Ii-ampoules ziphakathi kwezona zikhongozeli zithembekileyo nezikhuselekileyo zamayeza afakwa kwi-injection kwimizi-mveliso yamayeza kunye ne-biotech. Ii-ampoules zibonelela ngenye yezona ndlela zibalaseleyo zokugcina nokuhambisa amayeza ukugcina ubumdaka, ukuchaneka, kunye nokuhambelana kokuzaliswa kolwelo kwizikhongozeli zeglasi ezivaliweyo. Sekunjalo, ukuthintela umngcipheko wokungabi bumdaka kufuna izixhobo ezikhethekileyo zokuzalisa nokuvala, ezisetyenziswa yi-ampoule filler.

Eli nqaku lichaza umgaqo wokusebenza kwezithako ze-ampoule, amanyathelo athile kule nkqubo, izinto eziqukiweyo kule nkqubo, kunye nesizathu sokuba uninzi lweenkampani eziphambili zamayeza zisebenzisa izixhobo eziphambili ukuze zihlale zihambelana neemfuno ze-GMP kunye ne-FDA.

Ukuqonda iiMishini zokuzalisa iAmpoule

An umatshini wokuzalisa i-ampouleludidi oluthile lomatshini ochanekileyo wokugcwalisa ulwelo lwamayeza, olufana nemijovo, iiserum, kunye nee-antibiotics, kwii-ampoules zeglasi ezivaliweyo. Umatshini wokugcwalisa ii-ampoule uqinisekisa ukuba amayeza azaliswa kwii-ampoules zeglasi ezivaliweyo kwiimeko zokuzaliswa kwe-aseptic, kwaye atywinwe ngokungenamoya, ukuze imveliso yeyeza igcinwe ngaphandle kongcoliseko kulo lonke ixesha layo lokuphelelwa.

Oomatshini bokugcwalisa ii-ampoule basetyenziswa kumashishini amaninzi, kuquka amayeza, i-biotech, i-veterinary, kunye ne-cosmetic fillings, ezifuna ukungabi nazintsholongwane.

Izinto eziphambili zomatshini wokuzalisa i-Ampoule

Ngaphambi kokuba singene ngqo kwindlela oomatshini bokugcwalisa i-Ampoule, masiqale siqonde ukuba yintoni equlathe umatshini wokugcwalisa i-ampoule:

1.Isixhobo sokutya kunye neConveyor yeAmpoule:Ukuzisa ii-ampoules kwindawo efanelekileyo kwaye ulinde ukuba zifakwe kwinkqubo yokuzalisa

2.Inkqubo yokuhlamba:Ukuqinisekisa ukucoca ngokupheleleyo, ngaphakathi nangaphandle

3.Umjelo wokubulala iintsholongwane:Ukususa iintsholongwane ngokufanelekileyo kwii-ampoules.

4.Inkqubo yokuzalisa:Ukuze sithathe imveliso ngokuchanekileyo siza kuyipompa ivolumu efanelekileyo sisebenzisa iimpompo kunye ne-nozzle.

5.Isitishi sokutywina:Ukutywinwa kwetotshi/ilangatye nako kuyimfuneko ekutywinweni kwe-ampoule ngaphandle komoya.

6.Inkqubo yokuhlola:Iikhamera okanye ezinye izinzwa zokulawula umgangatho.

7.Iphaneli yoLawulo (PLC/HMI):Ukuze kwenziwe ngokuzenzekelayo, ukuxilongwa, kunye nokubeka esweni ngexesha langempela.

Umgaqo oSebenzayo weeMishini zokuzalisa i-Ampoule

Umgaqo osisiseko womatshini wokugcwalisa ii-ampoule yiseti yeenkqubo ezidibeneyo zokuguqula ityhubhu yeglasi engenanto ibe yi-ampoule engenazintsholongwane, egcweleyo, nevaliweyo elungele ukuthengiswa nokusetyenziswa kwikhemesti. Inqanaba ngalinye lenzelwe ukuqinisekisa ukuba iyeza alinazintsholongwane, ukujonga idosi ngokufanelekileyo, kunye nokuthobela imigaqo esebenzayo kwihlabathi liphela.

