包裝和儲(chǔ)存條件

麗珠集團(tuán)福州福興醫(yī)藥有限公司·標(biāo)準(zhǔn)譯文文件出處：USP38頁(yè)次：20/20<659>PACKAGINGANDSTORAGEREQUIREMENTS<659>包裝和儲(chǔ)存要求(ChaptertobecomeofficialMay1,2016)（本章節(jié)2016年5月1號(hào)正式生效）Deletethefollowing：以下內(nèi)容刪除：EverymonographintheUSPandNFshallhavepackagingandstoragerequirements.Forthepackagingportionofthestatement,thechoiceofcontainersisgiveninthischapter.Fordrugproductpackagingrequirements,definitionsareprovidedtoguideselectionandadaptation.Foractivepharmaceuticalingredients(APIs),thechoicewouldbetight,well-closedor,whereneeded,alight-resistantcontainer.Forexcipients,giventheirtypicalpresentationaslarge-volumecommodityitems(containersrangingfromdrumstotankcars),awell-closedcontainerisanappropriatedefault.在USP和NF的每個(gè)專(zhuān)論中應(yīng)要有包裝和儲(chǔ)存的要求。對(duì)于包裝的聲明部分，本章節(jié)提供了容器的選擇。對(duì)于藥品包裝的要求，定義進(jìn)行導(dǎo)向篩選和改編。對(duì)于API，要選擇密封的、密閉性好的或者根據(jù)需要選擇耐光的容器。對(duì)于賦形劑，和大容量商品一樣，鑒于他們的典型性質(zhì)，（容器從圓桶到罐車(chē)），默認(rèn)是一個(gè)密閉性好的容器。Wherenospecificdirectionsorlimitationsareprovidedinthearticle’slabeling,articlesshallbeprotectedfrommoisture,freezing,andexcessiveheatand,wherenecessary,fromlightduringshippinganddistribution.Drugsubstancesareexemptfromthisstandard.USP38.在物品的標(biāo)簽上沒(méi)有提供特定的方向或局限性。物品在運(yùn)輸和配送過(guò)程中應(yīng)該防潮、防凍、防過(guò)熱，必要時(shí)要避光。藥物不受這個(gè)標(biāo)準(zhǔn)限制。PACKAGING包裝Packagingmustnotinteractphysicallyorchemicallywithofficialarticlesinanywaythatcausestheirsafety,identity,strength,quality,orpuritytofailtoconformtorequirements.包裝不能以任何方式使物品化學(xué)和物理方面產(chǎn)生相互影響，從而導(dǎo)致他們的安全性、特性、強(qiáng)度、質(zhì)量或純度不符合要求。Packagingcontainerchoicesaregiveninthischapter.Fordrugproductsandactivepharmaceuticalingredients(APIs),thecontainerchoicesaretight,well-closed,or,whereneeded,light-resistant.Forexcipients,giventheirtypicalpresentationaslarge-volumecommodityitems(containersrangingfromdrumstotankcars),awell-closedcontainerisanappropriatedefault.Forarticlesotherthandrugsubstancesanddrugproducts,wherenospecificdirectionsorlimitationsareprovided,articlesshallbeprotectedfrommoisture,freezing,andexcessiveheat,and,wherenecessary,fromlightduringshippinganddistribution.本章節(jié)提供了包裝容器的選擇。對(duì)于藥品和API包裝的要求，要選擇密封的、密閉性好的或者根據(jù)需要選著耐光的容器。對(duì)于賦形劑，和大容量商品一樣，鑒于他們的典型性質(zhì)，（容器從圓桶到罐車(chē)），默認(rèn)是一個(gè)密閉好的容器。沒(méi)有提供特定的方向或局限性時(shí)，對(duì)于除了藥物和藥品外的其他物品，在運(yùn)輸和配送過(guò)程中應(yīng)該防潮、防凍、防過(guò)熱，必要時(shí)要避光。Thecompendialrequirementsfortheuseofspecifiedcontainersapplyalsotoarticlesaspackagedbythepharmacistorotherdispenser,unlessotherwiseindicatedintheindividualmonograph.USP38使用指定容器的藥典要求對(duì)藥劑師或其他分配者包裝物品時(shí)同樣適用，除非在專(zhuān)論中另有說(shuō)明。GENERALDEFINITIONS一般概念Packagingsystem(alsoreferredtoasacontainer–closuresystem):Thesumofpackagingcomponentsthattogethercontainandprotectthearticle.Thisincludesprimarypackagingcomponentsandsecondarypackagingcomponents,ifthelatterisintendedtoprovideadditionalprotection.包裝系統(tǒng)（也稱(chēng)為容器密封系統(tǒng)）：指共同盛裝和保護(hù)物品的所有包裝組件的總和。如果次級(jí)包裝組件具有為物品提供額外保護(hù)的功能，則容器密封系統(tǒng)包括初級(jí)包裝組件和次級(jí)包裝組件。