3.4.1.1 Kev tsim cov txheej txheem sib tw Devices (PCD)
Lub Txheej Txheem Sib Tw Ntaus Ntaus (PCD) yog qhov kev sib tw microbiological siv los ntsuas qhov tua tus nqi ntawm cov txheej txheem xaiv. Nws feem ntau yog ib lub cuab yeej lossis cov ntawv xeem uas muaj cov cim qhia txog kev lom neeg (xws li, Bacillus atrophaeus spores nrog paub suav suav). Kev ua haujlwm ntawm PCD rau cov txheej txheem kom tsis muaj menyuam yuav tsum muaj ntau dua lossis sib npaug ntawm qhov tsis kam ntawm cov khoom siv microbial nyob rau hauv qhov nyuaj tshaj plaws-rau-sterilize cheeb tsam ntawm cov khoom. Qhov ntau ntawm PCDs yuav tsum ua kom tau raws li qhov yuav tsum tau teev tseg hauv Table C.3 ntawm Cov Ntawv Ntxiv C hauv GB18279.1-2015. PCDs raug faib ua Internal PCDs (IPCD) thiab External PCDs (EPCDs).
a) Internal PCD (IPCD) Production
Internal PCDs feem ntau yog cov khoom siv kho mob xaiv los ntawm lub tuam txhab los sawv cev rau tsev neeg cov khoom. Raws li kev tsim thiab cov khoom muaj pes tsawg leeg, cov khoom no yog suav tias yog qee qhov nyuaj tshaj plaws kom tsis muaj menyuam. Cov cim qhia txog kab mob lom (BI) tau muab tso rau ntawm qhov nyuaj tshaj plaws-rau-sterilize txoj haujlwm ntawm cov khoom, kom ntseeg tau tias cov txheej txheem sterilization tsis thaiv cov channel lossis cuam tshuam rau cov khoom tsim.
Muab qhov taw qhia txog kab mob lom (BI) nyob rau hauv qhov nyuaj tshaj plaws-rau-sterilize cheeb tsam ntawm cov khoom, los yog inoculate cov kab mob kuaj kab mob (xws li, Bacillus atrophaeus) nyob rau hauv qhov chaw nrog rau cov feem ntau nyuaj-rau-ua kom tsis muaj menyuam tej yam kev mob.Yog hais tias tus BI los yog kuaj. Cov kab mob tsis tuaj yeem muab tso rau ntawm qhov nyuaj tshaj plaws-rau-ua kom tsis muaj menyuam, lwm yam khoom siv tuaj yeem tsim thiab muab tso rau hauv lub cev tsis muaj menyuam, kom ntseeg tau tias nws muaj tib yam tsis kam raws li qhov nyuaj tshaj plaws-rau-sterilize qhov chaw hauv cov khoom.
Feem ntau IPCDs suav nrog, tab sis tsis txwv rau:
Muab cov kab mob sib kis ntawm cov khoom xws li cov nplhaib, lub taub hau piston, cov tshuab ntxhua khaub ncaws, lossis cov syringe piston. Muab cov kab mob sib tw rau hauv nruab nrab ntawm lub catheter lumen, tom qab ntawd siv cov kua nplaum nplaum los yog cov khoom sib txuas los kho cov catheter thiab kho cov khoom kom zoo. kev sib tw ntawm lub piston interface.
b) Sab Nraud PCD (EPCD) Ntau lawm
Cov PCDs sab nraud tau muab tso rau sab nraud ntawm cov khoom thauj khoom. EPCDs feem ntau yog siv rau kev ua haujlwm niaj hnub thiab raug muab los ntawm kev thauj khoom tom qab kho. Kev tiv thaiv ntawm EPCD rau cov khoom siv roj ntsha ntawm cov khoom tsis huv yuav tsum tau muab piv nrog IPCD qhov tsis kam. EPCD tseem yuav tsum sawv cev rau qhov nyuaj tshaj plaws-rau-sterilize cov khoom nyob rau hauv lub load.
