OEB5 Injectable oncology vial turnkey laau
Fa'amatalaga o oloa:
O le IVEN Pharmatech o le paionia o lo'o tu'uina atu 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:
Vitio oloa
Fa'amatalaga autu
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:
* Au'aunaga faufautua a'o le'i fa'ainisinia
* Filifiliga o le gaosiga
* Filifiliga faʻataʻitaʻiga meafaigaluega ma faʻapitoa
* Faʻapipiʻiina ma faʻatonuina
* Faʻamaoniga o meafaigaluega ma faʻagasologa
* Faʻaliliuina tekinolosi gaosiga
* Faʻamaumauga malo ma vaivai
* A'oa'oga mo tagata faigaluega tomai ma isi.
Laasaga o le faagaoioiga o oloa
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, faʻapipiʻiina o 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.
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.
Tulaga lelei:
O le IVEN o lo'o i ai se 'au fa'atekinisi ma fa'ainisinia fa'apolofesa, o la matou a'oa'oga i luga ole laiga ma le lagolago ina ua uma ona fa'atau atu e mafai ona tu'uina atu se fa'amautinoaga fa'atekinisi mo se taimi umi mo lau la'au fa'atosina oncology turnkey.
IVEN O le tele o fa'amaumauga e mafai ona fesoasoani ia te oe e maua ai le GMP & FDA tusipasi mo lau laau toto IV (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:
O lo'o fa'atau atu fale gaosi oloa a le IVEN i atunu'u i fafo:
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, na matou fesoasoani ia matou tagata faʻatau e fausia 20+ vailaʻau ma falemaʻi turnkey laau i Uzbekistan, Tajikistan, Initonesia, Thailand, Saudi, Iraq, Nigeria, Uganda, Tanzania, Etiopia, Myanmar ma isi, aemaise lava mo 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.