低劑量γ-輻照滅菌不會影響藥廠環境監控之各種培養基的微生物生長效能

No Effect of Low-dose Gamma Ray Irradiation on the Microbial Growth Promotion Efficacy of Culture Media Used for Environmental Monitoring

楊霖(Lin Yang) ； 洪晟峰(Sheng-feng Hung) ； 蔡文城(Wen-cherng Tsai)

《檢驗及品保雜誌》 10卷4期 (2021/10) Pp. 167-173

https://doi.org/10.6573/JTQA.202110_10(4).04

摘要

生產無菌製劑的藥廠需要嚴格地進行生產環境的微生物監控，本研究利用啟新生物科技股份有限公司生產且經γ-輻照滅菌的六種環境監控培養基，以標準菌株進行生長效能試驗。測試時，將各測試菌包括Staphylococcus aureus（金黃色葡萄球菌）、Pseudomonas aeruginosa（綠膿桿菌）、Bacillus subtilis（枯草桿菌）、Clostridium sporogenes（產芽孢梭菌）、Candida albicans（白色鏈球菌）與Aspergillus brasilliensisn（巴西麴菌）分別以＜100 CFU的菌量利用塗抹法接種隨機採樣的測試平板培養基與前一批號之相同種類培養基，隨後培養在適當時間及環境後，進行生長菌量的計數，最後將兩批號所獲得的菌數結果進行比較，並計算回收率，結果指出環境監控培養基經過低劑量γ-輻照滅菌後，其等的pH值均達到藥典所規定的範圍，各菌種的回收率介於64%～174%之間，此範圍均符合藥典所建議之回收率的50%～200%允收標準。總之，低劑量γ輻照滅菌並不影響各種配方之環境監控培養基的生長效能。

關鍵字

γ-輻照滅菌 ； 環境監控培養基 ； 標準菌株 ； 生長效能試驗

並列摘要

Companies that manufacture sterile pharmaceuticals require strict microbiological monitoring of the production facility. Six types of triple-wrapped agar plates made with various kinds of culture media are available for such testing. In this study, we evaluated the growth promotion efficiency of six different types of agar plates for environmental monitoring produced by Creative Biotechnology Co., Ltd. To ensure the sterility of the agar plates, they were irradiated with low-dose gamma ray after being wrapped with three layers of different packaging materials. Each agar plate was inoculated with approximately 100 CFU of one kind of appropriate microorganism, i.e., Staphylococcus aureus, Pseudomonas aeruginosa, Bacillus subtilis, Clostridium sporogenes, Candida albicans, or Aspergillus brasilliensisn, and then incubated under proper conditions. Colonies that appeared on each agar plate were counted, and the results were compared with those of the tests performed with agar plates of the previous batch. Results showed that the pH values of gamma ray irradiated culture media were within the acceptable range and that microbial recovery rates were in the range of 64~174%, which is within the 50~200% acceptable range recommended by the Pharmacopoeia. Therefore, we conclude that low-dose gamma irradiation does not affect the growth promotion efficiency of culture media used for environmental monitoring of microorganisms.

並列關鍵字

γ-irradiation sterilization ； environmental monitoring media ； standard strains ； growth efficiency test