Module Txheej txheem cej luam
CIP / SIP Txheej Txheem Module ua kom tsis siv neeg tu thiab ua kom tsis muaj menyuam ntawm cov khoom siv thiab cov kav dej yam tsis muaj kev cuam tshuam. Los ntawm kev tswj xyuas tus neeg saib xyuas kom huv si, qhov kub thiab txias, tus nqi ntws, thiab cov khoom siv kom tsis muaj menyuam (ntshiab chav dej / dej kub dhau), nws ua kom muaj kev ua raws li GMP, FDA, thiab EHEDG cov qauv kev nyiam huv, tshem tawm hla - kev pheej hmoo kis kab mob thiab lav batch - rau - batch ntau lawm kev nyab xeeb.
Core Cheebtsam ntawm lub system
Tus neeg saib xyuas tso tsheb hlau luam (316L stainless hlau, cua sov- insulated rau concentrated alkali tsis kam)
Lub tshuab hluav taws xob ntshiab (khoom siv tshuaj): Saturated steam dryness Ntau dua lossis sib npaug li 95%, ua raws li EN 285
Overheated dej ncig chav tsev (khoom noj khoom haus): phaj kub exchanger + booster twj tso kua mis kom ceev kom tsis muaj menyuam kub ramp -up
Piping & Spray Module
Hygienic pipelines: DN25–DN100, welded/polished, slope >1℃rau kev tso dej kom tiav
Rotary spray balls (pharmaceutical): 360℃kev pab cuam, cuam tshuam lub zog ntau dua lossis sib npaug li 3 m / s (ASME BPE SD-3 raws)
Tsau tshuaj tsuag taub hau (khoom noj): Dav -lub kaum sab xis rau ntxuav lub tank loj
● Multistage centrifugal twj: VFD- tswj, ntws tus nqi 10–200 m³ / h (lub taub hau 60m), siab - kub / corrosion-resistant
● Dual rov qab systems:
-Tsev Tshuaj: Yaug cov dej rov ua dua rau cov dej huv huv (TOC Tsawg dua lossis sib npaug li 500 ppb)
- Khoom noj khoom haus: khib nyiab kua tank + pH neutralization (ua raws li kev tso tawm)
● SCADA + PLC tswj
-Cov kev pab cuam preloaded (xws li, CIP-1 alkaline tu, SIP ntshiab chav sterilization)
-Kev kuaj mob tsis raug: Nws pib- hloov mus rau cov kav xa dej thaub qab + tswb rau lub twj tso kua mis tsis zoo
● Kev koom ua ke IoT:
-Kev saib xyuas tej thaj chaw deb ntawm cov khoom siv (acid/alkali, purified water) nrog nws pib-replenishment
-Kev saib xyuas kev kwv yees: Kev soj ntsuam xyuas kev hnav, lim qhov sib txawv ntawm qhov sib txawv
● Online TOC analyzer (pharmaceutical): Yaug dej TOC Tsawg dua lossis sib npaug li 500 ppb
● ATP bioluminescence nrhiav tau (khoom noj): Nto microbial residue<50 RLU
● Sampling ports: Rau qhov thib peb - tog validation (xws li, swab tests)
Cov Ntsiab Cai Tswj Cov Ntsiab Lus
Precision Cleaning Control
● Ntau-theem program:
- Ua ntej- yaug → alkaline ntxuav → kua qaub → yaug zaum kawg (conductivity Tsawg dua lossis sib npaug li 5 μS / cm)
-Txoj kev hloov pauv hloov tau
● Kev saib xyuas qhov tseem ceeb:
- Kub qhov tseeb: ± 1℃(pharma) / ± 2℃(khoom noj khoom haus)
-Turbulent flow (Reynolds number >4,000) rau tag nrho cov kev pab them nqi (tuag-leg residue Tsawg dua lossis sib npaug li 0.1%)
-Kev tswj hwm: Online conductivity/acid-alkali meters + dosing twj (± 0.1% raug)
Sterilization Efficacy Assurance
● Pure steam sterilization (SIP):
-Cub-siab- lub sij hawm siv tau (piv txwv li, 121℃/ 30min, F0 Ntau dua lossis sib npaug li 15) nrog kev saib xyuas qhov chaw txias (ΔT Tsawg dua lossis sib npaug li 1 degree)
-Biological indicator testing (Geobacillus stearothermophilus), SAL Tsawg dua los yog sib npaug rau 10⁻⁶
-Overheated water sterilization: 121–135℃cycles rau chav dej - pub zaub mov / dej haus
Cleaning Media Management
● Kev noj tshuaj ntse: Kaw- voj tswj ntawm NaOH (1–4%) thiab HNO3 (0.5–2%) concentrations
● Recycling: Rov qab siv cov tshuaj lim dej (pharma) lossis tshem tawm cov pa tawm (khoom noj), txo nqi 30%
Data Integrity & Traceability
● 21 CFR Part 11-ua raws cov ntaub ntawv hluav taws xob
- Cov ntawv qhia txog kev tu/sterilization nrog kub nkhaus, tus nqi ntws, thiab lub sij hawm lub hom phiaj
● Tshawb xyuas txoj hauv kev
-Log rau kev hloov pauv, kev hloov pauv ntawm tus neeg teb xov tooj, thiab lub tswb nrov
Kev lag luam kev siv
Pharmaceuticals
Hauv -qhov chaw tu bioreactors, fermenters, thiab kua dej npaj
Khoom noj & dej haus
CIP tu ntawm cia / sib tov tso tsheb hlau luam, SIP sterilization ntawm sterile filling kab
Core zoo ntawm qhov system
Zoo meej & Ua tau zoo
● Txo lub sij hawm tu los ntawm 40% (tsim turbulent flow), 100% sterilization pass tus nqi
● Ntau dua los yog sib npaug rau 99.5% cov tshuaj tsuag (3D nozzle scanning verified)
Ua raws li & Kev ntseeg tau
● Raws li EU GMP Annex 15, FDA cov lus qhia kev siv tau zoo, thiab EHEDG ntawv pov thawj
● Tag nrho IQ / OQ / PQ validation pob nrog kev sib tw xeem raws tu qauv
Sustainability
● Thaum tshav kub kub rov qab (sub condensate rov siv dua) txo kev siv hluav taws xob los ntawm 25%
● Ntau dua lossis sib npaug li 70% tus neeg saib xyuas kev rov siv dua, 50% txo cov dej khib nyiab
Kev Pabcuam
Kev Pabcuam Kev Ua Haujlwm Zoo
-Kev ua kom huv si simulation
-Txoj kev tsom xam qhov seem (HPLC, microbial txwv)
Kev tswj hwm lub neej
-Qhia cov khoom seem seem rau kev hloov pauv sai ntawm cov pob tshuaj tsuag / foob
-Kev pab cuam xyuas kev ua raws cai