OEB5 Injectable oncology vial turnkey laau
IVEN Pharmatecho le paionia fa'atau atu o la'au turnkey e tu'uina atu fa'ainisinia fa'atasi mo fale gaosi oloa i le lalolagi atoa e pei ole IV solution, tui, oncology ma isi, e tusa ai ma EU GMP, US FDA cGMP, PICS, ma WHO GMP.
Matou te tuʻuina atu le faʻataʻitaʻiga sili ona talafeagai o le poloketi, meafaigaluega maualuga ma le auaunaga faʻapitoa i falemaʻi ma falemaʻi eseese mai le A i le Z mo le Non-PVC soft bag IV solution, PP fagu IV solution, Glass vial IV solution, Injectable Vial & Ampoule, Syrup, Tablets & Capsules, Vacuum blood collection tube etc.
O le a le mea a le IVEN Injectable oncology vial turnkey plant e aofia ai:
IVEN's integrated engineering solutions for pharmaceutical injectable oncology vial factory e aofia ai le potu mama, auto-control and monitoring system, pharmaceutical water treatment system, solution preparation and distribution system, vial washing - sterilizing and depyrogenation - filling - stoppering - capping - out washing, freeze. faiga fa'amamago, faiga tu'ufua, fa'apipi'i faiga, faiga logistics otometi, faiga pulea lelei, falesuesue tutotonu ma isi. Taulai atu i tagata fa'atau 'mana'oga ta'ito'atasi, IVEN customizes inisinia fofo mticulously mo tagata e faaaogāina i:
1. Injectable oncology vial fufuluina - sterilizing ma depyrogenation - faatumuina - taofi - tapuni - fufulu fafo laina gaosiga:
O lenei laina o loʻo faʻaaogaina e gaosia ai fagu oncology injectable, lea e aofia ai masini e 5: Full Servo Driven Vertical Ultrasonic Washing Machine, Hot Air Circulation Sterilizing & Depyrogenation Tunnel, Full Servo Driven Vial Filling-Stoppering Machine, Vial Capping Machine ma Faʻasao Faʻamalo i fafo.
A maeʻa ona faʻatumu, o le a alu i le semi-stoppering ma sauni mo le faʻamago faʻamago, ona faʻasolo lea i le masini faʻapipiʻi, a maeʻa, o le a alu i le masini fufulu fafo. Matou te faʻaaogaina le fuaina o luga ole laiga mo le faʻatumuina o masini, o mea e le faʻamaoniaina o le a teena otometi.
1. Fufulu
2. Fa'amama & Depyrogenation
3. Faatumu & Taofi
4. Fa'amau
5. Fufulu i fafo
6. mae'a
2. Fa'a'aisa fa'amago ma ta'avale uta ma la'u ese faiga:
Mo oloa lyophilized, pe a uma ona faʻatumu ma semi-stoppering, o le a tuʻuina atu e faʻamago faʻamago (Lyophilizer) otometi e ala i le faʻapipiʻiina o masini, pe a maeʻa le lyophilized, o le a tuʻuina atu i le masini faʻapipiʻi e ala i le faʻaogaina o masini.
3. Faiga fa'aesea:
Ona o le oncology o se mea oona, e mafai ona tatou faʻaauupegaina i le isolator e tausia ai le saogalemu o tagata faʻatautaia mai oloa, ia mautinoa o le gaosiga o gaioiga o loʻo puipuia atoatoa i lalo o le faʻaesea.
Folasaga Puupuu
1.Operator ua matua vavae ese mai le nofoaga gaosi sterile autu.
2.A tulaga i totonu eria gaosiga. C/D maualuga potu mama fafo.
3.Only e mafai ona tatala le isolator pe a uma le tapunia faiga, faʻamaonia e manaʻomia mo le toe faʻafouina.
4.Customize HPVS mo sterilization totonu.
5. Fa'amaufa'ailoga fa'asologa o faiga.
6.Adopt HEPA ea inletting, membrane e mafai uma ona puipuia toniga ea tafe ma le faamama.
7.seamless fausaga totonu, mamanu lapotopoto.
8.Adopt inflatable faamaufaailoga mo faitotoa tatala ma totigilima faamalama.
9. Mo oloa oona, faʻaaoga le taga-i-pe-pe-i fafo mamanu.
Isi Galuega
1.CIP/SIP faiga (SIP e VHP).
2.Particle Counter Mata'ituina i luga ole laiga.
3.Airborne Viable Particle Sampler.
