CIP (huv-hauv-qhov chaw)
Zaj piav
Cov thev naus laus zis uas ua rau sab hauv cov khoom siv ntau lawm los ntawm kev siv hluav taws xob yam tsis tau dismantling cov cuab yeej.
Daim Ntawv Thov Kev Thov
- Kws Tshuaj Kho Mob: Tu Reactors, Pipelines, ntsiav tshuaj nias, thiab lwm yam.
- Kev Lag Luam Khoom Noj: Kev tso tsheb hlau luam, cia cia.
- Tshuaj Kev Lag Luam: Tshem tawm cov tshuaj tiv thaiv cov tshuaj tiv thaiv.
Cov txheej txheem
- Ua ntej yaug: Tshem tawm cov ntawv tseem ceeb loj.
- Alkaline / Acid Rinsing: Siv cov tshuaj tua neeg ntxuav kom yaj cov tshuaj organic lossis inorganic.
- Tso yaug: Yaug nrog dej ntshiab lossis dej rau kev txhaj tshuaj (WFI) kom txog thaum nruab nrab.
- Kom qhuav: Kom qhuav los ntawm kev hla cov huab cua huv lossis nitrogen.
Qhov Zoo
Txo lub sijhawm poob qis, zam kev sib kis cov kev sib kis, thiab ua raws li GMP cov cai.
SIP (Sauilization-Hauv-Chaw)
Zaj piav
Kom tsis muaj menyuam yaus los yog siv hluav taws xob kub lossis tshuaj lom neeg yam tsis muaj disassembly ntawm cov khoom siv.
Daim Ntawv Thov Kev Thov
- Aseptic npaj ntau lawm (EG txhaj, biopharmaceuticals).
- Cov khoom noj khoom noj khoom noj khoom haus cov khoom noj.
- Kuaj hluav taws xob tso tsheb hlau luam, Lyophilizer.
Txojkev
- Chav kom tsis muaj menyuam: Cov roj noo saum toj no 121 degree, tswj 15-30 feeb.
- Kev Siv Khoom Kom Tsis Muaj Tshuaj: Hydrogen Peroxide (VHP), OZone, thiab lwm yam.
- Hluav taws xob kom tsis muaj menyuam: -ros (cov khoom siv sib xyaw yuav tsum tau).
Qhov yuav tsum tau ua
Kev sim sim nrog Bioindicator (piv txwv li, Bacillus thermophilus) yuav tsum muaj kev ntsuas kev ntsuas tsis muaj zog (sal tsawg dua los yog sib npaug ⁶ {.
Siv kev siv Synergistic siv ntawm CIP thiab PAS
Cov txheej txheem raug
CIP Tu → PM Sautilization → Rov Ua Dua.
Muaj cov cuab yeej siv tau
Ntsiav tshuaj nias (kws tshuaj), fermenters, cov tshuab raj, sau kab.
Caw Kaw Lus
Integrated PLC system los sau cov ntaub ntawv tseem ceeb xws li kub, lub siab, lub sijhawm, thiab lwm yam FDA 21 CFR Ntu 11).
Kev txiav txim siab tseem ceeb
Txoj hau
- Kev xaiv tus neeg sawv cev xaiv yuav tsum tau tshaj nrog cov khoom siv khoom siv (piv 48
- Txheeb xyuas cov khoom lag luam tu (toc, conductivity, thiab lwm yam).
Haus
- Zam kom tsis txhob ua kom khov kho (txoj kab nqes caj dab thiab cov ntxiab yuav tsum tau).
- Cua txias rau txheej txheem ntsuas kub yog qhov yuav tsum tau tom qab ua kom tsis muaj menyuam kom tiv thaiv kev cuam tshuam ntawm cov khoom siv kub.
Cov Kev Cai Tswjfwm
- Kws kev lag luam yuav tsum tau ua raws GMP, FDA / EMA cov lus qhia.
- Kev lag luam khoom noj khoom haus raws HACCP, ISO 22000.
Kev Lag Luam Kev Lag Luam
- Chaw ua tshuaj paus: Cov kab txhaj tshuaj ntau heev, cov hlau xaij hlau tso tsheb hlau luam kom paub meej tias cov menyuam kawm ntawv los ntawm CIP / SIP.
- Mov: Cov khoom siv ua haujlwm hauv qab yog ntxuav txhua hnub ntawm CIP thiab sterilized ib ntus los ntawm PAS.
- Biotechnology: Bioreactor Sterilization hauv Monoclonal Antibody ntau lawm.