Validation of a Rapid Microbiological Method for the Detection and Quantification of the Burkholderia cepacia Complex in an Antacid Oral Suspension.

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: 1

Abstract

Background: Despite the broad adoption of Soleris® technology in the food industry as semiquantitative method, it is almost completely unexplored in the pharmaceutical industry as a quantitative method for quantification of Burkholderia cepacia complex (Bcc).

Objective: The efficacy of an automated growth-based system for a quantitative determination of the Bcc in an antacid oral suspension was studied. The main purpose of this validation study was to prove that the alternative method's entire performance is not inferior to the conventional method for a quantitative determination of Bcc.

Method: The antacid oral suspension's preservatives were neutralized, leading to the Burkholderia complex's recovery by means of the alternative method and the reference method. A calibration curve was generated for each strain by plotting DTs relative to the corresponding log CFU values. An equivalence of results was done through the construction of calibration curves that allowed the establishment of numerically equivalent results between the enumeration data from the reference method and the alternative method.

Results: Thus following the guidelines of USP, essential validation parameters were shown, such as equivalence of results (CC >0.95), linearity (R2 >0.9025), accuracy (% recovery >70%), operating range, precision and ruggedness (DS <5 and CV <35%), specificity (inclusivity and exclusivity), limit of detection (LOD), and limit of quantification (LOQ).

Conclusions: It was shown that all the test results obtained from the alternative method were in statistical agreement with the standard method. Thus this new technology was found to meet all the validation criteria needed to be considered as an alternative method for the quantification of the Burkholderia complex in the antacid oral suspension tested.

Highlights: As outlined in USP chapter <1223> and demonstrated in this research the implementation of alternative methods can offer benefits in execution and automation while improving accuracy, sensitivity, and precision and can reduce the microbiological process time compared to the traditional ones.

抗酸口服混悬液中洋葱伯克氏菌复合体快速检测和定量的微生物学方法验证。
背景:尽管Soleris技术作为半定量方法在食品工业中被广泛采用,但在制药工业中,作为洋葱伯克霍尔德菌复合体(Bcc)的定量方法,它几乎完全没有被探索过。目的:研究基于生长的自动系统定量测定抗酸口服混悬液中Bcc的效果。本验证研究的主要目的是证明替代方法的整体性能不低于常规方法用于Bcc的定量测定。方法:采用替代法和参比法对抗酸口服混悬液中的防腐剂进行中和,使伯克霍尔德菌复体恢复。通过绘制dt相对于相应的对数CFU值生成每个应变的校准曲线。通过建立校准曲线,使参考方法和备选方法的枚举数据在数值上等效。结果:在USP的指导下,给出了基本的验证参数,如结果的等效性(CC >0.95)、线性度(R2 >0.9025)、准确度(回收率>70%)、工作范围、精密度和坚固性(DS)。结论:替代方法得到的所有试验结果与标准方法在统计学上一致。因此,这项新技术被发现满足所有的验证标准,需要考虑作为一种替代方法,定量伯克霍尔德菌复合体在抗酸口服混悬液测试。要点:正如USP章节所概述的和本研究中所展示的,替代方法的实施可以在执行和自动化方面提供好处,同时提高准确性,灵敏度和精度,并且与传统方法相比可以减少微生物处理时间。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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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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