【正文】 small number of viable microorganisms (not more than 100 cfu) to the final portion of sterile diluent used to rinse the filter.在將一個(gè)或多個(gè)供試容器中的內(nèi)容物轉(zhuǎn)移到濾膜之后，在最后一次的沖洗液中加入少量（不超過(guò)100cfu）試驗(yàn)菌.進(jìn)行一個(gè)生長(zhǎng)促進(jìn)試驗(yàn)作為陽(yáng)性對(duì)照。然后，無(wú)菌試驗(yàn)可以進(jìn)行，而無(wú)需進(jìn)一步的變更。TEST FOR STERILITY OF THE PRODUCT TO BE EXAMINED 供試產(chǎn)品的無(wú)菌檢查Number of Articles to Be Tested 供試物品數(shù)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. 除非在此章節(jié)的其他位置或在具體的各論中另有規(guī)定，供試物品的數(shù)量遵照表3中的規(guī)定。Table 2. Minimum Quantity to be Used for Each Medium 表2：用于每個(gè)培養(yǎng)基的最小數(shù)量Quantity per Container每個(gè)容器中的數(shù)量Minimum Quantity to be Used (unless otherwise justified and authorized)最小使用數(shù)量(除非另有依據(jù)和授權(quán))Liquids (other than anitbiotics)液體(除了抗生素)Devices設(shè)備Antibiotic solids 固體抗生物Not more than 200 containers不多于200個(gè)容器5% or 2 containers, whichever is the greater5%或者2個(gè)容器，選較多者M(jìn)ore than 200 containers多于200個(gè)容器10 containers10個(gè)容器If the product is presented in the form of singledose containers, applythe scheme shown above for preparations for parenteral use.如果該產(chǎn)品存在于單一劑量容器中，應(yīng)用上述用于注射用藥配制品的方案Bulk solid products散裝固體產(chǎn)品 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.此試驗(yàn)可以使用膜過(guò)濾法或培養(yǎng)基直接接種法進(jìn)行。Membrane Filtration 膜過(guò)濾Use membrane filters having a nominal pore size not greater than 181。例如，硝酸纖維素過(guò)濾器可用于水、油、稀醇溶液；而醋酸纖維素可用于濃醇溶液。如果使用不同直徑的過(guò)濾器，稀釋液和洗液的體積應(yīng)當(dāng)作相應(yīng)調(diào)節(jié)。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.如果適當(dāng)，將少量適當(dāng)?shù)臒o(wú)菌稀釋劑，例如液體A（見(jiàn)用于膜過(guò)濾的稀釋和沖洗液），轉(zhuǎn)移至設(shè)備中的濾膜上并過(guò)濾。立即過(guò)濾。每個(gè)培養(yǎng)基的體積與驗(yàn)證試驗(yàn)所用的一樣。SOLUBLE SOLIDS (other than antibiotics) 可溶固體（非抗生素）Use for each medium not less than the quantity prescribed in Tables 2 and 3 of the product dissolved in a suitable solvent, such as Fluid A (Diluting and Rinsing Fluids for Membrane Filtration), and proceed with the test as described above for Aqueous Solutions using a membrane appropriate to the chosen solvent.在每個(gè)培養(yǎng)基中，使用不少于表2和3規(guī)定的產(chǎn)品數(shù)量溶于適當(dāng)溶劑，例如溶液A（用于膜過(guò)濾的稀釋和沖洗液），并按照上述關(guān)于水性溶液的描述，使用適合所選溶劑的濾膜，繼續(xù)進(jìn)行該試驗(yàn)。如需要，粘稠油質(zhì)可以用適合的無(wú)菌稀釋劑進(jìn)行稀釋?zhuān)缫炎C實(shí)在該試驗(yàn)條件下不具有抗微生物活性的豆蔻酸異丙酯。盡可能迅速地過(guò)濾，并按照上面針對(duì)油和油性溶液所述內(nèi)容繼續(xù)操作。使用驗(yàn)證試驗(yàn)項(xiàng)下的直接接種，檢查針頭的無(wú)菌情況。ANTIBIOTIC SOLIDS FOR INJECTION 用于注射的抗生素Pharmacy Bulk Packages, 5 g— From each of 20 containers, aseptically transfer about 300 mg of solids, into a sterile 500mL conical flask, dissolve in about 200 mL of Fluid A (see Diluting and Rinsing Fluids for Membrane Filtration), and mix。Pharmacy Bulk Packages, 5 g— From each of 6 containers, aseptically transfer about 1 g of solids into a sterile 500mL conical flask, dissolve in about 200 mL of Fluid A, and mix。