干热灭菌温度指示剂的筛选和效果验证

利用结晶物质在一定温度下熔融的特性,通过对四种化学试剂进行熔点测定。选出试剂Ａ和试剂Ｂ作为干热灭菌温度指示剂和参考指示剂。试验结果表明,这两种温度指示剂终点明确,简便快速,能满足１８０℃干热灭菌的温度要求,可以对干热灭菌的温度验证提供客观证据     

灭菌生物指示剂的研究及在灭菌监测中的应用

本文论述有关生物指示剂的历史概况，在灭菌监测中，与物理、化学指示方法比较，生物指示剂的作用与地位。在生物制品、医院、食品行业等领域，生物指示剂的应用越来越受到人们的重视，并产生了良好的效果。本文论述了灭菌监测及生物指示剂的应用，与医院的感染的关系。美国药典（ＵＳＰ）和中国卫生部与也专门规定了生物指示剂的标准，应用及有关规定。在应用时，菌株的选择和具体方法尤为受人关注，本文列出有关应用中须注意的问题     

无热原蒸汽灭菌在疫苗生产中的应用与效果验证

为保证生物制剂生产的安全性,采用空载热分布试验,满载热穿透试验和微生物挑战试验对无热原蒸汽灭菌柜进行验证。另取疫苗生产中常用的Earle's液、PBS液及0.2%水解乳蛋白各5批,均采用无热原注射用水配制,无热原蒸汽灭菌。选用"Fluids121℃"15分钟循环程序和"Fluids115℃"20分钟循环程序检测热原质与灭菌效果。灭菌试验验证结果显示,无热原蒸汽灭菌符合现行GMP的要求。     

高压蒸汽灭菌柜性能验证方法的研究

高压蒸汽灭菌柜在使用之前和运行一定时间后,必须进行性能验证,采用热分布,热穿透和微生物挑战试验法对GE,GEV型脉冲式蒸汽灭菌柜的性能进行验证,多孔物质及流体物质灭菌循环中,灭菌腔内不存在冷点,具备有效的热穿透力,嗜热脂肪芽孢杆菌（ATCC7953）在规定灭菌时间内被完全杀死。因而确认高压灭菌柜的各项性能均达到生产要求,由此建立的一套验证方案及试验方法和结果得到了国家GMP认证中心的认可。     

三级综合性医院压力蒸汽灭菌设备配置的探讨

从量化研究和定性分析的角度,分析探讨了三级综合性医院压力蒸汽灭菌设备的配置数量的计算,安装位置的确定与设备的选型等方法。以期为医院合理配置高压灭菌设备提供一个通用的、标准的解决方案。     

高压蒸汽灭菌对钛合金内植入物的疲劳的影响

分析了制约骨折手术成功的因素,一是钛合金内植人物经受长期反复高压蒸汽灭菌造成材料疲劳引起断裂;二是AO手术的引起应力集中和疲劳断裂。提出了发展骨内固定植入物的建议。     

常用消毒剂对布鲁氏菌疫苗株的灭菌效果评估

[背景]布鲁氏菌是一种重要的人畜共患胞内寄生菌,是引起动物和人发生布鲁氏菌病(布病)的病原体.高效消毒剂杀灭环境中的布鲁氏菌是防控布病的关键措施.[目的]评价市面上常用消毒剂对布鲁氏菌的灭菌效果及差异.[方法]选用市面上9种不同类型的常用消毒剂,以高、中、低3种不同使用浓度分别研究其对牛种、羊种和猪种布鲁氏菌的杀灭效果...     

100～700 mL液体培养基的微波灭菌效果观察

为研究家用微波炉对少量液体培养基的灭菌效果,对100 -700 mL液体培养基采取微波分别进行灭菌,测定其灭菌时间,并对达到灭菌效果的培养基通过接种不同细菌进行质检.结果显示100、200、300、400、500、600、700 mL液体培养基分别在4.5、5.0、7.0、9.0、12.0、19.0、25.0 min达到最有效的灭菌效果.室温保存15 d仍无细菌生长.枯草杆菌黑色变种芽胞菌测试无菌生长.金黄色葡萄球菌、大肠埃希菌及普通变形杆菌在液体培养基里的生长现象、特种后细菌的菌落和形态染色特征及其生化反应均无明显差异.实验表明2 450 MHz,700 W的微波炉对100 - 700 mL的液体培养基不但能快速达到有效的灭菌效果,且营养成分不会被破坏.     