Container:Areceptaclethatholdsanintermediatecompound,activepharmaceuticalingredient,excipient,ordosageformandisormaybeUSP38indirectcontactwiththearticles.Theimmediatecontaineristhatwhichisindirectcontactwiththearticleatalltimes.Theclosureisapartofthecontainer.Beforebeingfilled,thecontainershouldbeclean.Specialprecautionsandcleaningproceduresmaybenecessarytoensurethateachcontaineriscleanandthatextraneousmatterisnotintroducedintoorontothearticle.USP38容器：能夠保存中間體、原料藥、輔料或劑型的容器，是或可能是和物品直接接觸。直接包裝的容器會(huì)一直直接接觸藥品。密封也是容器的一部分。在填裝之前，容器應(yīng)該干凈。特殊的預(yù)防措施和清潔程序可能是必要的，可以保證每個(gè)容器的干凈，異物不會(huì)引入或粘到藥品上。Packagingcomponent:Anysinglepartofthepackageorcontainer–closuresystemincludingthecontainer(e.g.,ampuls,prefilledsyringes,vials,bottles);containerliners(e.g.,tubecartridgeliners);closures(e.g.,screwcaps,stoppers);ferrulesandoverseals;closureliners;innerseals;administrationports;overwraps;administrationaccessories;andlabels.包裝組件：容器密封系統(tǒng)或包裝的任何一個(gè)部分，包括容器（如：安瓿、預(yù)灌封注射器、西林瓶、瓶子）；容器襯墊（例如管襯）；瓶塞（螺旋蓋、膠塞）；套管和膠塞頂封；瓶塞襯墊；內(nèi)封；輸液口；外包裝；給藥配件和標(biāo)簽。Primarypackagingcomponent:Packagingcomponentsthatareindirectcontactormaybecomeindirectcontactwiththearticle.初級(jí)包裝組件指的是與物品直接接觸或可能變成直接接觸的包裝組件。Secondarypackagingcomponent:Packagingcomponentsthatarenotandwillnotbeindirectcontactwiththearticle.USP38次級(jí)包裝組件指的是不與物品直接接觸的包裝組件。Tertiarypackaging:Packagingcomponentsthatarenotindirectcontactwiththearticlebutfacilitatethehandlingandtransportinordertopreventdamagefromphysicalhandlingandstorageconditionstowhichthearticleissubjected.三級(jí)包裝：包裝組件不直接接觸物品但是方便操作和運(yùn)輸，以避免來(lái)自物理操作和儲(chǔ)存條件對(duì)物品產(chǎn)生的損害。Materialsofconstruction:Referstothematerials(e.g.,glass,plastic,elastomers,metal)usedtomanufactureapackagingcomponent.結(jié)構(gòu)材料：指的是用于生產(chǎn)包裝組件的材料（如：玻璃、塑料、彈性纖維、金屬）。Multiple-dosecontainerUSP38(alsoreferredtoasmulti-dose):Apackagingsystemthatpermitswithdrawalofsuccessiveportionsofanarticleforparenteraladministrationwithoutchangingthesafety,strength,quality,orpurityoftheremainingportion.SeeMulti-DoseContainersinContainerContentforInjections697.USP38多劑量容器（也稱(chēng)為多劑量）：允許藥品連續(xù)部分取出進(jìn)行非消化道給藥的一個(gè)包裝系統(tǒng)，不改變余下部分的安全、強(qiáng)度、質(zhì)量或純度。見(jiàn)<697>注射劑容器部分的多劑量容器。.Multiple-unitcontainer:USP38Apackagingsystemthatpermitswithdrawalofsuccessiveportionsofanarticlewithoutchangingthesafety,strength,quality,orpurityoftheremainingportion.多單元包裝容器：允許一個(gè)藥品連續(xù)部分的取出的包裝系統(tǒng)，不改變余下部分的安全、強(qiáng)度、質(zhì)量或純度。Single-unitcontainer：USP38Apackagingsystemthatholdsaquantityofanarticleintendedforadministrationasasingledoseorasinglefinisheddeviceintendedforusepromptlyafterthecontainerisopened.Preferably,theimmediatecontainerand/ortheoutercontainerorprotectivepackagingshallbesodesignedastoshowevidenceofanytamperingwiththecontents.USP38一次用容器：盛有一定量藥品的包裝系統(tǒng)，打開(kāi)后能夠作為單劑量或一次性給藥的裝置，在容器打開(kāi)后能盡快使用。最好，應(yīng)設(shè)計(jì)直接包裝和/或外容器或保護(hù)性包裝，以作為內(nèi)容有任何篡改的證據(jù)。Single-dosecontainer:Asingle-dosecontainerisacontainerofsterilemedicationforparenteraladministration(injectionorinfusion)thatisnotrequiredtomeettheantimicrobialeffectivenesstestingcriteria.[Note—Forthisdefinitiononly,containerissynonymouswithpackagingsystemandcontainer–closuresystem.]Asingle-dosecontainerisdesignedforusewithasinglepatientasasingleinjection/infusion.1Asingle-dosecontainerislabeledassuchand,whenspacepermits,shouldincludeappropriatediscardinstructionsonthelabel.Examplesofsingle-dosecontainersarevials,ampuls,andprefilledsyringes.USP38單劑量容器：?jiǎn)蝿┝咳萜魇怯糜谧⑸溆脽o(wú)菌藥物（注射或輸液）的一種容器，不需要滿(mǎn)足抗菌效果的測(cè)試標(biāo)準(zhǔn)。