International Journal of Innovative Approaches in Science Research
Abbreviation: IJIASR | ISSN (Print): 2602-4810 | ISSN (Online): 2602-4535 | DOI: 10.29329/ijiasr

Original article | International Journal of Innovative Approaches in Science Research 2021, Vol. 5(1) 1-13

Evaluation of BACTECTM FX Blood Culture System for Rapid Sterility Testing of Human Medicinal Solutions for Infusion

Ferhat Yıldırım, Umur Kumrulu, Elif Kumrulu, Esma Yazar, Meryem Kuşcu, Gizem Antika & Tugba Boyunegmez Tumer

pp. 1 - 13   |  DOI: https://doi.org/10.29329/ijiasr.2021.338.1

Published online: March 30, 2021  |   Number of Views: 42  |  Number of Download: 81


Abstract

Human medicinal products for infusion should be tested for sterility at various stages of manufacturing including the final step before marketing. Conventional sterility methods recommended in pharmacopeia need a 14 days incubation period in order to get reliable analytical results. However, rapid alternative methods based on automated detection of microbial growth have the advantage of taking only 5 days for sterility testing of medicinal products which can be very important especially during pandemics and emergency conditions. The aim of the present study is to evaluate the microbial detection potential and capacity of the BACTEC FX system for the rapid sterility testing of Paracerol, a 10 mg/mL paracetamol containing pediatric medicine for infusion, and to specify time required for the detection of a variety of microorganisms. Accordingly, the results showed that there were no significant differences between the BACTEC and conventional membrane filtration methods for detecting contamination. All positive/negative controls and all samples intentionally contaminated with microorganisms were determined correctly by using both methods. BACTEC FX system detected all microorganisms including slow growers significantly faster than the membrane filtration method (p<0.05). This system can be considered as a rapid alternative over conventional sterility methods for the release of human medicinal products for infusion to the markets especially under emergency conditions. However, for each particular products, validation steps should be executed according to European Pharmacopoeia by using a broad range of microorganisms.

Keywords: Rapid Sterility Test, BACTEC Method, Paracetamol, Membrane Filtration


How to Cite this Article?

APA 6th edition
Yildirim, F., Kumrulu, U., Kumrulu, E., Yazar, E., Kuscu, M., Antika, G. & Tumer, T.B. (2021). Evaluation of BACTECTM FX Blood Culture System for Rapid Sterility Testing of Human Medicinal Solutions for Infusion . International Journal of Innovative Approaches in Science Research, 5(1), 1-13. doi: 10.29329/ijiasr.2021.338.1

Harvard
Yildirim, F., Kumrulu, U., Kumrulu, E., Yazar, E., Kuscu, M., Antika, G. and Tumer, T. (2021). Evaluation of BACTECTM FX Blood Culture System for Rapid Sterility Testing of Human Medicinal Solutions for Infusion . International Journal of Innovative Approaches in Science Research, 5(1), pp. 1-13.

Chicago 16th edition
Yildirim, Ferhat, Umur Kumrulu, Elif Kumrulu, Esma Yazar, Meryem Kuscu, Gizem Antika and Tugba Boyunegmez Tumer (2021). "Evaluation of BACTECTM FX Blood Culture System for Rapid Sterility Testing of Human Medicinal Solutions for Infusion ". International Journal of Innovative Approaches in Science Research 5 (1):1-13. doi:10.29329/ijiasr.2021.338.1.

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