Resumo

ARIAS PALACIOS, Janeth; ORTIZ GOMEZ, Diana Sofía  e  GONZALEZ ACERO, Adriana. Validation and implementation of a methodology for the microbiological analysis of a preserved liquid product produced in a pharmaceutical industry. Rev Cubana Farm [online]. 2013, vol.47, n.2, pp. 178-184. ISSN 0034-7515.

Objective: to validate and to implement a methodology for microbiological analysis of a liquid product preserved with parabens produced by a pharmaceutical company, based on the United States Pharmacopeia analytical methods, XXXIV version, 2011. Methods: the quantitative tests were carrying out for Staphylococcus aureus and Candida albicans, and qualitative tests for Escherichia coli, Staphylococcus aureus and Pseudomonas aeruginosa. Results: the results were consistent with those established by the USP. The described methodology was considered reproducible and robust because of its capacity of being unaffected by variations when implementing the technique, thus generating reliable and accurate results. Conclusions: all validation parameters met the USP specification, showing compliance with all the evaluated parameters.

Palavras-chave : microbiological analysis; accuracy; detection limit; linearity; precision; robustness; validation.

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