基于自动生长的系统和平板计数法检测个人护理产品中酵母菌和霉菌的效果比较。

IF 1.7 4区 农林科学 Q3 CHEMISTRY, ANALYTICAL
Harold A Prada-Ramírez, Sandra Celeita, Juan Camilo Fonseca
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引用次数: 0

摘要

目的:研究基于自动生长的系统对几种个人护理产品中白色念珠菌和巴西曲霉的定量测定效果。本验证研究的主要目的是证明替代方法在酵母和霉菌的定量测定中的整体性能不劣于传统的倒板法。因此,根据美国药典(USP-NF)《替代微生物方法验证》1223建立了性能等效性。方法:在方法测试的适用性中,将白色念珠菌和巴西白念珠菌合并用作接种物(相当于1.0×108CFU/mL)。通过替代微生物法(AMM)和倒板法对PCP的防腐剂进行化学中和,从而回收酵母和霉菌。通过绘制相对于相应对数CFU值的DT,为每个PCP生成相关曲线。结果:使用AMM对30个PCP进行了酵母和霉菌的定量测试。通过构建相关曲线,可以在参考方法(CFU)和替代方法(检测时间,DT)的枚举数据之间建立数值等效结果,从而实现结果的等效。因此,根据USP Ch.1223的指南,对基本验证参数进行了测试,如结果等效性(相关系数,CC>0.95)、线性度(R2>0.9025)、准确度(%回收率>70%)、操作范围、精密度(CV 0.05)、特异性、LOD和LOQ。因此,发现这项新技术符合所测试PCP中酵母和霉菌定量替代方法所需的所有验证标准。亮点:根据美国药典(USP-NF)《替代微生物方法验证》1223,与传统方法相比,替代方法的实施可以在执行和自动化方面带来好处,同时提高准确性、敏感性和精密度,并缩短微生物处理时间。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Efficacy Comparison of an Automated Growth-Based System and Plate-Count Method on the Detection of Yeasts and Molds in Personal Care Products.

Objective: The present investigation studies the efficacy of an automated growth-based system for a quantitative determination of Candida albicans and Aspergillus brasiliensis in several personal care products. The main purpose of this validation study was to prove that the alternative method's entire performance is not inferior to the conventional pour-plate method for a quantitative determination of yeasts and molds. Thus, a performance equivalence was established in accordance with the United Stated Pharmacopeia (USP-NF) Validation of Alternative Microbiological Methods ˂1223˃.

Methods: C. albicans and A. brasiliensis were pooled to use as inoculum (equivalent to 1.0 × 108 CFU/mL) in the suitability of the method test. PCP's preservatives were chemically neutralized leading to the yeast and mold recovery by means of the alternative microbiological method (AMM) and the pour-plate method. A correlation curve was generated for each PCP by plotting DTs relative to the corresponding log CFU values.

Results: Thirty PCPs have been tested for quantification of yeasts and molds using an AMM. An equivalence of results was made through the construction of correlation curves that allowed the establishment of numerically equivalent results between the enumeration data from the reference method (CFU) and the alternative method (Detection times, DTs). Thus, following the guidelines of USP Ch.1223, essential validation parameters were tested, such as equivalence of results (Correlation coeficient, CC >0.95), linearity (R2 >0.9025), accuracy (% recovery >70%), operating range, precision (CV <35%), ruggedness (one-way ANOVA, P > 0.05), specificity, LOD, and LOQ.

Conclusion: It was shown that all the test results obtained from the alternative method were in statistical agreement with the standard plate-count method (PCM). Thus, this new technology was found to meet all the validation criteria needed to be considered for an alternative method for yeast and mold quantification in the PCPs tested.

Highlights: In accordance with the United Stated Pharmacopeia (USP-NF) Validation of Alternative Microbiological Methods ˂1223˃, the implementation of alternative methods can offer benefits in execution and automation while improving accuracy, sensitivity, and precision and reduce the microbiological process time compared to the traditional ones.

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来源期刊
Journal of AOAC International
Journal of AOAC International 医学-分析化学
CiteScore
3.10
自引率
12.50%
发文量
144
审稿时长
2.7 months
期刊介绍: The Journal of AOAC INTERNATIONAL publishes the latest in basic and applied research in analytical sciences related to foods, drugs, agriculture, the environment, and more. The Journal is the method researchers'' forum for exchanging information and keeping informed of new technology and techniques pertinent to regulatory agencies and regulated industries.
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