Mīhini Paninga Tino Pai BGB-250F Hou me ngā Parai Paninga Ka taea te Whakawhiti
He hoahoa tuwhera whānui i te taha o mua
He ngāwari te horoi, kāore he kokonga mate
He whānui te wāhi tāutanga me te wāhi tiaki, ā, ka taea te whakakapi i ngā paraharaha
He hanganga hiri motuhake mō te pēke hau, he rūma kua kati katoa
Ka whakamahia e ia te pūnaha whakahaere aunoa a te HM land PLC, ā, ka taea te whakatutuki i ngā whakaritenga 21 CFR Wāhanga 11.
Ka tautoko i te whakawhitiwhiti o ngā peihana paninga mō ngā rahinga whakaputa rerekē, ka taea ai te mahi maha-kaupapa me te whakatutuki i ngā hiahia whakaputa ngāwari.
Te hoahoa o te hanganga o te tomokanga hau o runga me te putanga hau o raro, e whakanui ana i te whakamahinga o te otinga paninga mā te 5-10%.
E tautoko ana i tētahi tikanga tauira kati ipurangi.
Kei te wātea he whāngai hiki takahuri hei whiriwhiri, kia maeneene ai te whakawhiti o ngā papa ki roto i te paraharaha hei ārai i te pakaru, te pakaru rānei i puta mai i te pānga mai i ngā rerekētanga teitei, me te whakahaere māmā noa iho.
Te tukunga hurihuri whakamuri aunoa katoa, kāore he kuru papa, te tere tukunga 100%, me te whakaiti i te mahi ā-ringa.
He maeneene te whakawhiti pewa i waenga i te koeko pahu me te pereti mata, hei ārai i te kino o ngā papa.
Kua tāpirihia te mana whakahaere porowhita-kati mō te tere hurihuri o te paninga paninga: ka kitea te tere tuturu o te rakau (ka whakaaturia ki te mata), ka whakarite kia tika te tere kāore e pāngia e te kawenga, te pehanga tere rānei o te motuka; kei roto hoki te kitenga rahunga hononga me te mahi whakaoho tere rerekē.
Mā te whakahaere otinga paninga ka taea te whakatutuki i te pēhanga pumau me te tūnga rere pumau.
Te tātari puehu reanga F9, e tutuki ana i ngā paerewa tukunga ā-motu me te uara purenga iti iho i te 20mg/m³ (he tātari F9+H13 whiriwhiri mō te uara purenga
Te mahinga o te pūnaha whakahaere (ina whirihorahia ngā pūoko whiriwhiri): te tika o te whakahaere rōrahi hau tae atu ki te ±5%, te tika o te whakahaere pēhanga kino tae atu ki te ±15Pa, me te tika o te whakahaere pāmahana hau tuku tae atu ki te ±1.5℃.
Ngā mahi a te pūnaha whakahaere (me te papatohu whakamarie, te papatohu ahumahi rānei): te ara arotake, te tuhi raraunga, te kauwhata ia, me ētahi atu.
Ka tautokohia e ngā tohutao hanga aunoa me ngā tohutao horoi aunoa o te taputapu te mana whakahaere tukanga rerekē; ka taea te whakarite takitahi i ngā tawhā tukanga mō ia wāhanga kia tutuki ai ngā whakaritenga tukanga kua whakaritea e ngā kiritaki.
Kei te pūnaha he mīhini horoi hei whakatutuki i te korenga o ngā parahanga me te karo i te poke o ngā moroiti.
E tutuki ana i ngā paerewa tiwhikete EU CE, me ngā whakaritenga o te putanga hou o ngā ture GMP, CGMP, me te FDA.