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
Table 3. Minimum Number of Articles to be Tested in Relation to the Number of Articles in the
Batch 表3：与物品批量相关的最小供试物品数量
Minimum Number of Items to be Tested for Each Medium (unless otherwise justified and authorized)* Number of Items in the Batch 该批物品的数量 Parenteral preparations 注射用药的配制品 Not more than 100 containers 不多于100个容器 10%或4个容器，选较多者 More than 100 but not more than 500 containers 多于100个但不多于500个容器 More than 500 containers 多于500个容器 For large-volume parenterals 10 containers 10个容器 2% or 20 containers, whichever is less 2%或者20容器，选较少者 2% or 10 containers, whichever is less 2%或者10容器，选较少者 20 containers 20个容器 Pharmacy bulk packages ( 5 g) 药房散装( 5 g) Bulks and blends 散装并混合 Ophthalmic and other noninjectable preparations 6 containers 6个容器 See Bulk solid products 见散装固体产品 10% or 4 containers, whichever is the greater 每个培养基中的最小供试物品数量(除非另有依据或授权) 对于大体积注射用药制剂 Antibiotic solids 固体抗生物 Pharmacy bulk packages (<5 g) 药房散装(<5 g) Minimum Number of Items to be Tested for Each Medium (unless otherwise justified and authorized)* Number of Items in the Batch 该批物品的数量 每个培养基中的最小供试物品数量(除非另有依据或授权) 5% or 2 containers, whichever is the greater 5%或者2个容器，选较多者 More than 200 containers 多于200个容器 10 containers 10个容器 眼科和其他非注射配制品 Not more than 200 containers 不多于200个容器 If the product is presented in the form of single-dose containers, apply the scheme shown above for preparations for parenteral use. 如果该产品存在于单一剂量容器中，应用上述用于注射用药配制品的方案 Devices设备 Catgut and other surgical sutures for veterinary use 兽医用肠线和其他外科缝合线 2 % or 5 packages, whichever is the greater, up to a maximum total of 20 packages 2%或5个包装，选较多者，最多可达20个包装 Not more than 100 articles 不多于100个物品 More than 100, but not more than 500 articles 多于100但不多于500个物品 More than 500 articles 多于500个物品 Bulk solid products 10% or 4 articles, whichever is greater 10%或4个物品，选较多者 10 articles 10个物品 2% or 20 articles, whichever is less 2%或20个物品，选较少者 散装固体产品 Minimum Number of Items to be Tested for Each Medium (unless otherwise justified and authorized)* Number of Items in the Batch 该批物品的数量 Up to 4 containers 最多4个容器 More than 4 containers, but not more than 50 containers 多于4个容器，但不多于50个容器 More than 50 containers 超过50个容器 *每个培养基中的最小供试物品数量(除非另有依据或授权) Each container 每个容器 20% or 4 containers, whichever is greater 20%或4个容器，选较多者 2% or 10 containers, whichever is greater 2%或者10个容器，选较多者 If the contents of one container are enough to inoculate the two media, this column gives the number of containers needed for both the media together. 如果一个容器的内容物足够接种2个培养基，则此表格给出的容器数量为用于全部2个培养基的数量。 The test may be carried out using the technique of Membrane Filtration or by Direct Inoculation of the Culture Medium with the product to be examined. Appropriate negative controls are
included. The technique of membrane filtration is used whenever the nature of the product permits; that is, for filterable aqueous preparations, for alcoholic or oily preparations, and for preparations miscible with, or soluble in, aqueous or oily solvents, provided these solvents do not have an antimicrobial effect in the conditions of the test.
此试验可以使用膜过滤法或培养基直接接种法进行。应包括多个适当的阴性对照。只要该产品的性质许可，就应使用膜过滤法；这些性质是，可过滤的水溶性配制品、酒精或油性配制品、易混合或溶解于水或油性溶剂的配制品，只要这些溶剂在试验条件下没有抗生素效果。
Membrane Filtration 膜过滤
Use membrane filters having a nominal pore size not greater than 0.45 μm whose effectiveness to retain microorganisms has been established. Cellulose nitrate filters, for example, are used for aqueous, oily, and weakly alcoholic solutions; and cellulose acetate filters, for example, are used for strongly alcoholic solutions. Specially adapted filters may be needed for certain products (e.g., for antibiotics).
使用标称孔径不大于0.45 μm的膜过滤器，此孔径已知能够有效截留微生物。例如，硝酸纤维素过滤器可用于水、油、稀醇溶液；而醋酸纤维素可用于浓醇溶液。特定产品（例如，抗生素）可能需要特别改造过的过滤器。
The technique described below assumes that membranes about 50 mm in diameter will be used. If filters of a different diameter are used, the volumes of the dilutions and the washings should be adjusted accordingly. The filtration apparatus and membrane are sterilized by appropriate means. The apparatus is designed so that the solution to be examined can be introduced and filtered under aseptic conditions: it permits the aseptic removal of the membrane for transfer to the medium, or it is suitable for carrying out the incubation after adding the medium to the apparatus itself. 下面描述的方法所使用直径约50mm的滤膜。如果使用不同直径的过滤器，稀释液和洗液的体积应当作相应调节。以适当方法 将过滤设备和滤膜灭菌。该设备设计用于在无菌条件下加入和过滤供试溶液：其使得在无菌状态下将滤膜摘掉转移至培养基成为可能，或者其适合于将培养基加入该设备自身之中，并进行培养。
AQUEOUS SOLUTIONS 水性溶液
If appropriate, transfer a small quantity of a suitable, sterile diluent such as Fluid A (see Diluting and Rinsing Fluids for Membrane Filtration) onto the membrane in the apparatus and filter. The diluent may contain suitable neutralizing substances and/or appropriate inactivating substances, for example, in the case of antibiotics.
如果适当，将少量适当的无菌稀释剂，例如液体A（见用于膜过滤的稀释和冲洗液），转移至设备中的滤膜上并过滤。该稀释剂可以含有适当的中和物质和/或适当的灭活物质，例如针对抗生素。
Transfer the contents of the container or containers to be tested to the membrane or membranes, if necessary, after diluting to the volume used in the Validation Test with the chosen sterile diluent, but using not less than the quantities of the product to be examined prescribed in Tables 2 and 3. Filter immediately. If the product has antimicrobial properties, wash the membrane not less than three times by filtering through it each time the volume of the chosen sterile diluent used in the Validation Test. Do not exceed a washing cycle of 5 times 200 mL, even if during validation it has been demonstrated that such a cycle does not fully eliminate the antimicrobial activity. Transfer the whole membrane to the culture medium or cut it aseptically into two equal parts, and transfer one half to each of two suitable media. Use the same volume of each medium as in the Validation Test. Alternatively, transfer the medium onto the membrane in the apparatus. Incubate the media for not less than 14 days.