ANTIBIOTIC SOLIDS, BULKS, and BLENDS 抗生素固體、散裝品。按照關(guān)于水性溶液的規(guī)定，繼續(xù)操作。按照適合的關(guān)于水性溶液或油和油性溶液的規(guī)定，繼續(xù)操作。SOLIDS FOR INJECTION OTHER THAN ANTIBIOTICS 除了抗生素之外的注射用固體Constitute the test articles as directed on the label, and proceed as directed for Aqueous Solutions or Oils and Oily Solutions, whichever applies. [NOTE—If necessary, excess diluent can be added to aid in the constitution and filtration of the constituted test article.] 按照其標(biāo)簽上的規(guī)定配制供試物品，并按照適用的關(guān)于水性溶液或油和油性溶液的規(guī)定繼續(xù)進(jìn)行。PREFILLED SYRINGES 預(yù)裝填的注射器For prefilled syringes without attached sterile needles, expel the contents of each syringe into one or two separate membrane filter funnels or into separate pooling vessels prior to transfer. If a separate sterile needle is attached, directly expel the syringe contents as indicated above, and proceed as directed for Aqueous Solutions. Test the sterility of the needle, using Direct Inoculation under Validation Test.對(duì)于沒(méi)有附無(wú)菌針頭的預(yù)裝填注射器，在轉(zhuǎn)移之前，將每個(gè)注射器的內(nèi)容物排出至一個(gè)或兩個(gè)單獨(dú)的膜過(guò)濾器漏斗，或至若干單獨(dú)的合并容器。脂肪狀的油膏和水在油中形態(tài)乳化劑可以按照上面所述，在豆蔻酸異丙酯中稀釋至1%，如需要可加熱至不高于40 。每次過(guò)濾約100mL適當(dāng)?shù)臒o(wú)菌溶液，例如液體A（見(jiàn)用于膜過(guò)濾的稀釋和沖洗液），并含有適當(dāng)乳化劑且其濃度已證實(shí)適用于該試驗(yàn)的驗(yàn)證，例如濃度為10克每升的聚山梨酯80（液體K）。OILS and OILY SOLUTIONS 油和油性溶液Use for each medium not less than the quantity of the product prescribed in Tables 2 and 3. Oils and oily solutions of sufficiently low viscosity may be filtered without dilution through a dry membrane. Viscous oils may be diluted as necessary with a suitable sterile diluent such as isopropyl myristate shown not to have antimicrobial activity in the conditions of the test. Allow the oil to penetrate the membrane by its own weight, and then filter, applying the pressure or suction gradually. Wash the membrane at least three times by filtering through it each time about 100 mL of a suitable sterile solution such as Fluid A (see Diluting and Rinsing Fluids for Membrane Filtration) containing a suitable emulsifying agent at a concentration shown to be appropriate in the validation of the test, for example polysorbate 80 at a concentration of 10 g per L (Fluid K) . Transfer the membrane or membranes to the culture medium or media, or vice versa, as described above for Aqueous Solutions, and incubate at the same temperatures and for the same times.在每個(gè)培養(yǎng)基中，使用不少于表2和3中描述的產(chǎn)品用量。培養(yǎng)該培養(yǎng)基，不少于14天。即便驗(yàn)證中顯示5次200mL的沖洗循環(huán)沒(méi)有完全消除抗微生物活性，也不要超越這樣一個(gè)循環(huán)。該設(shè)備設(shè)計(jì)用于在無(wú)菌條件下加入和過(guò)濾供試溶液：其使得在無(wú)菌狀態(tài)下將濾膜摘掉轉(zhuǎn)移至培養(yǎng)基成為可能，或者其適合于將培養(yǎng)基加入該設(shè)備自身之中，并進(jìn)行培養(yǎng)。 and cellulose acetate filters, for example, are used for strongly alcoholic solutions. Specially adapted filters may be needed for certain products (., for antibiotics)