Reusable Clearrooma cov khaub ncaws uas ua kom haum, thiab cov kev ua haujlwm hauv qab no yog qhov kev sib tw ua kom huv si raws li kev sib cais huv thiab cov qauv kev kawm hauv kev sib cais:
1. Kev ntxhua khaub ncaws kom tsawg los ntawm kev faib tawm huv
ISO 8 / GMP Qib D: Cov ris tsho feem ntau yog ntxhua khaub ncaws txhua ob hnub .
ISO 7 / GMP qib C: Cov ris tsho yuav tsum tau ntxhua khaub ncaws thiab sterilized tom qab txhua pauv (ib zaug ua haujlwm) .
ISO 5-6 / GMP cov qib A-B: Cov ris tsho yuav tsum tau ntxhua khaub ncaws thiab sterilized tom qab txhua txhua qhov kev siv lossis cov khaub ncaws hloov mus rau qee kis yog tias muaj kev phom sij me me?.
2. Kev tswj hwm thiab Kev Lag Luam Kev Lag Luam
EU GMP Annex 1thiabIso 14644Qhia meej tias cov khaub ncaws yuav tsum tau ua rau cov chaw ntxhua khaub ncaws, cais tawm ntawm cov chaw tsim khoom, siv cov txheej txheem tu thiab kom tsis tu ncua.
En 14065Qhia txog biocontamination tswj tshuab rau cov khaub ncaws ntxhua khaub ncaws, kom muaj cov khaub ncaws ua kom sib luag ntawm cov txheej txheem xyaum kom huv si thoob plaws {}}
3. Kev Ntsuam Xyuas thiab Kev Tswj Xyuas Daus
TusMuaj pes tsawg tus naj npawb ntawm kev ntxhua khaub ncaws thiab kom tsis muaj menyuamyuav tsum tau txhais thaum lub sij hawm tsim nyog siv tau . Cov ris tsho kom ua tau zoo thiab tsis txhob thuam dua lub sijhawm.
RFID NrhiavthiabKev Tswj Xyuas Kev Tswjhwmyog pom zoo kom taug qab cov neeg ntxuav tawm thiab ua kom muaj kev ntxhua khaub ncaws ua ntej ua ntej .
Kev Pom Zoo Kev Tshuaj XyuasTom qab txhua ntxuav yog qhov tseem ceeb los kuaj xyuas kev puas tsuaj, paug, lossis hnav .
4. Kev txiav txim siab ua tau zoo
Kev tshawb fawb qhia tau tias ib co dej huv huv yuav tuaj yeem tiv thaiv tauTxog li 50-100 ntxuav / sterilization cycles, nyob ntawm cov khoom siv thiab cov qauv kev tsis sib xws (e {{{} g}}}}} autoclaving).
Sij hawm dhau mus, rov ua dua kev ntxhua khaub ncaws tuaj yeem txo cov txheej txheem particlle particlo kom zoo thiab nce cov hmoov av, yog liKawg-ntawm-lub neej ntsuasyog qhov tseem ceeb .
| Cov chav dej huv si | GMP qib | Laurdering zaus | Sau ntawv |
|---|---|---|---|
| ISO 8 | Qeb D | Txhua 2 hnub | Kev Tswj Cov Kev Tswj Kom Tsis Txaus |
| Iso 7 | Qib C | Ib qho kev ua haujlwm | Suav nrog kom tsis muaj menyuam |
| ISO 5-6 | Cov qib A-B | Tom qab siv txhua | Cov khaub ncaws uas tsis muaj menyuam |