4. Vaporized Hydrogen Dioxide Generator.
5. Leak Detector o totini lima.
6. Anemometer.
7.H/T Sensori.
8.ATEX Fa'ailoga.
9.Equinox Sterility Test Module.
10. Ea Sampling Masini.
11. Taga-i-pe-i fafo Filter Suia Fale.
4.Packing faiga:
E mafai ona fa'amae'a injectable vial oncology su'esu'ega moli otometi, leakage asiasiga, fa'ailoga, ma'i fa'apipi'i fa'apipi'i muamua, ma felauaiga pusa fa'amomoli.
E mafai ona matou faʻapipiʻiina le faʻapipiʻiina o pusa faʻapipiʻi otometi, tusi faʻatonuga ma le faʻaofiina o tusi faamaonia, faʻapipiʻi pusa, faʻamaufaʻailoga pusa, faʻailoga, faʻamaumauga o faʻamaumauga, ma le faʻaogaina o le taʻavale, lea e mafai ona teenaina pusa i le mamafa sese, poʻo i latou e le faʻamaonia igoa.
5.Pharmaceutical vai togafitiga:
E aofia ai le vai fa'amamāina (2RO+EDI), fa'amama vai (WFI), ma le afi afi mama. O lo'o iai fo'i le tane PW ma le tane WFI.
6.Clean potu & HVAC
E aofia ai panels puipui potu mama, faʻaalo panels, faamalama, faitotoa, fola, moli, ea taulimaina iunite, faamama HEPA, ala ea, mataʻutia, faiga pulea taavale ma isi Ina ia tausia le injectable vial oncology gaosiga faagasologa puipuia i lalo Vasega C + Isolator siosiomaga .
7.Black aoga
E aofia ai le ea compressor system ma boiler system e tu'uina atu ai le ea fa'apipi'i talafeagai ma le ausa mo injectable vial oncology gaosiga.
8. Falesu'esu'e
E aofia ai ituaiga uma o suʻega suʻega mea faigaluega, ma meafale fale e suʻe ai faʻataʻitaʻiga oncology injectable vial ma mea mata, e pei o le potu mautu, HPLC, atomic absorption, ultraviolet spectrometer, fourier transform infrared spectrometer etc.
9. Fa'asoa & paipa faiga
E aofia ai ituaiga uma o faiga pipeline ma alamanuia pipeline manaomia i injectable vial oncology turnkey laau, e pei o vai faamamaina, vai tui, ausa mama, vai malulu, vai malulu, ea compressed, ausa fale gaosi oloa ma isi.
IVENmaua se 'au fa'atekinisi fa'apolofesa ma fa'ainisinia, o la matou a'oa'oga i luga ole laiga ma le mae'a fa'atauga lagolago e mafai ona tu'uina atu se fa'amautinoaga fa'atekinisi umi mo lau NON-PVC IV turnkey plant:
IVEN E mafai ona fesoasoani le tele o fa'amaumauga e te mauaGMP & FDA tusi faamaoniamo lau laau toto IV faigofie (E aofia ai le IQ / OQ / PQ / DQ / FAT / SAT ma isi i le Igilisi ma le gagana Saina):
IVEN galuega ma le poto masani e mafai ona fesoasoani ia te oe e faauma atoa IV solution turnkey plant i se taimi sili ona puupuu ma aloese mai ituaiga uma o tulaga lamatia:
IVENmaua se 'au fa'atekinisi fa'apolofesa ma fa'ainisinia, o la matou a'oa'oga i luga ole laiga ma le mae'a fa'atauga lagolago e mafai ona tu'uina atu se fa'amautinoaga fa'atekinisi umi mo lau NON-PVC IV turnkey plant:
E oʻo mai i le taimi nei, ua uma ona matou tuʻuina atu le selau seti o mea tau vailaʻau ma mea faʻafomaʻi i le silia ma le 50 atunuu.
I le taimi nei, sa matou fesoasoani ia matou tagata faʻatau efausia 20+ falema'i ma falema'i turnkey falei Uzbekistan, Tajikistan, Initonesia, Thailand, Saudi, Iraq, Nigeria, Uganda, Tanzania, Etiopia, Myanmar ma isi, aemaise lava mo le IV solution, injectable vials ma ampoules. O nei poloketi uma na manumalo ai a matou tagata faʻatau ma a latou faʻamatalaga maualuga a le malo.
Na matou auina atu foʻi la matou laina faʻapipiʻi IV i Siamani.
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