[注意——只對(duì)于這個(gè)定義，容器是包裝系統(tǒng)和容器密封系統(tǒng)代名詞]。單劑量容器是為單個(gè)病人單次注射/輸液使用的。單劑量容器貼上標(biāo)簽，當(dāng)空間允許，應(yīng)在標(biāo)簽包括適當(dāng)?shù)膩G棄說(shuō)明。典型的單劑量容器是西林瓶、安剖、預(yù)灌封注射器）。Unit-dosecontainer：USP38Asingle-unitpackagingsystemforanarticleintendedforadministrationbyotherthantheparenteralrouteasasingledose.單一劑量容器：除了非腸道給藥，藥品單劑量給藥的一次用包裝系統(tǒng)。Unit-of-usecontainer:USP38Apackagingsystemthatcontainsaspecificquantityofanarticlethatisintendedtobedispensedassuchwithoutfurthermodificationexceptfortheadditionofappropriatelabeling.Unit-of-usepackagingmaynotberepackagedforsale.單位使用容器：含有特定數(shù)量藥品的包裝系統(tǒng)，這些藥品打算分發(fā)不能進(jìn)一步修改，除了增加適當(dāng)?shù)臉?biāo)簽。單位使用包裝不能重新包裝銷(xiāo)售。Pharmacybulkpackage:ApackagingsystemUSP38ofasterilepreparationforparenteralusethatcontainsmanysingledoses.Thecontentsareintendedforuseinapharmacyadmixtureprogramandarerestrictedtothepreparationofadmixturesforinfusionor,throughasteriletransferdevice,forthefillingofemptysterilesyringes.藥房大包裝：含有多個(gè)單劑量注射用滅菌制劑的包裝系統(tǒng)。其內(nèi)容物用于藥房調(diào)配且僅限于混合輸液的配制或者通過(guò)滅菌傳輸裝置，填充空的無(wú)菌注射器。Theclosureshallbepenetratedonlyonetimeafterconstitution,ifnecessary,USP38withasuitablesteriletransferdeviceordispensingsetthatallowsmeasureddispensingofthecontents.ThePharmacybulkpackageistobeusedonlyinasuitableworkareasuchasalaminarflowhood(oranequivalentclean-aircompoundingarea).組成藥房大包裝后只能刺穿封塞一次，如果必要，用一個(gè)合適的無(wú)菌傳輸設(shè)備或能夠允許測(cè)量調(diào)配藥量的配藥裝置。藥房大包裝只在合適的工作區(qū)域使用，如層流凈化罩（或相同的空氣潔凈級(jí)別的區(qū)域）。DesignationasaPharmacybulkpackageislimitedtoInjection,forInjection,orInjectableEmulsiondosageformsasdefinedinNomenclature1121,GeneralNomenclatureForms.USP38藥房大包裝僅限于注射，注射或可注射乳劑劑型在1121通用術(shù)語(yǔ)形式中的術(shù)語(yǔ)里有定義。Pharmacybulkpackage,althoughcontainingmorethanonesingledose,isexemptfromthemultiple-dosecontainervolumelimitof30mLandtherequirementthatitcontainsasubstanceorsuitablemixtureofsubstancestopreventthegrowthofmicroorganisms.SeeLabeling7forlabelingrequirements.USP38藥房大包裝，雖然含有一個(gè)以上的單劑量，但不受多劑量包裝30mL的體積限制，并不得含防止微生物生長(zhǎng)的種物質(zhì)或混合物。見(jiàn)7標(biāo)簽，對(duì)標(biāo)簽的要求。Small-volumeinjections:AninjectionthatUSP38ispackagedincontainerslabeledascontaining100mLorless.小容量注射劑：裝入標(biāo)示量為100mL或100mL以下容器的注射液。Large-volumeinjections:AnUSP38injectionthatisintendedforintravenoususe,andispackagedincontainerslabeledascontainingmorethan100mL.大容量注射劑：用于靜脈注射使用，并裝在標(biāo)示量大于100mL容器的注射液。Child-resistantpackaging:USP38ApackagingsystemdesignedorconstructedtomeetConsumerProductSafetyCommissionstandardspertainingtoopeningbychildren(16CFR§1700.20).兒童安全包裝：設(shè)計(jì)或構(gòu)建的包裝系統(tǒng)符合消費(fèi)者產(chǎn)品安全委員會(huì)標(biāo)準(zhǔn)適合對(duì)兒童開(kāi)放(16CFR§1700.20)。Senior-friendlypackaging:USP38ApackagingsystemdesignedorconstructedtomeetConsumerProductSafetyCommissionstandardspertainingtoopeningbysenioradults(16CFR§1700.20).老人適用型包裝：設(shè)計(jì)或構(gòu)建的包裝系統(tǒng)符合消費(fèi)者產(chǎn)品安全委員會(huì)標(biāo)準(zhǔn)適合對(duì)老年人開(kāi)放。