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).

Kev Lag Luam Eto Sterilizer Installation Verification Lub installation ntawm Kev Lag Luam Eto Sterilizer thiab tag nrho cov kev pabcuam cuam tshuam yuav tsum ua raws li cov cai

Cov dej humidification uas siv hauv ETO Sterilization Equipment yuav tsum tsis txhob muaj cov kab mob sib kis, yuav tsum tsis txhob ua kom tsis muaj zog ntawm ETO kom tsis muaj menyuam, thiab yuav tsum tsis txhob ua kom tsis muaj menyuam, cov khoom tsis muaj menyuam, lossis cov khoom thauj. Humidification yuav tsum tau ua los ntawm kev txhaj tshuaj, tsis yog los ntawm kev txhaj tshuaj atomized ncaj qha.

Hangzhou Bocon Mechanical and Electrical Equipment Co., Ltd., feem ntau hu ua HZBOCON, sawv tawm raws li lub chaw tsim khoom siv Ethylene Oxide (EO / ETO) sterilizer. Tsim los ntawm 2006, HZBOCON tau cog lus rau nws tus kheej rau kev tsim, kev tsim kho, thiab kev tsim khoom ntawm EO sterilization khoom, catering rau ntau yam kev lag luam uas yuav tsum tau ua kom tsis muaj menyuam zoo rau cov khoom siv thermosensitive.

PQ yog theem ntawm kev lees paub uas siv Ethylene oxide sterilization chamber los ua kom pom tias Ethylene oxide sterilization cov cuab yeej ua haujlwm tsis tu ncua raws li cov txheej txheem lees paub ua ntej thiab cov txheej txheem yields ib yam khoom uas tsis muaj menyuam thiab ua tau raws li qhov yuav tsum tau ua.

Hauv OQ, kev ua yeeb yam ntawm cov txheej txheem cuam tshuam yuav tsum txiav txim siab thiab software system yuav tsum tau sim los ntawm kev sim ua txhaum cov kev txhaum.

a.Equipment los siv rau hauv cov txheej txheem tsis muaj menyuam, yuav tsum ua raws cov ntaub ntawv tshwj xeeb, cov ntaub ntawv tsim qauv, hluav taws xob schematic daim duab, system schematic daim duab, thiab lwm yam)

Ethylene oxide sterilizer ua haujlwm ntawm qhov kub thiab txias, ua rau lawv zoo tagnrho rau kev ua kom tsis muaj cua sov thiab cov cuab yeej siv kho mob. Cov yam ntxwv no tso cai rau kev khaws cia ntawm kev ncaj ncees thiab kev ua haujlwm ntawm cov cuab yeej kho mob nyuaj uas yuav raug puas los ntawm cua sov.

Kev tiv thaiv kev tiv thaiv thiab kev piav qhia ntawm ETO Sterilizer System 2. Los ntawm lub neej ntawd, lub kaw lus yuav ua qhov kev kuaj pom ua ntej

1.Lub hom phiaj rau validation eto sterilization 1.1.the tau ntawm eto sterilization validation pov thawj tias cov cuab yeej siv rau ETO sterilization tau