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Validation of Alternative Microbiological Method in Non-sterile Pharmaceutical Product Through the Reference Strains and Productive Environment Bioburden
- Source :
- Repositório Institucional da USP (Biblioteca Digital da Produção Intelectual), Universidade de São Paulo (USP), instacron:USP
- Publication Year :
- 2019
- Publisher :
- Springer Science and Business Media LLC, 2019.
-
Abstract
- 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. 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. 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. 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.
- Subjects :
- Alternative methods
Computer science
business.industry
Pharmaceutical Science
MICROBIOLOGIA
02 engineering and technology
021001 nanoscience & nanotechnology
030226 pharmacology & pharmacy
Viable but nonculturable
Statistical power
Waste generation
Bioburden
Product (business)
03 medical and health sciences
0302 clinical medicine
Drug Discovery
Sensitivity (control systems)
Biochemical engineering
0210 nano-technology
business
Pharmaceutical industry
Subjects
Details
- ISSN :
- 19398042 and 18725120
- Volume :
- 15
- Database :
- OpenAIRE
- Journal :
- Journal of Pharmaceutical Innovation
- Accession number :
- edsair.doi.dedup.....f2d71d028c63683620f6aee8aa7ecb8c