| Physical Performance Qualification (PPQ) • Nws yuav tsum tau ua kom pom tias tag nrho cov kev lees paub tau teev tseg yog rov tsim dua thoob plaws hauv tag nrho cov txheej txheem. Yuav ua li cas khiav ntau npaum li cas cov txheej txheem PPQ yuav tsum ua? • Txhawm rau ua kom pom cov txheej txheem rov ua dua tshiab, yuav tsum muaj tsawg kawg 3 khiav; • Yog tias 3 lub voj voog ib nrab tau khiav thaum lub sij hawm MPQ, ces tsawg kawg yog 1 qhov kev khiav hauj lwm ntxiv nrog rau lub sij hawm raug tag nrho yuav tsum tau ua. |
Cov qauv siv:
- TS EN ISO 11135: 2014 (Cov cuab yeej kho mob EO sterilization validation)
- FDA Kev taw qhia (2007): Sterility Assurance for Terminal Sterilized Products
- EU GMP Annex 1 (2022): Sterilization txheej txheem validation yuav tsum.
Reproducibility pom tau li cas?
| Tsis muaj. | Txheej txheem txheej txheem | Yam khoom | Txoj kev |
|---|---|---|---|
| 1 | Kev kho ua ntej | Kub thiab av noo ntawm sterilized load yog nyob rau hauv lub teev ntau yam ntawm qhov kawg ntawm preconditioning | Ntsuas nyob rau hauv lub load |
| 2 | Chaw thau khoom | Lub sij hawm ncua ntawm qhov kawg ntawm preconditioning thiab pib sterilization yuav tsum nyob rau hauv lub teev ntau yam | Txheeb xyuas cov ntaub ntawv teev sijhawm |
| 3 | eo Sterilization | Ethylene oxide (EO) yog nkag mus rau hauv lub sterilizer hauv gaseous daim ntawv | Ntsuas cov roj txhaj tshuaj kub |
| 4 | eo Sterilization | Lub siab nce vim EO roj txhaj tshuaj yog nyob rau hauv qhov kev teev tseg | Ntsuas qhov siab thaum txhaj tshuaj |
| 5 | eo Sterilization | EO gas concentration nyob rau hauv lub sterilizer yog nyob rau hauv lub teev ntau yam | Ntsuas cov roj tank ua ntej / tom qab txhaj tshuaj thiab suav qhov sib txawvlos yog ncaj qha ntsuas roj concentration nyob rau hauv lub chamber |
| 6 | eo Sterilization | Cov khoom kub nyob rau hauv lub load yog nyob rau hauv lub teev nyob rau hauv lub sij hawm raug | Ntsuas cov khoom kub |
| 7 | Aeration | Cov khoom kub hauv qhov thauj khoom yog nyob rau hauv qhov kev teev tseg thaum lub sij hawm aeration | Ntsuas cov khoom kub |
Thaum ntsuas qhov ua tiav ntawm kev xeem PPQ, cov hauv qab no yuav tsum raug sau tseg:
• Puas yog cov ntsuas kub thiab cov av noo raws li qhov yuav tsum tau ua?
• Puas yog cov kev sojntsuam (kub thiab av noo) tso rau hauv cov pob khoom thauj khoom thiab muab tso rau ntawm qhov chaw phem tshaj plaws (feem ntau nyuaj-rau-sterilize txoj haujlwm)?
• Puas yog qhov kub ntawm cov khoom thauj khoom nyob rau hauv qhov kev teev tseg?
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