Cov lus teb luv luv: phim cov ntaub so rau qhov kev pheej hmoo ntawm cheeb tsam, ua ke nrog cov tshuaj tua kab mob uas siv tau, thiab quav nws kom txhua qhov hla siv qhov chaw tshiab. So nyob rau hauv overlapping, unidirectional strokes los ntawm kev huv mus rau qias neeg, ua kom qhov chaw ntub dej rau lub sij hawm sib cuag, thiab ua pov thawj qhov tshwm sim nrog kev saib xyuas ib puag ncig. Ib lub sterile so yog sterile nkaus xwb nyob rau hauv nws tus kheej. Nws tsis sterilize qhov nws kov. Ua kom raug, cov ntaub so tshem tawm cov kab mob; ua carelessly, nws kis nws.
Yog vim li cas "Sterile" tsuas yog ib feem ntawm zaj dab neeg
TS EN ISO 14644-1 Kev faib cov chav huv huv los ntawm cov pa hauv huab cua. Ntawm 0.5 µm thiab loj dua, ISO 5 tso cai rau 3,520 hais ib cubic meter, ISO 6 tso cai rau 35,200, ISO 7 tso cai 352,000, thiab ISO 8 tso cai 3,520,000. Cov kev txwv no piav qhia txog huab cua, thiab kev tu saum npoo yog qhov koj tiv thaiv lawv li cas.
Peb cov khoom feem ntau tsis meej pem:
Tsis muaj menyuamtxhais tau hais tias cov ntaub so nqa tsis muaj microbes siv tau, feem ntau los ntawm validated irradiation ntawm sterility assurance qib ntawm 10⁻⁶.
Tsawg-particletxhais tau tias nws tso ob peb fibers thiab tawm me ntsis extractable residue.
Tshuaj tua kab moblos ntawm chemistry ntawm cov ntaub so thiab lub sijhawm sib cuag, tsis yog los ntawm cov ntaub.
Ib daim ntaub so tuaj yeem ua rau tsis muaj menyuam thiab tseem tso tawm, lossis tsis muaj menyuam thiab tseem yuav saturated nrog tus neeg sawv cev tsis raug. Nyeem daim ntawv lo raws li "qhov chaw no yuav huv si" yog qhov teeb meem feem ntau pib.
Xaiv Txoj Cai So rau Thaj Chaw
Pib los ntawm koj lub tswv yim tswj kev sib kis, tsis yog phau ntawv teev npe. Nug thaj tsam twg koj tab tom tu, qhov twg cov kab mob ua rau koj txhawj xeeb tshaj plaws, qhov chaw twg yog tsim los ntawm, thiab cov tshuaj tua kab mob twg raug siv rau nws. Tom qab ntawd txheeb xyuas cov ntaub ntawv pov thawj ntawm tus neeg muag khoom: cov ntaub ntawv thiab cov ntaub ntawv rho tawm, ntau cov ntaub ntawv pov thawj, daim ntawv pov thawj tsis muaj menyuam, lub hnab - cov txiaj ntsig kev ncaj ncees, thiab kev cog lus kom ceeb toom koj txog kev hloov pauv. Tus nqi ib so tseem ceeb tsawg dua tus nqi ntawm ib qho kev mus ncig ua si.
Qee qhov chaw tseem xav tau cov ntaub so ua nyob ib puag ncig lawv tus kheej cov txheej txheem, xws li qhov loj me, ntug foob, saturant, lossis ntau - txheej ntim rau kev hloov pauv. Lub chaw tsim khoom huv huv xws li WestonWiper, uas txhawb nqa ob qho haujlwm OEM thiab ODM, tuaj yeem kho cov ntsiab lus no. Pairing ibISO Class 5–8 Cleanroom Sorau thaj chaw keeb kwm yav dhau nrog aSterile Cleanroom Sorau cov kev cuam tshuam tseem ceeb yog ib txoj hauv kev ua kom haum rau qib thiab tsis muaj menyuam rau txhua cheeb tsam es tsis txhob them tus menyuam tsis muaj menyuam nyob txhua qhov chaw.
Technique: Cov kauj ruam thiab yog vim li cas
Txhua txoj cai hauv qab no muaj rau kev siv tshuab lossis microbiological vim li cas. Cov neeg khiav dej num ua raws li txoj kev ntseeg siab dua thaum lawv nkag siab vim li cas.
