Solid phase cytometry applied to sterility tests for injecting 0.9% sodium chloride
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Data
2015-12
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Resumo
Sterility tests described in official compendia are carried out by membrane filtration or by direct
inoculation into suitable culture media. About 14 days are needed to provide results and release
products for sale, so speed is of the essence in rapid microbiological methods. Solid phase cytometry
is a fast innovative method for testing the sterility of injectable medications. It is based on the detection
of viable cells by using reagent viability markers which permeate the cell membrane, and are cleaved by
non-specific sterases to form fluorochrome, which is detected by a Chem Scan RDI®. This study set out
to evaluate this technology when applied to the sterility test in a 0.9% sodium chloride injection
solution, using Chem Scan RDI® equipment. Microorganisms recommended by the official compendia
Clostridium sporogenes NCTC12935 (ATCC 11437), Pseudomonas aeruginosa NCTC12924 (ATCC 9027),
Staphylococcus aureus NCTC10788 (ATCC 6538), Bacillus subtilis NCTC10400(ATCC 6633), Aspergillus
brasiliensis NCPF2275 (ATCC16404) and Candida albicans NCPF3179(ATCC 10231), and two “in house”
microorganisms, Micrococcus luteus and Staphylococcus epidermidis, obtained from monitoring the
pre-sterilization bioburden, were evaluated in order to validate the proposed method. When the solid
phase cytometry method was compared to the traditional membrane filtration sterility test for all the
microorganisms tested, it was found to be significantly faster in that it reduced analysis time from 14
days to approximately 3 h.
Descrição
Palavras-chave
Solid phase cytometry, Validation, Serility test by membrane filtration
Citação
SILVA, Gisele Badauy Lauria et al.Solid phase cytometry applied to sterility tests for injecting 0.9% sodium chloride. African Journal of Pharmacy and Pharmacology, Nairobi, v. 9, n. 45, p. 1051-1061, 2015.