I-non-PVC soft bag IV solution turnkey plant
Incazelo Yomkhiqizo:
I-IVEN Pharmatech ingumphakeli oyivulandlela wezitshalo ze-turnkey ezihlinzeka ngesisombululo sobunjiniyela esididiyelwe semboni yemithi yomhlaba wonke njengesixazululo se-IV, umgomo, i-oncology njll., ngokuhambisana ne-EU GMP, i-US FDA cGMP, i-PICS, ne-WHO GMP.
Sihlinzeka ngomklamo onengqondo kakhulu wephrojekthi, okokusebenza kwekhwalithi ephezulu kanye nensizakalo eyenziwe ngokwezifiso ezimbonini ezahlukene zemithi nezokwelapha kusukela ku-A kuya ku-Z ngesisombululo se-IV yesikhwama esithambile esingesona se-PVC, isisombululo sebhodlela le-PP IV, isisombululo se-Glass vial IV, Isitsha Esijova & I-Ampoule, Isiraphu, amaphilisi namaphilisi, ishubhu lokuqoqa igazi leVacuum njll.
Ifaka ini iphrojekthi ye-VENN Non-PVC yesikhwama esithambile se-IV ye-turnkey:
Ividiyo Yomkhiqizo
Incazelo eyinhloko
Izixazululo ezididiyelwe zobunjiniyela ze-VEN zefektri yemithi nezokwelapha zihlanganisa igumbi elihlanzekile, uhlelo lokulawula okuzenzakalelayo nokuqapha, uhlelo lokwelapha amanzi emithi, uhlelo lokulungiselela isixazululo nokudlulisa, uhlelo lokugcwalisa nokupakisha, uhlelo lwe-othomathikhi lwe-logistics, uhlelo lokulawula ikhwalithi, i-laboratory ephakathi nokunye. Igxile ezidingweni zamakhasimende ngazinye, i-VEN ihlela ngendlela oyifisayo izixazululo zobunjiniyela kubasebenzisi:
*Isevisi yokubonisana nobunjiniyela
*Ukukhetha inqubo yokukhiqiza
* Ukukhetha imodeli yesisetshenziswa nokwenza ngokwezifiso
*Ukufakwa kanye nokusebenza
*Ukuqinisekiswa kwemishini kanye nenqubo
*Ukudlulisa ubuchwepheshe bokukhiqiza
*Amadokhumenti aqinile futhi athambile
*Ukuqeqeshwa kwabasebenzi abanamakhono nokunye.
Izinyathelo zokusebenza komkhiqizo
I-1.Non-PVC isikhwama esithambile isixazululo se-IV Ukwakha-Ukugcwalisa-Ukuvala umugqa wokukhiqiza:
Lo mugqa usetshenziselwa ukukhiqiza isikhwama se-IV ngefilimu ye-Non-PVC (PP), kanye nokuqedela ukwakha isikhwama, ukuphrinta, ukugcwalisa nokufaka uphawu ngomshini ofanayo.
Usayizi wesikhwama se-IV usukela ku-100ml - 5000ml.Kudingeka isigamu sehora kuphela ukuze ushintshe usayizi owodwa uye komunye.Inomklamo okhethekile wobubanzi obungu-130mm ukuze kugcinwe ifilimu, futhi ingakwazi ukubona ukusetshenziswa kwefilimu okungu-100%, akukho okulahlwayo.
2.Isistimu yokubulala amagciwane:
Isetshenziselwa ukuvala inzalo isikhwama se-IV esiqediwe ngamanzi ashisayo ku-121 ℃.Isikhathi sokuvala inzalo singasukela emaminithini ayi-15 kuya kwengama-30 ngokuya ngezidingo ezihlukene zobuchwepheshe bokukhiqiza, izinga lokushisa lokuvala inzalo liyalungiseka.
Singahlomisa ngemishini yokulayisha isikhwama se-IV ezenzakalelayo, kanye nesistimu yokudlulisa inzalo ezenzakalelayo njengenketho.
3.Isistimu yokupakisha:
Ingaqeda ukomiswa kwesikhwama se-IV, ukutholwa kokuvuza, ukuhlola ukukhanya, ukumboza nokupakisha amabhokisi.
Singahlomisa ngokuvuleka kwebhokisi lokuthumela okuzenzakalelayo, imanuwali yeziqondiso nokufakwa kwesitifiketi, ukupakisha amabhokisi, ukuvala amabhokisi, ukulebula, isistimu yokulandelela idatha, nohlelo lokwenqaba okuzenzakalelayo, olunganqaba amabhokisi anesisindo esingalungile, noma lawo anelebula elingafaneleki.
4. Ukwelashwa kwamanzi ngemithi:
Kuhlanganisa ukuhlanzwa kwamanzi ahlanzekile (2RO+EDI), i-water distiller (WFI), kanye nejeneretha yesitimu esihlanzekile.Ithangi le-PW nethangi le-WFI lifakiwe futhi.
