OEB5 oncology injectable vial turnkey osisi
Ụlọ ọrụ IVEN Pharmatechbụ onye ọsụ ụzọ na-ebubata osisi turnkey nke na-enye ngwọta injinia agbakwunyere maka ụlọ ọrụ ọgwụ zuru ụwa ọnụ dị ka ngwọta IV, ọgwụ mgbochi, oncology wdg, na nnabata EU GMP, US FDA cGMP, PICS, na WHO GMP.
Anyị na-enye ndị kasị ezi uche oru ngo imewe, na elu àgwà akụrụngwa na ahaziri ọrụ dị iche iche na-emepụta ọgwụ na ọgwụ ụlọ ọrụ si A ruo Z maka Non-PVC soft akpa IV ngwọta, PP bottle IV ngwọta, Glass vial IV ngwọta, Injectable Vial & Ampoule, Syrup, mbadamba & Capsules, Vacuum blood collection tube wdg.
Kedu ihe IVEN injectable oncology vial turnkey osisi gụnyere:
Ihe ngwọta injinia agbakwunyere nke IVEN maka ụlọ ọrụ injectable oncology vial ụlọ ọrụ gụnyere ime ụlọ dị ọcha, sistemu njikwa akpaaka na nleba anya, usoro ọgwụgwọ mmiri ọgwụ, usoro nkwadebe na nkesa nkesa, ịsa vial - sterilizing na depyrogenation - ndochi - nkwụsị - capping - ịsacha mpụga, ifriizi. ihicha usoro, kewapụrụ usoro, mbukota usoro, akpaka lọjistik usoro, àgwà akara usoro, Central laabu na wdg lekwasịrị anya na Ihe ndị ahịa chọrọ, IVEN na-ahazi azịza injinia nke ọma maka ndị ọrụ na:
1.Injectable oncology vial ịsacha - sterilizing na depyrogenation - ndochi - nkwụsị - capping - mpụga mmepụta akara:
A na-eji ahịrị a na-emepụta vial oncology injectable, nke nwere igwe 5: Full Servo Driven Vertical Ultrasonic Washing Machine, Hot Air Circulation Sterilizing & Depyrogenation Tunnel, Full Servo Driven Vial Filling-Stoppering Machine, Vial Capping Machine na Mpụga Asụsụ Machine.
Mgbe emejuchara, ọ ga-aga na ọkara nkwụsị ma dị njikere maka ihicha oyi, wee gaa na igwe capping, mgbe nke ahụ gasịrị, ọ ga-aga na igwe ịsa ahụ dị n'èzí. Anyị na-agbaso usoro ntanetị maka igwe na-ejuputa, a ga-ajụ ngwaahịa ndị na-erughị eru na-akpaghị aka.
1. Ịsacha
2. Sterilizing & Depyrogenation
3. Ndochi & Nkwụsị
4. Capping
5. Ịsacha Mpụga
6. emechara
2.Freeze dryer na auto loading and unloading system:
Maka ngwaahịa lyophilized, mgbe emejuchara na ọkara nkwụsịtụ, a ga-ebuga ya na friza draya (Lyophilizer) na-akpaghị aka site na sistemu ntinye akpaaka, mgbe lyophilized gachara, a ga-ebuga ya na igwe capping site na sistemụ nbudata akpaaka.
3. Isolation usoro:
Dị ka oncology bụ ngwaahịa na-egbu egbu, anyị nwere ike ịkwado ya na isolator iji dobe nchekwa nke ndị na-arụ ọrụ na ngwaahịa, iji jide n'aka na echekwabara usoro mmepụta nke ọma n'okpuru usoro iche.
Okwu mmalite
1.Operator bụ kpamkpam kewapụrụ isi akpali mmasị mmepụta mpaghara.
2.A larịị ime mmepụta ebe. Ọkwa C/D mpụga ime ụlọ dị ọcha.
3.Only nwere ike imeghe isolator mgbe emechi usoro, nkwenye dị mkpa maka reboot.
4.Hazie HPVS maka ime ime ime.
5.Sealed mgbasa usoro.
6.Adopt HEPA ikuku inletting, akpụkpọ ahụ nwere ike ma chebe otu ikuku eruba na nzacha.
7.Seamless esịtidem Ọdịdị, rounding imewe.
8.Adopt inflatable akara maka ma oghere ọnụ ụzọ na glove windo.
9.N'ihi na ngwaahịa na-egbu egbu, jiri akpa-na-bag-out design.
Ọrụ ndị ọzọ
1.CIP/SIP usoro (SIP nke VHP).
2.Particle Counter Online nlekota oru.
3.Airborne Viable Particle Sampler.
4.Vaporized Hydrogen Dioxide Generator.
