OEB5 Injectable Onkoloji vial turnkey ọgbin
IVEN Pharmatechjẹ olutaja aṣáájú-ọnà ti awọn ohun ọgbin turnkey ti o pese ojutu imọ-ẹrọ iṣọpọ fun ile-iṣẹ elegbogi agbaye gẹgẹbi ojutu IV, ajesara, oncology ati bẹbẹ lọ, ni ibamu pẹlu EU GMP, US FDA cGMP, PICS, ati WHO GMP.
A pese apẹrẹ iṣẹ akanṣe ti o ni oye julọ, ohun elo didara to gaju ati iṣẹ adani si oriṣiriṣi awọn oogun ati awọn ile-iṣẹ iṣoogun lati A si Z fun apo asọ ti kii-PVC IV ojutu, ojutu PP igo IV, Gilaasi vial IV ojutu, Injectable Vial & Ampoule, Syrup, Tablets & Capsules, Vacuum blood collection tube etc.
Kini IVEN Injectable oncology vial turnkey plant pẹlu:
Awọn solusan imọ-ẹrọ ti irẹpọ ti IVEN fun ile-iṣẹ oncology injectable elegbogi vial factory pẹlu yara mimọ, iṣakoso-laifọwọyi ati eto ibojuwo, eto itọju omi elegbogi, ngbaradi ojutu ati eto pinpin, fifọ vial - sterilizing ati depyrogenation - kikun - idaduro - capping - fifọ ita, didi eto gbigbẹ, eto ipinya, eto iṣakojọpọ ti aarin ati bẹbẹ lọ, eto iṣakojọpọ laifọwọyi ati bẹbẹ lọ. Awọn ibeere olukuluku awọn alabara, IVEN ṣe akanṣe awọn ojutu imọ-ẹrọ ni pataki fun awọn olumulo lori:
1.Injectable Oncology vial fifọ - sterilizing ati depyrogenation - kikun - stoppering - capping - ita fifọ laini iṣelọpọ:
Laini yii ni a lo lati ṣe agbejade awọn lẹgbẹrun oncology injectable, eyiti o ni awọn ẹrọ 5: kikun Servo Driven Vertical Ultrasonic Washing Machine, Gbona Air Circulation Sterilizing & Depyrogenation Tunnel, Full Servo Driven Vial Filling-Stoppering Machine, Vial Capping Machine ati Ita Fifọ Machine.
Lẹhin kikun, yoo lọ si ologbele-idaduro ati ṣetan fun gbigbẹ didi, lẹhinna gbe lọ si ẹrọ capping, lẹhinna, yoo lọ si ẹrọ fifọ ita. A gba eto wiwọn ori ayelujara fun ẹrọ kikun, awọn ọja ti ko pe yoo kọ laifọwọyi.
1. Fifọ
2. Sterilizing & Depyrogenation
3. Nkún & Duro
4. Capping
5. Ita fifọ
6. pari
2.Freeze dryer ati auto loading and unloading system:
Fun awọn ọja lyophilized, lẹhin kikun ati ologbele-idaduro, yoo gbe lọ si didi ẹrọ gbigbẹ (Lyophilizer) laifọwọyi nipasẹ eto ikojọpọ adaṣe, lẹhin ti lyophilized, yoo gbe lọ si ẹrọ capping nipasẹ eto unloading auto.
3.Isolation eto:
Bii oncology jẹ ọja majele, a le ni ipese pẹlu isolator lati tọju aabo awọn oniṣẹ lati awọn ọja, lati rii daju pe ilana iṣelọpọ ti ni aabo ni kikun labẹ eto ipinya.
Ọrọ Iṣaaju kukuru
1.Operator jẹ iyatọ patapata lati agbegbe iṣelọpọ ifo.
2.A ipele ti abẹnu gbóògì agbegbe. C/D ipele ita mọ yara.
3.Only le ṣii isolator lẹhin tiipa eto, ijẹrisi jẹ pataki fun atunbere.
4.Customize HPVS fun ti abẹnu sterilization.
5.Sealed sisan eto.
6.Adopt HEPA air inletting, awo ilu le mejeeji daabobo ṣiṣan afẹfẹ aṣọ ati àlẹmọ.
7.Seamless ti abẹnu be, yika oniru.
8.Adopt inflatable seal fun awọn mejeeji ìmọ ẹnu-ọna ati ibọwọ windows.
9.For majele ti awọn ọja, lo apo-in-bag-out design.
Awọn iṣẹ miiran
1.CIP / SIP eto (SIP nipasẹ VHP).
2.Particle Counter Online Abojuto.
3.Airborne Viable Patiku Sampler.
4.Vaporized Hydrogen Dioxide Generator.
5.Leak Detector of Glove.
6.Anemometer.
7.H / T Sensọ.
8.ATEX Rating.
9.Equinox Sterility igbeyewo Module.
10.Air iṣapẹẹrẹ ẹrọ.
