EO Sterilization Validation Txheej txheem cej luam
Cov txheej txheem sau tseg siv los ua kom pom tias lub voj voog ethylene oxide sterilization tsis tu ncua ua tiav qhov yuav tsum tau muaj Sterility Assurance Level (SAL) rau cov khoom siv kho mob thiab cov khoom kho mob.
Kev lees paub yog qhov tseem ceeb rau cov tuam txhab ua haujlwm raws li:
- ISO 11135 Kev Tswj Xyuas
- ISO 13485 Kev Tswj Xyuas Kev Lag Luam
- GMP cov cai
- FDA cov cai
- EU MDR cov cai
Lub hom phiaj ntawm kev siv tau yog los xyuas kom meej tias tsis muaj kev tsis muaj menyuam, kev teeb tsa cov khoom lag luam, ntim tshuab, thiab cov txheej txheem tswj xyuas kom tsis txhob muaj cov khoom tsis muaj menyuam thaum tswj tau cov qib EO seem.
Kev them nyiaj yug Riches:Riches txhawb nqa cov neeg siv khoom nrog kev tsim kom tsis muaj menyuam, kev siv tau- npaj cov khoom siv, thiab cov txheej txheem sau cov ntaub ntawv daws teeb meem los pab txhawb kev tsim nyog thiab kev saib xyuas kev tsim khoom niaj hnub.
Vim li cas EO Sterilization Validation tseem ceeb
Validation qhia tau tias:
• Rov ua dua:Sterilization cycles yog rov ua dua
• Kev nkag mus:EO roj nkag mus rau txhua qhov chaw khoom
• Kev ncaj ncees:Ntim tshuab tswj kom tsis muaj menyuam
• Kev nyab xeeb:Cov qib EO seem nyob hauv cov kev txwv uas tau txais
• Kev lees paub:Sterility Assurance Level yuav tsum tau ua tiav
Yog tias tsis muaj kev lees paub, cov khoom kho mob tsis tuaj yeem tso tawm rau cov khw muag khoom.
Cov qauv tseem ceeb rau EO Sterilization Validation
ISO 11135 Kev Tswj Xyuas
Thawj tus qauv thoob ntiaj teb rau EO sterilization txheej txheem kev txhim kho, kev siv tau, thiab kev tswj xyuas niaj hnub. Kev pab cuam muaj xws li:
TS EN ISO 10993-7
Txhais tau txais EO residual txwv rau cov khoom siv kho mob. Kev ntsuas:
- EO residue
- Ethylene Chlorohydrin (ECH)
- Ethylene Glycol (EG)
ISO 11737 Kev Tswj Xyuas Kev Lag Luam
Txhais kev txiav txim siab bioburden thiab kev kuaj tsis muaj menyuam.
Validation Theem
Installation Qualification (IQ)
STAGE 1Lub hom phiaj:Xyuas kom tseeb tias cov cuab yeej raug ntsia raws li cov qauv tsim.
Kev txheeb xyuas suav nrog:
Kev them nyiaj yug Riches:Cov ntaub ntawv kev teeb tsa, kev taw qhia kev siv hluav taws xob, FAT / SAT cov ntaub ntawv
Kev Tsim Nyog Ua Haujlwm (OQ)
STAGE 2Lub hom phiaj:Xyuas kom tseeb tias cov sterilizer ua haujlwm kom raug thoob plaws qhov kev ua haujlwm tau teev tseg.
Cov kev ntsuam xyuas:
Riches muab:PLC cov ntaub ntawv kaw tseg, Kev them nyiaj yug kub ua haujlwm, ntsuas ntsuas ntsuas ntsuas
Kev Kawm Txuj Ci (PQ)
QHOV 3Lub hom phiaj:Txheeb xyuas qhov ua kom tsis muaj menyuam siv cov khoom siv tiag tiag thiab kev ntim khoom.
Xws li:
- Product load validation
- Qhov phem tshaj -xov xwm thauj khoom
- Cov kev tshawb fawb txog kev tshawb fawb txog biological
- Kev kuaj tsis muaj menyuam
Biological Indicator Validation
Cov cim qhia txog kab mob lom (BI) feem ntau yog siv los ua kom pom tias muaj peev xwm ua kom tsis muaj zog microbial.