5.Leak Detector of Glove.
6. Anemometer.
Ihe mmetụta 7.H/T.
8.ATEX ọkwa.
9.Equinox Sterility Test Module.
10.Air sampling Device.
11.Bag-in-Bag-out Filter Changing Housing.
4.Packing usoro:
Ọ nwere ike mechaa injectable vial oncology akpaka ọkụ nnyocha, leakage nnyocha, labeling, blister na isi katọn mbukota, na mbupu katọn mbupu.
Anyị nwere ike ịkwado oghere katọn mbupu akpaka, akwụkwọ ntuziaka na ntinye akwụkwọ ikike, nkwakọ ngwaahịa katọn, akara katọn, ịde aha, sistemụ nchọta data, yana sistemu ajụ akpaaka, nke nwere ike jụ katọn ndị nwere ibu na-ezighi ezi, ma ọ bụ ndị nwere akara na-erughị eru.
5.Ọgwụgwọ mmiri ọgwụ:
Ọ na-agụnye ọgwụgwọ mmiri dị ọcha (2RO + EDI), mmiri distiller (WFI), na igwe ọkụ ọkụ dị ọcha. A na-etinyekwa tankị PW na tank WFI.
6.Clean ụlọ & HVAC
Ọ na-agụnye mgbidi ụlọ dị ọcha, ogwe elu ụlọ, windo, ọnụ ụzọ, ala ala, ọkụ, ikuku njikwa, ihe nzacha HEPA, ikuku ducts, egwu, usoro njikwa ụgbọ ala wdg. Iji na-echekwa usoro mmepụta vial oncology injectable n'okpuru Klas C + Isolator gburugburu ebe obibi. .
7.Black uru
Ọ na-agụnye sistemu ikuku compressor na sistem ji esi mmiri ọkụ na-enye ikuku mkpakọ dị mkpa na uzuoku maka mmepụta oncology vial injectable.
8.Laboratory
Ọ gụnyere ụdị ngwa nyocha ụlọ nyocha niile, yana arịa ụlọ nyocha iji nwalee injectable vial oncology samples na akụrụngwa, dị ka ụlọ kwụsie ike, HPLC, absorption atomic, ultraviolet spectrometer, fourier transform infrared spectrometer wdg.
9.Distribution & pipeline usoro
Ọ na-agụnye ụdị ọ bụla nke usoro pipeline na ụlọ ọrụ pipeline dị mkpa na injectable vial oncology turnkey osisi, dị ka mmiri dị ọcha, mmiri injection, uzuoku dị ọcha, mmiri jụrụ oyi, mmiri oyi, ikuku abịakọrọ, uzuoku ụlọ ọrụ wdg.
IVENnwere ezigbo ọkachamara nka na injinia otu, anyị onsite ọzụzụ na mgbe-ịre ahịa nwere ike inye ogologo okwu mmesi obi ike maka gị NON-PVC IV mmiri turnkey osisi:
IVEN akwụkwọ zuru oke nwere ike inyere gị aka inwetaAkwụkwọ GMP & FDAmaka ihe ọkụkụ mmiri IV gị dị mfe (gụnyere IQ / OQ / PQ / DQ / FAT / SAT wdg ma na Bekee na ụdị China):
Ọrụ IVEN na ahụmịhe nwere ike inyere gị aka imecha osisi turnkey ngwọta IV n'ime obere oge wee zere ụdị ihe egwu dị iche iche:
IVENnwere ezigbo ọkachamara nka na injinia otu, anyị onsite ọzụzụ na mgbe-ịre ahịa nwere ike inye ogologo okwu mmesi obi ike maka gị NON-PVC IV mmiri turnkey osisi:
Ruo ugbu a, anyị enyelarị ọtụtụ narị ngwa ọgwụ na akụrụngwa ọgwụ n'ihe karịrị mba 50.
Ka ọ dị ugbu a, anyị nyeere ndị ahịa anyị akawuru 20+ ọgwụ na ọgwụ turnkey osisina Uzbekistan, Tajikistan, Indonesia, Thailand, Saudi, Iraq, Nigeria, Uganda, Tanzania, Ethiopia, Myanmar wdg, tumadi maka IV ngwọta, injectable vials na ampoules. Ọrụ ndị a niile meriri ndị ahịa anyị na nkwupụta gọọmentị ha dị elu.
Anyị na-ebupụkwara ahịrị mmepụta ihe ngwọta IV anyị na Germany.
Indonesia IV karama turnkey osisi
Vietnam IV bottle turnkey osisi
Uzbekistan IV karama turnkey osisi
Thailand Injectable vial turnkey osisi
Tajikistan IV karama turnkey osisi
