USP3011161430页翻译.docx

1、USP3011161430页翻译Methodology and Instrumentation for Quantitation of Viable Airborne Microorganisms 可培养的空气传播的微生物方法论和使用设备It is generally accepted by scientists that airborne microorganisms in controlled environments can influence the microbiological quality of the intermediate or final products manufa

2、ctured in these areas. Also, it generally is accepted that estimation of the airborne microorganisms can be affected by instruments and procedures used to perform these assays. Therefore, where alternative methods or equipment is used, the general equivalence of the results obtained should be ascert

3、ained. Advances in technology in the future are expected to bring innovations that would offer greater precision and sensitivity than the current available methodology and may justify a change in the absolute numbers of organisms that are detected.科学家普遍接受的观点是某区域的可控制空气传播的微生物能够影响在这个区域生产的中间产物和成品的品质。而且，

4、另一个普遍接受的观点是空气传播的微生物的评估受化验使用的器具和程序的影响。因此，二中择一的使用方法或设备，获得的一般等同的结果应当得到确认。随着未来科技的发展，这些状况期待得到革新，将提供比当前可获得的方法较准确和灵敏而且可能在绝对的生物体证明是正当的变化被发现。Today, the most commonly used samplers in the U.S. pharmaceutical and medical device industry are the impaction and centrifugal samplers. A number of commercially avail

5、able samplers are listed for informational purposes. The selection, appropriateness, and adequacy of using any particular sampler is the responsibility of the user.今天，在美国制药和医疗设备工业普遍使用的取样器是压紧和离心取样器。许多商业上列出的可使用取样器是用于报告的用途。使用者的责任是挑选使用任何一个特殊适当和足够取样器。Slit-to-Agar Air Sampler (STA) This sampler is the ins

6、trument upon which the microbial guidelines given in Table 3 for the various controlled environments are based. The unit is powered by an attached source of controllable vacuum. The air intake is obtained through a standardized slit below which is placed a slowly revolving Petri dish containing a nu

7、trient agar. Particles in the air that have sufficient mass impact on the agar surface and viable organisms are allowed to grow out. A remote air intake is often used to minimize disturbance of the laminar flow field.空气样品的琼脂条(STA)- 取样器是在表格3给定的为了各种以受控环境为基础的微生物指导方针的器具。单元是通过一个可控制的附上的真空吸尘器提供动力。空气吸入通过一个标

8、准化的裂缝入口，底部设置有缓慢旋转的含有营养琼脂的皮氏培养皿（有盖培养皿）。空气中的微粒足够大地影响琼脂表面，可培养的微生物允许长出。一个细微的空气吸气管通常用来降低薄片状的流场干扰。Sieve Impactor The apparatus consists of a container designed to accommodate a Petri dish containing a nutrient agar. The cover of the unit is perforated, with the perforations of a predetermined size. A vacu

9、um pump draws a known volume of air through the cover, and the particles in the air containing microorganisms impact on the agar medium in the Petri dish. Some samplers are available with a cascaded series of containers containing perforations of decreasing size. These units allow for the determinat

10、ion of the distribution of the size ranges of particulates containing viable microorganisms, based on which size perforations admit the particles onto the agar plates. 过滤压紧器，设备由一个容器组成，设计成容纳含有营养琼脂的皮氏培养皿，单元盖子是凿孔的，带有预定尺寸的穿孔。通过盖子，真空汞抽吸大量空气，空气中的微粒包含有微生物影响皮氏培养皿中的琼脂培养基。一些带有一系列含有渐减尺寸穿孔的喷流容器的取样器是可用的。这些单元允许的含

11、有可培养微生物的微粒尺寸范围的分布的确定基于允许微粒进入琼脂平板的穿孔的尺寸。Centrifugal Sampler The unit consists of a propeller or turbine that pulls a known volume of air into the unit and then propels the air outward to impact on a tangentially placed nutrient agar strip set on a flexible plastic base. 离心取样器单元由螺旋桨或涡轮机组成的，牵引大量的空气进入单元