Hom kab mob:Geobacillus stearothermophilus
Validation ntsuas:D-kev ua tau zoo, muaj peev xwm txo qis, kev ua kom tsis muaj menyuam
Qhov kev tso kawm BI feem ntau suav nrog:
- Hard-kom- ua kom tsis muaj menyuam qhov chaw
- Ntev lumens
- Cov chaw ntim khoom ntom ntom
- Cov khoom lag luam qhov chaw
Sterility Assurance Level (SAL)
Kev kho mob sterilization feem ntau lub hom phiaj:
Qhia txog qhov ua tau zoo ntawm qhov tsis muaj ntau tshaj ib qho khoom tsis yog- tsis muaj menyuam nyob hauv ib lab sterilized units.
Txheej txheem Parameters soj ntsuam thaum muaj tseeb
| Parameter | Hom kab mob |
|---|---|
| EO Concentration | 450-1000 mg / L |
| Kub | 35-60 degree |
| txheeb ze humidity | 40-80% RH |
| Lub sij hawm nphav raug | 4-15 hnub |
| Nqus Qib | -60 rau -95 kPa |
| Lub Sijhawm Aeration | 8-72 hn |
Kev lees paub tseeb tias cov kev ntsuas no nyob ruaj khov thiab rov ua dua.
EO Residual Validation
Dhau li ntawm sterility validation, residual validation tseem yuav tsum tau. Kev ntsuam xyuas ib txwm muaj xws li EO residual, ECH residual, thiab EG residual.
Cov yam ntxwv cuam tshuam rau qib residual:
- Cov khoom siv
- Ntim qauv
- Aeration kub
- Aeration duration
Cov txheej txheem nplua nuj tuaj yeem ua keywj siab aeration chav, cua khiav tswj, thiabtso pa kho tshuablos txhawb cov txheej txheem txo qhov seem.
Riches Validation Support Muaj peev xwm
Riches tsim EO sterilization tshuab nrog validation npaj hauv siab.
Kev them nyiaj yug Engineering
- Kev lees paub -Kev Tsim Cov Khoom Siv Taw Qhia
- Kev kub siab uniformity optimization
- Lub tshuab nqus tsev tswj kev ua haujlwm
- EO kev faib khoom
- Data acquisition systems
Cov ntaub ntawv txhawb nqa
- FAT qhia
- Cov ntaub ntawv SAT
- Cov cuab yeej siv phau ntawv
- Calibration cov ntaub ntawv
Kev sib xyaw ua ke
- PLC cov ntaub ntawv nkag
- SCADA kev koom ua ke
- MES kev sib txuas lus
Customized Solutions
- Chamber tsim customization
- Load configuration optimization
- Aeration system tsim
- Exhaust kho kev koom ua ke
FAQ
EO sterilization validation yog dab tsi?
EO sterilization validation qhia tau hais tias txoj kev ua kom tsis muaj menyuam tsis tu ncua ua tiav cov qib kev ua kom tsis muaj menyuam.
Tus txheej txheem twg tswj hwm EO sterilization validation?
ISO 11135 yog thawj tus qauv thoob ntiaj teb rau EO sterilization validation.
SAL 10⁻⁶ yog dab tsi?
SAL 10⁻⁶ sawv cev rau qhov ua tau zoo ntawm qhov tsis muaj ntau tshaj ib qho khoom tsis yog- tsis muaj menyuam hauv ib lab sterilized units.
IQ, OQ, thiab PQ yog dab tsi?
IQ txheeb xyuas kev teeb tsa, OQ txheeb xyuas kev ua haujlwm, thiab PQ txheeb xyuas qhov ua tau zoo raws li cov khoom siv tiag tiag.
Vim li cas thiaj siv cov ntsuas roj ntsha?
Cov cim qhia txog kev ua kom tsis muaj kab mob microbial inactivation zoo raws li kev ua kom tsis muaj menyuam.
Riches puas tuaj yeem txhawb nqa cov haujlwm raug cai?
Yog lawm. Riches muab kev lees paub tseeb -npaj EO sterilization systems, kev txhawb nqa cov ntaub ntawv, kev sau cov ntaub ntawv, thiab kev pabcuam engineering rau cov khoom siv kho mob kom tsis muaj menyuam.