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OEB5 Incology Incology iglasi yokujika isityalo

Intshayelelo emfutshane:

IVEN Pharmatech ngumboneleli onguvulindlela wezityalo ezijikajika ezibonelela ngesisombululo sobunjineli esidibeneyo kumzi mveliso wamachiza onje ngesisombululo se-IV, isitofu sokugonya, i-oncology njl., Ngokuthobela i-EU GMP, i-US FDA cGMP, iPICS, kunye ne-WHO GMP.

Sibonelela ngoyilo lweprojekthi olusengqiqweni, izixhobo ezikumgangatho ophezulu kunye nenkonzo elungelelanisiweyo kwimizi-mveliso eyahlukeneyo yoxubo kunye neyonyango ukusuka ku-A ukuya ku-Z ngesisombululo se-IV esingathambekiyo se-IV, isisombululo se-PP sebhotile IV, isisombululo seGlass vial IV, Inalable Vial & Ampoule, Isiraphu, Amacwecwe kunye neeCapsule, ityhubhu yokuqokelela igazi njl.


Iinkcukacha Product

Iimpawu zemveliso

Ingcaciso yeMveliso:

IVEN Pharmatech ngumboneleli onguvulindlela wezityalo ezijikajika ezibonelela ngesisombululo sobunjineli esidibeneyo kumzi mveliso wamachiza onje ngesisombululo se-IV, isitofu sokugonya, i-oncology njl., Ngokuthobela i-EU GMP, i-US FDA cGMP, iPICS, kunye ne-WHO GMP.

Sibonelela ngoyilo lweprojekthi olusengqiqweni, izixhobo ezikumgangatho ophezulu kunye nenkonzo elungelelanisiweyo kwimizi-mveliso eyahlukeneyo yoxubo kunye neyonyango ukusuka ku-A ukuya ku-Z ngesisombululo se-IV esingathambekiyo se-IV, isisombululo se-PP sebhotile IV, isisombululo seGlass vial IV, Inalable Vial & Ampoule, Isiraphu, Amacwecwe kunye neeCapsule, ityhubhu yokuqokelela igazi njl.

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Ibandakanya ntoni IVEN Incology ye-vial turnkey yesityalo ebandakanya:

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Imveliso yeVidiyo

Inkcazo engundoqo

Izisombululo zobunjineli ezidityanisiweyo ze-IVEN zefektri ye-oncology yefektri ibandakanya igumbi elicocekileyo, ulawulo oluzenzekelayo kunye nenkqubo yokubeka iliso, inkqubo yonyango lwamanzi, isisombululo ukulungiselela kunye nenkqubo yokuhambisa, ukuhlamba i-vial-sterilizing kunye ne-depyrogenation-ukuzalisa-ukumisa-ukucoca-ukuhlamba kwangaphandle, ukubanda Inkqubo yokumisa, inkqubo yokuzalela, inkqubo yokupakisha, inkqubo ye-othomathikhi, inkqubo yolawulo lomgangatho, ilabhoratri esembindini njl njl, egxile kwiimfuno zabathengi, IVEN izenzela izisombululo zobunjineli ngocoselelo kubasebenzisi kwi:

* Inkonzo yokubonisana ngaphambi kobunjineli
* Inkqubo yokhetho yokukhetha
* Ukukhethwa kwemodeli yezixhobo kunye nokwenza ngokwezifiso
* Ukufakwa kunye nokugunyaziswa
* Ukuqinisekiswa kwezixhobo kunye nenkqubo
* Itekhnoloji yokuvelisa idlulisa
* Amaxwebhu anzima kwaye athambileyo
* Uqeqesho lwabasebenzi abanezakhono njalo njalo.

Amanyathelo okusebenza kwemveliso

I-1.

Lo mgca usetyenziselwa ukuvelisa iibhotile ze-oncology ezingenaliti, ezibandakanya oomatshini aba-5: Umatshini oHlamba i-Servo oQinisekisiweyo we-Ultrasonic, Umatshini osasaza umoya oshushu kunye neTownyation Tunnel, umatshini opheleleyo wokugcwalisa i-Vial Fill-Stoppering Machine, Umatshini wokuCofa iVial kunye noMatshini wokuhlamba wangaphandle.

