OEB5 Ọgwụ maka oncology vial turnkey
IVEN Pharmatechbụ onye mbụ na-eweta ụlọ ọrụ mmepụta ihe na-enye ngwọta injinia agbakwunyere maka ụlọ ọrụ mmepụta ọgwụ zuru ụwa ọnụ dịka ngwọta IV, ọgwụ mgbochi, oncology wdg, dịka EU GMP, US FDA cGMP, PICS, na WHO GMP si dị.
Anyị na-enye nhazi ọrụ kachasị mma, akụrụngwa dị elu na ọrụ ahaziri ahazi nye ụlọ ọrụ ọgwụ na ahụike dị iche iche site na A ruo Z maka ngwọta IV nke na-abụghị PVC dị nro, ngwọta IV karama PP, ngwọta IV nke iko, Vial na Ampoule a na-agba n'ime, Syrup, Mbadamba na Kapsụlụ, tube nchịkọta ọbara vacuum wdg.
Kedu ihe osisi IVEN Injectable oncology vial turnkey gụnyere:
Ngwọta injinia agbakwunyere nke IVEN maka ụlọ ọrụ mmepụta ọgwụ maka oncology vial injectable gụnyere ụlọ dị ọcha, sistemụ njikwa akpaaka na nlekota, sistemụ ọgwụgwọ mmiri ọgwụ, sistemụ nkwadebe na nkesa ngwọta, ịsa vial - sterilizing na depyrogenation - njupụta - nkwụsị - mkpuchi - ịsa mpụta, sistemụ nkụ oyi, sistemụ iche, sistemụ nkwakọ ngwaahịa, sistemụ njikwa akpaka, sistemụ njikwa mma, ụlọ nyocha etiti na wdg. Dabere na ihe ndị ahịa chọrọ, IVEN na-ahazi ngwọta injinia nke ọma maka ndị ọrụ na:
1. Ịsa ihe mkpuchi oncology a na-agba n'ime ahụ - ime ka ọ dị ọcha ma wepụ ya - ijupụta - igbochi - mkpuchi - ahịrị mmepụta ịsa ahụ mpụga:
A na-eji ahịrị a emepụta karama oncology a na-agba ntụtụ, nke nwere igwe ise: Igwe Washing Ultrasonic zuru oke nke Servo Driven, Ọwara Mgbasa Ikuku Na-ekpo Ọkụ na Ọkụ, Igwe Filling-Stoping Vial zuru oke nke Servo Driven, Igwe Capping Vial na Igwe Washing Mpụga.
Mgbe e jupụtachara ya, a ga-eji ya mee ihe n'ime ọkara-stoppering ma dị njikere maka ịkpọ nkụ n'ime oyi, wee gaa na igwe mkpuchi, mgbe nke ahụ gasịrị, a ga-eji ya gaa na igwe ịsa ákwà mpụga. Anyị na-eji usoro nha nha n'ịntanetị maka igwe njupụta, a ga-ajụ ngwaahịa ndị na-erughị eru na akpaghị aka.
1. Ịsa ahụ
2. Ịmịpụta ọgwụ mgbochi na iwepụ nsị n'ahụ
3. Ijuputa na Ịkwụsị
4. Mkpuchi
5. Ịsa Mpụga
6. emechaala
2. Nhicha igwe nkụ na sistemụ mbuli na nbudata akpaka:
Maka ngwaahịa ndị e ji lyophilized mee, mgbe e jupụtachara ha ma mechie ha nke ọma, a ga-ebuga ha na igwe nkụcha ọkụ (Lyophilizer) na akpaghị aka site na sistemụ ibu akpaka, mgbe e mechara lyophilized ha, a ga-ebuga ha na igwe mkpuchi site na sistemụ ibupu akpaka.
3. Sistemụ nkewa:
Ebe ọ bụ na ọrịa kansa bụ ihe na-egbu egbu, anyị nwere ike itinye ihe na-egbochi ndị ọrụ iji chekwaa ngwaahịa ndị ahụ, iji hụ na usoro mmepụta ahụ echekwabara nke ọma n'okpuru sistemụ iche.
Okwu Mmalite Dị Mkpirikpi
1. A na-ekewapụ onye ọrụ kpamkpam site na mpaghara mmepụta ihe dị mkpa.
2. Ebe mmepụta ihe dị n'ime nke dị larịị. Ụlọ nhicha dị n'èzí nke dị larịị nke C/D.
3. Naanị ihe nwere ike imepe ihe nkesa ahụ mgbe sistemụ mechiri, nkwenye dị mkpa maka ịmalitegharị.
4. Hazie HPVS maka ime ka ọ dị ọcha n'ime.
5. Sistemụ mgbasa ozi emechiri emechi.
6. Nabata HEPA ikuku inletting, akpụkpọ ahụ nwere ike ichebe ikuku dị n'otu na nzacha ahụ.
7. Nhazi ime ụlọ na-enweghị ntụpọ, nhazi gburugburu.
8. Nabata akara mkpuchi a na-afụ ọkụ maka ọnụ ụzọ mepere emepe na windo uwe aka.
9. Maka ngwaahịa na-egbu egbu, jiri imewe akpa-n'ime akpa.
Ọrụ Ndị Ọzọ
1. Sistemụ CIP/SIP (SIP site na VHP).
2. Nlekota Ntanetị nke Ngụkọta Ihe Ngwugwu.
3. Ihe nlele ihe dị n'ime ikuku.
4. Ihe na-emepụta Hydrogen Dioxide nke a na-anaghị agbaze agbaze.
5. Ihe nchọpụta mmiri ozuzo nke uwe aka.
6. Anemometer.
7.H/T Sensọ.
