OEB5 chirongo cheOncology chinobaya jekiseni
IVEN Pharmatechndiyo kambani huru inopa mishonga yemagetsi inosanganisa mishonga yepasi rose yakaita semushonga weIV, mushonga wekudzivirira, chirwere chekenza nezvimwewo, zvichitevedzera zvinodiwa neEU GMP, US FDA cGMP, PICS, uye WHO GMP.
Tinopa dhizaini yemapurojekiti inonzwisisika, michina yemhando yepamusoro uye sevhisi yakagadzirirwa mafekitori akasiyana emishonga nekurapa kubva kuA kusvika kuZ yemhinduro yeIV isiri yePVC soft bag, mhinduro yeIV yebhodhoro rePP, mhinduro yeIV yegirazi, Vial & Ampoule inobayiwa jekiseni, Syrup, Mapiritsi & Makapisi, chubhu yekuunganidza ropa reVacuum nezvimwewo.
Chii chinosanganisira IVEN Injectable oncology vial turnkey plant:
Mhinduro dzeIVEN dzeinjiniya dzakabatanidzwa dzefekitori yemabhodhoro emishonga anopinzwa oncology dzinosanganisira imba yakachena, system yekuzvidzora otomatiki uye yekutarisa, system yekurapa mvura yemishonga, system yekugadzira nekuparadzira mhinduro, washing vial - sterilizing uye depyrogenation - filling - stoppering - cap - external washing, freeze drying system, Isolation system, packing system, automatic logistics system, quality control system, central laboratory nezvimwewo. IVEN inotarisa pane zvinodiwa nevatengi, inogadzirisa mhinduro dzeinjiniya zvine hungwaru kune vashandisi vari pa:
1. Kusuka chivharo che oncology chine jekiseni - kuuraya utachiona uye kubvisa hutachiona - kuzadza - kumisa - kuvhara - mutsetse wekugadzira wekuwachisa wekunze:
Mutsetse uyu unoshandiswa kugadzira mabhodhoro ekudzivirira chirwere chekenza anoiswa jekiseni, ane michina mishanu: Muchina wekuwachisa weFull Servo Driven Vertical Ultrasonic, Mugero weHot Air Circulation Sterilizing & Depyrogenation, Muchina wekuzadza mabhodhoro akazara weServo Driven, Muchina wekuvhara mabhodhoro uye Muchina wekuwachisa weExternal.
Mushure mekuzadza, inozoiswa muchikamu chekumisa uye yozoomeswa nechando, yozoendeswa kumuchina wekufukidza, mushure meizvozvo, inozoendeswa kumuchina wekugezesa wekunze. Tinoshandisa sisitimu yekuyera yepamhepo yemuchina wekuzadza, zvigadzirwa zvisina kukodzera zvinorambwa otomatiki.
1. Kugeza
2. Kuchenesa & Kubvisa hutachiona
3. Kuzadza & Kuvhara
4. Kuvhara
5. Kugeza Kunze
6. yapera
2. Kuomesa nekuomesa nekuisa otomatiki system yekurodha nekuburitsa zvinhu:
Kune zvigadzirwa zvakapfava, mushure mekuzadza nekumisa zvishoma, zvinoendeswa kuomesa nechando (Lyophilizer) otomatiki kuburikidza ne auto loading system, mushure me lyophilized, zvinoendeswa kumuchina wekuvharira ne auto unloading system.
3. Sisitimu yekuzviparadzanisa:
Sezvo oncology iri chigadzirwa chine chepfu, tinogona kushandisa isolator kuchengetedza kuchengetedzwa kwevashandi kubva kuzvigadzirwa, kuve nechokwadi chekuti maitiro ekugadzira akachengetedzwa zvizere pasi pehurongwa hwekuzviparadzanisa.
Nhanganyaya Pfupi
1. Mushandi akaparadzaniswa zvachose nenzvimbo yekugadzira isina utachiona.
2. Nzvimbo yekugadzira yemukati ine mwero weA. Imba yakachena yekunze ine mwero weC/D.
3.Inogona chete kuvhura isolator mushure mekudzima system, kusimbiswa kunodiwa kuti utangezve.
4.Gadzirisa HPVS kuti ivharwe mukati.
5. Sisitimu yekutenderera yakavharirwa.
6.Adopt HEPA air inletting, membrane inogona kuchengetedza kuyerera kwemhepo kwakafanana uye firita.
7. Chimiro chemukati chisina musono, dhizaini yekutenderera.
8. Tora chisimbiso chinofefetera chemusuwo wakavhurika uye mahwindo egirovhosi.
9. Kana muine chepfu, shandisai dhizaini yekuburitsa zvinhu mubhegi.
Mamwe Mabasa
1. Sisitimu yeCIP/SIP (SIP neVHP).
2. Kutarisa Pamhepo Zvidimbu zveChikamu.
3. Muenzanisi weZvidimbu Zvinoshanda Mumhepo.
4. Jenareta yeHydrogen Dioxide yakasanganiswa nemhepo.
5. Chinoongorora magirovhosi.
6. Chiyero cheAnemometer.
7.H/T Sensor.