对不同材料包扎的生产用容器灭菌效果的比较试验

为了改进长期以来细胞瓶以牛皮纸加无纺布包装后进行灭菌的方式,实验中依据国内外的有关资料和现行GMP的要求,结合生产的实际情况,以15L细胞瓶为对象,用不同材料(牛皮纸加无纺布、铝箔纸、两层无纺布、带砂芯的硅胶塞)包装后进行灭菌效果的比较试验及残留蒸汽冷凝水测量试验,结果显示用带砂芯的硅胶塞包装的细胞瓶在灭菌过程中瓶内实际温度均能达到设定要求,热穿透及微生物标的验证试验也符合《中华人民共和国药典》(三部)2005年版的标准要求,残留蒸汽冷凝水明显少于其它包装方式,有最好的实际应用价值。     

Temperature dependence of F-, D- and z-values used in steam sterilization processes

Aims:  To develop a model, based on microbiological principles, to safely optimize steam sterilization processes.
Methods and Results:  The minimum exposure time F for a decontamination process at a certain temperature is usually calculated from an empirical model with the decimal reduction time D and the temperature resistance coefficient z as parameters. These are implicitly assumed to be independent of temperature. Using a microbiological approach, it is shown that also D and z depend on temperature, indicating that the usual models provide only reliable results in a limited temperature region. The temperature dependence of F resulting from this approach describes the available experimental data very well. Safety margins to assure sterility can be included in a straightforward way.
Conclusions:  The results from the present approach can be used to safely optimize decontamination processes. The corresponding mathematical model can be implemented rather directly in process control systems.
Significance and Impact of the Study:  Our results show that for steam sterilization and disinfection processes the values of F predicted by the usual models largely underestimate the required minimum exposure times at temperatures below 120°C. This has important consequences for the optimization of such processes.     

Biological indicators for low temperature steam and formaldehyde sterilization: effect of variations in recovery conditions on the response of spores of Bacillus stearothermophilus NCIMB 8224 to low temperature steam and formaldehyde

Spores of a Bacillus stearothermophilus strain thought to be a good biological monitor for low temperature steam and formaldehyde (LTSF) sterilization have been subjected to different recovery environments following exposure to relevant LTSF treatments and prior to enumerating the numbers of surviving spores. The recovery treatments essentially consisted of holding samples at a temperature of 90°C for different time periods prior to plating out following exposure to 12 μg ml^-1 formaldehyde at temperatures between 63° and 83°C The data indicate that LTSF-exposed spores show a marked recovery when kept at 90°C prior to plating out; the extent of the recovery increases with increasing inactivation temperature between 73° and 83°C. The data bring into question the sporicidal activity of LTSF.     

Monitoring the efficacy of steam and formaldehyde treatment of naturally Salmonella-infected layer houses

AIMS: To monitor if a temperature-humidity-time treatment found to be effective in eliminating Salmonella in laboratory trials (Gradel et al. 2003) was efficient against Salmonella in naturally infected layer houses. METHODS AND RESULTS: Six layer houses with natural Salmonella infections were steam treated in a download period, aiming at >or=60 degrees C and 100% relative humidity (RH) during a 24-h period, with or without the addition of 30 ppm formaldehyde. In addition, two control layer houses were disinfected chemically. Salmonella samples taken from predetermined sites before and after treatment were tested qualitatively for Salmonella and coliforms. Samples with indicator bacteria (feed inoculated with Escherichia coli or Enterococcus faecalis and faeces with naturally occurring E. coli and enterococci) were placed during steam-treatment at 12 sites in each house (where the temperature was logged at 5-min intervals) and tested for surviving bacteria. Generally, the field test results confirmed the results of laboratory tests, especially when 30 ppm formaldehyde was added to the steam. In well-sealed houses, the recommended temperature-humidity-time scheme was accomplished at a minimum of 10 cm above floor level within 1 h. CONCLUSIONS: A steam treatment of >or=60 degrees C and 100% RH during a 24-h period with the addition of 30 ppm formaldehyde at the beginning of the process is recommended for eliminating Salmonella from naturally infected poultry layer houses. SIGNIFICANCE AND IMPACT OF THE STUDY: A specific recommendation for the elimination of Salmonella in poultry houses can be given.     

