1.Lub hom phiaj rau validation thiab sterilization
1.1.the tau txais cov ntaub ntawv pov thawj ntawm eto sterilization validation uas cov cuab yeej siv rau ETO sterilization tau muab thiab ntsia raws li nws cov specification thiab muaj peev xwm ruaj khov nyob rau hauv predetermined txwv thiab tsis tu ncua ua raws li cov txheej txheem predetermined thiab yog li yields khoom raws li nws specification.
1.2
Qhov no qhia meej txog cov kev cai rau kev txhim kho, kev siv tau thiab kev tswj hwm niaj hnub ntawm ETO sterilization txheej txheem thiab muab kev taw qhia rau nws kom ua raws li cov kev cai tswj hwm xws li ISO 11135.
2. Scope
2.1.Cov cuab yeej siv hauv ETO kom tsis muaj menyuam (chav ua ntej?Sterilizer?Aeration room?Incubator, thiab lwm yam).
3. Cov ntsiab lus thiab cov lus txhais
3.1. IQ Ib
Installation kev tsim nyog: IQ
3.2.o QH
Kev tsim nyog ua haujlwm: OQ
3.3.?PQ(MPQ/PPQ)
Kev ua tau zoo: PQ (Microbiological PQ / Physical PQ)
3.4.: Requalification
3.5.: Bioburden
3.6.:Biological taw qhia
3.7.: Fractional voj voog
3.8.: Ib nrab voj voog
3.9.: Tag nrho lub voj voog
3.10.PCD: txheej txheem kev sib tw ntaus ntawv
3.11.: Khoom thiab khoom tsev neeg
3.12.?: Usable ntim / Khoom ntim ntim
3.13.: Sterility
3.14.SAL: qib kev ruaj ntseg
4. Lub luag haujlwm
4.1 Lub eto sterilization validation engineer yog lub luag hauj lwm rau kev sau cov txheej txheem validation, thiab cov neeg ua hauj lwm cob qhia thiab cov kev siv yog lub luag hauj lwm rau ua qhov validation thiab sau cov ntaub ntawv tseem ceeb los pab nyob rau hauv ua kom tiav cov validation.
5. Cov txheej txheem
5.1.IQ tau lees paub los ua kom pom tias cov cuab yeej ua kom tsis muaj menyuam thiab lwm yam khoom ntxiv tau muab thiab ntsia raws li lawv qhov tshwj xeeb. Ua ntej ua IQ, cov chaw tsim khoom lag luam yuav ua FAT thiab SAT kom ntseeg tau tias cov khoom tau raug xa tuaj ib txwm.