Biological Sterilization Monitors: A Four-Year In-Use Evaluation of Two Systems
Biological Sterilization Monitors: A Four-Year In-Use Evaluation of Two Systems
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生物灭菌监测仪：两个系统的四年使用评估
DOI：
10.1017/s0195941700064808
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发表时间：
1985
期刊：
影响因子：
--
通讯作者：
N. Gantz
中科院分区：
文献类型：
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作者：
H. R. Kotilainen;N. Gantz
摘要生物监测器(BI)被认为是最好的灭菌过程监测器，但假阳性可能导致召回和质量保证困难。为了评估可疑结果的频率、类型和原因，我们对蒸汽和环氧乙烷(EO)的两种常用BI类型进行了为期4年的使用研究-孢子带(Spordi®)和自含式可压碎安瓶(Atest®)。在实验室验证了每个相关批次的一部分的时间/杀伤率后，在标准时间和温度下随机选择负载运行，将每种类型的2个BI放置在测试包中。所有阳性BI细胞均进行传代培养。蒸汽循环阳性不常见(32/1,1710例阳性，1.9%；20/1,710例阳性，1.2%)，可能与室温或蒸汽品质有关。每个负载的4个BI仅在3个负载中均为阳性；物理监视器显示严重故障。五个阳性的Spordi要么是由于污染物，要么是由于孵化器故障。EO相关阳性较常见(53/1109例阳性，4.8%；25/1109例阳性，2.3%)。孵化48小时后，有一半的Spordi检测呈阳性。从49.1%(26/53)的阳性试验中回收了除枯草杆菌以外的其他生物。这项证明值得注意的是它没有污染；25%的人只对斯氏假单胞菌呈阳性。在相对湿度低于20%的冬季月份，观察到的阳性反应更多。这一发现在EO证据中更为常见。总而言之，我们发现这两种BI的表现没有显著差异。应强调阳性菌的继代培养和在储存期间保持适当的湿度。
Abstract Biological monitors (BI) are considered to be the best monitor of the sterilization process yet false positives may result in recalls and quality assurance difficulties. To assess the frequency, type and reasons for questionable results, we undertook a 4-year in-use study of two commonly used BI types—spore strips (Spordi®) and a self-contained crushable ampule (Attest®)—for both steam and ethylene oxide (EO). After laboratory verification of time/kill ratios for a portion of each involved lot, 2 BI of each type were placed in test pack within a randomly selected load run at standard time and temperature. All resulting positive BI were subcultured. Steam cycle positives were uncommon (32/1,1710 positive Spordi, 1.9%; 20/1,710 positive Attest, 1.2%) and could be related to chamber temperature or steam quality. All of the 4 BI per load were positive in only three loads; physical monitors indicated gross malfunction. Five positive Spordi were due to either contaminants or a malfunctioning incubator. EO-related positives were more common (53/1,109 positive Spordi, 4.8%; 25/1,109 positive Attest, 2.3%). One-half of the Spordi tests became positive after 48 hours of incubation. Organisms other than B. subtilis were recovered from 49.1% of the positive tests (26/53). The Attest was remarkable for its lack of contamination; 1/25 was positive for Pseudomonas stutzeri only. More positives were observed during the winter months when relative humidity was below 20%. This finding was more commonly observed with the EO Attest. In summary, we found no significant difference in the performance of either BI. Subculturing of positives and maintenance of proper humidity during storage should be emphasized.