Biological indicators for low temperature steam and formaldehyde sterilization: investigation of the effect of change in temperature and formaldehyde concentration on spores of Bacillus stearothermophilus NCIMB 8224

A.M. WRIGHT, E.V. HOXEY, C.J. SOPER AND D.J.G. DAVIES. 1996. Five strains of Bacillus stearothermophilus have been studied to identify a spore strain to be used as a biological indicator organism for low temperature steam and formaldehyde sterilization. Three strains gave poor reproducibility of batch size and growth index and were discarded. The other two strains gave good reproducibility with a high growth index and gave rise to linear survivor curves when exposed to 5% aqueous formaldehyde. However, only NCIMB 8224 sporulates on a simpler medium and as it was the most resistant to formaldehyde, it was further studied. Tests were carried out in a modified miniclave and factors studied included temperature of the steam and formaldehyde concentration. All studies confirmed the suitability of this strain as a biological indicator organism.     

基于网络分析的生态建设评估指标体系定量选取——以福建省为例

科学有效的指标体系是开展区域生态建设评估以及规划、管理的重要技术手段。然而目前在生态指标体系构建中仍缺乏对指标内涵的系统研究,同时指标的选取过程不够透明,掺杂诸多主观臆断,损害了生态指标体系构建的科学性和有效性。针对福建省生态建设实践,将网络分析与量化指标选择过程相结合,(1)根据福建省生态建设规划和目标,建立主题导向的生态省建设评估网状指标体系;(2)从因果联系、生态过程和管理需求三方面分析各个备选指标之间的相互联系,形成基于主题导向的生态指标网络;(3)根据生态指标应用的科学性和实用性标准,基于网络分析原理,建立生态建设评估指标选择标准矩阵和备选指标矩阵;(4)构建面向经济社会成本和生态完整性的指标选取模型,定量化选取符合福建省实际发展特征的生态建设评估操作指标体系。将有助于深入理解生态建设评估指标体系的内涵,提高指标体系构建的科学性和系统性,提升生态指标体系在实际生态建设评估、规划和管理应用中的效用。     

Effects of temperature and relative humidity on biological indicators used for ethylene oxide sterilization.

A study was made to determine the effects of temperature and moisture on the D-value of a common biological indicator. Relative humidity (RH) was varied between 10 and 70% in increments of 10%, and temperature was varied between 30 and 70 degrees C in increments of 10 degrees C. Temperature was found to have a pronounced effect on the D-value. At 60% RH, the D-value varied from 15.0 min at 30 degrees C to 1.1 min at 70 degrees C. When RH was plotted against the average D-value at the various temperatures, the temperature curves at or above 50 degrees C were more erratic and the RH had a significant effect. The study showed that temperature and RH must be controlled if biological indicators are to be properly calibrated for use in ethylene oxide sterilization.     

Biological indicators for low temperature steam and formaldehyde sterilization: the effect of defined media on sporulation, growth index and formaldehyde resistance of spores of Bacillus stearothermophilus strains

Preliminary screening was carried out on spores of 29 strains of Bacillus stearothermophilus to determine their potential as biological indicator organisms for low temperature steam and formaldehyde sterilization. Each strain was sporulated on four chemically defined media. Fourteen strains produced satisfactory sporulation on one or more of the media but there was considerable variation in the extent of sporulation. The growth index of the spores, which was dependent on both the strain of organism and the sporulation medium, ranged from 1% to 90%. The spores were appraised on the basis of their resistance to inactivation by 0.5% w/v formaldehyde in aqueous solution at 70°C. The survivor curves obtained could be characterized into five types on the basis of the shape of the curve. Only five strains of Bacillus stearothermophilus produced spores with the characteristics of high resistance, linear semi-logarithmic survivor curve and high growth index that would be required of a potential biological indicator organism.