Objective: To evaluate the feasibility of BACTEC FX automated culture systems for rapid sterility test. Methods: According to the sterility test and alternative method validation guidancee in Chinese Pharmacopoeia 2015 and 2020, fifteen different types of sterility products were collected to validate the specificity, detection limit, repeatability and robustness. Results: The results of specificity test showed that the BACTEC FX system was suitable for some sterile products. The results indicated that there were no significant differences between the methods regarding the ability to detect microbial contamination in propofol injection. Conclusion: BACTEC FX automated culture systems have the advantages of high speed and sensitivity. Therefore, the BACTEC FX system is expected to bring effective supplement to pharmacopoeia sterility test.
YANG Yan, FENG Zhen, QIN Feng, LIU Hao, YANG Mei-cheng
. Evaluation of BACTEC FX automatic system for rapid detection of product sterility testing contaminants[J]. Chinese Journal of Pharmaceutical Analysis, 2021
, 41(11)
: 2017
-2023
.
DOI: 10.16155/j.0254-1793.2021.11.20
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