12、，然后驱使空气向外影响一个无关的放置有营养琼脂条启动一个柔韧性的塑料底部。Sterilizable Microbiological Atrium The unit is a variant of the single-stage sieve impactor. The units cover contains uniformly spaced orifices approximately 0.25 inch in size. The base of the unit accommodates one Petri dish containing a nutrient agar. A vacuum

13、 pump controls the movement of air through the unit, and a multiple-unit control center as well as a remote sampling probe are available. Surface Air System Sampler This integrated unit consists of an entry section that accommodates an agar contact plate. Immediately behind the contact plate is a mo

14、tor and turbine that pulls air through the units perforated cover over the agar contact plate and beyond the motor, where it is exhausted. Multiple mounted assemblies are also available. 灭菌的微生物心房这个单元是一个不同的单一阶段的过滤压缩器。这个单元的盖子包含均一的空间的孔大约0.25英寸的尺寸。一个真空汞控制空气通过单元的运动和一个多重单元控制中心，除了一个遥控取样探针可利用的。地面空气系统取样器一个综合

15、的单元由一个进入区段组成，提供一个琼脂接触皿。直接在接触皿后面是一个发动机和涡轮牵引空气，通过单元的多孔盖盖住琼脂接触皿和后面耗尽的发动机。多样的架好的集合部件也是可利用的。Gelatin Filter Sampler The unit consists of a vacuum pump with an extension hose terminating in a filter holder that can be located remotely in the critical space. The filter consists of random fibers of gelatin c

16、apable of retaining airborne microorganisms. After a specified exposure time, the filter is aseptically removed and dissolved in an appropriate diluent and then plated on an appropriate agar medium to estimate its microbial content. 凝胶滤镜采样器，这个组成部分由一个真空泵和一个延长软管组成，过滤器的持有人可持软管在远程的关键空间。随机纤维凝胶的过滤器组成能够保留住

17、空气中降落的微生物。一定暴露时间后，过滤器无菌移开并溶解于适当的稀释剂，然后涂上适当的琼脂培养基以估计其微生物含量。Settling Plates This method is still widely used as a simple and inexpensive way to qualitatively assess the environments over prolonged exposure times. The exposure of open agar-filled Petri dishes, or settling plates, is not to be used for

18、quantitative estimations of the microbial contamination levels of critical enviroments. 沉降盘，作为定性评估环境超长暴露时间的简单廉价方法已广泛使用。暴露的琼脂培养皿，或是沉降盘没有用来定量评估在危机环境中微生物污染水平。One of the major limitations of mechanical air samplers is the limitation in sample size of air being sampled. Where the microbial level in the a

19、ir of a controlled environment is expected to contain not more than three cfu per cubic meter, several cubic meters of air should be tested if results are to be assigned a reasonable level of precision and accuracy. Often this is not practical. To show that microbial counts present in the environmen

20、t are not increasing over time, it might be necessary to extend the time of sampling to determine if the time of sampling is a limiting factor or not. Typically, slit-to-agar samplers have an 80-liter-per-minute sampling capacity (the capacity of the surface air system is somewhat higher). If one cu

21、bic meter of air is tested, then it would require an exposure time of 15 minutes. It may be necessary to use sampling times in excess of 15 minutes to obtain a representative environmental sample. Although there are samplers reported to be capable of very high sampling volume rates, consideration in

22、 these situations should be given to the potential for disruption of the airflow patterns in any critical area or to the creation of a turbulence that could increase the probability of contamination.机械空气采样器的一个主要限制是采样空气样本大小的限制，控制环境中微生物水平预计每立方米不超过3个菌落单位，如果结果在合理的精密度和准确度水平上，就需要检测几立方米的空气，通常，这是不实际的。有表明，随着

