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OEB5 oncology vial turnkey osisi

Okwu mmalite:

IVEN Pharmatech bụ onye na -ebuputa ọsụ ụzọ nke osisi turnkey nke na -enye ngwọta injinịa agbakwunyere maka ụlọ ọrụ na -emepụta ọgwụ n'ụwa niile dịka ọgwụ IV, ọgwụ mgbochi ọrịa oncology, wdg, na nrube isi na EU GMP, US FDA cGMP, PICS, na WHO GMP.

Anyị na-enye atụmatụ ọrụ ezi uche dị na ya, akụrụngwa dị elu na ọrụ ahaziri iche maka ụlọ ọrụ ọgwụ na ụlọ ọgwụ dị iche iche site na A ruo Z maka akpa rọba na-abụghị PVC, ihe mkpuchi karama IV, iko vial IV, Injectable Vial & Ampoule, Sirop, Mbadamba ụrọ & Capsules, tube nchịkọta ọbara, wdg.


Nkọwa ngwaahịa

Mkpado ngwaahịa

Nkọwa ngwaahịa:

IVEN Pharmatech bụ onye na -ebuputa ọsụ ụzọ nke osisi turnkey nke na -enye ngwọta injinịa agbakwunyere maka ụlọ ọrụ na -emepụta ọgwụ n'ụwa niile dịka ọgwụ IV, ọgwụ mgbochi ọrịa oncology, wdg, na nrube isi na EU GMP, US FDA cGMP, PICS, na WHO GMP.

Anyị na-enye atụmatụ ọrụ ezi uche dị na ya, akụrụngwa dị elu na ọrụ ahaziri iche maka ụlọ ọrụ ọgwụ na ụlọ ọgwụ dị iche iche site na A ruo Z maka akpa rọba na-abụghị PVC, ihe mkpuchi karama IV, iko vial IV, Injectable Vial & Ampoule, Sirop, Mbadamba ụrọ & Capsules, tube nchịkọta ọbara, wdg.

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Kedu ihe IVEN Injectable oncology vial turnkey plant gụnyere:

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Vidiyo ngwaahịa

Isi nkọwa

Ngwọta injinịa agbakwunyere IVEN maka ụlọ ọrụ ọgwụ vial oncology injectable gụnyere ụlọ dị ọcha, njikwa akpaaka na sistemụ nleba anya, usoro ọgwụgwọ mmiri ọgwụ, ịkwadebe na nkesa nkesa, ịsa vial - sterilizing na depyrogenation - nju - nkwụsị - ịcha akwa - ịsa ahụ na mpụga, ifriizi sistemụ ihicha, sistemụ mwepu, sistemụ mbukota, sistemụ lọjistik akpaka, sistemụ njikwa mma, ụlọ nyocha etiti na wdg. Lekwasịrị anya n'ihe ndị ahịa chọrọ, IVEN na -ahazi usoro injinịa nke ọma maka ndị ọrụ na:

*Ọrụ ndụmọdụ tupu injinịa
*Nhọrọ usoro mmepụta
*Nhọrọ ụdị akụrụngwa na ịhazi ya
*Nwụnye na inye ọrụ
*Nkwado akụrụngwa na usoro
*Teknụzụ mmepụta na -ebufe
*Akwụkwọ siri ike ma dị nro
*Ọzụzụ maka ndị ọrụ nwere nka na ihe ndị ọzọ.

Nzọụkwụ ọrụ ngwaahịa

1. Ịsa ahụ oncology vial ịsa - sterilizing na depyrogenation - ndochi - ịkwụsị - ịcha akwa - ahịrị mmepụta ịsa mpụga:

A na-eji ahịrị a na-emepụta vials oncology injectable, nke nwere igwe ise: Full Servo Driven Vertical Ultrasonic Washing Machine, Hot Air Circulation Sterilizing & Depyrogenation Tunnel, Full Servo Driven Vial Fill-Stoppering Machine, Vial Capping Machine na igwe ịsa ahụ na mpụga.

Mgbe o juputara, ọ ga-aga na ọkara nkwụsị na njikere maka ihicha nkụ, wee kwaga na igwe mkpuchi, mgbe nke ahụ gasị, ọ ga-aga na igwe ịsa ahụ na mpụga. Anyị na -anabata usoro ịtụ ihe dị n'ịntanetị maka igwe na -ejuputa, a ga -ajụ ngwaahịa na -erughị eru na akpaghị aka.

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1. Ịsacha

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2. Sterilizing & Depyrogenation

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3. Njuputa & nkwụsị

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4. Ịkwado

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5. Ịsacha na mpụga

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6.chachara

2.Freeze draya na akpaaka loading na ebutu usoro:

Maka ngwaahịa lyophilized, mgbe o juputara na ọkara kwụsịtụrụ, a ga-ebuga ya na friza (Lyophilizer) na-akpaghị aka site na sistemụ itinye akpaaka, mgbe lyophilized gasịrị, a ga-ebuga ya na igwe mkpuchi site na sistemụ nbudata na akpaaka.

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3. Usoro iche:

Ebe oncology bụ ngwaahịa na -egbu egbu, anyị nwere ike kwadebe ya na onye na -ekewapụ ichebe nchekwa nke ndị na -arụ ọrụ na ngwaahịa ahụ, iji hụ na echekwara usoro nrụpụta n'okpuru sistemụ iche.