Tamper-evidentpackaging:USP38Apackagingsystemthatmaynotbeaccessedwithoutobviousdestructionofthesealorsomeportionofthepackagingsystem.Tamper-evidentpackagingshallbeusedforasterilearticleintendedforophthalmicoroticuse,exceptwhereextemporaneouslycompoundedforimmediatedispensingonprescription.Articlesintendedforsalewithoutprescriptionarealsorequiredtocomplywiththetamper-evidentpackagingandlabelingrequirementsoftheFDAwhereapplicable.Preferably,theimmediatecontainerand/ortheoutercontainerorprotectivepackagingusedbyamanufacturerordistributorforalldosageformsthatarenotspecificallyexemptisdesignedsoastoshowevidenceofanytamperingwiththecontents.防篡改包裝：是指只有明顯的破壞密封性或包裝系統(tǒng)的部分才能取出內(nèi)部產(chǎn)品的一種包裝系統(tǒng)。防篡改包裝應(yīng)用于眼用或耳用無(wú)菌產(chǎn)品，除非為了立即調(diào)配處方的無(wú)準(zhǔn)備混合。用于銷(xiāo)售的非處方藥也要求符合防篡改包裝和適用于FDA的標(biāo)簽要求。對(duì)于所有劑型而言，最好應(yīng)設(shè)計(jì)生產(chǎn)者或經(jīng)銷(xiāo)商所用的不能免除的直接包裝和/或外包裝或保護(hù)性包裝，以作為內(nèi)容有任何篡改的證據(jù)。Hermeticcontainer:Apackagingsystemthatisimpervioustoairoranyothergasundertheordinaryorcustomaryconditionsofhandling,shipment,storage,anddistribution.USP38密封容器：在處理、運(yùn)輸、存儲(chǔ)和分布的普通或習(xí)慣性條件下不受空氣或其他氣體影響的包裝系統(tǒng)。Tightcontainer:USP38ApackagingsystemthatprotectsthecontentsUSP38fromcontaminationbyextraneousliquids,solids,orvapors;fromlossofthearticle;andfromefflorescence,deliquescence,orevaporationundertheordinaryorcustomaryconditionsofhandling,shipment,storage,anddistributionandiscapableoftightreclosure.Whereatightcontainerisspecified,itmaybereplacedbyahermeticcontainerforasingledoseofanarticle.[Note—Wherepackagingandstorageinatightcontainerorwell-closedcontainerisspecifiedintheindividualmonograph,thecontainerusedforanarticlewhendispensedonprescriptionmeetstherequirementsinContainers—PerformanceTesting671.]USP38緊密容器：在處理、運(yùn)輸、存儲(chǔ)和分布的普通或習(xí)慣性條件下避免藥品受外來(lái)液體、固體或蒸汽的污染；避免藥品損失和風(fēng)化、潮解或蒸發(fā)且能夠密封的包裝系統(tǒng)，且該包裝系統(tǒng)可以重新緊密包裝。密閉容器是指定的，用于單劑量藥物時(shí)可以被密封容器取代。[注意——藥品包裝和儲(chǔ)存的密閉容器或?qū)Ｕ撝兄付ǖ拿芊馊萜?，?dāng)分配處方時(shí)，藥物所使用的容器符合671容器-性能測(cè)試的要求。Well-closedcontainer:USP38ApackagingsystemthatprotectsthecontentsUSP38fromcontaminationbyextraneoussolidsUSP38andfromlossofthearticleundertheordinaryorcustomaryconditionsofhandling,shipment,storage,anddistribution.SeeContainers—PerformanceTesting671.密封容器：在處理、運(yùn)輸、存儲(chǔ)和分布的普通或習(xí)慣性條件下避免藥品受到外來(lái)固體污染，避免藥品損失的包裝系統(tǒng)。見(jiàn)671容器-性能測(cè)試。Light-resistantcontainer:USP38ApackagingsystemthatprotectsthecontentsUSP38fromtheeffectsoflightbyvirtueofthespecificpropertiesofthematerialofwhichitiscomposed,includinganycoatingappliedtoit.Aclearandcolorlessoratranslucentcontainermaybemadelight-resistantbymeansofanopaquecoveringorbyuseofsecondarypackaging,inwhichcasethelabelofthecontainerbearsastatementthattheopaquecoveringorsecondarypackagingisneededuntilthearticlesaretobeusedoradministered.Whereitisdirectedto“protectfromlight”inanindividualmonograph,preservationinalight-resistantcontainerisintended.SeeContainers—PerformanceTesting671,LightTransmissionTest.耐光容器：由特定性能材料組成能保護(hù)藥物不受光的影響的包裝系統(tǒng)，包括所使用的任何涂層。清晰和無(wú)色或半透明容器可以通過(guò)一個(gè)不透明的覆蓋方法制成耐光的，或用于次級(jí)包裝。在這種情況下，容器的標(biāo)簽必需要有不透明的覆蓋物或次級(jí)包裝的聲明，直到藥品被使用或給藥。專(zhuān)論中針對(duì)“閉光”，要求保存在耐光容器。見(jiàn)671容器-性能測(cè)試，光傳輸測(cè)試。Blackclosuresystemorblackbands:Theuseofablackclosuresystemonavial(e.g.,ablackcapoversealandablackferruletoholdtheelastomericclosure)ortheuseofablackbandorseriesofbandsabovetheconstrictiononanampulisprohibited,exceptforPotassiumChlorideforInjectionConcentrate.SeeLabeling7.USP38黑色密封系統(tǒng)或黑色封邊：除了氯化鉀濃縮注射液外，在小瓶上使用黑色密封系統(tǒng)（如：黑色頂封蓋和黑色金屬箍來(lái)維持橡膠塞）或安瓿上使用黑色封邊或一系列封邊均是被禁止的。