Nco tseg 1: Ethylene Oxide sterilization tej yam kev mob yuav tsum tau txais los ntawm validation kev pom zoo thiab yuav tsum tau mus xyuas nrog kev saib xyuas thiab niaj hnub tswj nyob rau hauv txhua txhua sterilization voj voog. Cov kev cai rau kev siv tau thiab kev tswj xyuas niaj hnub tau teev tseg hauv GB 18279.

Lus Cim 2: Txoj kev sim no kuj tseem siv tau rau A chav kawm Ethylene Oxide sterilizers nruab nrog preset Ethylene Oxide sterilization cov kev pab cuam.

E.1 Khoom siv

E.1.1

Plaub txheej txheem sib tw cov cuab yeej yuav tsum tau ua raws li hauv qab no:

• Cov txheej txheem kev sib tw ntaus ntawv muaj lub raj tsis muaj steel hlau thiab ib nrab kaw chamber loaded nrog cov kab mob sib kis. Lub raj steel thiab chamber txuas nrog O-ring seals thiab threaded txuas. Txoj kev mus rau hauv lub chamber nkaus xwb yog los ntawm qhov ntev ntawm lub raj.
• Lub raj ntev yog 4.55 m (nominal), nrog rau sab hauv txoj kab uas hla ntawm 3.0 hli (nominal), muab qhov ntev-rau-qhov sib piv ntawm 1500: 1. Tag nrho cov ntim sab hauv yog kwv yees li 32 mL, ntawm 0.85 mL yog qhov ntim ntawm lub chamber.

E.1.2

Yim lub hnab ntim ntawv-yas uas ua raws li GB/T19633, YY/T0698.4, thiab YY/T0698.5.

E.1.3

Cov kab mob sib kis uas ua raws li GB18281.1 thiab GB18281.2.

E.1.4

Tsim nyog rov qab kab lis kev cai xov xwm rau cov kis kab mob.

E.1.5

Cultivation lauj kaub.

E.2 Cov kauj ruam xeem

E.2.1

Xaiv qhov kev pab cuam kom tsis muaj menyuam Ethylene Oxide los kuaj.

E.2.2

Muab ib tus neeg kis kab mob tso rau hauv chav kuaj ntawm txhua tus txheej txheem kev sib tw ntaus ntawv. Qhwv txhua txoj kev sib tw ntaus ntawv nrog ob lub hnab ntim ntawv-yas, muab txhua lub hnab ntim nrog lub tshuab sealing.

E.2.3

Cov txheej txheem kev sib tw ntaus ntawv tsis xav tau pib tab sis yuav tsum tau khaws cia ntawm 20 ° C ± 5 ° C rau tsawg kawg ib teev ua ntej kuaj.
Nco tseg: Qhov no simulates cov xwm txheej phem tshaj plaws.

E.2.4

Nqa cov Ethylene Oxide sterilizer rau qhov ntsuas kub kom tsis muaj menyuam, thauj khoom plaub txheej txheej txheem sib tw rau hauv Ethylene Oxide sterilizer chamber, thiab pib lub voj voog ntsuas hauv 15 feeb tom qab thauj khoom. Lub sij hawm raug rau cov tshuaj tua kab mob thaum lub sij hawm kuaj yuav tsum yog ib nrab ntawm lub sij hawm teev tseg rau lub voj voog Ethylene Oxide sterilization.

E.2.5

Tom qab lub voj voog kev sim ua tiav, tshem tawm cov txheej txheem kev sib tw los ntawm Ethylene Oxide sterilizer.

E.2.6

Tshem tawm cov kab mob sib kis los ntawm chav kuaj, coj lawv raws li cov chaw tsim khoom cov lus qhia, thiab txheeb xyuas kev ua raws li cov cai ntawm ntu 2.13.

E.2.7

Kab lis kev cai ib tug unexposed contaminated carrier los ntawm tib batch raws li lub khw cov lus qhia; nws yuav tsum tau qhia tias muaj cov kab mob uas siv tau. Yog tias tsis yog, qhov kev sim no suav tias yog qhov tsis raug, thiab rov kuaj dua yuav tsum tau ua.

E.2.8

Rov ua qhov kev sim ob zaug ntxiv.

Yog tias koj xav paub ntau ntxiv txog Ethylene Oxide Sterilization

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