For a fluid specimen that consists of a true solution, or a suspension in water or a hydroalcoholic vehicle containing less than 30 percent of alcohol, and for a solid that dissolves readily and practically completely in 90 mL of pH 7.2 Phosphate Buffer or the media specified, proceed as directed under Total Aerobic Microbial Count, and under Test for Staphylococcus aureus and Pseudomonas aeruginosa and Test for Salmonella species and Escherichia coli.
对于液体样品,其中包括了能在水中或在不低于30%乙醇的醇水载体中形成的真溶液或者悬浮液,以及比较容易且彻底地溶解在90mLpH值7.2磷酸盐缓冲液或指定介质中的固体样品,如好氧微生物总数检查法、金黄色葡萄球菌和绿脓杆菌检查法、沙门氏菌和大肠杆菌检查法项下的规定继续进行。
For water-immiscible fluids, ointments, creams, and waxes, prepare a suspension with the aid of a minimal quantity of a suitable, sterile emulsifying agent (such as one of the polysorbates), using a mechanical blender and warming to a temperature not exceeding 45 , if necessary, and proceed with the suspension as directed under Total Aerobic Microbial Count, and under Test for Staphylococcus aureus and Pseudomonas aeruginosa and Test for Salmonella species and Escherichia coli.
对于与水不混溶的液体、油膏、乳膏、蜡状物,以最小剂量的适合的无菌乳化剂,使用机械混合器并在需要时加温到不超过45 ,来制备悬浮液,并如好氧微生物总数检查法、金黄色葡萄球菌和绿脓杆菌检查法、沙门氏菌和大肠杆菌检查法项下的规定使用该悬浮液继续进行。
For a fluid specimen in aerosol form, chill the container in an alcohol- mixture for approximately 1 hour, cut open the container, allow it to reach room temperature, permit the propellant to escape, or warm to drive off the propellant if feasible, and transfer the quantity of test material required for the procedures specified in one of the two preceding paragraphs, as appropriate. Where 10.0 g or 10.0 mL of the specimen, whichever is applicable, cannot be obtained from 10 containers in aerosol form, transfer the entire contents from 10 chilled containers to the culture medium, permit the propellant to escape, and proceed with the test on the residues. If the results of the test are inconclusive or doubtful, repeat the test with a specimen from 20 more containers.
对于以气体中悬浮颗粒状态存在的液体样品,在乙醇-干冰混合物中冷却约1小时,打开该容器,令其达到室温,使推进剂散发掉,或者加温(如果可行)以驱推进剂,并且如果适合则按照下面两个段落中一段所指定的此步骤所必需的数量转移供试品。如果10.0g或10.0mL(不论那种单位适合此种情况)供试品无法从10个气体悬浮颗粒状态的容器中获得,将10个冷却后的容器的全部内容物转入培养基,使推进剂散发掉,并使用剩余物继续进行该试验。如果试验的结果是不确定的或者可疑的,使用来自20个容器的供试品重复该试验。
Total Aerobic Microbial Count好氧微生物总数检查法
For specimens that are sufficiently soluble or translucent to permit use of the Plate Method, use that method; otherwise, use the Multiple-Tube Method. With either method, first dissolve or suspend 10.0 g of the specimen if it is a solid, or 10 mL, accurately measured, if the specimen is a liquid, in pH 7.2 Phosphate Buffer, Fluid Soybean–Casein Digest Medium, or Fluid Casein Digest–Soy Lecithin-Polysorbate 20 Medium to make 100 mL. For viscous specimens that cannot be pipeted at this initial 1:10 dilution, dilute the specimen until a suspension is obtained, i.e., 1:50 or 1:100, etc., that can be pipeted. Perform the test for absence of inhibitory (antimicrobial) properties as described under Preparatory Testing before the determination of Total Aerobic Microbial Count. Add the specimen to the medium not more than 1 hour after preparing the appropriate dilutions for inoculation.
对于能够充分溶解或透明、可以采用平皿法的样品,需使用该方法;否则,使用多管法。不管使用哪一种方法,首先将10.0g固体样品或精密量取的10mL液体样品,放入pH 7.2的磷酸盐缓冲液,或液体大豆酪蛋白消化物培养基,或液体酪蛋白消化物-大豆卵磷脂-聚山梨酯20中,制成100mL的溶液或悬浮液。对于在此初始的1:10溶液中无法移取的黏稠样品,稀释该样品直到得到可以移取的悬浮液,例如1:50或1:100等。如好氧微生物总数检查法之前的预备试验项下的描述,进行证实样品不具备抑制(抗微生物)特性的试验。在用于接种的适当稀释液制备之后1小时内,将样品加入培养基。