8. Ọkwa ATEX.
9. Modulu Ule Nnwale Equinox Sterility.
10. Ngwaọrụ Nnwale Ikuku.
11. Ebe a na-agbanwe ihe nzacha n'ime akpa.
4. Sistemụ nkwakọ ngwaahịa:
Ọ nwere ike imecha nyocha ọkụ akpaka nke vial oncology, nyocha ntapu mmiri, akara, ọnya nwere ngwugwu katọn mbụ, yana mbupu katọn.
Anyị nwere ike iji ngwa mbupu akpaka, ntuziaka ntuziaka na ntinye asambodo, nkwakọ ngwaahịa katọn, mkpuchi katọn, akara, sistemụ nsuso data, na sistemụ ịjụ akpaka, nke nwere ike ịjụ katọn ndị nwere oke ibu na-ezighi ezi, ma ọ bụ ndị nwere akara na-erughị eru.
5. Ọgwụgwọ mmiri ọgwụ:
Ọ gụnyere ọgwụgwọ mmiri dị ọcha (2RO+EDI), ihe na-eme ka mmiri dị ọcha (WFI), na ihe na-emepụta uzuoku dị ọcha. Tankị PW na tankị WFI dịkwa.
6. Ụlọ dị ọcha na HVAC
Ọ gụnyere ogwe mgbidi ụlọ dị ọcha, ogwe elu ụlọ, windo, ọnụ ụzọ, ala ụlọ, ọkụ, ihe njikwa ikuku, nzacha HEPA, ọkpọkọ ikuku, sistemụ njikwa akpaaka wdg. Iji chekwaa usoro mmepụta oncology vial a na-agba n'ime mmiri n'okpuru gburugburu Klas C + Isolator.
7. Ọrụ ojii
Ọ gụnyere sistemụ ikuku compressor na sistemụ boiler iji nye ikuku na uzuoku dị mkpa maka mmepụta oncology vial a na-agba ọgwụ.
8. Ụlọ nyocha
Ọ gụnyere ụdị ngwa nyocha ụlọ nyocha niile, yana arịa ụlọ nyocha iji nwalee ihe nlele oncology vial a na-agba ntụtụ na ihe eji arụ ọrụ, dị ka ụlọ nkwụsi ike, HPLC, ntinye atọm, spectrometer ultraviolet, spectrometer infrared fourier transform, wdg.
9. Sistemụ nkesa na pipeline
Ọ gụnyere ụdị ọkpọkọ usoro niile na ọkpọkọ ụlọ ọrụ mmepụta ihe dị mkpa na osisi oncology turnkey nke a na-agba ọgwụ, dị ka mmiri dị ọcha, mmiri injection, uzuoku dị ọcha, mmiri oyi, mmiri oyi, ikuku a na-agbakọ, uzuoku ụlọ ọrụ wdg.
IVENInwe ndị otu teknụzụ na injinia ọkachamara nke ukwuu, ọzụzụ anyị n'ebe a na-ere ahịa na nkwado mgbe ire ere gasịrị nwere ike inye nkwa teknụzụ ogologo oge maka ụlọ ọrụ ntụgharị mmiri mmiri nke NON-PVC IV gị:
IVEN Akwụkwọ niile dị iche iche nwere ike inyere gị aka inwetaAsambodo GMP na FDAmaka osisi mmiri mmiri gị ngwa ngwa (gụnyere IQ / OQ / PQ / DQ / FAT / SAT wdg ma n'asụsụ Bekee na nke China):
Ọrụ na ahụmịhe IVEN nwere ike inyere gị aka imecha ụlọ ọrụ mmepụta ihe ngwọta IV niile n'ime obere oge ma zere ụdị ihe egwu niile nwere ike ime:
IVENInwe ndị otu teknụzụ na injinia ọkachamara nke ukwuu, ọzụzụ anyị n'ebe a na-ere ahịa na nkwado mgbe ire ere gasịrị nwere ike inye nkwa teknụzụ ogologo oge maka ụlọ ọrụ ntụgharị mmiri mmiri nke NON-PVC IV gị:
Ruo ugbu a, anyị enyela ọtụtụ narị ngwa ọgwụ na ngwa ahụike nye ihe karịrị mba iri ise.
Ka ọ dịgodị, anyị nyeere ndị ahịa anyị akaỤlọ ọrụ mmepụta ọgwụ na ahụike ruru ihe karịrị iri abụọ (20+)na Uzbekistan, Tajikistan, Indonesia, Thailand, Saudi, Iraq, Naịjirịa, Uganda, Tanzania, Etiopia, Myanmar wdg, ọkachasị maka ọgwụ IV, vials na ampoules a na-agba n'ime ahụ. Ọrụ ndị a niile dọtara ndị ahịa anyị na gọọmentị ha okwu dị elu.
Anyị na-ebupụkwa usoro mmepụta ihe ngwọta IV anyị na Germany.
Osisi karama Indonesia nke anọ
Osisi karama Vietnam IV turnkey
Ụlọ ọrụ karama karama Uzbekistan IV
Thailand injectionable vial turnkey plant
Osisi karama karama nke Tajikistan nke anọ