Kev sib raug zoo ntawm EPCDs thiab cov qauv kuaj cov khoom tsis huv yuav tsum tau tshuaj xyuas ib ntus kom ntseeg tau tias tsis muaj kev hloov pauv tau tshwm sim hauv cov khoom siv kom tsis muaj menyuam thiab cov EPCD tseem sawv cev rau cov khoom nyuaj tshaj plaws-rau-sterilize hauv cov khoom thauj.
Thaum muab BI rau hauv PCD, PCD yuav tsum muaj tsawg kawg yog qhov kev tiv thaiv ib yam li qhov nyuaj tshaj plaws-rau-sterilize qhov chaw hauv cov khoom.
Feem ntau EPCDs suav nrog, tab sis tsis txwv rau:
Muab qhov taw qhia txog roj ntsha (BI) rau hauv cov khoom ntim khoom lossis sib npaug, xws li hnab yas, uas tom qab ntawd muab tso rau hauv lub hnab ntawv Manila.Tau qhov taw qhia txog roj ntsha hauv lub hnab yas tuab uas tau muab ntim rau ib lub sijhawm teev.Placing qhov taw qhia txog roj ntsha. nyob rau hauv ntau qhov chaw ntawm lub syringe, xws li nyob rau hauv lub piston ntxhua khaub ncaws los yog lub taub hau piston.Sealed yas raj uas muaj kab mob, nrog los yog tsis muaj ntxiv ntim.
PCDs ua raws li cov lus saum toj no tau ntim siv tib txoj kev raws li cov khoom tsim tawm ib txwm muaj, muab faib sib npaug hauv cov khoom thauj khoom, thiab muab tso rau los npog qhov chaw txias hauv chav sterilizer.
3.4.1.2 Ib nrab voj voog (Short Cycle) Testing
Tom qab xaiv PCD, nws qhov tsim nyog tau lees paub los ntawm kev khiav ib feem ntawm lub voj voog. Txoj kev ntsuam xyuas yog raws li nram no:
a) Txiav txim siab txoj hauv kev tso rau PCDs, kuaj cov qauv, thiab cov ntsuas ntsuas raws li cov txiaj ntsig ntawm kev ntsuas kev ua haujlwm. Tus naj npawb thiab kev faib tawm ntawm PCDs yuav tsum txaus. Yog tias EPCD xaiv tau siv rau kev saib xyuas cov txheej txheem kom tsis muaj menyuam, nws yuav tsum muab tso rau ntawm cov khoom thauj raws li txoj kev npaj thiab txheej txheem.
b) Raws li tus nqi D, ST lub sij hawm, thiab KT lub sij hawm ntawm qhov taw qhia lom neeg, teem caij luv luv. Lwm qhov kev ntsuas yuav tsum tau sim ntawm qhov txwv qis ntawm cov txheej txheem ua kom tsis muaj menyuam tsis tu ncua. Txoj kev xeem yuav tsum xa mus rau Cov Ntawv Ntxiv A ntawm GB18281.2. Tom qab lub sij hawm raug lawm, tshem tawm cov khoom, IPCD, thiab EPCD rau microbial cultivation thiab soj ntsuam cov txiaj ntsig.
Cov txiaj ntsig kev cog qoob loo yuav tsum qhia tias qhov kev tiv thaiv ntawm PCD yog ntau dua lossis sib npaug ntawm cov khoom siv roj ntsha tsis zoo ntawm qhov nyuaj tshaj plaws-rau-sterilize qhov chaw hauv cov khoom:
IPCD thiab EPCD yuav tsum muaj qee qhov tsis zoo; tag nrho qhov tsis zoo los yog tag nrho cov txiaj ntsig zoo yuav qhia tau tias qhov kev xeem tsis ua haujlwm.Qhov kev tiv thaiv ntawm IPCD yuav tsum ntau dua li cov khoom, thiab qhov kev tiv thaiv ntawm EPCD yuav tsum ntau dua lossis sib npaug ntawm IPCD.