5. Uhlelo lokulungiselela isixazululo:
Isetshenziselwa ukuxuba umuthi namanzi omjovo ndawonye.Sihlomisa ngamasethi angu-2 amathangi okulungisa isixazululo, aneseli yomthwalo we-Mettler-Toledo, kanye nesistimu eshukumisayo kazibuthe.
6.Hlanza igumbi ne-HVAC:
Kuhlanganisa amaphaneli odonga lwamakamelo ahlanzekile, amaphaneli osilingi, amafasitela, iminyango, i-flooring, ukukhanya, iyunithi yokusingatha umoya, izihlungi ze-HEPA, imigudu yomoya, ezesabekayo, uhlelo lokulawula okuzenzakalelayo njll. .
7.Usizo olumnyama
Kuhlanganisa isistimu ye-compressor yomoya kanye nesistimu ye-boiler ukuhlinzeka komoya ocindezelwe odingekayo kanye nesitimu sokukhiqiza isixazululo se-Non-PVC sesikhwama esithambile IV.
8.Ilabhorethri:
Kuhlanganisa zonke izinhlobo zamathuluzi okuhlola elebhu, kanye nefenisha yelebhu yokuhlola amasampula esikhwama se-IV nezinto ezingavuthiwe, njengegumbi lokuzinza, i-HPLC, ukumuncwa kwe-athomu, i-ultraviolet spectrometer, i-fourier transform infrared spectrometer njll.
9.Isistimu yokusabalalisa kanye nepayipi:
Kuhlanganisa zonke izinhlobo zepayipi lenqubo kanye nepayipi lezimboni ezidingekayo ku-Non-PVC IV isikhwama sokujika isikhwama, njengamanzi ahlanziwe, amanzi omjovo, isitimu esihlanzekile, amanzi okupholisa, amanzi abandayo, umoya ocindezelweyo, umusi wezimboni njll.
Izinzuzo eziyinhloko zomugqa wokukhiqiza we-IV wesikhwama esithambile se-IV ye-IV:
* Ukusetshenziswa kwefilimu okungu-100%: akukho umkhawulo wokumosha phakathi kwezikhwama ezimbili ze-IV, kunciphisa kokubili ukusetshenziswa kwempahla namandla.
* Uhlelo oluthembekile lokushisisa nokushisela: Qiniseka ukuthi izinga lokuvuza kwezikhwama ze-IV lingaphansi kuka-0.03%.
* Ukushintsha okusheshayo: Udinga kuphela ihora elingu-0.5-1 ukuze ushintshe usuka kusayizi wesikhwama se-IV uye kwesinye.
* Isakhiwo esihlangene, nciphisa ubude be-1/3 bomshini, yonga indawo yegumbi kanye nezindleko zokusebenza.
* Uhlelo oluzinzile olusebenzayo nolokudlulisa: sebenzisa idizayini ye-combo-port, udinga kuphela uhlelo olu-1 lokulawula, i-HMI engu-1 kanye no-opharetha ongu-1.
* Umbhobho wokugcwalisa ophephile: Gcwalisa ukugcwaliswa kobunikazi belungelo lobunikazi, akukho sixazululo esichichimayo, akukho kukhiqizwa kwezinhlayiya ngesikhathi senqubo yokugcwalisa isikhwama se-IV.
* Ukutholwa okuzenzakalelayo kanye nohlelo lokwenqaba olunephutha lokwenqaba izikhwama ze-IV ezingafanelekile ngokuzenzakalelayo ngemuva kokushiselwa kwe-cap.
Ukonga izindleko zezikhwama ze-IV eziklanyelwe ilungelo lobunikazi le-IV:
a.Idizayini yesikhwama esikhethekile se-IV enobubanzi obungu-130mm, isikhwama esisodwa se-IV singonga ifilimu engu-10mm kunabanye abahlinzeki.
b.Alukho unqenqema olumoshekile phakathi kwezikhwama ze-IV namaqembu, ukusetshenziswa kwefilimu okungu-100%.
c.Ingakwazi ukonga izikhwama ezingu-250 iv ngaphezulu ngeroli ngayinye yefilimu kunezinye ezinobubanzi obungu-135mm
I-IVEN ineqembu elichwepheshile lezobuchwepheshe nobunjiniyela, ukuqeqeshwa kwethu endaweni kanye nokwesekwa kwangemuva kokuthengisa kunganikeza isiqinisekiso sobuchwepheshe sesikhathi eside sesitshalo sakho sokujika ukhiye we-NON-PVC IV:
I-VEN Uhlu olugcwele lwemibhalo lungakusiza ukuthi uthole isitifiketi se-GMP & FDA sesitshalo sakho esiwuketshezi lwe-IV kalula (Kubandakanya i-IQ / OQ / PQ / DQ / FAT / SAT njll kokubili ngesiNgisi nesiShayina):
Ubungcweti nesipiliyoni se-VEN kungakusiza ukuthi uqedele isitshalo sonke se-IV solution turnkey ngesikhathi esifushane futhi ugweme zonke izinhlobo zezingozi ezingaba khona:
I-ven amakhasimende ezitshalo ze-turnkey zemithi yaphesheya kwezilwandle:
Kuze kube manje, sesivele sinikeze amakhulukhulu emishini yokwenza imithi kanye nemishini yezokwelapha emazweni angaphezu kuka-50.