Emva kokugcwalisa, iya kuya kwi-semi-stoppering kwaye ilungele ukumiswa komkhenkce, emva koko uye kumatshini wokufaka, emva koko, iya kumatshini wokuhlamba wangaphandle. Sisebenzisa inkqubo yokulinganisa online yokugcwalisa umatshini, iimveliso ezingafanelekanga ziya kunqatshwa ngokuzenzekelayo.

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1. Ukuhlamba

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2. Ukucoca kunye nokunyibilikisa umzimba

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3. Ukuzalisa kunye nokumisa

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4. Ukuthatha amanqaku

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5. Ukuhlamba umzimba kwangaphandle

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6. ugqibile

2.Freeze isomisi kunye auto ekulayisheni kunye nokothula inkqubo:

Kwiimveliso ezine-lyophilized, emva kokugcwalisa kunye nokuyeka ukumisa, kuya kudluliswa kukomisa isomisi (iLyophilizer) ngokuzenzekelayo ngenkqubo yokulayisha ngokuzenzekelayo, emva kwe-lyophilized, iya kudluliselwa kumatshini wokubamba ngenkqubo yokukhuphela ngokuzenzekelayo.

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Inkqubo yokuzihlukanisa:

Njengoko i-oncology iyimveliso enetyhefu, sinokuxhobisa sodwa ukugcina ukhuseleko lwabasebenza kwiimveliso, ukuqinisekisa ukuba inkqubo yemveliso ikhuselwe ngokupheleleyo phantsi kwenkqubo yokuzahlula.

Intshayelelo emfutshane
I-1.Operator yahlulwe ngokupheleleyo kwindawo engundoqo yokuvelisa.
Umgangatho wendawo yemveliso yangaphakathi. Inqanaba le-C / D igumbi langaphandle elicocekileyo.
3. Ngu-kuphela onokuvula i-isolator emva kokuvalwa kwenkqubo, ubunyani buyimfuneko ukuze uqalise ukusebenza.
4.Yenza i-HPVS yenzalo yangaphakathi.
Inkqubo yokujikeleza evaliweyo.
6.Adopt HEPA yokungenisa umoya, inwebu inokukhusela ukuhamba kwomoya okufanayo kunye nefilitha.
Ulwakhiwo lwangaphakathi olungenamthungo, uyilo lokujikeleza.
8.Adopt inflatable itywina kuzo zombini iingcango zomnyango ezivulekileyo kunye neiglavu.
9.Kwimveliso enetyhefu, sebenzisa uyilo lwebhegi-ebhegini-ngaphandle.

Eminye iMisebenzi
Inkqubo yeCIP / SIP (SIP yiVHP).
2.Ukubekwa kweliso kwi-Intanethi.
3.Sampler yeParticle Sampler esebenzayo.
4.Vaporized Hydrogen dioxide Generator.
5.Ukuvuza kwesiKhuseli seGlove.
6. Isilinganisi somzimba.
7.H / T woluvo.
Ukulinganiswa kwe-8.
Imodyuli yovavanyo lokuzala.
10.Air Isampulu Icebo.
11.Bag-in-bag-out Filter Ukutshintsha izindlu.

Inkqubo 4.Packing:

Inokugqiba i-oncology ye-vial oncology yokuhlola ukukhanya okuzenzekelayo, ukuhlolwa kokuvuza, iilebheli, i-blister kunye nokupakisha kwebhokisi yokuqala, kunye nokupakisha ibhokisi.
Sinokuxhobisa ngokuvula ngokuzenzekelayo ibhokisi yokuhambisa, ukufaka incwadi yemiyalelo kunye nokufaka isatifikethi, ukupakisha ibhokisi, ukutywina ibhokisi, ukuphawula, inkqubo yokukhangela idatha, kunye nenkqubo yokulahla imoto, enokwala iibhokisi ezinobunzima obuphosakeleyo, okanye ezo zinelebheli engafanelekanga.

Unyango lwamayeza 5.Pharmaceutical:

Kubandakanya ukucocwa kwamanzi okucoca (i-2RO + i-EDI), i-distiller yamanzi (i-WFI), kunye ne-generator yomphunga omsulwa. Itanki le-PW kunye netanki yeWFI ifakiwe nayo.

