动态英文

动态英文

旅游业发展现状-动物世界真奇妙

2023年2月21日发(作者：初三记叙文)

SOPonusageofDynamicpassbox（动态传递窗

使用操作程序）

PostedBy:PharmaceuticalGuidanaceon:August18,2016In:Production,SOPNo

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Objective:TolaydownaprocedureonusageofDynamicpassbox.

Scope:

ThisSOPisapplicableforusageofDynamicpassboxinformulation

plantofpharmaceuticalcompany.

Responsibility:

ProductionOfficer/Executiveshallberesponsibleforfollowthe

procedurementionedinthisSOP.

Accountability责任:

ProductionHeadandQAHeadshallbeaccountableforcomplianceof

SOP.生产主管和质量保证负责人应对SOP的遵守情况负责

Procedure程序:

Theusageofdynamicpassboxesdependonareainwhich

installed,namicpassboxesasperrespectiveaseptic

areaisdescribedherein动态传递箱的使用取决于安装的区域，例如。本文

描述了四个按无菌区划分的动态通箱。:

DynamicPassBox(01)–Itisusedformaterialtransferfrom

lowingitemsusedinaseptic

（无菌的）areaaretransferredthroughDynamicPassBox:

Goggles（护目镜）,MediaPlates（介质板）,SamplingAids（艾滋病毒样

品）,Aspirator（吸液器）Containerwithhosepipe（橡胶软管）,Pre-filters

（初效过滤器）ofLaminarAirFlow（层流）,Disinfectant(消毒剂）spray

bottles（喷壶）,PAOapparatus（仪器）,particlecounter（粒子计数器）,

Filterintegritytestapparatus（过滤器完整性测试装置）,weighing

balance（称重天平）,markerpen（记号笔）,airsampler（空气取样器）,

toolbox（工具箱）.AnyotheritemtobeusedinsideAseptic[ˌeɪˈseptɪk]

area（无菌区）istobetransferredaftertakingpermissionofthe

Productionofficer.

DynamicPassBox(02)–Itisusedfortransferofmaterialfrom

coolingzonetovialfillingroom（小瓶灌装室）.Thefollowingitemsused

inasepticareaaretransferredthroughDynamicPassBox:

MediaPlates,SamplingAids,AspiratorContainerwithhosepipe（带

软管的吸入器容器）,Pre-filtersofLaminarAirFlow（层流预滤器）,

Disinfectantspraybottles（消毒喷雾瓶）,PAOapparatus,particle

counter,Filterintegritytestapparatus,weighingbalance,marker

pen,airsampler,toolbox,fillingandbungingmachinechangeparts

（灌装机械换件）.AnyotheritemtobeusedinsideAsepticareaistobe

transferredaftertakingpermissionoftheProductionofficer.

DynamicPassBox(03)–Itisusedfortransferofsanitized（清洁）

Aluminumseals（铝密封件）,sealingmachinechangeparts（封口机换

件）,MediaPlatesandSamplingAids,Pre-filtersofLaminarAirFlow,

Disinfectantspraybottles,PAOapparatus,markerpen,airsampler

eritemtobetransferredonlyaftertaking

permissionoftheProductionofficer.

DynamicPassBox(04)–Itisusedfortransferofsterileraw（生的，未

加工的）materialcontainer（无菌原料容器）,samplingaidsfromIRM

（Intermediaterawmaterial中间品）

otheritemtobeusedinsideAsepticareaistobetransferredafter

takingpermissionoftheProductionofficer.

OperationofDynamicPassBox(01)

EnsurethatthepowersuppliesofDynamicpassboxareconnected.

Cleanandsanitizetheentiredynamicpassboxfromasepticareaside

withlintfreeduster(无绒抹布）soakedin70percentIsopropylAlcohol

（异丙醇）.

Ensurethatnomaterialispresentinthepassboxandboththedoors

ofpassboxareclosed.

SwitchONthepassboxfromtheelectricboardandCheckthatthe

Ultravioletlightisproperlyworking

Checkthatinterlocking（联锁的）ofdoorisproperlyworking.

SwitchONfromtheMains（总控）tostarttheblowerofpassboxand

checkthereadingonmegnehelicgauge（压差计）.Itshouldbewithin

rangeof8mmto15mmofwater.

Cleanandsanitizetheitemtobetransferredwithlintfreeduster

soakedin20%VirosilPharma（？）.



theitemstobetransferredtoasepticareaandclosethedoor.

