Dab tsi yog lub luag haujlwm tseem ceeb ntawm ib puag ncig tsis muaj menyuam nyob hauvsyringe filling txheej txheem?
Tiv thaiv cov khoom paug
Kev npaj tshuaj lom neeg, tshuaj tiv thaiv, thiab cov tshuaj txhaj tshuaj muaj txiaj ntsig zoo rau cov kab mob. Kev tuav ib puag ncig aseptic zoo thaiv qhov nkag ntawm cov kab mob, fungi, thiab cov teeb meem me me, yog li ua kom cov khoom tsis muaj menyuam.
Risk Mitigation: Kev kis kab mob tuaj yeem ua rau tsis yog tsuas yog ua rau cov khoom tsis zoo xwb tab sis kuj ua rau muaj kev phom sij loj rau cov neeg mob, suav nrog kev kis kab mob.
Ua raws li Kev Tswj Xyuas Kev Lag Luam
Kev tsim tshuaj lag luam yuav tsum ua raws li Kev Tswj Xyuas Zoo (GMP) cov lus qhia, qhov twg aseptic filling yog ib qho tseem ceeb rau kev ua kom cov khoom zoo thiab kev ua raws cai.
Ua kom cov txheej txheem ruaj khov thiab sib xws
Kev ua haujlwm ua haujlwm puv hauv qhov chaw tswj hwm aseptic txo qis cov kev hloov pauv sab nraud uas tuaj yeem cuam tshuam kev ua tiav qhov tseeb (hauv ± 1% kam rau ua) thiab lub thawv kaw kev ncaj ncees. Qhov no ncaj qha pab txhawb rau tus nqi qis dua.
Safeguarding End-Kev nyab xeeb ntawm cov neeg siv
Ua ntej- cov koob txhaj tshuaj puv yog feem ntau siv rau kev tswj hwm ncaj qha (xws li, tshuaj tiv thaiv, insulin). Kev tsis sib haum xeeb hauv kev tsis muaj menyuam thaum lub sijhawm sau ua rau muaj kev pheej hmoo ncaj qha rau cov neeg mob thiab tuaj yeem ua rau muaj teeb meem kev noj qab haus huv tseem ceeb.
Kev daws teeb meem rau Intelligent Aseptic syringe filling txheej txheem
Txhawm rau ua kom tau raws li qhov xav tau nruj ntawm aseptic filling, cov khoom lag luam muab cov kev daws teeb meem sib xyaw ua ke:
1. Tsim thiab Automation kev koom ua ke
* Fully Enclosed Isolation Unit: Lub cev muaj kev cuam tshuam tag nrho cais cov neeg ua haujlwm los ntawm qhov chaw ntim khoom tseem ceeb.
* Siab -Precision Automated Filling Mechanism: Siv lub servo lub cev muaj zog-tsav precision metering twj tso kua mis muaj peev xwm ua tiav ± 1% filling raug. Ib qho tsis yog -kev sib cuag filling nozzle tsim tiv thaiv kev sib kis -.
2. Kev tu thiab saib xyuas ib puag ncig huv
* Barrier Protection thiab Cleanliness Qib Assurance: Koom nrog Cov Txheej Txheem Txwv Kev Nkag Mus Nkag (RABS) kom tswj tau qhov chaw nyob qib A, txhawb nqa los ntawm qib B keeb kwm yav dhau. Tiag -Lub sij hawm saib xyuas ntawm cov pa hauv huab cua yog tus qauv.
* Optimized Airflow Management: Ua haujlwm unidirectional laminar airflow ( ntsug lossis kab rov tav) chav muab ISO Class 5 (Qib A) cov xwm txheej. Qhov no ua kom cov khoom tsis sib haum, nrog rau huab cua tshaj tawm tsis tu ncua ntawm 0.45 ± 0.1 m / s.
3. Kev tu thiab ua kom tsis muaj menyuam
* Hauv -Situ Sterilization Capability: Cov txheej txheem syringe filling yog nruab nrog txoj hauv kev xws li UV-C irradiation rau kev ua kom tsis zoo ib puag ncig.