Apha ngezantsi kukhouhlalutyo lwenyathelo ngenyatheloindlela esebenza ngayo le nkqubo:

1. Ukutya kunye nokuQhelaniswa kweAmpoule

Siqala ngee-ampoules ezingenanto. Ii-ampoules ezingenanto zingena kumatshini nge-'hopper' okanye i-tray loader. Ii-ampoules zisuswa kwindawo yokutya ngoncedo lwe-conveyor kunye ne-star-wheel, ngalo lonke ixesha kuqinisekiswa ukuba umzantsi we-ampoule awuchukumisi i-conveyor, eyenziwe ngentsimbi engagqwaliyo ukuze kuthintelwe ukukrweleka okanye ukuqhekeka okuncinci kwiglasi.

Ukubekwa ngokuchanekileyo kunye nokubekwa kwe-ampoules kubaluleke kakhulu, njengoko nokuba ukungalungelelani okuncinci kunokuchaphazela kakubi inkqubo yokuhlamba okanye yokutywina elandelayo.

2. Ukuhlamba iiAmpoule

Emva kokuba ii-ampoules zilungelelaniswe, ziqhubekela kwindawo yokuhlamba.

1.Ukuhlamba ngaphakathi:I-ampoule nganye ihlanjwa ngaphakathi ngee-sprayers, kusetyenziswa amanzi angenazintsholongwane okujova (i-WFI) okanye umoya ocinezelweyo, iijethi zoxinzelelo oluphezulu zikhupha amasuntswana, uthuli, kunye neentsalela ngaphakathi kwe-ampoule.

2.Ukuhlamba ngaphandle:Umphezulu ongaphandle uyahlanjwa ukuqinisekisa ukuba ucocekile.

Ezinye iinkqubo eziphuculweyo ziya kusebenzisa ukucoca nge-ultrasound ukukhupha izinto ezingabonakaliyo ezingcolisa ukuzala.

Emva kokuhlamba, ii-ampoules zibonakala zicacile, azinazo iinxalenye, zilungele ukubulala iintsholongwane.

3. Ukubulala iintsholongwane kunye nokususa iintsholongwane emzimbeni

Ukucoceka akuthethi ukuba akusoloko kuthetha ukuba akunazintsholongwane. Ukuze kususwe naziphi na iintsholongwane eziseleyo kunye nee-pyrogens (ii-endotoxins ezibangela umkhuhlane), ii-ampoules zidlula kwi-ampoulesumjelo wokususa i-pyrogenation.

1. Apha, bavezwaubushushu obomileyo kwi-300–320°Cphantsi kwendawo elawulwayo.

2. Ubushushu obuphezulu butshabalalisa iintsholongwane, iintsholongwane kunye nee-pyrogens.

Eli nyathelo libaluleke kakhuluamayeza afakwa kwi-injection, njengoko nee-trace pyrogens zinokubangela iziphumo eziyingozi kwizigulana.

4. Ukuphola kunye nokuDlulisa

Ii-ampoules kufuneka zipholiswe ngaphambi kokuba zizaliswe emva kokubulala iintsholongwane. Ukupholisa kuya kwenzeka kwindawo yokucoca yeClass 100 (ISO 5), phantsi komlambo we-laminar, apho umoya ocociweyo ocociweyo ugcina iimeko zokungacoceki.

Ukupholisa nokudlulisa kuqinisekisa ukuba iingcali zezifo ezingenayo igram zinexesha lokuzalisa ii-ampoules kubushushu obukhuselekileyo nobuzinzileyo ngaphambi kokuba ulwelo luvezwe, okuvumela iindlela zokufuma ukuba zenzeke okanye ukusebenzisana kweekhemikhali kwenzeke nobushushu.

