Umugqa wokukhiqiza we-Ampoule kanyeumugqa wokugcwalisa ama-ampoule(eyaziwa nangokuthi umugqa ohlangene we-ampoule) yimigqa ejovwayo ye-cGMP ehlanganisa ukugeza, ukugcwalisa, ukuvala, ukuhlola, kanye nezinqubo zokulebula. Kuma-ampoule omlomo ovaliwe kanye nomlomo ovulekile, sinikeza imigqa yama-ampoule omjovo oketshezi. Sinikeza imigqa yokugcwalisa ama-ampoule ezenzakalelayo ngokuphelele kanye nemigqa yokugcwalisa e-semi-automatic, efanele imigqa emincane yokugcwalisa ama-ampoule. Yonke imishini emigqeni yokugcwalisa ezenzakalelayo ihlanganiswe ukuze isebenze njengohlelo olulodwa, oluhlangene. Ukuze kuhambisane ne-cGMP, zonke izingxenye zokuxhumana zakhiwe ngezinto ezivunyelwe yi-FDA noma insimbi engagqwali engu-316L.

Umugqa Wokugcwalisa Ama-Ampoule Ozenzakalelayo

Imigqa Yokugcwalisa Ama-Ampoule Okuzenzakalelayozakhiwe ngemishini yokubhala amalebula, ukugcwalisa, ukuvala, kanye nokuwasha. Yonke imishini ixhunywe ekusebenzeni njengohlelo olulodwa, oluhlangene. Ukuzenzakalela kusetshenziswa emisebenzini yokususa ukungenelela kwabantu. Le migqa yaziwa nangokuthi iMigqa Yokugcwalisa Ama-Ampoule E-Production Scale noma iMigqa Yokukhiqiza Ama-Ampoule E-High-Speed. Imishini kulolu hlobo lomugqa wokugcwalisa ibhalwe ngezansi:

Umshini Wokuwasha Ama-Ampoule Ozenzakalelayo

Inhloso ye-ampoule washer ezenzakalelayo, eyaziwa nangokuthiumshini wokuwasha we-ampoule ozenzakalelayo,ukuhlanza ama-ampoules ngenkathi kunciphisa ukuthintana kwezingxenye zomshini nama-ampoules ukuze kuhambisane nemithethonqubo ye-cGMP. Ukuwashwa kwama-ampoules okuhle kuqinisekiswa umshini onohlelo lwe-Gripper oluthuthukisiwe olubamba i-ampoule entanyeni bese luyiguqula kuze kube yilapho inqubo yokuwasha isiphelile. I-ampoule bese ikhishwa ohlelweni lwe-feedworm oluphumayo lusesimweni esiqondile ngemva kokuwasha. Usebenzisa izingxenye ezithathelwanayo, umshini ungahlanza ama-ampoules asukela ku-1 kuya ku-20 milliliters.

Umhubhe Wokubulala Inzalo

Ama-ampoules engilazi nama-vial ahlanziwe ayahlanzwa futhi asuswe i-pyrogenation online kusetshenziswa umhubhe wokuhlanza nokususa i-pyrogenation, owaziwa nangokuthi i-pharma.umhubhe wokubulala amagciwaneAma-ampoules engilazi nama-vials athuthwa kusuka emishinini yokuwasha ezenzakalelayo (engenabo amagciwane) kuya entanjeni yokufaka amafayili (indawo engenabo amagciwane) emhubheni ngentambo yensimbi engagqwali.

Umshini Wokugcwalisa Nokuvala Ama-Ampoule

Ama-ampoules engilazi yemithi agcwaliswa futhi apakishwe kusetshenziswa i-umshini wokugcwalisa nokuvala ama-ampoule, eyaziwa nangokuthi i-ampoule filler. Uketshezi luthelwa kuma-ampoule, akhishwa kamuva kusetshenziswa igesi ye-nitrogen bese luvalwa ngamagesi avuthayo. Umshini unephampu yokugcwalisa eyenzelwe ngqo ukugcwalisa uketshezi ngqo ngenkathi igxilisa intamo phakathi ngesikhathi senqubo yokugcwalisa. Lapho nje uketshezi selugcwalisiwe, i-ampoule ivalwa ukuze kuvinjelwe ukungcola. Yenziwe ngokuhambisana nemithetho ye-cGMP kusetshenziswa izingxenye zensimbi engagqwali ze-premium 316L.

Umshini Wokuhlola Ama-Ampoule

Ama-ampoule engilazi angafakwa angahlolwa kusetshenziswa umshini wokuhlola ama-ampoule ozenzakalelayo. Imizila emine ye-Umshini Wokuhlola Ama-AmpouleZenziwe nge-nylon-6 roller chain, futhi ziza ne-spinning assembly ehlanganisa ama-AC Drive Rejection Units kanye ne-24V DC wiring. Ngaphezu kwalokho, ikhono lokushintsha isivinini lenziwe laba nokwenzeka nge-variable AC frequency drive. Zonke izingxenye zokuthintana zomshini zakhiwe ngama-polymer agunyaziwe anjiniyela kanye nensimbi engagqwali, ngokuhambisana nemithetho ye-cGMP.

Umshini Wokulebula we-Ampoule

Imishini esezingeni eliphezulu, eyaziwa ngokuthiumshini wokulebula we-ampoulenoma ilebula lama-ampoule, isetshenziselwa ukulebula ama-ampoule engilazi, ama-vial, namabhodlela okuphonsa amehlo. Ukuze uphrinte inombolo yebhetshi, usuku lokukhiqiza, kanye nolunye ulwazi kumalebula, faka iphrinta kukhompyutha yakho. Amabhizinisi ekhemisi anenketho yokwengeza ukuskena ibhakhodi kanye nezinhlelo zokubona ezisekelwe ekhamera. Kunezinhlobo ezahlukene zamalebula ezingasetshenziswa, kufaka phakathi amalebula ephepha, amalebula asobala, kanye namalebula e-BOPP anezinhlobo zezitika ezinamathelayo.