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范方玲,赵 田,张华琼.SPF 金黄仓鼠笼具及饮水脉动真空灭菌的效果验证[J].中国比较医学杂志,2021,31(8):101~107.
SPF 金黄仓鼠笼具及饮水脉动真空灭菌的效果验证
Verification of SPF golden hamster cages and drink water pulsating vacuum sterilization
投稿时间:2020-09-24  
DOI:10. 3969 / j.issn.1671-7856. 2021. 08. 015
中文关键词:  笼具  饮水  脉动真空灭菌  验证
英文关键词:cage  drink water  pulsating vacuum sterilization  verification
基金项目:
作者单位E-mail
范方玲 成都生物制品研究所有限责任公司,成都 610023 fflyjy@ 126.com 
赵 田 成都生物制品研究所有限责任公司,成都 610023  
张华琼 成都生物制品研究所有限责任公司,成都 610023  
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中文摘要:
       目的 确认脉动真空灭菌器的性能,验证 SPF 金黄仓鼠笼具和饮水在规定的装载方式和灭菌条件下进行脉动真空灭菌的效果。 方法 用专业温度探头、生物指示剂通过化学和物理方法对同载的不同物品进行脉动真空灭菌。 首先进行脉动真空灭菌器空载真空保压试验和 B-D 试验及空载热分布试验,确认灭菌器本身的性能,然后按照规定的装载方式和灭菌条件进行满载热分布试验/ 热穿透试验/ 微生物挑战试验,以及无菌试验。 结果 脉动真空灭菌器的性能合格:真空保压、B-D 试验、空载热分布试验均合格;SPF 金黄仓鼠笼具和饮水按照规 定的装载方式和灭菌条件进行满载热分布试验/ 热穿透试验/ 微生物挑战试验,所有试验结果合格;抽样高压后的垫料和饮水接种培养基中培养 14 d 后,培养基中未见菌落生长,无菌试验合格。 结论 SPF 金黄仓鼠笼具和饮水在规定的装载方式和灭菌条件下进行脉动真空灭菌后能达到灭菌效果。
英文摘要:
       Objective To confirm the performance of the pulsating vacuum sterilizer and its effect on SPF golden hamster cages and drinking water under specified loading and sterilization conditions. Methods The pulsating vacuum sterilization of different articles in the same load were performed by chemical and physical method with a professional temperature probe and biological indicator. First, a no-load pressure holding test and B-D test of the pulsating vacuum sterilizer and no-load heat distribution test were performed to confirm the performance of the sterilizer itself. Then, full-load heat distribution / heat penetration / microbial challenge, and asepsis tests were performed according to the specified loading method and sterilization conditions. Results The performance of the pulsating vacuum sterilizer was determined: vacuum holding pressure, B-D test, and no-load heat distribution test were all qualified. The test result of SPF golden hamster cages and drinking water subjected to full-load heat distribution / heat penetration / microbial challenge tests in accordance with specified loading method and sterilization conditions were qualified. After high pressure conditions, the sampling pads and drinking water were placed in culture medium for 14 days, but no bacterial colony growth was observed indicating the success of the sterility test. Conclusions SPF golden hamster cages and drinking water can be sterilized by pulsating vacuum sterilization under specified loading method and sterilization conditions.
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