見(jiàn)7標(biāo)簽。Addthefollowing:以下是增加的內(nèi)容：INJECTIONPACKAGING注射液包裝Validationofcontainer–closureintegritymustdemonstratenopenetrationofmicrobialcontaminationorchemicalorphysicalimpurities.Inaddition,thesolutesandthevehiclemustmaintaintheirspecifiedtotalandrelativequantitiesorconcentrationswhenexposedtoanticipatedextremeconditionsofmanufacturingandprocessing,storage,shipment,anddistribution.Closuresformultiple-dosepackagingsystemspermitthewithdrawalofthecontentswithoutremovalordestructionoftheclosure.Theclosurepermitspenetrationbyaneedleand,uponwithdrawaloftheneedle,closesatonce,protectingthecontentsagainstcontamination.Validationofthemultiple-dosecontainer–closureintegritymustincludeverificationthatsuchapackagepreventsmicrobialcontaminationorlossofproductcontentsunderanticipatedconditionsofmultipleentryanduse.容器密封完整性驗(yàn)證必須證明沒(méi)有微生物污染或化學(xué)或物理雜質(zhì)的進(jìn)入。除此之外，當(dāng)容器暴露于生產(chǎn)和加工、儲(chǔ)存、運(yùn)輸和銷(xiāo)售的極端環(huán)境下時(shí)，溶質(zhì)和溶劑必須保持其標(biāo)示總量和相對(duì)量或濃度。多劑量包裝系統(tǒng)的封塞應(yīng)能在不除去或毀壞封塞的情況下抽出內(nèi)容物。塞子可被針頭刺入，當(dāng)抽出針頭時(shí)，應(yīng)立即封閉容器以防污染。多劑量容器密封完整性驗(yàn)證必須包括確認(rèn)此包裝在多次刺入和使用的預(yù)期條件下能夠防止微生物污染或者產(chǎn)品含量的損失。Piggybackpackagingsystemsareusuallyintravenousinfusioncontainer–closuresystemsusedtoadministerasecondinfusionthroughaconnectorofsometypeoraninjectionportontheadministrationsetofthefirstfluid,therebyavoidingtheneedforanotherinjectionsiteonthepatient'sbody.Piggybackpackagingsystemsalsoareknownassecondaryinfusioncontainers.便攜式包裝系統(tǒng)通常是靜脈輸液容器密封系統(tǒng)，該系統(tǒng)通過(guò)多種類(lèi)型的連接器或第一次輸注給藥的裝置的注射孔進(jìn)行第二次輸注給藥，因此避免了在病人身上在此尋找注射位置。便攜式包裝系統(tǒng)也被稱(chēng)為第二次輸注容器。Thevolumeofinjectioninasingle-dosepackagingsystemprovidestheamountspecifiedforone-timeparenteraladministrationandinnocaseismorethansufficienttopermitthewithdrawalandadministrationof1L.單劑量包裝系統(tǒng)注射液的容量規(guī)定了一次性注射用指定的數(shù)量，并在任何情況下，足以允許1L的抽取和給藥量。Preparationsintendedforintraspinal,intracisternal,orperiduraladministrationarepackagedonlyinsingle-dosepackagingsystems.脊柱內(nèi)注射、腦池液注射或硬膜外注射給藥的制劑，只能灌裝在單劑量容器中。Unlessotherwisespecifiedintheindividualmonograph,amultiple-dosepackagingsystemcontainsavolumeofinjectionsufficienttopermitthewithdrawalofNMT30mL.除非專(zhuān)論另有規(guī)定，多劑量包裝系統(tǒng)含有的可抽出注射液體積不得超過(guò)30ml。Thefollowinginjectionsareexemptfromthe1-Lrestrictionoftheforegoingrequirementsrelatingtopackaging:以下的注射液不受上述關(guān)于包裝的1L要求的限制。Injectionspackagedforextravascularuseasirrigationsolutionsorperitonealdialysissolutions.灌洗用或腹膜透析用的血管外注射液包裝。Injectionspackagedforintravascularuseasparenteralnutritionorasreplacementorsubstitutionfluidtobeadministeredcontinuouslyduringhemofiltration.胃腸外營(yíng)養(yǎng)用或血液過(guò)濾期間不斷給藥的置換液用的血管內(nèi)注射液包裝。Injectionspackagedforintravascularusethatmaybeusedforintermittent,continuous,orbolusreplacementfluidadministrationduringhemodialysisorotherprocedures,unlessexceptedabove,mustconformtothe1-Lrestriction.Injectionslabeledforveterinaryuseareexemptfrompackagingandstoragerequirementsconcerningthelimitationtosingle-dosepackagingsystemsandthelimitationonthevolumeofmultiple-dosecontainers.