Npaj.Txheeb xyuas qhov ntau, hnub tas sij hawm, thiab lub hnab ruaj khov, thiab ntxuav cov hnab looj tes. Npaj koj txoj kev kom koj tsis txhob hla qhov chaw uas huv si tshiab.
Hloov hauv.Tshem tawm lossis tua kab mob cov hnab sab nraud ntawm qhov hla dhau - dhau. Cov txheej txheej sab nraud yeej tsis nkag mus rau ISO 5, vim tias lawv tau raug qis dua - qib huab cua.
Quav.Ib lub quarter fold muab rau koj ob peb lub ntsej muag huv si thiab lub ncoo tswj uas ua kom cov npoo xoob los ntawm kev rub hla saum npoo.
So nyob rau hauv ncaj, overlapping strokes.Vajvoog scrubbing redistributes particles, thiab overlap tiv thaiv tsis tau strips.
Ua haujlwm huv kom qias neeg, sab saum toj mus rau hauv qab, rov qab mus rau pem hauv ntej, nrog rau cov cua ntws.Cov khoom poob thiab taug kev nrog huab cua, yog li koj tsis txhob rov- tej thaj chaw uas koj tau ntxuav lawm.
Siv lub ntsej muag tshiab rau txhua qhov hla.Tsis txhob rov-dip lossis rov siv lub ntsej muag. Lub ntsej muag loaded tso dab tsi nws tau sau.
Saib xyuas lub sijhawm sib cuag.Khaws qhov chaw kom pom kev ntub dej rau lub sijhawm siv tau, thiab rov- ntub yog tias nws qhuav ntxov. Disinfection tshwm sim thaum sib cuag, tsis yog thaum so.
Tshem cov residue qhov xav tau.Tom qab tus neeg sawv cev sporicidal, ua raws li cov dej tsis muaj menyuam-rau- txhaj tshuaj lossis IPA so- cia rau ntawm cov khoom- tiv tauj lossis corrosion- qhov chaw yooj yim.
Tshem tawm thiab ua ntaub ntawv.Muab pov tseg cov ntaub so siv tam sim, rov ntim cov pob khoom, saib hauv - siv sijhawm txwv, thiab sau cov haujlwm.
Dab tsi hloov ntawm ISO 5 rau ISO 8
Cov txheej txheem nyob ib yam ntawm cov qib. Qhov kev hloov pauv dab tsi yog qhov kev pheej hmoo txhua cheeb tsam yog, thiab yog li ntawd cov ntaub so thiab kev qhuab qhia nyob ib puag ncig nws.
HauvISO 5, sterile wipes yog tus qauv. Qhov tseem ceeb tshaj plaws yog kev txav me me, tiv thaiv huab cua thawj zaug, thiab so ntawm kev cuam tshuam ntau dua li ntawm lub sijhawm xoob. HauvISO 6 thiab 7, cov ntaub so tsis muaj menyuam feem ntau yog siv hauv thaj chaw aseptic. Cov kev pheej hmoo tseem ceeb yog hla - tsheb khiav, hla- los ntawm kev hloov tsheb, thiab cov khoom seem tsim - nce, yog li teem caij ntxuav cov phiaj xwm thiab tshuaj tua kab mob sib hloov tseem ceeb tshaj plaws. HauvISO 8, low-cov ntaub ntawv tsis muaj- cov ntaub so tsis muaj menyuam feem ntau tau txais, tab sis cov ntaub so tsis huv ua kom tsim nyog nyob qhov twg hauv chav tsev cuam tshuam nrog qib siab dua lossis kev ntsuas kev pheej hmoo hais tias yog li ntawd. Kho ISO 8 raws li thawj kab ntawm kev tiv thaiv, tsis yog thaj chaw so, vim tias kev ua tsis tiav ntawm kev sib tshuam nkag mus rau sab hauv.
Cov no yog cov qauv tsim. Koj tus kheej lub tswv yim tswj kev sib kis thiab cov kev cai uas siv rau koj txiav txim siab cov lus teb kawg.