8. Kuyera kweATEX.
9. Module yeKuedza Kusabereka yeEquinox.
10. Mudziyo weKutora Sample yeMhepo.
11. Chigadziko chekuchinja cheFirita chiri mubhegi.
4. Sisitimu yekurongedza:
Inogona kupedzisa kuongororwa kwechiedza chega chega kwejekiseni remubhodhoro, kuongororwa kwekubuda kwemvura, kunyora mazita, blister ine kurongedza kwekutanga kwekatoni, uye kurongedza katoni yekutumira.
Tinogona kugadzira mabhokisi ekutumira otomatiki, bhuku remirayiridzo uye kuisa zvitupa, kurongedza mabhokisi, kuvharira mabhokisi, kunyora mazita, sisitimu yekutsvaga data, uye sisitimu yekuramba otomatiki, izvo zvinogona kuramba mabhokisi ane huremu husina kunaka, kana ane label isina kukodzera.
6. Kamuri rakachena & HVAC
Inosanganisira mapaneru emadziro emakamuri akachena, mapaneru edenga, mahwindo, magonhi, pasi, mwenje, unit yekubata mhepo, mafirita eHEPA, machubhu emhepo, anotyisa, auto control system nezvimwewo. Kuchengetedza maitiro ekugadzira kenza yemubhodhoro inobayiwa yakachengetedzwa pasi peClass C + Isolator environment.
8. Rabhoritari
Inosanganisira marudzi ese emidziyo yekuyedza murabhoritari, uye fenicha yerabhoritari yekuyedza samples dzeincology dzemubhodhoro wejekiseni nezvinhu zvakasvibiswa, zvakaita se stability chamber, HPLC, atomic absorption, ultraviolet spectrometer, fourier transform infrared spectrometer nezvimwewo.
9. Kugovera & sisitimu yemapaipi
Inosanganisira marudzi ese emapipi ekugadzira uye mapaipi eindasitiri anodiwa mujekiseni re oncology remuchina we injectable vial, senge mvura yakacheneswa, mvura yejekiseni, utsi hwakachena, mvura inotonhorera, mvura inotonhorera, mhepo yakamanikidzwa, utsi hweindasitiri nezvimwewo.
IVENTine timu yehunyanzvi uye yeinjiniya ine hunyanzvi, kudzidziswa kwedu panzvimbo iyi uye rutsigiro rwekutevera kutengesa kunogona kupa vimbiso yenguva refu yehunyanzvi hwechigadzirwa chako cheNON-PVC IV fluid turnkey:
Magwaro akazara anogona kukubatsira kuwanaChitupa cheGMP & FDAKuti ushandise mushonga wemuchina wako wemuchina wemuchina zviri nyore (Kusanganisira IQ / OQ / PQ / DQ / FAT / SAT nezvimwewo muChirungu nemuChinese):
Basa neruzivo rweIVEN zvinogona kukubatsira kupedzisa chirimwa che "whole IV solution turnkey plant" munguva pfupi uye kudzivirira njodzi dzese dzingangoitika:
IVENTine timu yehunyanzvi uye yeinjiniya ine hunyanzvi, kudzidziswa kwedu panzvimbo iyi uye rutsigiro rwekutevera kutengesa kunogona kupa vimbiso yenguva refu yehunyanzvi hwechigadzirwa chako cheNON-PVC IV fluid turnkey:
Kusvika pari zvino, tatove nemazana emidziyo yemishonga nemidziyo yekurapa kunyika dzinopfuura makumi mashanu.
Panguva iyi, takabatsira vatengi vedu kutivakavaka nzvimbo dzinopfuura makumi maviri dzekugadzira mishonga nedzekurapamuUzbekistan, Tajikistan, Indonesia, Thailand, Saudi Arabia, Iraq, Nigeria, Uganda, Tanzania, Ethiopia, Myanmar nezvimwewo, kunyanya mushonga wemushonga wemutsinga, mabhodhoro emushonga unobayiwa jekiseni nemaampoules. Mapurojekiti ese aya akafadza vatengi vedu nehurumende yavo.
Takatumirawo mutsetse wedu wekugadzira mhinduro dzemuchina weIV kuGermany.
Chirimwa chemuchina wekugadzira mabhodhoro emuIndonesia IV
Chivako cheVietnam IV chekugadzira mabhodhoro
Chirimwa chebhodhoro cheUzbekistan IV
Chirimwa cheThailand chinobaya jekiseni remuchina wekushandura majekiseni
Chirimwa cheTajikistan IV chekugadzira mabhodhoro