在血液透析或其他程序過(guò)程中可能用于間歇性、連續(xù)性或大劑量更換給藥的血管內(nèi)注射液的包裝必須符合1L限制，除非不屬于以上條件。獸用標(biāo)記的注射器不受關(guān)于單劑量包裝系統(tǒng)和多劑量容器體積限制的包裝和儲(chǔ)存要求。Sterilesolidspackaging:Containers,includingtheclosures,fordrysolidsintendedforinjectiondonotinteractphysicallyorchemicallywiththepreparationinanymannertoalterthestrength,quality,orpuritybeyondtheofficialrequirementsundertheordinaryorcustomaryconditionsofhandling,shipment,storage,sale,anduse.Apackagingsystemforasterilesolidpermitstheadditionofasuitablesolventandwithdrawalofportionsoftheresultingsolutionorsuspensioninsuchmannerthatthesterilityoftheproductismaintained.WheretheAssayinamonographprovidesaprocedurefortheSamplesolution,inwhichthetotalwithdrawablecontentsaretobewithdrawnfromasingle-dosepackagingsystemwithahypodermicneedleandsyringe,thecontentsaretobewithdrawnascompletelyaspossibleintoadryhypodermicsyringeofaratedcapacitynotexceedingthreetimesthevolumetobewithdrawnandfittedwitha21-gaugeneedleNLT2.5cm(1inch)inlength,withcarebeingtakentoexpelanyairbubbles,anddischargedintoacontainerfordilutionandassay.USP38無(wú)菌固體包裝：用于注射給藥干燥固體的容器，包括封塞，不應(yīng)與制劑產(chǎn)生物理或化學(xué)的相互作用以致在規(guī)定或通常處理、運(yùn)輸、存儲(chǔ)、銷(xiāo)售及使用中以任何方式對(duì)強(qiáng)度、質(zhì)量和純度超出法定要求。無(wú)菌固體包裝系統(tǒng)允許加入適宜的溶劑，抽出制成的溶液或懸浮液部分，這樣能保持產(chǎn)品的無(wú)菌度。在專(zhuān)論的“含量測(cè)定”中規(guī)定樣品溶液程序，規(guī)定用皮下注射針頭和注射器從單劑量容器中抽出全部?jī)?nèi)容物，應(yīng)盡可能完全地抽出，抽到干燥的皮下注射器中，注射器的標(biāo)示容量不得超過(guò)抽出量的3倍，并應(yīng)裝長(zhǎng)度不少于2.5cm（1英寸）的21號(hào)針頭，小心排出氣泡，轉(zhuǎn)移入一個(gè)容器進(jìn)行稀釋和測(cè)定。MEDICALGASPACKAGING藥用氣體包裝Gascylinder:Agascylinderisametallicpackagingsystemconstructedofsteeloraluminumdesignedtoholdmedicalgasesunderpressure.MedicalgasesincludeCarbonDioxideUSP,HeliumUSP,MedicalAirUSP,nitricoxide,NitrousOxideUSP,NitrogenNF,andOxygenUSP.Asasafetymeasure,forcarbondioxide,cyclopropane,helium,medicalair,nitrousoxide,andoxygen,thePin-IndexSafetySystemofmatchedfittingsisrecommendedforcylindersofSizeEorsmaller.氣瓶：氣瓶是一個(gè)金屬包裝系統(tǒng)，由鋼或鋁構(gòu)成，在壓力下用來(lái)保存醫(yī)療氣體。醫(yī)療氣體包括二氧化碳USP,醫(yī)用空氣USP,一氧化氮,一氧化二氮USP,氮?dú)釴F和氧氣USP。Pin-Index安全系統(tǒng)作為一項(xiàng)安全措施，為二氧化碳、環(huán)丙烷、氦、醫(yī)療空氣、一氧化二氮和氧推薦的匹配配件是型號(hào)為E或更小的氣瓶。ASSOCIATEDCOMPONENTS相關(guān)組件Manyassociatedcomponentsaregraduatedfordoseadministration.Itistheresponsibilityofthemanufacturertoensurethattheappropriatedosingcomponentisprovidedorthatageneralpurposecomponent,suchasthosedescribedinthissection,isspecifiedfordeliveringtheappropriatedosewiththeintendedaccuracy.Thegraduationsshouldbelegibleandindelible.許多相關(guān)組件根據(jù)給藥劑量是有刻度的。廠家有責(zé)任確保提供符合劑量的組件或通用組件，如這個(gè)章節(jié)所描述的那些組件，用于發(fā)放適當(dāng)?shù)膭┝?，在預(yù)期的準(zhǔn)確度里?？潭葢?yīng)該是清晰的，不可磨滅的。Graduatedassociatedcomponentsdescribedinthissectionareforgeneraluse.Graduatedmarkingsshouldbelegible,indelible,andonanextraoralnonproductcontactsurface.Underidealconditionsofuse,thevolumeerrorincurredinmeasuringliquidsforindividualdoseadministrationbymeansofsuchgraduatedcomponentsshouldbeNMT10%oftheindicatedamountoftheliquidpreparationwithwhichthegraduatedcomponentwillbeused.Fewliquidpreparationshavethesamesurfaceandflowcharacteristics.Therefore,thevolumedeliveredvariesmateriallyfromonepreparationtoanother.本章節(jié)所描述的有刻度的相關(guān)組件是普遍使用的。刻度標(biāo)記應(yīng)該是清晰，不可磨滅的，且在產(chǎn)品不能接觸的外表面。