11.Bag-in-bag-out Filter Change Housing.
4.Packing eto:
O le pari injectable vial oncology ayewo ina laifọwọyi, ayewo jijo, isamisi, roro pẹlu iṣakojọpọ paali akọkọ, ati iṣakojọpọ paali gbigbe.
A le ṣe ipese pẹlu ṣiṣi kaadi gbigbe gbigbe laifọwọyi, itọnisọna itọnisọna ati fifi sii ijẹrisi, iṣakojọpọ kaadi, paali paali, isamisi, eto wiwa data, ati eto ijusile adaṣe, eyiti o le kọ awọn paali pẹlu iwuwo ti ko tọ, tabi awọn ti o ni aami ti ko pe.
5.Pharmaceutical omi itọju:
O pẹlu itọju omi ti a sọ di mimọ (2RO+EDI), distiller omi (WFI), ati olupilẹṣẹ ategun mimọ. Ojò PW ati ojò WFI wa pẹlu.
6.Clean yara & HVAC
O pẹlu awọn panẹli ogiri yara mimọ, awọn panẹli aja, awọn window, awọn ilẹkun, ilẹ-ilẹ, ina, ẹrọ mimu afẹfẹ, awọn asẹ HEPA, awọn ọna afẹfẹ, itaniji, eto iṣakoso adaṣe bbl Lati tọju ilana iṣelọpọ vial oncology injectable ni aabo labẹ Kilasi C + Isolator ayika.
7.Black IwUlO
O pẹlu eto konpireso afẹfẹ ati eto igbomikana lati pese afẹfẹ fisinuirindigbindigbin pataki ati nya si fun iṣelọpọ oncology vial injectable.
8.Laboratory
O pẹlu gbogbo iru awọn ohun elo idanwo lab, ati ohun-ọṣọ lab lati ṣe idanwo injectable vial oncology awọn ayẹwo ati ohun elo aise, gẹgẹbi iyẹwu iduroṣinṣin, HPLC, gbigba atomiki, spectrometer ultraviolet, spectrometer infurarẹẹdi mẹrin ti yipada ati bẹbẹ lọ.
9.Pinpin & opo gigun ti epo
O pẹlu gbogbo iru opo gigun ti epo ati opo gigun ti ile-iṣẹ nilo ni injectable vial oncology turnkey plant, gẹgẹ bi omi mimọ, omi abẹrẹ, nya si mimọ, omi itutu agbaiye, omi tutu, afẹfẹ fisinuirindigbindigbin, nya si ile-iṣẹ ati bẹbẹ lọ.
IVENni ẹgbẹ imọ-ẹrọ alamọdaju pupọ ati imọ-ẹrọ, ikẹkọ wa lori aaye ati atilẹyin lẹhin-tita le fun ni idaniloju imọ-ẹrọ igba pipẹ fun ohun ọgbin turnkey NON-PVC IV rẹ:
IVEN Awọn iwe aṣẹ ni kikun le ṣe iranlọwọ fun ọ lati gbaGMP & FDA ijẹrisifun ọgbin ito IV rẹ ni irọrun (pẹlu IQ / OQ / PQ / DQ / FAT / SAT ati bẹbẹ lọ mejeeji ni Gẹẹsi ati ẹya Kannada):
Iṣẹ-iṣẹ IVEN ati iriri le ṣe iranlọwọ fun ọ lati pari gbogbo ohun ọgbin turnkey ojutu ni akoko kukuru ati yago fun gbogbo iru awọn eewu ti o pọju:
IVENni ẹgbẹ imọ-ẹrọ alamọdaju pupọ ati imọ-ẹrọ, ikẹkọ wa lori aaye ati atilẹyin lẹhin-tita le fun ni idaniloju imọ-ẹrọ igba pipẹ fun ohun ọgbin turnkey NON-PVC IV rẹ:
Titi di bayi, a ti pese awọn ọgọọgọrun awọn eto ohun elo elegbogi ati ohun elo iṣoogun si awọn orilẹ-ede to ju 50 lọ.
Nibayi, a ran awọn onibara wa latiitumọ ti 20+ elegbogi ati egbogi turnkey ewekoni Uzbekisitani, Tajikistan, Indonesia, Thailand, Saudi, Iraq, Nigeria, Uganda, Tanzania, Ethiopia, Myanmar ati be be lo, nipataki fun IV ojutu, injectable lẹgbẹrun ati ampoules. Gbogbo awọn iṣẹ akanṣe wọnyi gba awọn alabara wa ati awọn asọye giga ti ijọba wọn.
A tun gbejade laini iṣelọpọ ojutu IV wa si Germany.
Indonesia IV igo turnkey ọgbin
Vietnam IV igo turnkey ọgbin
Usibekisitani IV igo turnkey ọgbin
Thailand Injectable vial turnkey ọgbin
Tajikistan IV igo turnkey ọgbin