Yog tias cov txiaj ntsig tsis tau raws li qhov xav tau, tshawb xyuas qhov laj thawj. Feem ntau, kev hloov kho rau PCD tsis kam lossis tsis muaj kev ua kom tsis muaj menyuam yuav tsum tau ua, ua raws li kev sim rov qab kom txog thaum cov txiaj ntsig tau ua raws li kev cia siab. Yog tias tag nrho peb (cov khoom lag luam, IPCD, thiab EPCD) qhia tias tsis muaj kev loj hlob ntawm cov kab mob microbial, txo lub sijhawm EO raug tsim nyog thiab sim dua. Yog tias txhua yam qhia txog kev loj hlob ntawm cov kab mob microbial, nce EO lub sij hawm raug thiab rov kuaj dua.
3.4.1.3 Ib nrab-Cycle Test
Tom qab ua tiav qhov kev xeem luv luv, khiav peb qhov kev xeem ib nrab-lub voj voog sib law liag los ua kom pom qhov ua tau zoo (SAL = 10^-6) thiab rov tsim dua ntawm EO sterilization txheej txheem. Txoj kev ntsuam xyuas yog raws li nram no:
Teem lub cim qhia txog kev ua kom tsis muaj menyuam raws li tus qauv, thiab teeb tsa lwm yam kev ua kom tsis muaj menyuam rau qhov kev txwv qis ntawm kev ua kom tsis muaj menyuam tsis tu ncua (piv txwv li, kev kho mob ua ntej hloov mus rau hauv qhov teev tseg). Maj mam txo lub sij hawm ua kom tsis muaj menyuam ib nrab ntawm qhov pib ua kom tsis muaj menyuam thiab tshem tawm cov cim qhia txog roj ntsha los ntawm PCD tom qab lub sijhawm ua kom tsis muaj menyuam sib txawv. Cog lawv nyob rau hauv ib qho chaw tsis muaj menyuam kom txog thaum muaj menyuam tsis taus. Lub sijhawm ua kom tsis muaj menyuam luv tshaj plaws (lub sijhawm tseem ceeb) yog li txiav txim siab yuav yog lub sijhawm ib nrab ntawm lub voj voog, thiab tsawg kawg yog ob qhov kev sim ntxiv yuav tsum tau ua nrog tib lub sijhawm luv tshaj.
Tag nrho peb qhov kev ntsuam xyuas yuav tsum ua kom pom qhov ua tiav ntawm tag nrho cov kev ntsuas kev lom neeg (piv txwv li suav tsis pub tsawg dua 1 × 10^6) kom paub meej tias qhov tsawg kawg nkaus EO raug siv sijhawm. Lub sij hawm raug nyob rau hauv cov txheej txheem sterilization niaj hnub yuav tsum yog tsawg kawg ob zaug lub sij hawm tsawg kawg no.
Cov cim qhia txog kev cog qoob loo yuav tsum qhia tag nrho IPCDs thiab EPCDs tsis zoo. Yog tias qhov kev ntsuas luv luv qhia tau tias EPCD qhov kev tiv thaiv ntau dua li ntawm IPCD, EPCD yuav pom qhov zoo ib nrab.
Yog tias cov txiaj ntsig tsis tau raws li qhov kev cia siab, tshawb xyuas qhov laj thawj thiab feem ntau kho cov kev ua kom tsis muaj menyuam ua ntej rov sim dua kom txog thaum cov txiaj ntsig tau ua raws li qhov kev cia siab.
Piv txwv:
Xav tias thawj ib nrab-lub voj voog ua kom tsis muaj menyuam lub sijhawm yog 4 teev. Yog tias tsis muaj menyuam, txo lub sijhawm kis mus rau 2 teev rau kev sim tom ntej; yog tias microbial loj hlob tuaj, nce lub sij hawm raug raws li 4-teev raug.
