Comparative analysis of ampoules and vials in sterile and conventional packaging as to microbial load and sterility test / Análise comparativa de ampolas e frascos-ampolas em embalagens estéreis e convencionais quanto a carga microbiana e teste de esterilidade

ABSTRACT Objective To compare sterility and microbial (bacteria and fungi) load in the outer part of hyperbaric bupivacaine (Neocaína®) in ampoule and bupivacaine in vial, in conventional and sterile pack formulations. Methods The sterile packs were divided into two groups: G1 (n=16) with ampoules and G2 (n=16) with vials. Conventional formulations were divided into two groups, being G3 (n=16) with ampoules and G4 (n=16) with vials. The ampoules and vials were opened and had their content drawn. The empty bottles were then placed in sterile plastic bags and sent for analysis of microbial load (bacteria and fungi) and sterility testing. Data were analyzed using the χ2 test with Yates correction, and 95% confidence interval. Results G1 and G2 showed no bacterial growth when compared to conventional groups (p<0.001). The most common agent in conventional microbiological samples was Staphylococcus aureus. There was no fungal growth in both groups. Conclusion The use of (sterile pack) reduces the microbial load of bottles, and would decrease the chance of exposure to potential contamination of the anesthetic solution.

RESUMO Objetivo Comparar a esterilidade e a carga microbiana (bactérias e fungos) da parte externa dos frascos de envasamento de bupivacaína hiperbárica (Neocaína®) em ampola e bupivacaína em frasco-ampola das apresentações convencional e estéril (sterile pack). Métodos As apresentações estéreis (sterile pack) foram distribuídas em dois grupos, sendo que o G1 (n=16) continha as ampolas e o G2 (n=16), os frascos-ampola. As apresentações convencionais foram distribuídas em dois grupos, a saber G3 (n=16) com as ampolas e G4 (n=16) com os frascos-ampola. As ampolas e os frascos-ampolas eram abertos e tinham seu conteúdo aspirado. Os frascos vazios eram, então, acondicionados em sacos plásticos estéreis e enviados para análise quanto à carga microbiana (bactérias e fungos), bem como para o teste de esterilidade. Os dados foram analisados por meio do teste χ2 com correção Yates com intervalo de confiança de 95%. Resultados Os grupos G1 e G2 não apresentaram crescimento bacteriano quando comparado aos grupos convencionais (p<0,001). O microbiano mais comum nas amostras convencionais foi o Staphylococcus aureus. Não houve crescimento de fungos em nenhum dos grupos. Conclusão O uso de embalagens estéreis (sterile pack) diminui a carga microbiana dos frascos de envasamentos, o que diminuiria a chance de exposição a uma potencial contaminação da solução anestésica.

The growth of micrococcus varians by utilizing sugar cane blackstrap molasses as susbstrate

Comparative studies on the growth of Micrococcus varians were carried out in BHI culture medium (control) as well as in a culture medium with 2(per cent) diluted sugar cane blackstrap molasses, enriched with 0.1 (per cent) yeast extract. The experiment was conducted with three samples of the experimental and control media in a 5 liter fermentor with working volume of 3.5 liters, continuous agitation (150 rpm), 35ñ0.1oC temperature, 0.7 L air. 1-1 medium.min-1, initial pH 7.0ñ 0.2, 24 hour fermentation period, and approximate inoculum of 6.0 log10 CFU/ml. Samples were collected at 2-hour intervals. Micrococcus varians grew in the two culture media studied, which confirms the experimental medium viability for the growth of this species. The final average concentration of biomass was higher in the control medium than in the experimental medium: 0.99 g.1-1 and 0.78 g.1-1, respectively. The final number of viable cells at the end of fermentation was 20.65 log10 CFU/ml for the control medium (BHI), while in the experimental medium the number of viable cells was 19.43 log10 CFU/ml. The consumption of total sugars was higher for the biomass in the control medium (79,78 per cent), while only 50.53(per cent) was consumed for the experimental medium.