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OEB5 Semela sa oncology se nang le ente ea vial turnkey

Kenyelletso e Khutšoanyane:

IVEN Pharmatech ke mofani oa pele oa limela tsa turnkey tse fanang ka tharollo ea boenjiniere e kopantsoeng bakeng sa fektheri ea lefats'e ea meriana e kang tharollo ea IV, ente, oncology joalo-joalo, ho latela EU GMP, US FDA cGMP, PICS, le WHO GMP.

Re fana ka moralo o nepahetseng ka ho fetesisa oa projeke, lisebelisoa tsa boleng bo holimo le ts'ebeletso e ikhethileng ho lifeme tse fapaneng tsa meriana le tsa bongaka ho tloha ho A ho ea ho Z bakeng sa tharollo ea Non-PVC mokotla IV, tharollo ea botlolo ea PP, tharollo ea Glass vial IV, Injectable Vial & Ampoule, Sirapo, Matlapa le Li-capsules, Tube ea pokello ea mali ea Vacuum joalo-joalo.


Lintlha tsa Sehlahisoa

Li-tag tsa Sehlahisoa

Tlhaloso ea Sehlahisoa:

IVEN Pharmatech ke mofani oa pele oa limela tsa turnkey tse fanang ka tharollo ea boenjiniere e kopantsoeng bakeng sa fektheri ea lefats'e ea meriana e kang tharollo ea IV, ente, oncology joalo-joalo, ho latela EU GMP, US FDA cGMP, PICS, le WHO GMP.

Re fana ka moralo o nepahetseng ka ho fetesisa oa projeke, lisebelisoa tsa boleng bo holimo le ts'ebeletso e ikhethileng ho lifeme tse fapaneng tsa meriana le tsa bongaka ho tloha ho A ho ea ho Z bakeng sa tharollo ea Non-PVC mokotla IV, tharollo ea botlolo ea PP, tharollo ea Glass vial IV, Injectable Vial & Ampoule, Sirapo, Matlapa le Li-capsules, Tube ea pokello ea mali ea Vacuum joalo-joalo.

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Semela sa VENN Injectable oncology vial turnkey se kenyelletsa eng:

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Video ea Sehlahisoa

Tlhaloso ea mantlha

Litharollo tsa boenjiniere tse kopaneng tsa IVEN bakeng sa fektheri e nang le ente ea oncology e kenyelletsang kamore e hloekileng, taolo ea likoloi le sistimi ea ho beha leihlo, sistimi ea kalafo ea metsi ea meriana, mokhoa oa ho lokisa le ho aba, ho hlatsoa vial - sterilizing le depyrogenation - ho tlatsa - ho emisa - ho koala - ho hlatsoa kantle, ho hatsetsa. tsamaiso ea ho omisa, tsamaiso ea ho itšehla thajana, tsamaiso ea ho paka, tsamaiso ea thepa e ikemetseng, tsamaiso ea boleng ba boleng, laboratori e bohareng le joalo-joalo E tsepamisitse maikutlo ho litlhoko tsa motho ka mong tsa bareki, IVEN e etsa litharollo tsa boenjiniere ka hloko bakeng sa basebelisi ho:

*Tsebeletso ea boeletsi ba pele ho boenjiniere
* Khetho ea mokhoa oa tlhahiso
* Khetho ea mofuta oa lisebelisoa le ho e etsa
*Ho kenya le ho kenya tshebetsong
* Ho netefatsa lisebelisoa le ts'ebetso
* Phetiso ea theknoloji ea tlhahiso
* Litokomane tse thata le tse bonolo
*Koetliso ea basebetsi ba nang le litsebo joalo-joalo.

Mehato ea ts'ebetso ea sehlahisoa

1. Injectable oncology vial hlatsoa - sterilizing le depyrogenation - ho tlatsa - stoppering - capping - line ea tlhahiso ea ho hlatsoa kantle:

Mohala ona o sebelisetsoa ho hlahisa lijana tsa oncology tse nang le ente, tse nang le mechine e 5: Mochini o Hlatsoang oa Full Servo Driven Vertical Ultrasonic, Hot Air Circulation Sterilizing & Depyrogenation Tunnel, Full Servo Driven Filling-Stoppering Machine, Vial Capping Machine le External Washing Machine.