Xav tias qhov thib ob ib nrab-lub voj voog ua kom tsis muaj menyuam lub sijhawm yog 2 teev. Yog tias tsis muaj menyuam, txo lub sijhawm kis mus rau 1 teev rau kev sim tom ntej; yog tias microbial loj hlob tuaj, ncua lub sij hawm raug rau 3 teev.
Xav tias peb lub sijhawm ua kom tsis muaj menyuam ib nrab yog 3 teev. Yog tias tsis muaj menyuam, rov ua qhov kev sim 3-teev ob zaug. Yog tias tag nrho cov txiaj ntsig tsis muaj menyuam, lees paub 3 teev raws li lub sijhawm ua haujlwm yam tsawg kawg nkaus. Yog tias qhov kev loj hlob ntawm microbial tshwm sim, rov kuaj dua nrog 4-teev raug, thiab yog tias tag nrho cov txiaj ntsig tsis muaj menyuam, lees paub 4 teev raws li lub sijhawm ua haujlwm yam tsawg kawg nkaus.
3.4.1.4 Kev Ntsuas Tag Nrho
Thaum lub sij hawm tag nrho kev ntsuas, teem lub sij hawm EO raug rau ob zaug ntawm ib nrab-lub voj voog yam tsawg kawg nkaus lub sij hawm ua tau zoo, thiab lwm yam tsis mus rau lub sab sauv txwv tsis pub ua kom tsis muaj menyuam tsis tu ncua los xyuas qhov kev ntseeg tau thiab rov tsim dua ntawm cov txheej txheem sterilization.
Tus naj npawb ntawm cov ntsuas kub thiab cov av noo siv yuav tsum ua tau raws li qhov yuav tsum tau muaj ntawm Cov Ntawv Ntxiv C hauv GB18279.1, sib npaug sib npaug hauv cov khoom siv kom tsis muaj menyuam. Qhov ntsuas kub ntsuas qhov ntsuas qhov ntsuas kub yuav tsum suav nrog ob qho tib si txias thiab kub qhov chaw nyob rau hauv lub sterilizer chamber thaum lub sij hawm ua hauj lwm Qualification (OQ).
Tom qab kev sim, cov txiaj ntsig ntawm kev cog qoob loo ntawm cov khoom thiab EPCD yuav tsum ua kom pom kev ua kom tsis muaj menyuam tiav (tag nrho qhov tsis zoo).
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| TS EN ISO 11135: 2014 | Sterilization ntawm cov khoom kho mob - Ethylene oxide - Cov kev xav tau rau kev txhim kho, kev siv tau thiab niaj hnub tswj kev ua kom tsis muaj menyuam rau cov khoom siv kho mob |
|---|---|
| ISO 14161: 2009 | Sterilization ntawm cov khoom kho mob - Cov cim qhia txog kev lom neeg - Kev taw qhia rau kev xaiv, siv thiab txhais cov txiaj ntsig |
| ISO 10993-7: 2008 | Kev soj ntsuam lom ntawm cov cuab yeej kho mob - Ntu 7: Ethylene oxide sterilization residuals |
| ISO 11737-1: 2018 | Sterilization ntawm cov khoom kho mob - Cov txheej txheem microbiological - Ntu 1: Kev txiav txim siab ntawm cov pej xeem ntawm cov kab mob ntawm cov khoom |
| ISO 11737-2: 2009 | Sterilization ntawm cov cuab yeej kho mob - Cov txheej txheem microbiological - Ntu 2: Kev ntsuas kev ua kom tsis muaj menyuam ua nyob rau hauv lub ntsiab lus, kev siv tau thiab kev saib xyuas cov txheej txheem kom tsis muaj menyuam |
| TIM 16:2017 | Microbiological yam ntawm ethylene oxide sterilization |