Umgca wokuvelisa i-Ampoule kunyeumgca wokuzalisa i-ampoule(ekwaziwa ngokuba ngumgca odibeneyo we-ampoule) yimigca efakwa kwi-cGMP equka ukuhlamba, ukuzalisa, ukuvala, ukuhlola, kunye neenkqubo zokulebhelisha. Kwii-ampoule zomlomo ovaliweyo kunye nomlomo ovulekileyo, sinikezela ngemigca ye-ampoule ye-injection engamanzi. Sinikezela ngemigca yokuzalisa i-ampoule ezenzekelayo ngokupheleleyo kunye neye-semi-automatic, efanelekileyo kwimigca yokuzalisa i-ampoule encinci. Zonke izixhobo ezikwimigca yokuzalisa ezenzekelayo zihlanganisiwe ukuze zisebenze njengenkqubo enye, edibeneyo. Ukuthobela i-cGMP, zonke iindawo zoqhagamshelwano zakhiwe ngezinto ezivunyiweyo yi-FDA okanye ngentsimbi engagqwaliyo eyi-316L.

Umgca Wokuzalisa I-Ampoule Ozenzekelayo

Imigca yokuzalisa ii-ampoule ngokuzenzekelayoZenziwe ngoomatshini bokubhala iilebheli, ukuzalisa, ukuvala, kunye nokuhlamba. Wonke umatshini uqhagamshelwe ukusebenza njengenkqubo enye, edibeneyo. Ukwenziwa kwezinto ngokuzenzekelayo kusetyenziswa kwimisebenzi yokususa ukungenelela kwabantu. Le migca ikwaziwa ngokuba yiMigca yokuzalisa iMigca yeSikali seMveliso okanye iMigca yokuZalisa iMigca yeSikhathi esiPhezulu. Izixhobo ezikule hlobo lomgca wokuzalisa zidweliswe ngezantsi:

Umatshini wokuhlamba i-ampoule ozenzekelayo

Injongo yomatshini wokuhlamba ii-ampoule ozenzekelayo, okwaziwa ngokuba yi-umatshini wokuhlamba i-ampoule ozenzekelayo,kukucoca ii-ampoules ngelixa kunciphisa ukudibana kweendawo zomatshini nee-ampoules ukuze kuhambelane nemigaqo ye-cGMP. Ukuhlamba ii-ampoules ezifanelekileyo kuqinisekiswa ngumatshini onenkqubo yeGripper eyenzelwe ngokukodwa ebamba i-ampoule entanyeni ize iyiguqule ide igqitywe inkqubo yokuhlamba. I-ampoule emva koko ikhutshwa kwinkqubo ye-outfeed feedworm ikwindawo ethe nkqo emva kokuhlamba. Usebenzisa iindawo ezitshintshiweyo, umatshini unokucoca ii-ampoules ukusuka kwi-1 ukuya kwi-20 milliliters.

Umjelo wokubulala iintsholongwane

Ii-ampoules zeglasi kunye neebhotile ezicociweyo ziyacocwa kwaye zisuswe iintsholongwane kwi-intanethi kusetyenziswa umjelo wokubulala iintsholongwane kunye nokususwa kweentsholongwane, okwaziwa ngokuba yi-pharma.umjelo wokubulala iintsholongwaneIi-ampoules zeglasi kunye neebhotile zisuswa kwiimashini zokuhlamba ezizenzekelayo (ezingenazintsholongwane) ziye kumgca wokufaka impahla (indawo engenazintsholongwane) kwitonela ngesixhobo sokuhambisa ucingo sentsimbi engatyiwayo.

Umatshini wokuzalisa kunye nokutywina i-Ampoule

Ii-ampoules zeglasi zamayeza zizaliswa kwaye zipakishwe kusetyenziswa i-umatshini wokuzalisa kunye nokutywina i-ampoule, okwaziwa ngokuba yi-ampoule filler. Ulwelo lugalelwa kwii-ampoule, ezithi emva koko zikhutshwe kusetyenziswa igesi ye-nitrogen kwaye zitywinwe ngeegesi ezinokutsha. Lo matshini unepompo yokuzalisa eyenzelwe ngokukodwa ukuzalisa ulwelo ngokuchanekileyo ngelixa iphakathi entanyeni ngexesha lenkqubo yokuzalisa. Kwakamsinya nje ukuba ulwelo luzaliswe, i-ampoule iyavalwa ukuthintela ungcoliseko. Yenziwe ngokuhambelana nemigaqo ye-cGMP kusetyenziswa izinto ze-premium stainless steel 316L.

Umatshini wokuhlola i-Ampoule

Ii-ampoules zeglasi ezinokutofwa zinokuhlolwa kusetyenziswa umatshini wokuvavanya ii-ampoule ngokuzenzekelayo.Umatshini wokuhlola i-AmpouleZenziwe nge-nylon-6 roller chain, kwaye ziza ne-spinning assembly equka ii-AC Drive Rejection Units kunye neentambo ze-24V DC. Ukongeza, ukukwazi ukuguqula isantya kwenzeke nge-variable AC frequency drive. Zonke iindawo zoqhagamshelwano zomatshini zenziwe ngee-polymers ezivunyiweyo ezenziwe ngobunjineli kunye nentsimbi engagqwaliyo, ngokuhambelana nemigaqo ye-cGMP.

Umatshini Wokulebhelisha we-Ampoule

Izixhobo zodidi oluphezulu, ezaziwa ngokubaumatshini wokulebhelisha i-ampouleokanye ilebheli yee-ampoule, isetyenziselwa ukulebhelisha ii-ampoule zeglasi, ii-vials, kunye neebhotile ze-eye drop. Ukuprinta inombolo yebhetshi, umhla wokwenziwa, kunye nolunye ulwazi kwiilebheli, faka iprinta kwikhompyutha yakho. Amashishini eekhemesti anokukhetha ukongeza ukuskena ibhakhodi kunye neenkqubo zokubona ezisekelwe kwikhamera. Kukho iintlobo ezahlukeneyo zeelebheli ezinokusetyenziswa, kubandakanya iilebheli zephepha, iilebheli ezibonakalayo, kunye neelebheli ze-BOPP ezineentlobo zezitikha ezizincamathelayo.