OEB5 Isityalo se-oncology esitofwayo kwivial turnkey
VEN Pharmatechngumboneleli onguvulindlela wezityalo ze-turnkey ezibonelela ngesisombululo sobunjineli esihlanganisiweyo kwifektri yamayeza yehlabathi jikelele njengesisombululo se-IV, isitofu, i-oncology njl., ngokuhambelana ne-EU GMP, i-US FDA cGMP, i-PICS, kunye ne-WHO GMP.
Sinikezela ngeyona projekthi ifanelekileyo yoyilo, izixhobo ezikumgangatho ophezulu kunye nenkonzo elungelelanisiweyo kwiifektri ezahlukeneyo zamayeza kunye nezonyango ukusuka kwi-A ukuya ku-Z ye-Non-PVC ye-soft bag IV isisombululo, isisombululo se-PP sebhotile IV, isisombululo seglasi yeglasi ye-IV, i-Injectable Vial & Ampoule, Isiraphu, iitafile kunye neeCapsules, ityhubhu yokuqokelela igazi njl njl.
Yintoni i-VEN etofwayo i-oncology vial turnkey plant iquka:
Izisombululo zobunjineli ezidibeneyo ze-VEN ze-oncology ye-oncology ye-pharmaceutical injectable vial factory iquka igumbi elicocekileyo, ulawulo oluzenzekelayo kunye nenkqubo yokubeka iliso, inkqubo yokucoca amanzi amayeza, ukulungiswa kwesisombululo kunye nenkqubo yokusabalalisa, ukuhlamba i-vial - sterilizing kunye ne-depyrogenation - ukuzaliswa - ukumisa - ukuvala - ukuhlamba ngaphandle, ukumisa. inkqubo yokomisa, inkqubo yokwahlukaniswa, inkqubo yokupakisha, inkqubo yolungiselelo oluzenzekelayo, inkqubo yokulawula umgangatho, ilebhu esembindini kunye njl.njl. iimfuno zomntu ngamnye zabathengi, i-VEN ilungisa izisombululo zobunjineli ngobuchule kubasebenzisi kwi:
I-1.I-oncology yokuhlanjwa kwe-vial ene-injectable - sterilizing kunye ne-depyrogenation - ukuzaliswa - ukumisa - i-capping - umgca wemveliso yangaphandle yokuhlamba:
Lo mgca usetyenziselwa ukuvelisa i-oncology vials injectable, equkethe oomatshini be-5: I-Servo Driven Vertical Vertical Ultrasonic Machine, i-Hot Air Circulation Sterilizing & Depyrogenation Tunnel, i-Servo Driven Full Vial Filling-Stoppering Machine, i-Vial Capping Machine kunye ne-External Washing Machine.
Emva kokuzaliswa, iya kuhamba kwi-semi-stoppering kwaye ilungele ukomiswa komkhenkce, emva koko uye kumatshini we-capping, emva koko, uya kumatshini wokuhlamba wangaphandle. Samkela inkqubo yokulinganisa i-intanethi yokuzalisa umatshini, iimveliso ezingafanelekanga ziya kugatywa ngokuzenzekelayo.
1. Ukuhlamba
2. Ukuvala inzala kunye ne-Depyrogenation
3. Ukuzalisa nokuyeka
4. Capping
5. Ukuhlamba Kwangaphandle
6. ugqibile
2.Mkhenkce isomisi kunye nenkqubo yokulayisha kunye nokukhulula:
Kwiimveliso ze-lyophilized, emva kokuzaliswa kunye ne-semi-stoppering, iya kuhanjiswa kwi-dryer dryer (Lyophilizer) ngokuzenzekelayo nge-auto loading system, emva kokuba i-lyophilized, iya kuhanjiswa kumatshini we-capping nge-auto unloading system.
3.Inkqubo yokuzahlula :
Njengoko i-oncology iyimveliso eyityhefu, sinokuxhobisa nge-isolator ukugcina ukhuseleko lwabaqhubi kwiimveliso, ukuqinisekisa ukuba inkqubo yokuvelisa ikhuselwe ngokupheleleyo phantsi kwenkqubo yokwahlula.
Intshayelelo emfutshane
I-1.Operator yahlulwe ngokupheleleyo kwindawo yokuvelisa eyinyumba engundoqo.
2.Inqanaba lendawo yemveliso yangaphakathi. Igumbi le-C/D elicocekileyo langaphandle.
3.Kuphela kunokuvula i-isolator emva kokuvalwa kwenkqubo, ukuqinisekiswa kuyafuneka ukuze uqalise kwakhona.
4.Yenza ngokwezifiso i-HPVS yokuvala inzala yangaphakathi.
5.Isistim sokujikeleza esitywiniweyo.
I-6.Adopt i-HEPA yokungena emoyeni, i-membrane inokukhusela zombini ukuhamba komoya okufanayo kunye nesihlungi.
7.Isakhiwo sangaphakathi esingenamthungo, uyilo olujikelezayo.
8.Adopt inflatable isitywina kuzo zombini ucango oluvulekileyo kunye neefestile zeglavu.
9.Kwimveliso ezinetyhefu, sebenzisa i-bag-in-bag-out design.
Eminye imisebenzi
Inkqubo ye-1.CIP/SIP (SIP ngeVHP).
2.I-Particle Counter Online Monitoring.