5. Ukuzaliswa kolwelo

Kulapho kuzaliswa khona, kwaye yeyona nxalenye inomdla kakhulu yomgca wokugcwalisa. Nje ukuba kufikelelwe kwindawo yokuzalisa, ii-ampoules ziya kuzaliswa ngeempompo zokulinganisa (ii-peristaltic, i-vacuum, okanye ii-piston pumps - kuxhomekeke kwiyeza elithile kunye nobukhulu bee-nozzles zamayeza) ngomlinganiselo ochanekileyo ofunekayo ukuzalisa i-ampoule nganye. Izinto eziphambili zezi:

1.Ukuchaneka:Oomatshini bokuzalisa banamhlanje bafikelela kwinqanaba lokunyamezela ukuzalisa le-+/- 0.5%.

2.Iimeko ezibangela i-Aseptic:Zonke iindlela zokuzalisa zenzeka phantsi komoya ohamba kancinci ukuze indawo yokuzalisa ingangcoliswa kukungcola okubangelwa ngumoya.

3.Ukuphatha ngobunono:Ngokuncedwa zii-nozzles ezihamba kakuhle, ukugqwala okanye ukutshiza kuyancitshiswa kwaye ngenxa yoko akuchaphazeli ukuthembeka kwesiyobisi.

Ezinye iimatshini zizalisa iintloko ezininzi, ezinokuzalisa ii-ampoules ezininzi ngaxeshanye, nto leyo eyonyusa umlinganiselo wokugcwalisa.

6. Ukutshiza igesi ngaphambi kokuba ikhutshwe (Ukhetho)

Ukuba imveliso yimveliso ebuthathaka kwioksijini, njengee-vaccine ezithile okanye izinto eziphilayo, xa i-ampoule izaliswe, i-ampoule ingahlanjwa nge-nitrogen ngaphambi kokuba ivalwe okanye ngaphambi kokuba izaliswe.

1. Oku kususa ioksijini ekhoyo kwindawo yentloko.

2. Iya kuzinzisa imveliso, yandise ixesha layo lokuphelelwa, kwaye inciphise okanye isuse amathuba okuba i-oxidation ivele.

Nangona kungekho mfuneko yokusetyenziswa kwegesi ngaphambi kokusetyenziswa, kwimeko ye-biotech okanye iifomyula ezifakwa ngenaliti ezixabisa kakhulu, kubalulekile.

7. Ukutywinwa kwe-Ampoule

Ngokukhawuleza emva kokuzalisa, ii-ampoules ziya kwi-isikhululo sokutywinaIsangqa sezinto zokutshisa sikhokelela ilangabi elishushu kakhulu entanyeni ye-ampoule.

1. Iglasi iyathamba ize itsalwe ibe sisitywino esincinci.

2. Isiphumo si-ukuvalwa kwe-hermetic,Ayingeni moya, ayiphazamisi kuphazamiseka, kwaye ayingcolisi.

Ngokuxhomekeke kuyilo, ukutywina kunokuvelisaii-ampoules ezivulekileyo ezivalwe ngelangatye(itywinwe ngencam) okanyeii-ampoules ezivaliweyo(kunye neentloko ezenziwe kwangaphambili).

Eli nyathelo liqinisekisa ukuba imveliso ihlala ingenazintsholongwane de kube lixesha lokusetyenziswa.

8. Ukuhlolwa kunye nokwaliwa

Inyathelo lokugqibela laziwa njengoqinisekiso lomgangatho. Ii-ampoules zidlula kwinkqubo yokuhlola ezenzekelayo eneekhamera ezinesisombululo esiphezulu kunye neesensa eziphendulayo, ezihlola:

1. Ivolumu yokugcwalisa echanekileyo

2. Itywina yelangatye echanekileyo

3. Iiglasi ziyaqhekeka okanye ziphosakele

4. Iinxalenye ezincinci

Ukuba kukho nayiphi na i-ampoule enengxaki, iya kwaliwa, ngoko ke kuphela ii-ampoule ezamkelekileyo eziya kuthunyelwa kwinkqubo yokupakisha.

La manyathelo ahlukeneyo ayinxalenye yenkqubo yokwenziwa kwemveliso evaliweyo nengenazintsholongwane eguqula ii-ampoules zeglasi ezivuthiweyo zibe zikhongozeli ezipakishiweyo zeemveliso zamayeza asindisa ubomi, ngaphandle kokungcola.

