); Production: Staphylococcus spp (50%), Micrococcus spp (17%), Kocuria spp (11%), Leuconostoc spp (8 %), Bacillus spp and related genera (6%). The Group of Indicator Microorganisms for the Production Unit was identified as Staphylococcus spp (49.5%), Micrococcus spp (23 %) and Bacillus spp and related genera (8.1%). The regularly used disinfectants for strains from the Group of Indicator Microorganisms showed a high microbicidal efficacy.
Conclusion: the results provide information about the environmental bioburden, which will be useful for the understanding of the microbial entry points and spreading and the implementation of measures to prevent microbial contamination, so critical for manufacture of safe, pure and effective vaccines.


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