* Cov txheej txheem xaiv khoom: Tag nrho cov khoom-cov chaw tiv tauj yog tsim los ntawm kev huv, corrosion{1}}cov ntaub ntawv tiv taus zoo li cov kws tshuaj- qib silicones thiab 316L stainless hlau.
4. Ntau Lawm Flexibility thiab Adaptability
* Hloov pauv sai rau ntau hom ntawv: Lub kaw lus muaj cov cuab yeej sib hloov tau, tso cai rau kev hloov pauv sai rau ntau yam ua ntej - puv syringe hom los ntawm 1mL txog 20mL, txhim kho cov kab ntau lawm.
Daim ntawv thov teb thiab cov ntaub ntawv siv tib yam
Peb qhov project tshiab
Shanghai ALWELL machinery tej yaam num
Kev txhaj tshuajtej yaam num
Rau cov khoom siv tshuaj tiv thaiv, yuav tsum muaj Sterility Assurance Level (SAL) tsawg dua lossis sib npaug li 10⁻⁶.
Biologics Manufacturing
: Muaj cov tshuaj tiv thaiv kab mob monoclonal, insulin, thiab lwm yam, feem ntau xav tau nitrogen purging thaum lub sij hawm sau los tiv thaiv oxidation.
Tshwj xeeb Injectable Production
: Xws li ophthalmological thiab orthopedic txhaj tshuaj, uas yuav tsum tau aseptic filling raws li ib tug ua ntej - kev kho mob kauj ruam ua ntej terminal sterilization.
Integrated tus nqi xa rau cov neeg siv
Txhim khu kev ua tau zoo thiab kev nyab xeeb: Qhov tseem ceeb txo qhov kev pheej hmoo ntawm cov khoom rov qab los ntawm kev sib kis.
Kev ua tau zoo ntau lawm: Kev ua haujlwm tsis siv neeg ua haujlwm ua kom puv nrawm txog li 700 - 1400 units ib teev (nyob ntawm hom thiab teeb tsa).
Kev txhawb nqa rau Kev Ua Raws Li Kev Ua Haujlwm Tsis Muaj: Ib qho qauv tsim qauv pab txhawb kev txhim kho yav tom ntej thiab kev nthuav dav, ua kom muaj kev hloov pauv mus rau cov qauv kev cai.
Cov txheej txheem filling tsim rau precision, tiv thaiv txhua kauj ruam kom muaj kev nyab xeeb.
Nyob rau hauv lub ntiaj teb no ntawm aseptic filling, txhua microliter ntawm precision thiab txhua kauj ruam ntawm kev huv huv yog qhov tseem ceeb rau kev nyab xeeb thiab kev ua tau zoo ntawm cov tshuaj. Cov txheej txheem tsim khoom ua ntej - cov koob txhaj tshuaj embodies hwm lub neej thiab cov qauv kev tshawb fawb nruj.
Shanghai ALWELL Machineryspecializes nyob rau hauv lub teb ntawm aseptic filling, cog lus los muab cov neeg muas zaub nrog ruaj khov thiab txhim khu kev qha filling kev daws teeb meem los ntawm ntse thiab siab - cov cuab yeej precision thiab technology. Los ntawm cov tshuaj tiv thaiv thiab biologics mus rau cov tshuaj rhiab heev, peb pab cov tuam txhab tshuaj tsim cov txheej txheem tsim ua raws, ua tau zoo, thiab hloov pauv tau.
Yog tias koj xav tau:
Kawm paub ntxiv txog cov txheej txheem ua tiav cov txheej txheem syringe filling
Tau txais aseptic filling system daws teeb meem uas ua tau raws li GMP cov cai
Sib tham txog yuav ua li cas txhawm rau txhim kho qhov tseeb thiab kev ua haujlwm ntawm koj cov kab uas twb muaj lawm
Thov koj txhob xav li castiv tauj peb. Peb pawg kws tshaj lij yuav muab cov lus teb rau cov txheej txheem kev tshaj lij thiab cov ncauj lus kom ntxaws thiab cov lus qhia txog kev npaj ua haujlwm rau koj.