OEB5 Te tipu pouaka werohanga mate pukupuku
IVEN Pharmatechko te kaiwhakarato paionia o ngā tipu kua oti te whakarite e whakarato ana i te otinga hangarau whakauru mō ngā wheketere rongoā o te ao pēnei i te otinga IV, te kano kano, te mate pukupuku me ētahi atu, i runga anō i ngā whakaritenga a te EU GMP, te US FDA cGMP, PICS, me te WHO GMP.
Ka whakaratohia e mātou te hoahoa kaupapa tino whaitake, ngā taputapu kounga teitei me te ratonga ritenga ki ngā wheketere rongoā me te hauora rerekē mai i A ki Z mō te otinga whaowhia pēke ngohengohe kore-PVC, te otinga whaowhia pounamu PP, te otinga whaowhia pounamu karāhe, te pounamu werohanga me te ampoule, te tirikara, ngā papa me ngā kāpū, te ngongo kohi toto korehau me ētahi atu.
He aha ngā mea kei roto i te tipu IVEN Injectable oncology vial turnkey:
Ko ngā otinga hangarau whakauru a IVEN mō te wheketere pounamu rongoā werohanga oncology ko te rūma ma, te pūnaha whakahaere-aunoa me te aroturuki, te pūnaha maimoatanga wai rongoā, te pūnaha whakarite me te tohatoha otinga, te horoi pounamu - te whakahoromata me te tango i te pyrogenation - te whakakī - te aukati - te taupoki - te horoi o waho, te pūnaha whakamaroke tio, te pūnaha wehe, te pūnaha tākai, te pūnaha whakahaere aunoa, te pūnaha whakahaere kounga, te taiwhanga pokapū me ētahi atu. E arotahi ana a IVEN ki ngā hiahia takitahi o ngā kiritaki, ka whakarite tika a IVEN i ngā otinga hangarau mō ngā kaiwhakamahi i runga i:
1. Te horoi i te pounamu oncology werohanga - te whakahoromata me te tango i te pyrogenation - te whakakī - te aukati - te taupoki - te raina whakaputa horoi o waho:
E whakamahia ana tēnei raina hei hanga ipu rongoā werohanga, e rima ngā mīhini kei roto: Mīhini Horoi Ultrasonic Poutū e Whakahaeretia ana e te Servo Katoa, te Tūranga Whakahoromata me te Whakakorenga Piro mō te Tirohanga Hau Wera, te Mīhini Whakakī-Ārai Piro e Whakahaeretia ana e te Servo Katoa, te Mīhini Taupoki Piro me te Mīhini Horoi o Waho.
I muri i te whakakī, ka kati-haurua, ā, ka rite mō te whakamaroke tio, kātahi ka neke ki te mīhini taupoki, ā, muri iho, ka neke ki te mīhini horoi o waho. Ka whakamahia e mātou he pūnaha pauna ipurangi mō te mīhini whakakī, ā, ka whakakorehia aunoatia ngā hua kāore i te tika.
1. Te horoi
2. Te Whakahoromata me te Whakakorenga Piro
3. Whakakī me te Ārai
4. Te taupoki
5. Horoi o Waho
6. kua oti
2. Pūnaha whakamaroke tio me te pūnaha uta me te tango aunoa:
Mō ngā hua kua whakakīia ki te wai, i muri i te whakakī me te ārai-haurua, ka haria aunoa ki te mīhini whakamaroke tio (Lyophilizer) mā te pūnaha uta aunoa. I muri i te whakakīia ki te wai, ka haria ki te mīhini taupoki mā te pūnaha tango aunoa.
3. Pūnaha wehewehe:
I te mea he hua paitini te mate pukupuku, ka taea e tātou te whakamahi i tētahi taputapu wehe hei tiaki i te haumaru o ngā kaiwhakahaere mai i ngā hua, kia tino tiakina ai te tukanga whakaputa i raro i te pūnaha wehe.
Kupu Whakataki Poto
1. Kua wehea rawatia te kaiwhakahaere mai i te wāhi whakaputa matua.
2.Wāhi whakaputa ā-roto taumata A. Rūma ma o waho taumata C/D.
3. Ka taea anake te whakatuwhera i te wehewehe i muri i te whakawetonga o te pūnaha, me manatoko te pūnaha hei whakaara anō.
4. Whakaritea te HPVS mō te whakahoromata ā-roto.
5. Pūnaha tohanga hiri.
6. Whakamahia te whakaurunga hau HEPA, ka taea e te kiriuhi te tiaki i te rere o te hau ōrite me te tātari.
7. Hanganga ā-roto maeneene, hoahoa porowhita.
8. Whakamahia he hiri pupuhi mō ngā tatau tuwhera me ngā matapihi karapu.
9. Mō ngā hua paitini, whakamahia te hoahoa putea-ki-roto, putea-ki-waho.
Ngā Mahi Kē Atu
1.Pūnaha CIP/SIP (SIP mā VHP).
