美國(guó)藥典usp31無(wú)菌檢查doc-資料下載頁(yè)

　　

【正文】 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.將一個(gè)或多個(gè)供試容器的內(nèi)容物轉(zhuǎn)移到濾膜，如需要可先使用選定的無(wú)菌稀釋劑稀釋至驗(yàn)證試驗(yàn)中所用體積，但須使用不少于表2和3中規(guī)定的供試產(chǎn)品數(shù)量。立即過(guò)濾。如果該產(chǎn)品具有抗微生物特性，沖洗濾膜不少于3次，每次均將驗(yàn)證試驗(yàn)中所使用的無(wú)菌稀釋劑體積濾過(guò)該濾膜。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)。轉(zhuǎn)移整個(gè)濾膜至培養(yǎng)基，或以無(wú)菌操作將其切開至相等的2部分，并將每一部分轉(zhuǎn)移至適當(dāng)?shù)呐囵B(yǎng)基中。每個(gè)培養(yǎng)基的體積與驗(yàn)證試驗(yàn)所用的一樣。或者，將培養(yǎng)基轉(zhuǎn)移至設(shè)備中的濾膜上。培養(yǎng)該培養(yǎng)基，不少于14天。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)。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。粘性足夠低的油和油性溶液可能在不經(jīng)稀釋的情況下濾過(guò)干燥濾膜。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，例如已證實(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。使該油質(zhì)依靠其自身的重量穿過(guò)濾膜，然后逐漸應(yīng)用壓力或抽吸過(guò)濾。每次過(guò)濾約100mL適當(dāng)?shù)臒o(wú)菌溶液，例如液體A（見用于膜過(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）。將一個(gè)或多個(gè)濾膜轉(zhuǎn)移到一個(gè)或多個(gè)培養(yǎng)基，或反之，如上面關(guān)于水性溶液的描述，并在相同溫度下培養(yǎng)同樣的時(shí)間。OINTMENTS and CREAMS 油膏和乳膏Use for each medium not less than the quantities of the product prescribed in Tables 2 and 3. Ointments in a fatty base and emulsions of the waterinoil type may be diluted to 1% in isopropyl myristate as described above, by heating, if necessary, to not more than 40 . In exceptional cases it may be necessary to heat to not more than 44 . Filter as rapidly as possible, and proceed as described above for Oils and Oily Solutions.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。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 。在特別情況下，其可能必須加熱到不超過(guò)44 。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。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。如果附了單獨(dú)的滅菌針頭，直接按照上面的規(guī)定將注射器內(nèi)容物直接排出，并按照關(guān)于水性溶液的規(guī)定繼續(xù)進(jìn)行。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。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。[注意：如需要，可以加入額外的稀釋劑以幫助對(duì)已配制的供試物品進(jìn)行再配制和過(guò)濾]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。 or constitute, as directed in the labeling, each of 20 containers and transfer a quantity of liquid or suspension, equivalent to about 300 mg of solids, into a sterile 500mL conical flask, dissolve in about 200 mL of Fluid A, and mix. Proceed as directed for Aqueous Solutions or Oils and Oily Solutions, whichever applies. 藥房散裝 5 g：取20個(gè)容器，每個(gè)容器均以無(wú)菌操作將約300mg固體轉(zhuǎn)移至一個(gè)無(wú)菌的500mL錐形燒瓶，溶解于約200mL液體A中（見用于膜過(guò)濾的稀釋和沖洗液），并混勻；或取20個(gè)容器，每個(gè)容器均按照標(biāo)簽上的規(guī)定配制，并將相當(dāng)于大約300mg固體的液體或懸浮液轉(zhuǎn)移至一個(gè)無(wú)菌的500mL錐形燒瓶，溶解于約200mL液體A中，并混勻。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。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。 or constitute, as directed in the labeling, each of 6 containers and transfer a quantity of liquid, equivalent to about 1 g of solids, into a sterile 500mL conical flask, dissolve in about 200 mL of Fluid A, and mix. Proceed as directed for Aqueous Solutions. 藥方散裝 5 g：取6個(gè)容器，每個(gè)均以無(wú)菌操作將大約1克的固體轉(zhuǎn)移至一個(gè)無(wú)菌的500mL錐形燒瓶，溶解于約200mL液體A中，并混勻；或取6個(gè)容器，每個(gè)均按照標(biāo)簽的規(guī)定配制，將相當(dāng)于1g固體的液體轉(zhuǎn)移至一個(gè)無(wú)菌的500mL錐形燒瓶，溶解于200mL液體A中，并混勻。按照關(guān)于水性溶液的規(guī)定，繼續(xù)操作。ANTIBIOTIC SOLIDS, BULKS, and BLENDS 抗生素固體、散裝品