Chemistry thiab sijhawm sib cuag
Ib qho tshuaj 70% IPA feem ntau ua tau zoo dua tiv thaiv cov kab mob vegetative tshaj 100% IPA, vim tias cov dej pab cov denature proteins. IPA tsis yog sporicidal, yog li nws tawm qhov sib txawv. EU GMP Annex 1 xav kom muaj tus neeg sawv cev sporicidal siv ib ntus thiab cov tshuaj tua kab mob yuav tsum tau tig los yog tsim nyog. Hydrogen peroxide, peracetic acid, thiab hypochlorite tag nrho muaj cov tshuaj tua kab mob, tab sis txhua qhov kev lag luam tawm tawm tsam corrosion, residue, thiab tus neeg teb xov tooj raug.
Cov ntawv thov kev ua tau zoo los ntawm lub chaw kuaj mob tsis tuaj yeem siv rau hauv koj lub tsev, phab ntsa, lossis cov hlau tsis muaj steel. Tsim nyog cov tshuaj tua kab mob ntawm daim coupon ntawm koj tus kheej cov ntaub ntawv nto. Kuj tseem ceeb rau kev nyab xeeb: IPA yog nplaim taws, yog li qhov cua thiab qhov hluav taws xob muaj teeb meem, thiab qee cov yas raug kev nyuaj siab tawg ntawm qhov raug rov qab.
Feem ntau yuam kev
- Kho "sterile so" li "sterile nto."Qhov no ua rau muaj kev ntseeg cuav thiab ua rau lwm tus tswj tsis tau.
- Scrubbing nyuaj dua.Aggressive scrubbing lifts thiab redistributes particles thiab tuaj yeem ua kom puas qhov chaw.
- Siv ib daim ntaub so rau tag nrho chav.Cov ntaub so ua ib lub tsheb rau kev sib kis flora.
- Cia qhov chaw qhuav sai sai.Yog tias lub sijhawm sib cuag tsis tau ntsib, cov kab mob tseem nyob.
- Cia cov pob qhib ntev dhau lawm.Evaporation hloov saturant concentration thiab nthuav tawm cov ntsiab lus.
- Sib tov so thiab tshuaj tua kab mob yam tsis muaj kev txheeb xyuas kev sib raug zoo.Qhov tshwm sim tuaj yeem yog residue, degradation, lossis tso tawm fiber ntau.
Ua pov thawj Nws ua haujlwm
Kev ntxuav uas tsis tuaj yeem ua qauv qhia tsuas yog kev cai dab qhuas xwb. Kev saib xyuas ib puag ncig muab cov pov thawj rau koj: tsis yog- suav cov khoom siv tau, kho cov phaj, thiab daim hlau tiv tauj, txhua qhov sib txawv tiv thaiv kev ceeb toom thiab qib ua haujlwm. Siv cov tshuaj nruab nrab hauv daim hlau tiv tauj kom cov tshuaj tua kab mob seem tsis npog cov suav tiag.
Thaum ib qho kev mus ncig tshwm sim, teeb meem hauv qhov kev txiav txim siab. Thawj cov txheej txheem tshuaj xyuas thiab kev cob qhia tus neeg ua haujlwm. Tom qab ntawd xyuas cov ntaub so ntau thiab lub hnab kom zoo, ua raws li cov tshuaj tua kab mob thiab lub sijhawm sib cuag. Thaum kawg, siv lub cev profile raws li qhov tseeb. Tib neeg flora taw qhia rau kev hnav khaub ncaws lossis cov txheej txheem, spore- cov neeg ua haujlwm taw qhia rau qhov sib txawv ntawm sporicide, thiab fungi taw tes rau cov khoom lossis cov av noo. Kaw lub voj nrog kev kho kom raug thiab hloov kho SOP yog li txhua kauj ruam piav qhia nws vim li cas.
Los ntawm Ritual mus rau Validated Control
Lub hom phiaj tsis yog los so ntau, tab sis so hauv ib txoj kev uas koj tuaj yeem piav qhia, rov ua dua, thiab ua pov thawj. Xaiv los ntawm kev pheej hmoo, siv ib txoj hauv kev uas tshem tawm cov kab mob tsis txhob txav mus los, txhawb nqa nws nrog txoj cai chemistry thiab lub sijhawm tiv tauj, thiab xyuas nws nrog cov ntaub ntawv. Ua qhov no tsis tu ncua nyob rau hauv ISO Class 5-8 ib puag ncig thiab cov ntaub so dhau los ua cov cuab yeej tswj tsis yog qhov sib txawv zais.