Ka mor'a ho tlatsa, e tla ea ho semi-stoppering 'me e loketse ho omisoa ka leqhoa, ebe e fallela mochine oa capping, ka mor'a moo, e tla ea mochine oa ho hlatsoa ka ntle.Re sebelisa sistimi ea ho bekha inthaneteng bakeng sa mochini o tlatsang, lihlahisoa tse sa tšoaneleheng li tla hanoa ka bohona.

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1. Ho hlatsoa

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2. Sterilizing & Depyrogenation

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3. Ho tlatsa le ho emisa

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4. Capping

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5. Ho Hlatsoa Kantle

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6. phethile

2.Freeze dryer le autoloading le ho laolla sistimi:

Bakeng sa lihlahisoa tse nang le lyophilized, ka mor'a ho tlatsa le ho emisa, li tla fetisetsoa ho se omisa (Lyophilizer) ka bohona ka sistimi ea autoloading, ka mor'a hore e be le lyophilized, e tla fetisetsoa mochining oa capping ka sistimi ea ho laolla koloi.

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3. Sistimi ea ho itšehla thajana :

Joalo ka ha oncology e le sehlahisoa se chefo, re ka hlomella ka ho itšehla thajana ho boloka polokeho ea basebetsi ho tsoa lihlahisoa, ho etsa bonnete ba hore ts'ebetso ea tlhahiso e sirelelitsoe ka botlalo tlasa sistimi ea ho itšehla thajana.

Kenyelletso e Khutšoanyane
1.Operator e arohane ka ho feletseng ho tloha sebakeng sa bohlokoa sa tlhahiso ea nyopa.
2.A boemo ba sebaka sa tlhahiso ea ka hare.Kamore ea kamore e hloekileng ea boemo ba C / D.
3.Only e ka bula isolator ka mor'a ho tima tsamaiso, ho netefatsa ho hlokahala bakeng sa ho qala hape.
4.Customize HPVS bakeng sa sterilization ka hare.
5.Sealed circulation system.
6.Adopt HEPA air inletting, membrane ka bobeli e ka sireletsa ho phalla ha moea o ts'oanang le sefahla.
7.Sebopeho sa ka hare se se nang moeli, moralo o pota-potileng.
8.Adopt inflatable seal bakeng sa lifensetere tse bulehileng tsa mamati le liatlana.
9.Bakeng sa lihlahisoa tse chefo, sebelisa moralo oa mokotla-ka-bag-out.

Mesebetsi e meng
1.CIP/SIP tsamaiso (SIP ka VHP).
2.Particle Counter Online Tlhokomelo.
3.Airborne Viable Particle Sampler.
4.Mofuthu oa Hydrogen Dioxide Generator.
5.Leak Detector of Glove.
6.Anemometer.
7.H/T Sensor.
8.ATEX Rating.
9.Equinox Sterility Test Module.
10.Air Sampling Sesebelisoa.
11.Mokotla-ka-mokotla Sesefa Ho Fetola Bolulo.

4.Packing system:

E ka qeta tlhahlobo e ikemetseng ea mabone a vial oncology, tlhahlobo ea ho lutla, ho ngola mabitso, blister e nang le mabokose a mantlha a pakang, le ho paka mabokose a thomello.
Re ka hlomella ka ho bula mabokose a othomathiki a ho tsamaisa thepa, bukana ea litaelo le ho kenya setifikeiti, ho paka mabokose, ho tiisa mabokose, ho ngola, sistimi ea ho lata data, le sistimi ea ho hana likoloi, e ka hanang mabokose a boima bo fosahetseng, kapa a nang le lengolo le sa tšoaneleheng.

5. Phekolo ea metsi ka meriana:

E kenyelletsa kalafo ea metsi a hloekisitsoeng (2RO + EDI), distiller ea metsi (WFI), le jenereithara e hloekileng ea mouoane.Tanka ea PW le tanka ea WFI e kenyelelitsoe hape.

