Umshini Wokugcwalisa Ibhodlela Lomkhiqizi Wemithi Ye-Glass
Ulayini wokukhiqiza wokugcwalisa i-vial wakhiwe umshini wokuwasha amabhodlela we-ultrasonic, i-dryer sterilizer, umshini wokumisa ukugcwalisa, nomshini we-capping.Ingakwazi ukuqedela amanzi okufafaza, ukuhlanzwa kwe-ultrasonic, ukugezwa kodonga lwangaphakathi nangaphandle lwebhodlela, ukushisa kuqala, ukomisa nokuvala inzalo, ukususa umthombo wokushisa, ukupholisa, ukukhipha ibhodlela, (ukugcwalisa kuqala i-nitrogen), ukugcwalisa, (ukugcwalisa i-nitrogen post-filling), isivalo. ukunganyakazi, ukucindezela isivalo, i-cap unscramling, i-capping kanye neminye imisebenzi eyinkimbinkimbi, ebona ukukhiqizwa okuzenzakalelayo kwayo yonke inqubo.Umshini ngamunye ungasetshenziswa ngokwehlukana, noma kulayini wokuxhumanisa.Wonke umugqa usetshenziselwa ukugcwalisa imijovo ye-vial liquid kanye nemijovo ye-powder efriziwe efrijini emafektri emithi, ungasetshenziswa futhi ekukhiqizeni ama-antibiotics, i-bio-pharmaceuticals, imithi yamakhemikhali, imikhiqizo yegazi njll.
Imodeli | I-SHPD4 | I-SHPD6 | I-SHPD8 | I-SHPD10 | I-SHPD12 | I-SHPD20 | I-SHPD24 |
Ukucaciswa okusebenzayo | 2 ~ 30ml amabhodlela vial | ||||||
Egcwalisa amakhanda | 4 | 6 | 8 | 10 | 12 | 20 | 24 |
Amandla okukhiqiza | 50-100bts/min | 80-150bts/min | 100-200bts/min | 150-300bts/min | 200-400bts/min | 250-500bts/min | 300-600bts/min |
Ukumisa izinga lokufaneleka | >=99% | ||||||
Ukuhlanzeka komoya we-laminar | Ibanga le-100 | ||||||
Isivinini sokumpompa nge-vacuum | 10m3/h | 30m3/h | 50m3/h | 60m3/h | 60m3/h | 100m3/h | 120m3/h |
Ukusetshenziswa kwamandla | 5 kw | ||||||
Ukunikezwa kwamandla kagesi | 220V/380V 50Hz |
1.Umugqa wokukhiqiza wokugcwalisa i-vial uhlangabezana nezidingo ezintsha ze-GMP, futhi umphumela wokuhlanza uhlangabezana namazinga nezidingo ezintsha ze-Pharmacopoeia.
2.Wonke ulayini ungathatha isakhiwo somugqa oqondile noma isakhiwo esimise odongeni kuya odongeni ukuze kuncishiswe ingcuphe yokungcola okuphambene nokuqinisekisa izinga le-aseptic.
3. Ukucaciswa okusebenzayo: 1ml-100ml vial (ngokwesidingo somsebenzisi ngamunye)
4.Ikhono Lokukhiqiza: 1000-36000BPH
I-5.Inombolo yekhanda lokugcwalisa: 1-20, okumele ikhethwe ngokusho kokuphumayo
I-6.Ukugcwalisa Ukunemba komshini wokugcwalisa i-vial: ≤ ± 1% (ngokwezici zezidakamizwa)
I-7.Ukukhethwa kwamaphampu ahlukahlukene okugcwalisa: iphampu yeglasi, ipompo yensimbi, ipompo ye-peristaltic, ipompo ye-ceramic;
8.Capping izinga elifanelekile: ≥99.9%
9.Isakhiwo esiqinile nesilula, sithatha indawo encane;
10.Ukusebenza komkhiqizo okuzinzile, ukusebenza okulula nokuthembekile, ukubukeka okuhle;
11.Izinga eliphezulu lokuzenzakalela, kudingeka ama-opharetha ambalwa;
Ibhodlela elomile elingenayo (elifakwe inzalo nelifakwe i-siliconise) liphakelwa nge-unscrambler futhi liqondiswe ngokufanelekile ebhandeni elihambisayo le-delrin slat ngesivinini esidingekayo sokubekwa okulungile ngezansi kweyunithi yokugcwalisa.Iyunithi yokugcwalisa iqukethe Ikhanda Lokugcwalisa, Amasyringe & Nozzles asetshenziselwa ukugcwalisa uketshezi.Amasirinji enziwe ngokwakhiwa kwe-SS 316 futhi zombili, ingilazi kanye namasirinji e-SS angasetshenziswa.Kuhlinzekwa Isondo Lenkanyezi elibamba ibhodlela ngesikhathi sokusebenza kokugcwalisa.Inzwa inikeziwe.