Okwu mmalite
1.Operator na -ekewapụ onwe ya kpam kpam site na mpaghara mmepụta isi.
2. A larịị esịtidem mmepụta ebe. Ime ụlọ dị ọcha mpụga C/D.
3. Naanị nwere ike mepee onye na -anọpụ iche mgbe emechiri sistemụ, nyocha dị mkpa maka ịmalitegharị.
4.Customize HPVS maka sterilization ụlọ.
5.Sealing mgbasa usoro.
6.Adopt ntinye ikuku HEPA, akpụkpọ ahụ nwere ike ichebe ikuku ikuku edo edo na nzacha.
7.Seamless esịtidem Ọdịdị, agba gburugburu imewe.
8.Adopt akara inflatable maka ọnụ ụzọ mepere emepe na windo ogwe aka.
9.N'ihi ngwaahịa na-egbu egbu, jiri nhazi akpa-n'ime-akpa.

Ọrụ ndị ọzọ
1.CIP/SIP sistemụ (SIP site na VHP).
2.Particle Counter Online Monitoring.
3. Sampler nke nwere ike ịfe n'ọdụ ụgbọ elu.
4.Vaporized Hydrogen Dioxide Generator.
5.Leak Detector nke uwe aka.
6. Igwe ọkụ.
7.H/T ihe mmetụta.
Ntụle 8.ATEX.
9.Equinox Sterility Test Module.
10. Ngwa nlele ikuku.
11. akpa-in-akpa-si Myọcha Na-agbanwe agbanwe Housing.

4.Packing usoro:

Ọ nwere ike mechaa nyocha oncology vial oncology akpaka, nyocha mgbapụta, akara, ọnya na mbukota katọn, yana mbupu katọn.
Anyị nwere ike jiri oghere katọn mbupu akpaka, akwụkwọ ntuziaka na ịtinye asambodo, ịkwakọ ngwaahịa katọn, akara katọn, ịdebanye aha, usoro ịchụ data, na sistemụ ịjụ akpaaka, nke nwere ike jụ katọn na -adịchaghị mma, ma ọ bụ ndị nwere akara erughị eru.

5.Pharmaceutical mmiri ọgwụgwọ:

Ọ gụnyere ọgwụgwọ mmiri dị ọcha (2RO+EDI), distiller mmiri (WFI), na igwe na -enye ọkụ. Agụnyere PW tank na WFI tank.

5.Pharmaceutical mmiri ọgwụgwọ:

Ọ gụnyere ọgwụgwọ mmiri dị ọcha (2RO+EDI), distiller mmiri (WFI), na igwe na -enye ọkụ. Agụnyere PW tank na WFI tank.

7.Clean ụlọ & HVAC:

Ọ gụnyere ogwe mgbidi ụlọ dị ọcha, ogidi ụlọ, windo, ọnụ ụzọ, ala, ọkụ, igwe njikwa ikuku, ihe nzacha HEPA, ọwa ikuku, ihe na -emenye ụjọ, sistemụ njikwa akpaaka wdg.... .

8.Iji ojii

Ọ gụnyere sistemụ ikuku ikuku na sistemụ ji esi mmiri iji nye ikuku mkpakọ na uzuoku maka mmepụta oncology vial injectable.

9. Ụlọ nyocha:

Ọ gụnyere ụdị ngwa nyocha ụlọ nyocha niile, yana arịa ụlọ nyocha iji nwalee nlele oncology vial oncology na akụrụngwa, dị ka ụlọ nkwụsi ike, HPLC, mmịkọ atọm, ultraviolet spectrometer, fourier na -agbanwe spectrometer infrared wdg.

Usoro nkesa na pipeline:

Ọ na -agụnye ụdị pipeline usoro na paịpụ ụlọ ọrụ dị mkpa na osisi turnkey vial oncology, dị ka mmiri dị ọcha, mmiri ntụtụ, uzuoku dị ọcha, mmiri jụrụ oyi, mmiri jụrụ oyi, ikuku mkpakọ, uzuoku ụlọ ọrụ wdg.

Uru:

IVEN nwere ndị otu ọrụ nka na injinịa ọkachamara, ọzụzụ anyị nọ ebe a na nkwado ahịa mgbe ọ bụla nwere ike inye nkwa ọrụ aka ogologo oge maka osisi mgbanaka oncology vial oncology injectable:

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IVEN Akwụkwọ zuru oke nwere ike inyere gị aka nweta asambodo GMP & FDA maka osisi mmiri mmiri IV gị dị mfe (gụnyere IQ / OQ / PQ / DQ / FAT / SAT wdg ma n'asụsụ Bekee na Chinese):

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Ọrụ na ahụmịhe nke IVEN nwere ike inyere gị aka rụchaa osisi turnkey ihe ọkụkụ IV n'ime obere oge wee zere ụdị ihe egwu ọ bụla:

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Ndị ahịa ndị na -ere ọgwụ turnkey ndị na -ere ọgwụ na IVEN:

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Ruo ugbu a, anyị enyelarị ihe karịrị mba iri ise ngwa ngwa ọgwụ na akụrụngwa ọgwụ.

Ka ọ dị ugbu a, anyị nyeere ndị ahịa anyị aka ka ha wuo ụlọ ọgwụ ọgwụ na ọgwụ ọgwụ 20+ na Russia, Uzbekistan, Tajikistan, Indonesia, Thailand, Saudi, Iraq, Nigeria, Uganda, Tanzania, Ethiopia, Myanmar wdg, ọkachasị maka ngwọta IV, vials injectable na ampoules. . Ọrụ ndị a niile meriri ndị ahịa anyị na nkwupụta gọọmentị ha dị elu.

Anyị na -ebupụkwa usoro mmepụta ngwọta IV anyị na Germany.

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Indonesia IV karama turnkey osisi

Vietnam IV karama turnkey osisi

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Uzbekistan IV karama turnkey osisi

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Thailand osisi vial turnkey osisi

Tajikistan IV karama turnkey osisi

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Saudi Arabia IV akpa turnkey osisi

Oke ikike nke IVEN incology oncology vial turnkey plant:

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