2. Aroturuki Ipurangi i te Tatau Matūriki.
3. Kaiwhakamātautau Matūriki Ora ā-Hau.
4. Pūkaha Whakaputa Hauhāora Kua Kohuatia.
5. Pūoko turuturu o te karapu.
6. Inemāta.
7. Pūoko H/T.
8. Whakatauranga ATEX.
9. Wāhanga Whakamātautau Parekura o Equinox.
10. Pūrere Whakamātautau Hau.
11. Whare Whakawhiti Tātari Pute-ki-roto-pute-ki-waho.
4. Pūnaha tākai:
Ka taea e ia te whakaoti i te tirotiro rama aunoa mō te oncology pounamu werohanga, te tirotiro turuturu, te tapanga, te mirumiru me te tākai kātene tuatahi, me te tākai kātene tuku.
Ka taea e mātou te whakarato i ngā taputapu whakatuwhera kātene aunoa mō te tuku, te pukapuka tohutohu me te whakauru tiwhikete, te tākai kātene, te hiri kātene, te tapanga, te aroturuki raraunga, me te pūnaha whakakore aunoa, e taea ai te whakakore i ngā kātene he taumaha hē, ngā kātene rānei kāore i te tika te tapanga.
5. Te maimoatanga wai rongoā:
Kei roto ko te maimoatanga wai parakore (2RO+EDI), te mīhini whakatā wai (WFI), me te whakaputa mamaoa parakore. Kei roto hoki te tāke PW me te tāke WFI.
6. Te horoi i te rūma me te HVAC
Kei roto ko ngā panera pakitara rūma ma, ngā panera tuanui, ngā matapihi, ngā tatau, ngā papa, ngā rama, te waeine whakahaere hau, ngā tātari HEPA, ngā paipa hau, ngā whakaoho, te pūnaha whakahaere aunoa me ētahi atu. Hei pupuri i te tukanga whakaputa oncology o te pounamu werohanga kia tiakina i raro i te taiao Class C + Isolator.
7. Whaipainga pango
Kei roto ko te pūnaha kōpeke hau me te pūnaha kōhua hei whakarato i te hau kōpeke me te mamaoa e tika ana mō te hanga oncology ipu werohanga.
8. Taiwhanga
Kei roto ko ngā momo taputapu whakamātautau taiwhanga katoa, me ngā taonga taiwhanga hei whakamātautau i ngā tauira oncology pounamu werohanga me ngā rauemi mata, pērā i te rūma pumau, te HPLC, te mimiti ngota, te ine hihi ultraviolet, te ine hihi infrared whakawhiti Fourier me ētahi atu.
9. Pūnaha tohatoha me te paipa
Kei roto ko ngā momo paipa tukatuka katoa me ngā paipa ahumahi e hiahiatia ana i roto i te tipu oncology vial werohanga, pērā i te wai parakore, te wai werohanga, te mamaoa parakore, te wai whakamatao, te wai matao, te hau kōpeke, te mamaoa ahumahi me ētahi atu.
IVENHe tino ngaio ā mātou tīma hangarau me te miihini, ā, ka taea e tā mātou whakangungu ā-papa me te tautoko muri-hoko te whakarato i te whakamana hangarau mō te wā roa mō tō tipu turnkey wai NON-PVC IV:
Ka taea e IVEN te āwhina i a koe ki te whiwhi i ngā tuhinga katoaTiwhikete GMP me te FDAmō tō tipu wai IV ngāwari (tae atu ki te IQ / OQ / PQ / DQ / FAT / SAT me ētahi atu i roto i te putanga Ingarihi me te putanga Hainamana):
Mā te mahi ngaio me te wheako o IVEN koe e āwhina ki te whakaoti i te tipu otinga IV katoa i roto i te wā poto rawa, me te karo i ngā momo mōrearea katoa:
IVENHe tino ngaio ā mātou tīma hangarau me te miihini, ā, ka taea e tā mātou whakangungu ā-papa me te tautoko muri-hoko te whakarato i te whakamana hangarau mō te wā roa mō tō tipu turnkey wai NON-PVC IV:
Tae noa mai ki tēnei wā, kua tukuna e mātou ngā rau huinga taputapu rongoā me ngā taputapu hauora ki te neke atu i te 50 whenua.
I taua wā tonu, i āwhina mātou i ā mātou kiritaki ki tei hanga neke atu i te 20 ngā whare rongoā me te hauora kua oti te whakaritei Uzbekistan, Tajikistan, Indonesia, Thailand, Saudi Arabia, Iraq, Nigeria, Uganda, Tanzania, Ethiopia, Myanmar me ētahi atu, ko te nuinga mō te otinga IV, ngā ipu werohanga me ngā ampoule. I riro i ēnei kaupapa katoa ngā urupare pai ki ā mātou kiritaki me te kāwanatanga.
I kaweake atu hoki mātou i tā mātou raina whakaputa otinga IV ki Tiamana.
Te wheketere pounamu IV o Initonīhia
Te tipu whakakapi mō te pounamu IV o Vietnam
Te wheketere pounamu IV o Uzbekistan
Te tipu pouaka werohanga o Thailand
Te wheketere pounamu IV o Tajikistan
