ETO Sterilization Re-qualification Requirements

1. Re-qualification zaus

•Yam tsawg kawg nkaus txhua xyoo
• Tsawg kawg ib xyoos ib zaug, cov ntaub ntawv pov thawj, cov ntaub ntawv rov qab siv tau tom qab, thiab cov ntaub ntawv ua haujlwm niaj hnub yuav tsum tau tshuaj xyuas
• Lub peev xwm ntawm kev rov tsim nyog yuav tsum tau txiav txim siab thiab sau tseg
• Cov txheej txheem tshuaj xyuas yuav tsum tau sau tseg

2. Puas Yuav Tsum Tau Txais Kev Tsim Nyog Yog Tsis Muaj Cov Khoom Muag Hloov?

•Yog lawm, tseem yuav tau txais kev tsim nyog rov qab

3. Cov khoom tsim nyog rov qab

•Raws li qee qhov xwm txheej ua ntej, cov kev xaiv hauv qab no muaj:

  • Tag nrho rov tsim nyog
  • Tsis xav tau lub cev los yog microbial re-validation
  • Me me microbial kev ua tau zoo validation

Yam yuavtsum tau kawm uantej rau Re-qualification

a) Cov hauv qab no yuav tsum tau tshuaj xyuas / sim:
b) Seb puas muajcov kev hloov tseem ceeb cuam ​​tshuam cov khoom sterility tau tshwm sim hauv:

  • Khoom tsim
  • Kev tsim khoom / ntim khoom
  • PCD (Kev Sib Tw Ntaus Ntaus)
  • Cov neeg muab khoom
  • Chaw tsim khoom / chaw
  • Load configurations los yog manufacturing txheej txheem
    c)Bioburden trend analysis ntawm cov khoom;
    d) SebKev tshawb fawb txog qhov kub thiab txias thiab kev ua kom tsis muaj menyuam ua kom pom kev hloov pauv tseem ceeb txij li kev tsim nyog kawg;
    e) SebKev ntsuas kub ntawm kev faib tawm thiab rov ua dua nyob rau hauv preconditioning chambers los yog aeration zones qhia kev hloov tseem ceeb txij li thaum kawg tsim nyog;
    f) Seb ETO Sterilization txheej txheem keeb kwm txij li thaum kawg validation qhia tau hais tias reproducibility;
    g) Sebhloov tswj thiab tiv thaiv cov ntaub ntawv khaws cia paub meej tias tsis muaj kev hloov kho cov cuab yeej cuam tshuam rau cov txheej txheem;
    h) SebTsis muaj kev hloov pauv rau ETO Sterilization txheej txheem cuam ​​tshuam sterility tau tshwm sim;
    i) YogETO Sterilization txheej txheem specifications hloov, re-kev tsim nyog yuav tsum muaj kev txheeb xyuas ntawmEO residue txwv ua raws li kev cai tswj hwm.

Txoj Cai Tswjfwm

  • TS EN ISO 11135: 2014 (Sec. 9.2: Cov qauv tsim nyog)
  • FDA 21 CFR 211.113 (Sterilization txheej txheem tswj)
  • EU GMP Annex 1: 2022 (Sec. 8.5: Revalidation Requirement)

ETO Sterilization Re-qualification Requirements

Qhov kev tsim nyog rov ua dua yuav tsumsuav nrog kev tshuaj xyuas ntawm chamber kev ua tau zoo thiab kev hloov pauv engineering txhua xyoo los xyuas kom meej qhov tseem ceeb IQ/OQ cov txiaj ntsig tseem siv tau. Kev ntsuam xyuas yuav tsum npog:

  • Preconditioning cheeb tsam kub / humidity profiles (yog muaj);
  • Qhov tseeb khoob chamber humidity profiles;
  • Aeration cheeb tsam kub (yog muaj);
  • Tsis tas li ntawd, txawm tias cov txheej txheem specifications tau ntsib, kev tshuaj xyuas yuav tsum tau ua los ntawm:
    • Kev tsis zoo ntawm cov khoom siv ua haujlwm,
    • Sterility tsis ua hauj lwm;
    • Txhawm rau txiav txim siab seb qhov kev lees paub rov qab raug lees paub.
  • Sterilization kws txawj yuav tsum txhais lub Scope ntawm yuav tsum tauLub cev thiab microbial re-validation raws li kev txheeb xyuas cov txiaj ntsig.

Kev txiav txim siab tseem ceeb rau Sterilization Re-qualification

1. Tswj cov kev hloov pauv tseem ceeb

• Yogkev hloov loj raug txheeb xyuas thaum rov tsim nyog, rov ua tiav ntawm IQ / OQ / PQ yuav tsum:

  • IQ (Installation Qualification): Txheeb xyuas cov cuab yeej hloov kho / kev teeb tsa software.
  • OQ (Operational Qualification): Rov ntsuam xyuas qhov cuam tshuam txog kev ua haujlwm.
  • PQ (Kev Kawm Txuj Ci): Rov ua kom tsis muaj menyuam ua tau zoo raws li cov xwm txheej tshiab.

2. Cov kev xav tau ntxiv rau kev tso tawm Parametric

Rau cov chaw sivkev tso tawm parametric (nyob ntawm cov ntaub ntawv txheej txheem ntau dua li kev sim BI):
a)Re-validation zaus: Yuav tsum tau uatsawg kawg ib xyoos ib zaug;
b)Re-validation Scope: Yuav tsum muajkev tshawb fawb microbiological kom paub meej:

Cov xwm txheej Yuav Tsum Muaj Kev Tsim Nyog Tag Nrho (IQ/OQ/PQ):

a)Kev saib xyuas tseem ceeb ntawm sterilizer;
b)Cov qauv, qhov chaw, lossis ib puag ncig hloov pauv;
c)Unexplained sterility poob lawm;
d)Kev hloov pauv hauv EO muab khoom / xa tawm, diluent, lossis chamber load configuration.

Kev zam ntawm lub cev los yog Microbial Re-qualification

Thaum ntsib cov xwm txheej hauv qab no:

  • Tsis muaj kev hloov pauv hauv cov khoom, ntim, khoom siv / kev pabcuam, lossis cov txheej txheem;
  • Chamber Performance thiab engineering xyuas muaj peev xwm;
  • Cov txheej txheem sterilization niaj hnub tau ua haujlwm ruaj khov thaum lub sijhawm;
    ?Kev txiav txim siab tuaj yeem txiav txim siab tias lub cev lossis microbial rov tsim nyog yogtsis xav tau mus txog qhov kev tshuaj xyuas tom ntej.

Limited-Scale Microbial Performance Qualification

•Tej zaum yuav xav tau hauv cov xwm txheej tshwj xeeb, xws li:

  • Tshawb xyuas txuas ntxiv tsim nyog ntawm BIs txheeb ze rau cov khoom bioburden;
  • Muab pov thawj tias tsis muajtsis xav hloov tshwm sim txij li yav dhau los (re) kev kawm tsim nyog tom qab lub sijhawm teem tseg.
    •Cov kev cai dav dav (yam tsawg kawg nkaus):
  • Ibluv-cycle los yog ib nrab-lub voj voog khiav;
  • suav nrogntsuas kub thiab av noo ntawm cov khoom sterilized.

YOG KOJ XAV PAUB TIAS

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