Umatshini wokuzalisa iBhotile yoLwabi lweMichiza yeeNjongo kunye neSitofu sokugonya
Umgca wemveliso yokuzalisa i-vial yenziwe ngumatshini wokuhlamba iibhotile ze-ultrasonic, i-dryer sterilizer, umatshini wokumisa wokuzalisa, kunye nomatshini wokuvala.Inokugqiba ukutshiza amanzi, ukucocwa kwe-ultrasonic, ukugungxulwa kodonga lwangaphakathi nangaphandle lwebhotile, ukufudumeza, ukomisa kunye nokuvala inzalo, ukususa umthombo wobushushu, ukupholisa, ukukhupha ibhotile, (ukuzaliswa kwangaphambili kwe-nitrogen), ukuzaliswa, (i-nitrogen post-filling), isithinteli. ukungakrwaquli, ukucinezela isivalo, ukukrazula i-cap, i-caping kunye neminye imisebenzi enzima, ukuqonda ukuveliswa okuzenzekelayo kwayo yonke inkqubo.Umatshini ngamnye unokusetyenziswa ngokwahlukileyo, okanye kumgca wokudibanisa.Umgca wonke usetyenziselwa ukugcwalisa i-vial liquid injections kunye ne-freeze-dried powder injections kwiifektri zamachiza, ingasetyenziselwa ukuveliswa kwe-antibiotics, i-bio-pharmaceuticals, i-pharmaceuticals yamachiza, iimveliso zegazi njl.
Umzekelo | SHPD4 | SHPD6 | SHPD8 | SHPD10 | SHPD12 | SHPD20 | SHPD24 |
Iinkcukacha ezisebenzayo | I-2 ~ 30ml iibhotile ze-vial | ||||||
Ukuzalisa iintloko | 4 | 6 | 8 | 10 | 12 | 20 | 24 |
Umthamo wemveliso | 50-100bts/min | 80-150bts/min | 100-200bts/min | 150-300bts/min | 200-400bts/min | 250-500bts/min | 300-600bts/min |
Ukuyekwa kwenqanaba lesiqinisekiso | =99% | ||||||
Ucoceko lomoya weLaminar | Ibanga le-100 | ||||||
Isantya sokumpompa ngevacuum | 10m3/h | 30m3/h | 50m3/h | 60m3/h | 60m3/h | 100m3/h | 120m3/h |
Ukutya umbane | 5kw | ||||||
Ukunikezwa Amandla | 220V/380V 50Hz |
I-1.Umgca wokuvelisa ukutywinwa kwe-vial udibana neemfuno ezintsha ze-GMP, kwaye umphumo wokucoca uhlangabezana nemigangatho entsha ye-Pharmacopoeia kunye neemfuno.
2.Umgca wonke unokusebenzisa i-straight-line layout okanye udonga olune-L-shaped layout ukunciphisa umngcipheko we-cross-contamination kunye nokuqinisekisa inqanaba le-aseptic.
3.Ingcaciso esebenzayo: 1ml-100ml vial (ngokwemfuno yomsebenzisi ngamnye)
4.Umthamo wokuvelisa: 1000-36000BPH
5.Inombolo yokuzalisa intloko: 1-20, ukuba ikhethwe ngokwemveliso
6.Ukuzalisa Ukuchaneka komatshini wokuzalisa i-vial: ≤ ± 1% (ngokweempawu zeziyobisi)
I-7.Ukukhethwa kweepompo zokuzalisa ezahlukeneyo: ipompo yeglasi, ipompo yensimbi, ipompo ye-peristaltic, ipompo ye-ceramic;
8.Capping izinga elifanelekileyo: ≥99.9%
I-9.Isakhiwo esincinci kunye nesilula, sithatha indawo encinci;
I-10.Ukusebenza kwemveliso ezinzileyo, ukusebenza okulula nokuthembekileyo, ukubonakala okuhle;
I-11.Izinga eliphezulu lokuzenzekelayo, abambalwa abaqhubi abafunekayo;
I-vial eyomileyo engenayo (i-sterilized kunye ne-siliconised) yondliwa nge-unscrambler kwaye ikhokelwa ngokufanelekileyo kwibhanti yokuhambisa i-delrin slat kwisantya esifunekayo sokubekwa okuchanekileyo ngaphantsi kweyunithi yokuzalisa.Iyunithi yokuzalisa iqulethe iNtloko yokuZalisa, iiSyringe kunye neeNozzles ezisetyenziselwa ukuzaliswa kwamanzi.Iisirinji zenziwe nge-SS 316 yokwakha kwaye zombini, iglasi kunye neesirinji ze-SS zingasetyenziswa.Ivili leNkwenkwezi libonelelwe elibambe ivial ngexesha lokuzalisa.Uluvo lunikiwe.
1) Oku kuzalisa imibhobho, yimibhobho ephezulu ephuma kumazwe angaphandle.Kukho iivalve kumbhobho, iya kusela ulwelo emva kokuzaliswa kanye.Ngoko ke imilomo yokuzalisa ayiyi kuvuza.
I-2) Isakhiwo se-roller ye-multi-roller yepompo yethu ye-peristaltic iphucula ngakumbi ukuzinza kunye nokungabikho kwempembelelo yokuzaliswa kwaye yenza ukuzaliswa kolwelo kuzinzile kwaye akukho lula ukubetha.Kuyafaneleka ngokukodwa ukuzalisa i-liquid kunye nemfuno ephezulu.
3)Le yi-aluminium Cap yokutywina intloko.Inerola ezintathu zokutywina.Iya kutywina i-Cap ukusuka kumacala amane, ngoko ke i-Cap etywiniweyo iqinile kwaye intle.Ayisayi konakalisa iCap okanye ukuvuza kweCap.