CIP (Clean-nyob rau hauv-Place) automated tu tshuab yog siv dav siv cov thev naus laus zis ntxuav hauv kev tsim khoom niaj hnub no, tshwj xeeb tshaj yog nyob rau hauv cov zaub mov, tshuaj, khoom noj siv mis, thiab tshuaj lom neeg kev lag luam, qhov twg lawv cov kev ua tau zoo, automation, thiab sib xws yog qhov zoo. Txhawm rau kom ntseeg tau tias cov txiaj ntsig kev ntxuav tau ua tau raws li kev nyiam huv thiab kev nyab xeeb, kev tsim, kev ua haujlwm, thiab kev saib xyuas ntawm CIP systems yuav tsum nruj me ntsis ua raws li cov qauv kev coj ua. Kab lus no tau piav qhia meej txog kev siv cov txheej txheem ntawm CIP automated cleaning systems los ntawm kev pom ntawm cov qauv kev lees paub thoob ntiaj teb, kev lag luam- cov kev cai tshwj xeeb, thiab cov kev tswj xyuas tseem ceeb.
Kev lees txais thoob ntiaj teb Standard Framework
Kev siv ntawm CIP systems yog ua raws li ntau qhov kev tso cai thoob ntiaj teb cov qauv, uas muab kev qhia thoob ntiaj teb rau kev ntxuav cov txheej txheem thoob ntiaj teb.
TS EN ISO 28521: 2020 "Kev siv tshuab ua zaub mov-Kev tsim qauv huv si rau CIP systems"
Cov qauv no, luam tawm los ntawm International Organization for Standardization (ISO), qhia meej txog cov qauv tsim kev nyiam huv rau CIP cov txheej txheem hauv kev ua zaub mov, suav nrog cov yeeb nkab nqes hav (Ntau dua lossis sib npaug li 1%), tuag- kaum -dawb tsim (luv tsawg dua lossis sib npaug li 1.5 npaug ntawm txoj kab uas hla), cov khoom siv sib xws (xws li 1 6 stainless hlau qhov yuav tsum tau ua rau corrosion L. Qib kev huv ntawm cov ntsaws ruaj ruaj (yuav tsum ua raws li FDA lossis EU 1935/2004 tus qauv).
2. EHEDG (European Hygienic Engineering Design Group) Cov Lus Qhia
EHEDG's "CIP System Validation Guidelines" qhia txog cov txheej txheem rau kev ua kom muaj txiaj ntsig zoo, xws li tshawb xyuas cov khoom seem uas siv "fluorescent labeling method," thiab xav kom CIP cov kev txwv tsis pub dhau (kub, concentration, sij hawm) validated raws li "phem tshaj - rooj plaub" tej yam kev mob. Tsis tas li ntawd, EHEDG muab ntau qhov ntsuas rau cov tshuaj tsuag pob (Ntau dua lossis sib npaug ntawm 98% ntawm qhov chaw sib cuag) thiab cov dej tsis muaj zog (ntws tshaj tawm Ntau dua lossis sib npaug li 1.5 m / s kom ntseeg tau tias muaj kev kub ntxhov).
3. US FDA 21 CFR Part 11 thiab 3-A Hygiene Standards
US Food and Drug Administration (FDA) 21 CFR Part 11 xav kom cov ntaub ntawv hluav taws xob ntawm CIP systems (xws li kev ntxuav cov txheej txheem thiab lub tswb ntsuas) muaj cov ntaub ntawv tiv thaiv kev ncaj ncees (xws li kev tshawb xyuas cov kab thiab kos npe hluav taws xob). Txawm li cas los xij, 3-A tus qauv kev nyiam huv, txawm li cas los xij, tshwj xeeb rau kev lag luam khoom noj siv mis, qhia meej tias qhov roughness ntawm CIP system cov khoom hauv kev sib cuag nrog cov khoom yuav tsum yog Ra Less tshaj lossis sib npaug li 0.8 μm, thiab txwv tsis pub siv cov xov txuas (siv clamps lossis vuam es tsis txhob txo qhov kev pheej hmoo ntawm kev sib kis).
Kev lag luam-Cov qauv siv tshwj xeeb
Qhov sib txawv ntawm cov txheej txheem ntau lawm thoob plaws kev lag luam sib txawv yuav tsum tau ua kom CIP systems ua tau raws li cov qauv kev cai. Cov hauv qab no yog cov kev cai tseem ceeb rau kev lag luam ib txwm:
1. Pharmaceutical Industry (GMP thiab USP<1229>)
CIP systems nyob rau hauv kev tsim tshuaj yuav tsum nruj me ntsis ua raws li Kev Tswj Xyuas Zoo (GMP) thiab United States Pharmacopeia (USP) Tshooj 1229, "Tsev Khoom Siv Ua Haujlwm Zoo." Cov qauv tseem ceeb muaj xws li:
• Cov kev txwv ntawm kev ntxuav cov khoom seem: Cov khoom muaj nyob hauv cov dej yaug zaum kawg yuav tsum qis dua 10 ppm (los yog qhov kev txwv nruj dua raws li cov ntaub ntawv toxicological);
• Kev tswj cov kab mob microbial: Tag nrho cov microbial suav ntawm cov khoom siv tom qab ntxuav Tsawg dua lossis sib npaug li 10 CFU / cm² (cov kev cai nruj dua rau kev npaj tsis muaj menyuam, xws li Tsawg dua lossis sib npaug li 1 CFU / 25 cm²);
• Cov ntaub ntawv pov thawj: yuav tsum muaj daim ntawv qhia txog kev ua kom tiav (nrog rau cov kev sim rov qab los thiab qhov phem tshaj -cov ntaub ntawv sib tw).