5. Phekolo ea metsi ka meriana:

E kenyelletsa kalafo ea metsi a hloekisitsoeng (2RO + EDI), distiller ea metsi (WFI), le jenereithara e hloekileng ea mouoane.Tanka ea PW le tanka ea WFI e kenyelelitsoe hape.

7.Hloekisa kamore le HVAC:

E kenyelletsa likarolo tse hloekileng tsa marako a kamoreng, liphanele tsa siling, lifensetere, mamati, fatše, mabone, lisebelisoa tsa moea, li-filters tsa HEPA, li-ducts tsa moea, tse tšosang, tsamaiso ea likoloi, joalo-joalo Ho boloka ts'ebetso ea tlhahiso ea injectable vial oncology e sirelelitsoe tlas'a Class C + Isolator tikoloho. .

8.Black utility

E kenyelletsa sistimi ea compressor ea moea le sistimi ea boiler ho fana ka moea o hatelitsoeng le mouoane o hlokahalang bakeng sa tlhahiso ea ente ea vial oncology.

9.Laboratori:

E kenyelletsa mefuta eohle ea lisebelisoa tsa tlhahlobo ea lab, le thepa ea ka tlung ho leka lisampole tsa vial oncology le lisebelisoa tse tala, joalo ka kamore ea botsitso, HPLC, ho monya atomic, spectrometer ea ultraviolet, spectrometer e feto-fetohang tse nne jj.

10. Tsamaiso le tsamaiso ea lipeipi:

E kenyelletsa mefuta eohle ea lipeipi tsa ts'ebetso le lipeipi tsa indasteri tse hlokahalang setsing sa "vial oncology turnkey", joalo ka metsi a hloekisitsoeng, metsi a ente, mouoane o hloekileng, metsi a pholileng, metsi a batang, moea o hatelitsoeng, mouoane oa indasteri jj.

Melemo:

IVEN e na le sehlopha se hloahloa sa tekheniki le boenjiniere, koetliso ea rona e fumanehang sebakeng sa rona le tšehetso ea kamora ho rekisa e ka fana ka tiisetso ea nako e telele ea tekheniki bakeng sa semela sa hau se nang le ente ea vial oncology turnkey:

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IVEN Litokomane tse felletseng li ka u thusa ho fumana setifikeiti sa GMP & FDA bakeng sa semela sa hau sa mokelikeli oa IV habonolo (Ho kenyeletsoa IQ / OQ / PQ / DQ / FAT / SAT joalo-joalo ka Senyesemane le Sechaena):

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Boiphihlelo le boiphihlelo ba VEN li ka u thusa ho qeta semela sa IV sa turnkey ka nako e khuts'oane le ho qoba mefuta eohle ea likotsi tse ka bang teng:

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VENN ea bareki ba limela tsa turnkey tsa mose ho maoatle:

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Ho fihlela joale, re se re fane ka makholo a lisebelisoa tsa meriana le lisebelisoa tsa bongaka linaheng tse fetang 50.

Ho sa le joalo, re thusitse bareki ba rona ho haha ​​​​limela tsa 20+ tsa meriana le tsa bongaka Russia, Uzbekistan, Tajikistan, Indonesia, Thailand, Saudi, Iraq, Nigeria, Uganda, Tanzania, Ethiopia, Myanmar joalo-joalo, haholo-holo bakeng sa tharollo ea IV, li-vials tse nang le ente le li-ampoules. .Merero ena kaofela e hapile bareki ba rona le maikutlo a bona a phahameng a mmuso.

Re boetse re rometse mohala oa rona oa tlhahiso ea tharollo ea IV Jeremane.

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Indonesia IV bottle turnkey semela

Semela sa turnkey sa botlolo ea Vietnam IV

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Semela sa turnkey sa botlolo ea Uzbekistan IV

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Thailand Semela se nang le ente ea vial turnkey

Tajikistan IV bottle turnkey semela

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Saudi Arabia IV bag turnkey plant

Lethathamo la bokhoni ba semela sa VEN se nang le ente ea oncology:

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  • E fetileng:
  • E 'ngoe:

  • Lihlopha tsa lihlahisoa

    Re romelle molaetsa oa hau:

    Ngola molaetsa wa hao mona mme o re romele wona