Objective: To establish a suitable method to prepare samples in microbial limit test of drug packaging materials. Methods: Bacillus astrophaeus (ATCC9372) spore was inoculated on the surface of drug packaging films materials, sheet materials and aluminium foil to make artificial pollution samples. Samples were prepared using manual shaking method, mechanical shaking method and stomacher processing method. Microorganisms were collected by membrane filtration. Personnel comparison was performed in manual shaking method group. Data was analyzed by one way analysis of variance(ANOVA) or t-test. Results: Among the three methods, the highest microorganism recovery efficiency (P<0.000 1) was obtained from manual shaking method. For manual shaking method, personnel comparison was conducted during these three kinds of drug packaging materials, and showed a little difference (P>0.05). Conclusion: Manual shaking method is considered as the best method to prepare samples of drug packaging materials under the consideration of recovery efficiency, operability and repeatability.
FANG Liang-yan, WANG Wen-qing, LUAN Tong-qing, LI Cui, GUO Xian-hu, MA Heng
. Study on sample pretreatment of microbial limit test of drug packaging materials[J]. Chinese Journal of Pharmaceutical Analysis, 2023
, 43(2)
: 355
-358
.
DOI: 10.16155/j.0254-1793.2023.02.20
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