23、时间的推移，环境中微生物数量是不增加的，如果采样时间是限制因素的，有必要延长采样时间。通常，狭缝至琼脂采样器有每分钟80升的取样能力（表面空气系统容量有点高）。如果一立方米的空气测试，那么将需要曝露15分钟时间。它可能需要采样时间超过15分钟，以取得有代表性的环境样品。虽然报道有的样本有非常高的采样体积利率，考虑在这些情况下，应考虑到潜在的干扰气流的模式，在任何关键领域，或建立一个动荡可能会增加的概率污染。For centrifugal air samplers, a number of earlier studies showed that the samples demonstrated

24、a selectivity for larger particles. The use of this type of sampler may have resulted in higher airborne counts than the other types of air samplers because of that inherent selectivity.离心式空气采样器，很多早期研究表明，样本中显示了较大的选择性粒子。与其他类型的空气采样器相比，由于固有的选择性，这种类型采样器的使用可能导致较高的空气降落计数。When selecting a centrifugal sampl

25、er, the effect of the sampler on the linearity of the airflow in the controlled zone where it is placed for sampling should be taken into consideration. Regardless of the type of sampler used, the use of a remote probe requires determining that the extra tubing does not have an adverse effect on the

26、 viable airborne count. This effect should either be eliminated or, if this is not possible, a correction factor should be introduced in the reporting of results.在选择离心采样器的时候，应当考虑采样器对控制区线性气流的效果，不考虑使用的采样器类型，偏远探针的使用表明额外油管的对空气降落计数没有不良影响。如果不能在结论的报告中应该引入一个控制因子，决定这种效果是否会被淘汰。Methodology and Equipment for Sa

27、mpling of Surfaces for Quantitation of Viable Microbial Contaminants in Controlled Environments 在受控环境中用于取样的表面定量可行的微生物污染物的方法和设备Another component of the microbial environmental control program in controlled environments is surface sampling of equipment, facilities, and personnel gear used in these env

28、ironments. 在受控环境中微生物的环境控制程序的另一个组成部分是表面取样的设备，设施，和在这些环境中人员的安排使用。The standardization of surface sampling methods and procedures has not been as widely addressed in the pharmaceutical industry as the standardization of air sampling procedures.3表面取样方法和程序的标准，在制药业作为空气采样操作标准没有得到广泛讨论。To minimize disruptions

29、to critical operations, surface sampling is performed at the conclusion of operations. Surface sampling may be accomplished by the use of contact plates or by the swabbing method. Surface monitoring is generally performed on areas that come in contact with the product and on areas adjacent to those

30、contact areas. Contact plates filled with nutrient agar are used when sampling regular or flat surfaces and are directly incubated at the appropriate time for a given incubation temperature for quantitation of viable counts. Specialized agar can be used for specific quantitation of fungi, spores, et

31、c.为了尽量减少关键操作的干扰，在操作的最后进行表面取样，通过接触板或抽汲方法能完成表面取样，表面监测一般是在与产品接触和邻近区域完成，当定期抽样或平坦表面，并且在适当的时间直接培养为定量可行计数的某一特定培养温度时使用充满营养琼脂的接触板。专门琼脂可用于具体的定量的真菌，孢子，等等。The swabbing method may be used for sampling of irregular surfaces, especially for equipment. Swabbing is used to supplement contact plates for regular surfa

32、ces. The swab is then placed in an appropriate diluent and the estimate of microbial count is done by plating of an appropriate aliquot on or in specified nutrient agar. The area to be swabbed is defined using a sterile template of appropriate size. In general, it is in the range of 24 to 30 cm2. Th

33、e microbial estimates are reported per contact plate or per swab.该抽汲方法可用于采样的不规则表面，特别是对设备。抽汲是作为整齐的表面接触板的补充，然后，海绵放置在一个适当的稀释剂，通过适当的分量上或指定营养琼脂的平板培养法来估计微生物计数，使用合适大小的无菌模板来擦洗该区域，一般而言，在24-30 cm2.范围内，报道每个接触板或每个拭子的微生物估计。Culture Media and Diluents Used for Sampling or Quantitation of Microorganisms 用于取样或定量的微生物的培养基和稀释剂T