Unyango lwamayeza 5.Pharmaceutical:

Kubandakanya ukucocwa kwamanzi okucoca (i-2RO + i-EDI), i-distiller yamanzi (i-WFI), kunye ne-generator yomphunga omsulwa. Itanki le-PW kunye netanki yeWFI ifakiwe nayo.

Igumbi 7.Clean & HVAC:

Ibandakanya igumbi elicocekileyo iiphaneli zophahla, iiphaneli zesilingi, iifestile, iingcango, i-flooring, ukukhanya, iyunithi yokuphatha umoya, iifilitha ze-HEPA, imibhobho yomoya, eyothusayo, inkqubo yolawulo oluzenzekelayo njl. Ukugcina inkqubo yemveliso ye-oncology yenaliti ekhuselweyo phantsi kweCandelo C + Isolator bume .

Ukusetyenziswa okuMnyama

Ibandakanya inkqubo yecompressor yomoya kunye nenkqubo yebhoyila yokubonelela ngokunyanzeliswa komoya kunye nomphunga kwimveliso ye-oncology ye-vial.

9. Ilabhoratri:

Ibandakanya zonke iintlobo zezixhobo zokuvavanya ilebhu, kunye nefenitshala yeelebhu ukuvavanya iisampulu ze-oncology ezinokufakwa ngaphakathi kunye nezinto ezingafunekiyo, ezinje ngegumbi lokuzinza, i-HPLC, ukufakwa kwe-atom, i-spectrometer ye-ultraviolet, i-fourier transform infrared spectrometer njl.

Ukusasazwa kunye nenkqubo yombhobho:

Ibandakanya zonke iintlobo zenkqubo yombhobho kunye nombhobho weefektri ofunekayo kwisirinji se-oncology isitshixo sesityalo, njengamanzi acociweyo, amanzi enaliti, umphunga omsulwa, amanzi okupholisa, amanzi abandayo, umoya oxinzelelweyo, umphunga wamashishini njl.

Izinto eziluncedo:

I-IVEN ineqela lobuchwephesha kunye nelobunjineli, uqeqesho lwethu olusecaleni kunye nenkxaso yasemva kokuthengisa inokunika isiqinisekiso sobuchwephesha bexesha elide kwisitya sakho se-oncology se-turnkey:

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IVEN Uluhlu olupheleleyo lwamaxwebhu lunokukunceda ufumane isatifikethi se-GMP kunye ne-FDA sesityalo sakho se-IV fluid ngokulula (kubandakanywa i-IQ / OQ / PQ / DQ / FAT / SAT njl.

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Umsebenzi we-IVEN kunye namava kunokukunceda ugqibe isisombululo esipheleleyo se-IV ngexesha lokufutshane kwaye uphephe zonke iintlobo zobungozi:

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IVEN phesheya kwezilwanyana ezivelisa amayeza abathengi bezityalo:

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Ukuza kuthi ga ngoku, sele sinike amakhulu iiseti zezixhobo zoxubo mayeza kunye nezixhobo zonyango kumazwe angaphezu kwama-50.

Okwangoku, sincede abathengi bethu ukuba bakhe izityalo ezingama-20 + zokuxuba amayeza kunye nezonyango eRussia, Uzbekistan, Tajikistan, Indonesia, Thailand, Saudi, Iraq, Nigeria, Uganda, Tanzania, Ethiopia, Myanmar njl., Ikakhulu isisombululo se-IV, izitya ezinokutofa kunye nee-ampoules . Zonke ezi projekthi ziphumelele abathengi bethu kunye noorhulumente.

Sikwathumela imveliso yethu yesisombululo se-IV eJamani.

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Indonesia IV ibhotile yezityalo

Isityalo seVietnam IV sokujika kwebhotile

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Uzbekistan IV ibhotile yezityalo

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I-Thailand Isityalo esingenalutho esine-vial turnkey

Isityalo sebhotile yeTajikistan IV

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Isityalo se-Saudi Arabia IV esikhwameni

Uluhlu lwe-IVEN yesitofu se-oncology se-vial turnkey:

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