发布时间 : 星期六 文章美国药典USP31 71 无菌检查法 双语版更新完毕开始阅读ad54fea69b89680202d8250b
To each L of Fluid A add 1 mL of polysorbate 80, adjust to a pH of 7.1 ± 0.2, dispense into
containers, and sterilize using a validated process. Use this fluid for articles containing lecithin or oil, or for devices labeled as ―sterile pathway.‖
向每升液体A中，加入1mL聚山梨酯80，调节pH值至7.1 ± 0.2，分装入容器中，并使用经过验证的工艺灭菌。此液体用于含有卵磷脂或油脂的物品，或用于标为 ―无菌通道‖的设备。
Fluid K 液体K
Dissolve 5.0 g of peptic digest of animal tissue, 3.0 g of beef extract, and 10.0 g of polysorbate 80 in water to make 1 L. Adjust the pH to obtain, after sterilization, a pH of 6.9 ± 0.2. Dispense into containers, and sterilize using a validated process.
将5.0g动物组织胃蛋白酶消化物、3.0g牛肉提取物、10.0g聚山梨酯80溶解于1L水中。调节pH值，以便使pH值在灭菌后呈6.9 ± 0.2。分装入容器中，并使用经过验证的工艺灭菌。
VALIDATION TEST 验证试验
Carry out a test as described below under Test for Sterility of the Product to be Examined using exactly the same methods, except for the following modifications.
按照下面供试产品无菌检查项下的描述，使用除了下面变更之外完全相同的方法，进行试验。
Membrane Filtration 膜过滤
After transferring the content of the container or containers to be tested to the membrane, add an inoculum of a small number of viable microorganisms (not more than 100 cfu) to the final portion of sterile diluent used to rinse the filter.
在将一个或多个供试容器中的内容物转移到滤膜之后，在最后一次的冲洗液中加入少量（不超过100cfu）试验菌.
Direct Inoculation 直接接种
After transferring the contents of the container or containers to be tested (for catgut and other surgical sutures for veterinary use: strands) to the culture medium, add an inoculum of a small number of viable microorganisms (not more than 100 cfu) to the medium.
在将一个或多个供试容器（对于兽医的肠线和其他外科缝合用线：若干股线）中的内容物转移至培养基之后，将少量试验菌（不超过100cfu）加入至培养基中。
In both cases use the same microorganisms as those described above under Growth Promotion Test of Aerobes, Anaerobes, and Fungi. Perform a growth promotion test as a positive control. Incubate all the containers containing medium for not more than 5 days.
在这两种情况中，均按照上述好氧菌、厌氧菌、霉菌生长促进试验项下的描述，使用同样的微生物。进行一个生长促进试验作为阳性对照。培养所有含有培养基的容器，培养时间不超过5天。
If clearly visible growth of microorganisms is obtained after the incubation, visually comparable to that in the control vessel without product, either the product possesses no antimicrobial activity under the conditions of the test or such activity has been satisfactorily eliminated. The test for sterility may then be carried out without further modification.
如果在培养后得到清晰可见的微生物生长，看起来与没有产品的对照容器中的生长类似，则该产品在此试验条件下没有任何抗微生物活性，或者此活性已经被令人满意地消除了。然后，无菌试验可以进行，而无需进一步的变更。
If clearly visible growth is not obtained in the presence of the product to be tested, visually comparable to that in the control vessels without product, the product possesses antimicrobial activity that has not been satisfactorily eliminated under the conditions of the test. Modify the conditions in order to eliminate the antimicrobial activity, and repeat the validation test.
如果用肉眼与没有产品的对照容器比较，无法在存在供试产品的情况下得到清晰可见的生长，则该产品在试验条件下所具有的抗微生物活性尚未令人满意地消除。变更条件以便消除抗微生物活性，并重复验证试验。
This validation is performed (a) when the test for sterility has to be carried out on a new product; and (b) whenever there is a change in the experimental conditions of the test. The validation may be performed simultaneously with the Test for Sterility of the Product to be Examined.
当(a)一个新产品必须进行无菌试验时，和(b)无论何时该试验的试验条件发生改变时，则需进行此验证试验。该验证可以与供试产品的无菌试验同时进行。
TEST FOR STERILITY OF THE PRODUCT TO BE EXAMINED
供试产品的无菌检查
Number of Articles to Be Tested 供试物品数量
Unless otherwise specified elsewhere in this chapter or in the individual monograph, test the
number of articles specified in Table 3. If the contents of each article are of sufficient quantity (see Table 2), they may be divided so that equal appropriate portions are added to each of the specified media. [NOTE—Perform sterility testing employing two or more of the specified media.] If each article does not contain sufficient quantities for each medium, use twice the number of articles indicated in Table 3.
除非在此章节的其他位置或在具体的各论中另有规定，供试物品的数量遵照表3中的规定。如果每个物品的内容物有足够数量（见表2），可以将其分成若干等份，将适当的等份加入到每个指定的培养基。[注意：使用两个或更多指定培养基，来进行无菌试验。]如果每个物品内容物的数量不够每个培养基的用量，使用表3中所规定物品数量的2倍。
Table 2. Minimum Quantity to be Used for Each Medium
表2：用于每个培养基的最小数量
Minimum Quantity to be Used (unless otherwise justified and authorized) 最小使用数量(除非另有依据和授权) Quantity per Container 每个容器中的数量 Liquids (other than anitbiotics) 液体(除了抗生素) Less than 1 mL 少于1mL 1–40 mL The whole contents of each container 每个容器的总内容物 Half the contents of each container, but not less than 1 mL 每个容器中内容物的一半，但不得少于1mL Greater than 40 mL, and not greater than 100 mL 大于40mL，但不大于100mL Greater than 100 mL 大于100mL 该容器内容物的10%，但不得少于20mL Antibiotic liquids 1 mL 10% of the contents of the container, but not less than 20 mL 20 mL 抗生素液体 Quantity per Container 每个容器中的数量 Minimum Quantity to be Used (unless otherwise justified and authorized) 最小使用数量(除非另有依据和授权) Other preparations soluble in water or in isopropyl The whole contents of each container to myristate provide not less than 200 mg 溶于水或豆蔻酸异丙酯的其他配制品 每个容器的全部内容物，以提供不少于200mg Insoluble preparations, creams, and ointments to be Use the contents of each container to provide suspended or emulsified not less than 200 mg 待悬浮或乳化的不溶性配制品、乳膏、油膏 Solids固体 Less than 50 mg 少于50mg 50 mg or more, but less than 300 mg 50mg或者更多，但少于300mg 使用每个容器的内容物，以提供不少于200mg The whole contents of each container 每个容器的全部内容物 Half the contents of each container, but not less than 50 mg 每个容器内容物的一半，但不少于50mg 300 mg–5 g Greater than 5 g 多于5g Devices设备 150 mg 500 mg Catgut and other surgical sutures for veterinary use 3 sections of a strand (each 30-cm long) 兽医用肠线和其他外科缝合线 Surgical dressing/cotton/gauze (in packages) 外科敷料/棉花/纱布(在包装中) 一股线的3部分(每个30cm长) 100 mg per package 100 mg每包装 Sutures and other individually packaged single-use The whole device material 整个设备 缝合线合其他单个包装的一次性使用物料 Other medical devices 其他医用设备 整个设备，切成片或拆开 The whole device, cut into pieces or disassembled