Module Txheej txheem cej luam
Cov txheej txheem ua kua ua kua yog ib qho kev daws teeb meem zoo rau qhov hnyav, sib tov, tswj qhov kub thiab txias, thiab xa cov kua / semi-kua raw cov ntaub ntawv. Los ntawm kev tswj cov txheej txheem ntse, nws ua kom ntseeg tau tias cov txheej txheem npaj ua kua ua tau raws li cov qauv kev lag luam xws li GMP, FDA, thiab ISPE, ua tau raws li qhov yuav tsum tau ua ntawm siab precision, traceability, thiab muaj kuab paug- ua haujlwm dawb.
specializing nyob rau hauv architecture, sab hauv tsim, branded ib puag ncig, tswv yim lanning, thiab nroog tsim.
Lub hauv paus system
Integrated tank nrog pom iav, sampling valve, thiab breather
Kev xaiv lub tshuab nqus tsev degassing thiab pom hauv online (0.22μm sterilization theem) ua haujlwm
Automated Tswj System
PLC/HMI tib neeg- tshuab interface, preset txheem txheej txheem qauv
Txhawb OPC-UA thiab Modbus raws tu qauv, sib txuas nrog MES/ERP systems
Cov Txheej Txheem Pabcuam
Purified Water / Water for Injection (PW/WFI) Supply Unit
Cov Khoom Siv Hluav Taws Xob thiab Cov Hluav Taws Xob Hluav Taws Xob rov qab thiab kho cov cuab yeej
Temperature Control Module (TCU)
Technology Thawj
Precise Weighing and Feeding Control
● Ua haujlwm siab - qhov ntsuas qhov ntsuas qhov tseeb (± 0.1% raug) thiab poob- nce / nce qhov hnyav
● Anti-hloov- qauv tsim kab mob: kev ywj pheej hnyav module, kaw qhov chaw noj mov, thiab cov khoom siv plua plav
● Tsis siv neeg calibration thiab kev ua yuam kev them nyiaj ua haujlwm kom paub meej cov khoom siv raw zoo sib xws
Dynamic Mixing thiab Homogenization
● Ntau-theem stirring tshuab (paddle/magnetic/high-shear emulsification) adaptable rau cov kua dej sib txawv viscosities
● Tiag -lub sij hawm saib xyuas kev sib xyaw ua ke (conductivity, pH, kub tawm tswv yim)
● Laminar / turbulent flow switching muaj nuj nqi los tiv thaiv kev tsim npuas (tsim rau kev npaj tshuaj txhaj)
Kub thiab txheej txheem Parameter Control
● Jacketed tank tsim, txhawb cua sov / txias (PID kub tswj ± 0.5 degree)
● Kev saib xyuas online ntawm qhov tseem ceeb: kub, siab, theem, turbidity, yaj oxygen (tsim rau biopharmaceuticals)
Ntxuav thiab Sterilization (CIP / SIP)
● Ua haujlwm siab - qhov ntsuas qhov ntsuas qhov tseeb (± 0.1% raug) thiab poob- nce / nce qhov hnyav
● Anti-hloov- qauv tsim kab mob: kev ywj pheej hnyav module, kaw qhov chaw noj mov, thiab cov khoom siv plua plav
● Tsis siv neeg calibration thiab kev ua yuam kev them nyiaj ua haujlwm kom paub meej cov khoom siv raw zoo sib xws
Cov ntaub ntawv Traceability thiab ua raws
● Kev koom ua ke nrog SCADA system los sau cov ntaub ntawv tsim tawm batch (kev kos npe hauv hluav taws xob, kev tshawb xyuas txoj kev)
● Lub tswb tsis zoo thiab tsis siv neeg kaw kev tiv thaiv (hierarchical access contro
Kev lag luam kev siv
Kev lag luam kws tshuaj
Loj -Volume parenteral solution npaj, npaj kua qhov ncauj, tshuaj tiv thaiv adjuvant mixing, cell culture nruab nrab npaj, thiab lwm yam.
Kev lag luam tshuaj
Txheej dispersion, nplaum synthesis, tshuaj tiv thaiv kev npaj, tshuaj npaj, thiab lwm yam.
Bioengineering
Fermentation broth pub, protein purification buffer npaj, thiab lwm yam.
Khoom noj khoom haus thiab dej haus
Additive formulation, kua npaj systems
Qhov zoo ntawm qhov system tseem ceeb
Ua tau zoo thiab meej
Batch npaj lub sij hawm txo los ntawm 30%, sib tov yuam kev Tsawg dua los yog sib npaug rau 0.5%
Muaj kev nyab xeeb thiab ua raws
Ua raws li 21 CFR Part 11 thiab GMP Annex 11 cov ntaub ntawv kev ntseeg siab
Flexible thiab Expandable
Modular tsim txhawb nqa kev muaj peev xwm thiab kev hloov pauv
Kev Pabcuam
Customized txheej txheem validation
Ua raws li FDA, GMP, thiab OSHA cov qauv kev nyab xeeb, muab DQ / IQ / OQ / PQ / FAT cov ntaub ntawv
Full Lifecycle Management
Cov chaw taws teeb tswj kev ua haujlwm thiab kev txhawb nqa kev saib xyuas, kev tsim cov khoom siv ntse ntse, kev ua kom zoo dua qub, kev saib xyuas kev kwv yees (IoT nkag)