在理想的使用條件下，單劑量給藥時(shí)用這些刻度組件測(cè)量液體所招致的體積誤差小于等于10%，表示在有刻度元件內(nèi)的液體制劑的量是可用的。一些液體制劑具有相同的表面和流動(dòng)特性。因此，從一個(gè)制劑到另一個(gè)制劑的輸液量實(shí)際上是不同的。PolymersandingredientsaddedtopolymersthatareusedinthefabricationofassociatedcomponentsmustconformtotherequirementsintheapplicablesectionsoftheCodeofFederalRegulations,Title21,IndirectFoodAdditives.用于制造相關(guān)組件的聚合物和添加到聚合物的材料必須符合美國(guó)聯(lián)邦法規(guī)，標(biāo)題21，間接食品添加劑適用章節(jié)的要求。Dosingcup:Ameasuringdeviceconsistingofasmallcupthatispackagedwithoralliquidarticlesorthatmaybesoldandpurchasedseparately.加藥杯：由一個(gè)包裝口服液體藥物的小杯子組成的一個(gè)測(cè)量容器，也可以單獨(dú)出售和購(gòu)買(mǎi)。Dosingspoon:Ameasuringdeviceconsistingofabowlandahandlethatispackagedwithoralliquidarticlesorthatmaybesoldandpurchasedseparately.Thehandlemaybeagraduatedtube.加藥匙：由一個(gè)包裝口服液體藥物的碗狀物和手柄組成的一個(gè)測(cè)量容器，也可以單獨(dú)出售和購(gòu)買(mǎi)。柄可能是個(gè)刻度管。Medicinedropper:Ameasuringdeviceconsistingofatransparentortranslucentbarrelortubethatisgenerallyfittedwithacollapsiblebulb.Itispackagedwithoralliquidarticlesormaybesoldandpurchasedseparately.醫(yī)藥用滴管:由透明或半透明的槍管或管組成的測(cè)量容器，通常配有一個(gè)可折疊的球狀物。包裝口服液體藥物，可以單獨(dú)出售和購(gòu)買(mǎi)。Dropperstypicallyvaryincapacity;however,thedeliveryendshouldbearoundopeninghavinganexternaldiameterofabout3mm.Thebarrelmaybegraduated.[Note—Fewmedicinalliquidshavethesamesurfaceandflowcharacteristicsaswater,andthereforethesizeofdropsvariesmateriallyfromonepreparationtoanother.]滴管通常在容量上是多變的，然而，出口端應(yīng)該是一個(gè)外直徑為3mm的圓孔。槍管要有刻度。[注意——一些藥用液體具有和水相同的表面和流量特性，因此，從一個(gè)制劑到另一個(gè)制劑的滴量實(shí)際上是變化的]。Oralsyringe:Ameasuringdeviceconsistingofaplungerandbarrelmadeofsuitablerigid,transparentortranslucentplasticmaterialandasealontheend.Itispackagedwithoralliquidarticlesormaybesoldandpurchasedseparately.Thesyringeshouldexpelameasuredamountofaliquidarticledirectlyintothepatient'smouth.Fingergripslocatedattheopenendofthebarrelshouldbetheappropriatesize,shape,andstrength,andshouldallowthesyringetobeheldsecurelyduringuse.Thebarrelmaybegraduated.口腔注射器：由一個(gè)活塞和剛性適合的透明或半透明塑料制成的管組成的測(cè)量容器，且在末端封口。用于包裝口服液體藥品或者可以單獨(dú)出售和購(gòu)買(mǎi)。注射器可以將被測(cè)量液體直接進(jìn)注入病人的嘴。位于筒開(kāi)口端的指套應(yīng)有適當(dāng)?shù)拇笮?，形狀，和力量，且?yīng)該允許注射器在使用期間能夠保持安全牢固。管需要標(biāo)刻度。Teaspoon:Ameasuringdeviceconsistingofashallowbowl,ovalorround,attheendofahandle.Ateaspoonhasbeenestablishedascontaining4.93±0.24mL.Forthepracticeofadministeringarticles,theteaspoonmayberegardedasrepresentingavolumeof5mL.茶匙：是由一個(gè)圓形或橢圓形的，末端有個(gè)柄的淺碗組成。既定的茶匙有4.93±0.24mL。根據(jù)藥物給藥的實(shí)踐，茶匙可以被視為是5mL的量。Articlesintendedforadministrationbyteaspoonshouldbeformulatedonthebasisofdosagein5-mLunits,suchthatanycomponentusedtoadministerliquidarticlesshoulddeliver5mLwhereverateaspooncalibrationisindicated.Ahouseholdspoonisnotanacceptablealternativetothegraduatedteaspoondescribedherein.用茶匙給藥的藥物應(yīng)該建立在用量是5-mL每單元的基礎(chǔ)上。這樣任何用于液體藥品給藥的元件應(yīng)該提供5mL，無(wú)論有沒(méi)有指明茶匙要校準(zhǔn)。家里的勺子不能代替這里所描述的有標(biāo)量的茶匙。POISONPREVENTIONPACKAGINGACT(PPPA)防毒包裝法案（PPPA）Thisactrequiresspecialpackagingofmosthumanoralprescriptiondrugs,oralcontrolleddrugs,certainnon-oralprescriptiondrugs,certaindietarysupplements,andmanyover-the-counter(OTC)drugpreparationsinordertoprotectthepublicfrompersonalinjuryorillnessfrommisuseofthesepreparations(16CFR§1700.14).該法案要求對(duì)大多數(shù)人用口服處方藥，口服控制藥物，某些非口服處方藥，某些膳食補(bǔ)充劑，以及很多非處方藥（OTC）的藥物制劑進(jìn)行特殊包裝，其目的是為了保護(hù)公眾免受濫用這些制劑帶來(lái)的人身傷害或疾?。▍⒖?6CFR§1700.14）。TheimmediatepackagingofsubstancesregulatedunderthePPPAmustcomplywiththespecialpackagingstandards(16CFR§1700.15and16CFR§1700.16)andappliestoallpackagingtypesincludingreclosable,nonclosable,andunit-dosetypes.在防毒包裝法案（PPPA）監(jiān)管下，直接接觸藥物的包裝必須符合特殊包裝標(biāo)準(zhǔn)（參考16

