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Validation of Alternative Microbiological Method in Non-sterile Pharmaceutical Product Through the Reference Strains and Productive Environment Bioburden

  • Michelle Andrade LemosEmail author
  • Daniela Dal Molim Ghisleni
  • Terezinha de Jesus Andreoli Pinto
Original Article
  • 5 Downloads

Abstract

Purpose

The traditional methods described in pharmacopeias most commonly used by the pharmaceutical industry are easy to perform and the costs are affordable, but they require long periods of time to obtain the results and often do not present sensitivity for recovering microorganisms in vulnerable physiological states known as viable but nonculturable. Thus, the objectives of this study were to evaluate the potential applicability of flow cytometry in non-sterile pharmaceutical products.

Methods

This paper implemented the analytical validation steps, through the reference strains and productive environment bioburden, by analyzing the traditional method in parallel to the alternative method with flow cytometry.

Results

The results indicated, with a 95% probability of detection, that there were no significant differences between the methods in relation to the ability to detect microbial contamination; however, the detection was faster with the flow cytometry method than the traditional method, which indicates that this technology is a viable alternative to be implemented.

Conclusions

The study demonstrated that the alternative microbiological method presents greater sensitivity in the analyses carried out, guaranteeing greater patient safety, besides allowing results to be obtained in a short period of time, thus enabling anticipation of investigations on possible failures that may occur during the process. Additionally, the study contributes to the environment by reducing waste generation and saving energy.

Keywords

Flow cytometry Non-sterile pharmaceutical product Alternative microbiological method Viable but nonculturable Rapid microbiology method 

Notes

Acknowledgments

The authors are grateful to the leaders of the Pharmaceutical Industry for providing the flow cytometry technology, the experimental batches of the product, the consumables, and all the support necessary for performing this study.

Compliance with Ethical Standards

Conflict of interest

The authors declare that they have no conflict of interest.

Ethical Approval

This article does not contain any studies with human participants or animals performed by any of the authors.

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Copyright information

© Springer Science+Business Media, LLC, part of Springer Nature 2019

Authors and Affiliations

  • Michelle Andrade Lemos
    • 1
    Email author
  • Daniela Dal Molim Ghisleni
    • 1
  • Terezinha de Jesus Andreoli Pinto
    • 1
  1. 1.Department of Pharmacy, Faculty of Pharmaceutical SciencesUniversity of São PauloSão PauloBrazil

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