2. Kev Lag Luam Mis thiab Dej Haus (IDF thiab BSI Standards)
Lub International Dairy Federation (IDF)'s "Cov Lus Qhia rau Kev Siv CIP Systems hauv Cov Zaub Mov" yuav tsum:
• Ntxuav Cycle Classification: Xaiv cov alkaline (pH 10-12), acidic (pH 2-4), los yog cov tshuaj ntxuav tu nruab nrab raws li hom kab mob sib kis (protein, rog, lossis mineral deposits), thiab qhia lub sij hawm ntawm txhua kauj ruam (feem ntau 10-30 feeb);
• Tswj Kev Kub Kub: Khaws qhov kub ntawm 65-85℃thaum lub sij hawm ntxuav alkaline (txhim kho cov protein solubility), thiab 40-60℃thaum lub sij hawm acidic theem (kom tiv thaiv hlau corrosion);
• British Standard BS EN 12048 qhia tias CIP system nyob rau hauv cov dej filling kab yuav tsum xeem dhau "dye penetration test" los xyuas qhov kev sib khi ntawm welds thiab pob qij txha.
Cov Txheej Txheem Tswjhwm Tseem Ceeb thiab Kev Ua Haujlwm Kev Ua Haujlwm Kev ua tau zoo ntawm CIP system nyob ntawm kev tswj hwm ntawm cov ntsiab lus tseem ceeb, uas yuav tsum tau qhia meej meej hauv tus qauv thiab saib xyuas hauv lub sijhawm:
1. Tus Cwj Pwm Cuam Tshuam Kev Ua Haujlwm
• Alkaline ntxuav cov neeg ua haujlwm (piv txwv li, NaOH) concentration feem ntau yog 0.5%-2% (kev lag luam zaub mov) lossis 1%-3% (cov kab mob hnyav heev);
• Cov tshuaj ntxuav cov kua qaub (piv txwv li, HNO₃ lossis citric acid) concentration yog 0.2%-1%, yuav tsum tau saib xyuas lub sijhawm ntawm lub tshuab hluav taws xob hauv online thiab sib piv nrog tus qauv nkhaus ( yuam kev tsawg dua lossis sib npaug ± 5%).
2. Kub thiab sijhawm
• Kev tswj qhov kub thiab txias yuav tsum ncav cuag ± 2℃(piv txwv li, ± 1℃rau CIP systems hauv cov khoom siv pasteurization);
• Lub sijhawm tsawg kawg nkaus ntawm txhua kauj ruam ntxuav yuav tsum tau txiav txim siab ua ntej (piv txwv li, ua ntej- yaug Ntau dua lossis sib npaug li 5 feeb, lub ntsiab yaug Ntau dua lossis sib npaug li 15 feeb), thiab lub sijhawm yuam kev yuav tsum tau teem rau hauv PLC program.
3. Flow Rate thiab Siab
• Tus nqi ntws hauv cov kav dej loj yuav tsum siab dua lossis sib npaug li 1.5 m / s (qhov dej ntws tawm, Reynolds tus naj npawb Re> 4000), thiab hauv cov kav xa hluav taws xob ntau dua lossis sib npaug li 0.8 m / s;
• Lub twj tso kua mis qhov hluav taws xob siab yog feem ntau 0.3-0.6 MPa (siab dhau yuav tsum tau zam kom tsis txhob muaj cov kav xa dej vibration lossis foob tsis ua haujlwm).
Kev lees paub thiab kev ua raws li Nruam Cov qauv kev siv rau CIP systems tsis txwv rau theem tsim tab sis yuav tsum muaj kev lees paub tsis tu ncua kom ntseeg tau ntev - ua raws li lub sijhawm:
• Initial Validation: Qhov no suav nrog Kev Tsim Nyog Tsim Nyog (IQ), Kev Tsim Nyog Kev Ua Haujlwm (OQ), thiab Kev Tsim Nyog Kev Ua Haujlwm (PQ), xws li kev txheeb xyuas cov kev pab tu xyuas los ntawm "kev sim rov qab ua dua";
• Periodic Revalidation: Cov kev ntsuas tseem ceeb (xws li cov tshuaj tsuag pob ntws tawm thiab ntxuav tus neeg sawv cev kom sib npaug) yuav tsum tau rov ua dua txhua 6-12 lub hlis;
• Deviation Handling: Yog tias kuaj pom cov khoom seem ntau dhau los yog cov kab mob microbial, yuav tsum tau pib txheej txheem CAPA (Kev Kho thiab Tiv Thaiv Kev Ua Haujlwm), thiab Tus Txheej Txheem Kev Ua Haujlwm (SOP) yuav tsum tau kho dua.
Cov qauv siv rau CIP automated tu tshuab yog cov ntaub ntawv tseem ceeb rau kev ua kom huv si thiab kev nyab xeeb ntawm kev tsim khoom. Los ntawm cov qauv kev lees paub thoob ntiaj teb mus rau kev lag luam- cov kev cai tshwj xeeb, los ntawm kev tswj hwm qhov tseem ceeb mus rau kev tswj xyuas kev siv tau, cov kev cai tsim nyog suav nrog tag nrho cov kab ke hauv lub neej. Cov tuam txhab lag luam yuav tsum sib txuas lawv tus kheej cov txheej txheem cov yam ntxwv, nruj me ntsis ua raws li cov qauv tsim nyog, thiab txuas ntxiv ua kom zoo dua thiab txhim kho kev ua kom huv si thiab ua raws qib kom ua tiav cov hom phiaj ntawm cov khoom zoo thiab kev nyab xeeb ntawm kev tsim khoom.