CFR

§1700.15

和16

CFR

§1700.16），且適用于包括可重新密封、不可密封和單位劑量類(lèi)型所有包裝類(lèi)型。Specialpackagingisnotrequiredeitherfordrugsdispensedwithinahospitalsettingforinpatientadministrationorbymanufacturersandpackagersofbulk-packagedprescriptiondrugsrepackagedbythepharmacist.PPPA-regulatedprescriptiondrugsmaybedispensedinnonchild-resistantpackagingupontherequestofthepurchaserorwhendirectedinalegitimateprescription(15U.S.C.§1473).無(wú)論是為住院病人管理設(shè)置的醫(yī)院內(nèi)用藥量，還是藥師重新包裝由生產(chǎn)商和包裝商散裝包裝的處方藥都不需要特殊包裝?；诓少?gòu)人的要求，或者當(dāng)一個(gè)合法的處方指導(dǎo)時(shí)，PPPA監(jiān)管的處方藥可能分配到非兒童安全包裝。（參考15

U.S.C.

§1473）ManufacturersorpackagersofPPPA-regulatedOTCpreparationsareallowedtopackageonesizeinnonchild-resistantpackagingaslongaspopular-size,specialpackagesarealsosupplied.Thenonchild-resistantpackagingrequiresspeciallabeling(16CFR§1700.5).允許PPPA監(jiān)管的OTC制劑的生產(chǎn)商或包裝商包裝一個(gè)非兒童安全包裝尺寸，只要這個(gè)尺寸受歡迎，也可以提供特殊包裝。非兒童安全包裝需要特殊標(biāo)簽。（參考16

CFR

§1700.5）Changetoread:STORAGECONDITIONS儲(chǔ)存條件Specificdirectionsarestatedinsomemonographswithrespecttostorageconditions,e.g.,thetemperatureorhumidityatwhichanarticlemustbestoredandshipped.Suchdirectionsapply,exceptwherethelabelonthearticlehasdifferentstorageconditionsthatarebasedonstabilitystudies.Wherenospecificstorageconditionsareprovidedintheindividualmonograph,butthelabelofanarticlestatesstorageconditionsbasedonstabilitystudies,suchlabeledstoragedirectionsapply.USP38在一些專(zhuān)論中對(duì)儲(chǔ)存條件有一些特定的規(guī)定，如藥物儲(chǔ)存和運(yùn)輸必需的溫度和濕度。這些方向的應(yīng)用，除了在藥物的標(biāo)簽上有不同的儲(chǔ)存條件，也建立在穩(wěn)定性研究的基礎(chǔ)上。在專(zhuān)論上沒(méi)有提供特定儲(chǔ)存條件，但是藥物標(biāo)簽上的儲(chǔ)存條件，建在穩(wěn)定性的基礎(chǔ)上，這樣標(biāo)為儲(chǔ)存方向適用。Freezer:Aplaceinwhichthetemperatureismaintainedbetween-25°and-10°(-13°and-14°F).冷凍箱：溫度維持在-25°到-10°之間的地方（-13°和-14°F）。Refrigerator:AcoldUSP38placeinwhichthetemperatureismaintainedbetween2°and8°(36°and46°F).冰箱：溫度維持在2°和8°之間的一個(gè)寒冷的地方（36°和46°F)Cold:Anytemperaturenotexceeding8°(46°F).冷凍：不超過(guò)8°的任意溫度(46°F)。Cool:Anytemperaturebetween8°and15°(46°and59°F).[Note—Anarticleforwhichstorageinacoolplaceisdirectedmay,alternatively,bestoredandshippedasrefrigerated,unlessotherwisespecifiedbytheindividualmonograph.]陰涼：8°和15°(46°和59°F)之間的任意溫度。[注意——儲(chǔ)存陰涼處的藥物直接或者用冰箱儲(chǔ)存或運(yùn)輸。除非專(zhuān)論另有規(guī)定]。Roomtemperature:Thetemperatureprevailinginaworkarea.室溫：一般工作區(qū)域的溫度。Controlledroomtemperature:ThetemperaturemaintainedthermostaticallythatencompassesUSP38attheusualandcustomaryworkingenvironmentof20°–25°(68°–77°F).Thefollowingconditionsalsoapply.控制的室溫：溫度保持自動(dòng)調(diào)溫，包括20°–25°(68°–77°F)的習(xí)慣性工作環(huán)境。下列的條件同樣適用。Meankinetictemperaturenottoexceed25°.USP38Excursionsbetween15°and30°(59°and86°F)thatareexperiencedinpharmacies,hospitals,andwarehouses,andduringshippingareallowed.ProvidedUSP38themeankinetictemperaturedoesnotexceed25°,transientU