Imigangatho yokuthobela imithetho kunye nomgangatho

Ii-ampoules zithwala amayeza kwiimveliso zonyango ezifakwa kwi-injection. Ukuthobela imigangatho yehlabathi kubalulekile. Oomatshini bokugcwalisa ii-ampoule banamhlanje bakhelwe oku kulandelayo:

1.Izikhokelo ze-EU GMP

2.I-FDA cGMP yaseMelika

3.I-WHO GMP

4.Imigaqo yePIC/S

Le migangatho iqinisekisa ukuba izigulane azikwazi ukuzala, ziyaphinda-phinda, kwaye zikhuselekile.

Kutheni Ukhetha i-IVEN Pharmatech kwiZisombululo zokuzalisa i-Ampoule?

Nangona kubalulekile ukuqonda umgaqo wokusebenza komatshini wokugcwalisa i-ampoule, kubaluleke ngokulinganayo ukwazi apho ungayifumana khona inkqubo ethembekileyo.IVEN Pharmatechliqabane elincomekayo. Baye baba liqabane elithembekileyo kwiinkampani zamayeza ezinamava aphantse abe yiminyaka engama-20 kwihlabathi liphela, benceda abathengi ngoomatshini bokuzalisa ii-ampoule abazimeleyo kunye nemigca yemveliso epheleleyo.

Okubangela ukuba i-IVEN ibonakale kakhulu kukuba inako ukulawula iiprojekthi eziqala ekupheleni. Baza kubonelela ngoomatshini, kodwa bakwabonelela ngoyilo lwegumbi lokucoca, kunye nokudibanisa izixhobo, ukufakelwa, ukuqinisekiswa, kwaye baza kubonelela ngenkxaso yobugcisa ubomi bonke. Imigca yabo yokuvelisa i-ampoule yokuzalisa yenzelwe ukusebenza kakuhle, ukungabi nazintsholongwane, kunye nokuchaneka.

Ngoku ungadibanisa ukuhlamba, umjelo wokubulala iintsholongwane, ukuzaliswa kolwelo ngokuchanekileyo, kunye nokutywinwa okufakwe kwi-hermetic konke oku kwinkqubo enye engaphazanyiswayo enika uyilo olufanelekileyo lwesalathiso.

Njengenkampani ebisebenza phantse iminyaka engama-20, ineendawo zokwenza iimveliso kumazwe angaphezu kwama-50, i-IVEN ihlangabezana nemigangatho ephezulu efanelekileyo kushishino lwamayeza njengoko inxulumene nemigangatho, izikhokelo zobungcali ezimiselwe yimigangatho elawulwa ngokusisiseko njengoko imiselwe yi-GMP, i-FDA, i-EU, kunye ne-WHO. Ukuba ufuna ukuthembeka kunye nexesha elifutshane lokuthengisa, xa uthenga kwi-IVEN, ufumana okungaphezulu kwezixhobo; sisisombululo esipheleleyo, esiqinisekisiweyo nesihambelanayo nesakhayo.

Isiphelo

Umgaqo osebenzayo womatshini wokugcwalisa ii-ampoule ngendlela ehlengahlengisiweyo nelawulwa ngononophelo, kukuhlamba, ukubulala iintsholongwane, ukuzalisa, kunye nokuvala ukuze kunikezelwe amayeza angenazintsholongwane nachanekileyo kwizigulana. Ukuqonda umgaqo osebenzayo womatshini wokugcwalisa ii-ampoule kuvumela iinkampani zamayeza ukuba zizalisekise uxanduva lwazo lolawulo kwaye zikwazi ukubonelela ngenkqubo yokuvelisa esebenzayo nekhuselekileyo kwizigulana.

Ngaphandle koko, ukusebenza nomthengisi oqinisekisiweyo nohloniphekileyo ofana ne-IVEN Pharmatech kubonelela ngokukodwa koomatshini bokugcwalisa ii-ampoule kunye nokuphuhlisa izisombululo ezipheleleyo, eziqinisekisiweyo, nezithobelayo ezinciphisa umngcipheko kwaye zikhawulezise ixesha lokuthengisa.