Ngaleso sikhathi, sisize amakhasimende ethu ukuthi akhe izitshalo ezingu-20+ ze-turnkey zemithi nezokwelapha e-Russia, Uzbekistan, Tajikistan, Indonesia, Thailand, Saudi, Iraq, Nigeria, Uganda, Tanzania, Ethiopia, Myanmar njll, ikakhulukazi isixazululo se-IV, izitsha ezijovwayo nama-ampoules. .Wonke la maphrojekthi azuze amakhasimende ethu kanye nokuphawula kwawo okuphezulu kukahulumeni.
Siphinde sathumela umugqa wethu wokukhiqiza isixazululo se-IV eJalimane.
Indonesia IV ibhodlela turnkey plant
Vietnam IV ibhodlela turnkey plant
Uzbekistan IV ibhodlela turnkey plant
Thailand Umjovo vial turnkey plant
Tajikistan IV ibhodlela turnkey plant
I-Saudi Arabia IV bag turnkey plant
Ububanzi bomthamo we-IVN Non-PVC isikhwama esithambile se-IV se-turnkey plant:
| Into | Okuqukethwe Okuyinhloko | ||||||||
| Imodeli | I-SRD1A | I-SRD2A | SRS2A | I-SRD3A | I-SRD4A | I-SRS4A | I-SRD6A | I-SRD12A | |
| Amandla Okukhiqiza Angempela | 100ML | 1000 | 2200 | 2200 | 3200 | 4000 | 4000 | 5500 | 10000 |
| 250ML | 1000 | 2200 | 2200 | 3200 | 4000 | 4000 | 5500 | 10000 | |
| 500ML | 900 | 2000 | 2000 | 2800 | 3600 | 3600 | 5000 | 8000 | |
| 1000ML | 800 | 1600 | 1600 | 2200 | 3000 | 3000 | 4500 | 7500 | |
| Umthombo wamandla | 3 Isigaba 380V 50Hz | ||||||||
| Amandla | 8KW | 22KW | 22KW | 26KW | 32KW | 28KW | 32KW | 60KW | |
| Ingcindezi Yomoya Ecindezelwe | Umoya ocindezelwe owomile nongenawo uwoyela, ukuhlanzeka kungu-5um, ukucindezela kungaphezu kuka-0.6Mpa.Umshini uzoxwayisa ngokuzenzakalelayo futhi ume lapho ingcindezi iphansi kakhulu. | ||||||||
| Ukusetshenziswa Komoya Ocindezelwe | 1000L/mim | 2000L/mim | 2200L/mim | 2500L/mim | 3000L/mim | 3800L/mim | 4000L/mim | 7000L/mim | |
| Hlanza Umfutho Womoya | Ukucindezela komoya ocindezelwe ohlanzekile kungaphezu kuka-0.4Mpa, ukuhlanzeka kungu-0.22um | ||||||||
| Ukusetshenziswa Komoya Okuhlanzekile | 500L/min | 800L/min | 600L/min | 900L/min | 1000L/min | 1000L/min | 1200L/min | 2000L/min | |
| Ukupholisa Umfutho Wamanzi | >0.5kgf/cm2 (50kpa) | ||||||||
| Ukusetshenziswa Kwamanzi Okupholisa | 100L/H | 300L/H | 100L/H | 350L/H | 500L/H | 250L/H | 400L/H | 800L/H | |
| Ukusetshenziswa kwe-nitrogen | Ngokwezidingo ezikhethekile zekhasimende, singasebenzisa i-nitrogen ukuvikela umshini, ingcindezi ingu-0.6Mpa.Ukusetshenziswa kungaphansi kuka-45L/min | ||||||||
| Umsindo Ogijimayo | <75dB | ||||||||
| Izidingo zegumbi | Izinga lokushisa lemvelo kufanele libe ngu-≤26℃, umswakama: 45% -65%, Max.umswakama kufanele ube ngaphansi kuka-85% | ||||||||
| Usayizi Ophelele | 3.26x2.0x2.1m | 4.72x2.6x2.1m | 8x2.97x2.1m | 5.52x2.7x2.1m | 6.92x2.6x2.1m | 11.8x2.97x2.1m | 8.97x2.7x2.25m | 8.97x4.65x2.25m | |
| Isisindo | 3T | 4T | 6T | 5T | 6T | 10T | 8T | 12T | |
I-IVN Non-PVC soft bag IV solution turnkey plant ingakunikeza izinhlobo ezahlukene zemiklamo yezikhwama:
