Umatshini wokuzalisa iVial yeGlasi yoMenzi
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.
- I-1.Ipompo ye-Peristaltic okanye ukuchaneka okuphezulu kwe-peristaltic yepompo yokuzaliswa, isantya sokuzalisa siphezulu kwaye impazamo yokuzalisa incinci.
2. Isixhobo se-Groove cam sibeka iibhotile ngokuchanekileyo.Ukubaleka kuzinzile, utshintsho inxalenye isempuma ukutshintsha.
3. Iphaneli yokulawula iqhosha kulula ukuyisebenzisa kwaye inezinga eliphezulu lokuzenzekelayo.
4. Ukuwa kwebhotile auto ekhatywayo kwi-turntable, akukho bhotile, akukho ukuzaliswa;umatshini auto uyeka xa kungekho sithinteli;auto alarms xa
isivalo esingonelanga.
5. Ukuxhobisa ngomsebenzi wokubala ngokuzenzekelayo.
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.
1.Sinokubonelela nge-OEC / ODM design.
2.Sinikezela ngewaranti yonyaka o-1 kunye nonikezelo lwasimahla lweendawo ezisecaleni (hayi ezenziwe ngumntu ezaphukileyo), siya kulungiselela iindawo ezaneleyo ezizisiweyo.
kunye noomatshini.
3.Umatshini wethu wenzelwe kwisakhiwo esilula, ukuze kube lula ukusebenza kunye nokulungiswa kweempazamo.
4.Iinjineli ezifumanekayo kumatshini wenkonzophesheya kolwandle