3.Airborne Viable Particle Sampler.
4.Ijenereyitha yeHydrogen Dioxide engumphunga.
5.Isixhobo esivuzayo seGlove.
6.Anemometer.
7.H/T Uluvo.
8.ATEX Umlinganiselo.
9.Equinox Sterility Test Modyuli.
10.Isixhobo seSampulu somoya.
11.I-Bag-in-bag-out Isihluzi Ukutshintsha iZindlu.
4.Inkqubo yokuPakisha:
Inokugqiba ukuhlolwa kwe-vial ye-oncology etofwayo ngokuzenzekelayo, ukuhlolwa kokuvuza, ukuleyibhile, i-blister ene-carton yokupakisha, kunye nokupakishwa kweekhathoni zokuthumela.
Sinokuxhobisa ngokuvulwa kweebhokisi zokuthumela ngokuzenzekelayo, incwadana yomyalelo kunye nokufakwa kwesatifikethi, ukupakishwa kweebhokisi, ukutywinwa kweebhokisi, ukuleyibhile, inkqubo yokulandelela idatha, kunye nenkqubo yokulahlwa kwe-auto, enokugatya iibhokisi ezinobunzima obungalunganga, okanye abo baneleyibhile engafanelekanga.
5.Unyango lwamanzi olwenziwa ngamayeza:
Iquka ukucocwa kwamanzi ahlambulukileyo (2RO + EDI), i-distiller yamanzi (i-WFI), kunye nejeneretha ecocekileyo yomphunga. Itanki ye-PW kunye ne-WFI itanki ifakiwe nayo.
6.Coca igumbi & HVAC
Ibandakanya iipaneli zodonga ezicocekileyo zegumbi, iipaneli zesilingi, iifestile, iingcango, i-flooring, ukukhanya, iyunithi yokuphatha umoya, izihlungi ze-HEPA, i-air ducts, ezothusayo, inkqubo yokulawula i-auto njl. .
7.Uncedo olumnyama
Ibandakanya inkqubo yecompressor yomoya kunye nenkqubo yebhoyila ukubonelela umoya ocinezelweyo oyimfuneko kunye nomphunga wokuvelisa i-oncology ye-vial etofwayo.
8.Ilebhu
Ibandakanya zonke iintlobo zezixhobo zokuvavanya elebhu, kunye nefanitshala yelabhu yokuvavanya iisampuli ze-oncology ezitofwayo kunye nemathiriyeli ekrwada, efana negumbi lozinzo, i-HPLC, ukufunxwa kweathom, i-ultraviolet spectrometer, i-fourier transform infrared spectrometer njl.
9.Ukuhanjiswa kunye nenkqubo yombhobho
Ibandakanya zonke iintlobo zombhobho wenkqubo kunye nombhobho wemizi-mveliso ofunekayo kwi-vial oncology turnkey plant, njengamanzi acociweyo, amanzi okuhlamba, umphunga ococekileyo, amanzi okupholisa, amanzi abandayo, umoya oxinzelelweyo, umphunga wamashishini njl.
IVENube neqela lobuchwephesha lobuchwephesha kunye nobunjineli, uqeqesho lwethu kwi-site kunye nenkxaso emva kokuthengisa inokunika isiqinisekiso sobugcisa sexesha elide kwi-NON-PVC IV yesityalo sakho sokujika ulwelo:
I-VEN Uluhlu olupheleleyo lwamaxwebhu lunokukunceda ufumaneIsiqinisekiso se-GMP kunye ne-FDAkwisityalo sakho se-IV fluid ngokulula (Kubandakanya i-IQ / OQ / PQ / DQ / FAT / SAT njl njl zombini kwinguqulelo yesiNgesi nesiTshayina):
Ubuchwephesha be-VEN kunye namava anokukunceda ugqibezele isisombululo se-IV sesityalo sokujika ngexesha elifutshane kwaye uthintele zonke iintlobo zomngcipheko onokuthi ubekho:
IVENube neqela lobuchwephesha lobuchwephesha kunye nobunjineli, uqeqesho lwethu kwi-site kunye nenkxaso emva kokuthengisa inokunika isiqinisekiso sobugcisa sexesha elide kwi-NON-PVC IV yesityalo sakho sokujika ulwelo:
Ukuza kuthi ga ngoku, sele sinike amakhulu eesethi zezixhobo zonyango kunye nezixhobo zonyango kumazwe angaphezu kwama-50.
Ngeli xesha, siye sanceda abathengi bethu ukubawakha izityalo ze-20+ zamachiza kunye nezonyango zokujikae-Uzbekistan, eTajikistan, e-Indonesia, eThailand, eSaudi, e-Iraq, eNigeria, e-Uganda, eTanzania, e-Ethiopia, eMyanmar njl, ikakhulu kwisisombululo se-IV, ii-vials ezitofwayo kunye nee-ampoules. Zonke ezi projekthi ziphumelele abathengi bethu kunye nezimvo zabo eziphezulu kurhulumente.
Siphinde sathumela umgca wethu wokuvelisa isisombululo se-IV eJamani.
Indonesia IV ibhotile turnkey plant
Vietnam IV ibhotile turnkey plant
Uzbekistan IV ibhotile turnkey plant
Thailand Isityalo se-vial turnkey esitofwayo
Tajikistan IV ibhotile turnkey plant