1)Lokhu ukugcwalisa amapayipi, kungamapayipi angenisiwe asezingeni eliphezulu.Kunamavalvu epayipini, lizomunca uketshezi ngemuva kokugcwalisa kanye.Ngakho ukugcwalisa ama-nozzles ngeke kuvuze.
2) Isakhiwo se-multi-roller sepompo yethu ye-peristaltic sithuthukisa ukuzinza kanye nokungabi nomthelela wokugcwalisa futhi senza ukugcwaliswa koketshezi kuzinze futhi kungabi lula ukuqhunyiswa.Kufanelekile ngokukhethekile ukugcwalisa uketshezi ngesidingo esiphezulu.
3) Leli yikhanda lokuvala uphawu le-aluminium Cap.Ine-roller emithathu evala uphawu.Izovala i-Cap ezinhlangothini ezine, ngakho-ke i-Cap evaliwe iqina kakhulu futhi yinhle.Ngeke ilimaze i-Cap noma i-Leakage Cap.
- I-1.Ipompo ye-Peristaltic noma ukunemba okuphezulu kwepompo yokugcwalisa i-peristaltic, isivinini sokugcwalisa siphezulu futhi iphutha lokugcwalisa lincane.
2. Idivayisi ye-Groove cam ibeka amabhodlela ngokunembile.Ukugijima kuzinzile, shintsha ingxenye isempumalanga ukushintsha.
3. Iphaneli yokulawula izinkinobho kulula ukuyisebenzisa futhi inezinga eliphezulu lokuzenzakalela.
4. Ukuwa kwebhodlela okuzenzakalelayo kwenqatshiwe ku-turntable, akukho bhodlela, akukho ukugcwaliswa;umshini ozenzakalelayo uyama lapho kungekho sivimbi;auto alamu lapho
isivalo esinganele.
5. Hlomisa ngomsebenzi wokubala ngokuzenzakalelayo.
Ibhodlela elomile elingenayo (elifakwe inzalo nelifakwe i-siliconise) liphakelwa nge-unscrambler futhi liqondiswe ngokufanelekile ebhandeni elihambisayo le-delrin slat ngesivinini esidingekayo sokubekwa okulungile ngezansi kweyunithi yokugcwalisa.Iyunithi yokugcwalisa iqukethe Ikhanda Lokugcwalisa, Amasyringe & Nozzles asetshenziselwa ukugcwalisa uketshezi.Amasirinji enziwe ngokwakhiwa kwe-SS 316 futhi zombili, ingilazi kanye namasirinji e-SS angasetshenziswa.Kuhlinzekwa Isondo Lenkanyezi elibamba ibhodlela ngesikhathi sokusebenza kokugcwalisa.Inzwa inikeziwe.
1)Lokhu ukugcwalisa amapayipi, kungamapayipi angenisiwe asezingeni eliphezulu.Kunamavalvu epayipini, lizomunca uketshezi ngemuva kokugcwalisa kanye.Ngakho ukugcwalisa ama-nozzles ngeke kuvuze.
2) Isakhiwo se-multi-roller sepompo yethu ye-peristaltic sithuthukisa ukuzinza kanye nokungabi nomthelela wokugcwalisa futhi senza ukugcwaliswa koketshezi kuzinze futhi kungabi lula ukuqhunyiswa.Kufanelekile ngokukhethekile ukugcwalisa uketshezi ngesidingo esiphezulu.
3) Leli yikhanda lokuvala uphawu le-aluminium Cap.Ine-roller emithathu evala uphawu.Izovala i-Cap ezinhlangothini ezine, ngakho-ke i-Cap evaliwe iqina kakhulu futhi yinhle.Ngeke ilimaze i-Cap noma i-Leakage Cap.
1.Singakwazi ukuhlinzeka ngomklamo we-OEC/ODM.
2.Sinikeza iwaranti yonyaka ongu-1 kanye nezingxenye eziyisipele zamahhala (hhayi eziphukile ezenziwe umuntu), sizolungisa izingxenye ezisele ezanele ezilethiwe
kanye nemishini.
3.Umshini wethu uklanywe ngesakhiwo esilula, ukuze kube lula ukusebenza nokulungisa iphutha.
4.Onjiniyela abatholakalayo emishinini yosizophesheya kwezilwandle