KeeptheitemstobetransferredunderUVlightinsidethepassboxfor

atleast30minutes.

Inform（通知）thepersonontheothersideforunloadingtheitems

inasepticarea.

Openthedoorofdynamicpassboxfromasepticareaside,unloadthe

itemsandclosethedoor.

OperationofDynamicPassBox（02）

EnsurethatthepowersuppliesofDynamicpassboxareconnected.

Cleanandsanitizetheentiredynamicpassboxfromcoolingzoneand

vial（小瓶）fillingroomsidewithlintfreedustersoakedin70percent

IsopropylAlcohol.

Ensurethatnomaterialispresentinthepassboxandboththedoor

ofpassboxareclosed.

SwitchONfromtheelectricboardandCheckthattheUltraviolet

lightofDynamicpassboxisworkingproperly.

Checktheinterlockingofdoorisproperlyworking

SwitchONfromtheMainstostarttheblowerofpassboxandcheck

ldbewithinrangeof8mm

to15mmofwater.

eitems

tobetransferredtoasepticareaandclosethedoor.

Informthepersonontheothersideforunloadingtheitemsinvial

fillingroom.

Forunloadingtheiteminvialfillingroomopenthedoorandunload

hedoorimmediatelyafterunloading.

Transfertheitemstotheirrespective（各自的）storageplacesinvial

fillingroom.

OperationofDynamicPassBox(03)

EnsurethatthepowersuppliesofDynamicpassboxareconnected.

Cleanandsanitizetheentiredynamicpassboxfromvialsealingroom

（小瓶密封室）sideandcorridor（腐蚀性）sidewithlintfreeduster

soakedin70percentIsopropylAlcohol.

Ensurethatnomaterialpresentinthepassboxandboththedoorof

passboxareclosed.

SwitchONfromtheelectricboardandCheckthattheUltraviolet

lightofDynamicpassboxisproperlyworking.

Checktheinterlockingofdoorisproperlyworking.

SwitchONfromtheMainstostarttheblowerofpassboxandcheck

ldbewithinrangeof8mm

to15mmofwater.

Openthedoorofdynamicpassboxfromcorridorsideandloadthe

itemstobetransferredtovialsealingroomandclosethedoor.

KeeptheitemstobetransferredunderUVlightinsidethepassboxfor

atleast30minutes.

Informthepersonontheothersideforunloadingtheitemsinvial

sealingroom.

Openthedoorofdynamicpassboxfromvialsealingroom,unloadthe

items,andclosethedoor.

OperationofPassBox[04]

EnsurethatthepowersuppliesofDynamicpassboxareconnected.

CleanandsanitizetheentiredynamicpassboxfromIRM

（Intermediaterawmaterial中间品）storesideandsamplingroom

sidewithlintfreedustersoakedin70percentIsopropylAlcohol.

Ensurethatnomaterialpresentinthepassboxandboththedoorof

passboxareclosed.

SwitchONfromtheelectricboardandCheckthattheUltraviolet

lightofDynamicpassboxisproperlyworking.

Checktheinterlockingofdoorisproperlyworking.

SwitchONtheMainstostarttheblowerofpassboxandcheckthe

readingofmegnehelicgaugeshouldbewithinrange.

CleanandsanitizetheoutersurfaceofRawmaterialcontainertobe

transferredwithlintfreedustersoakedin20percentVirosilPharma.

OpenthedoorofdynamicpassboxfromIRMstoresideandloadthe

sterilerawmaterialcontainertobetransferredtosamplingroom

andclosethedoor.

KeepthecontainerstobetransferredunderUVlightinsidethepass

boxforatleast30minutes.

Informthepersonontheothersideforunloadingtheitemsin

samplingroom.

Openthedoorofdynamicpassboxfromsamplingroomsideand

unloadthecontainers.

Immediatelyclosethedoorsafterunloadingthecontainers.

Recordthedetailsofitemstransferredthroughdynamicpassboxin

checklist（核对表）formaterialtransferredthroughdynamicpassbox.

RecordthedetailsofUVlightburningintheformat（格式单）for

sspecimenattachedwithAnnexure-I（格

式见附件1）.

Recordthereadingsofdifferentialpressureintheformatfor

differentialpressuremonitoring（监视）record.

ListofAnnexure/Format（附件/格式清单）

s-Annexure-I

Reasonforrevision（修订）

NewSOP.

Abbreviations（缩写）

IPA:Isopropylalcohol

IRM:Intermediaterawmaterial（中间品）

UV:UltraViolet

Annexure-I（附件1）