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2016, Number 1

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Rev Cubana Farm 2016; 50 (1)

Establishing internal microbiological limits for D gradeclassified areas

Javier BA, Ceferina RLM

Language: Spanish
References: 27
Page: 30-43
PDF size: 132.52 Kb.


ABSTRACT

Objective: to contribute to ensuring the microbiological quality of a vaccine manufacturing plant through the establishment of internal microbiological alert and action limits for their grade D classified areas.
Methods: the resident microbiota of each grade D classified area was studied. Air samples taken by the volumetric method were analyzed. The surfaces and the staff's gowning were evaluated by the contact method. The microorganism counts were statistically analyzed to determine the alert and action limits.
Results: the microbiological alert and action limits have been established for each Grade D classified area of the production plant of the National Institute of Human Viral Diseases, based on the determination of the usual working ranges. Limits were set, as in the case of gloves after work for a Grade D area, where the standard does not define them.
Conclusions: the results generally agreed with the limits recommended by the national regulatory authority ANMAT, and additionally, this study provided information on the microbiological flora of grade D classified environments, which will be useful for both understanding the entrance and circulation of microorganisms and implementing measures to prevent biocontamination, which are critical aspects in the manufacture of effective, pure and safe vaccines.


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