On the cause of performance variation of biological indicator used for sterility assurance.
On the cause of performance variation of biological indicator used for sterility assurance.
复制标题
无菌保证用生物指示剂性能变异的原因分析
DOI：
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发表时间：
2000
影响因子：
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通讯作者：
J. Akers
中科院分区：
文献类型：
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作者：
H. Shintani;J. Akers
已报告了几种类型的商业生物指示剂（BI）的生物指示剂（BI）致死率变化。在同一供应商的相同种属和菌株BI的不同批次中观察到该现象。来自不同供应商但具有相同种属和菌株的BI也报告了该问题，这些BI旨在挑战相同的一般类型灭菌过程。尽管已广泛报告了BI变异性，但尚未具体确定观察到的致死率变异性的促成因素。这是因为之前的报告在一定程度上忽略了商业BI生产中使用的载体材料、一级包装材料和培养基的差异。已广泛报道了可归因于载体材料的致死率差异，即所谓的“底物效应”。对于本实验中的BI制备，使用相同的载体材料、一级包装材料和培养基。唯一的变量是使用不同BI生产商提供的不同孢子混悬液。作者发现通过BI抗性测量的BI性能无显著差异。BI菌群可能因回收技术或购买的BI混悬液中的菌群变异性而异。与一些先前发表的研究不同，我们的研究没有迹象表明特定的BI制造商提供的BI具有更高的耐药性或更大的群体。
Variations in biological indicator (BI) lethality have been reported for several types of commercial BIs. This phenomenon has been observed among different lots of the same species and strain BIs from a single vendor. It has also been reported among BIs from different vendors but of the same species and strain that are intended to challenge the same general type of sterilization process. Although BI variability has been widely reported, the contributing factors to the variation in observed lethality have not been specifically identified. This is because the previous reports overlooked, to some extent, the differences in carrier materials, primary packaging materials, and culture media used in the manufacture of commercial BIs. The differences in lethality attributable to the carrier material, for so called "substrate effects," have been widely reported. For the BI preparation in this experiment, the same carrier material, primary packaging material, and culture medium were used. The only variable was the use of different spore suspensions supplied from different BI manufacturers. The authors found no significant difference in BI performance as measured by BI resistance. BI population may vary depending on the retrieval technique or population variability in a purchased BI suspension. Unlike some previously published studies, there was no indication from our studies that a specific BI manufacturer supplied BIs with either greater resistance or greater population.