Kev tsim cov khoom lag luam aseptic tau keeb kwm yog qhov kev xav tau tshaj plaws thiab pheej hmoo tshuaj ua haujlwm. Ntau lub tuam txhab tshuaj tau ntsib nrog "qhov teeb meem" ntawm kev hloov cov txheej txheem tsim khoom lossis tso tseg cov khoom lag luam aseptic uas tsis tuaj yeem ua kom tsis muaj menyuam.
Kab lus no yuav muab piv rau cov txheej txheem aseptic ib txwm ua, txheej txheem ziab kom qhuav, thiab bfs aseptic filling txheej txheem los qhia koj vim li cas ASEPTIC BFS MACHINE yog koj qhov kev xaiv zoo tshaj.
Aseptic BFS Filling Txheej Txheem:
Qhov tshwm sim ntawm Blow Fill Seal "peb-hauv-ib" aseptic filling txheej txheem (tom qab no hu ua BFS txheej txheem) yuav tsum tau cim los ntawm BFS tshuab tsim los ntawm German engineer Gerhard Hansen hauv 1962. Lub tshuab BFS tuaj yeem ua tiav CIP / SIP (on-line tu / on-line sterilization) ntawm tag nrho cov khoom siv pipelines nyob rau hauv kev tswj ntawm lub computer cov kev pab cuam, thiaj li hais tias peb txheej txheem ntawm lub raj mis ua, filling thiab sealing tiav nyob rau hauv tib lub sterile ib puag ncig nyob rau hauv kev tiv thaiv ntawm chav kawm ntawv A cua da dej .
Tag nrho cov txheej txheem tswj ntau lawm yog ua tiav los ntawm lub khoos phis tawj program raws li qhov kev pab cuam predetermined. Cov kev pheej hmoo ua tau (ib puag ncig, qhov kub thiab txias, qhov sib txawv ntawm qhov sib txawv, thiab lwm yam) hauv cov txheej txheem raug saib xyuas los ntawm lub khoos phis tawj tswj hwm raws li cov txheej txheem teeb tsa. Cov kev txwv tsis pub muaj tag nrho hauv lub computer thiab tuaj yeem sab laj txhua lub sijhawm, tab sis tsis tuaj yeem hloov pauv. Qhov no yog cov txheej txheem sau nrog qhov muaj zog tshaj plaws sterility lav muaj peev xwm tam sim no.
BFS Aseptic Filling Technology Txheej Txheem yog qhia hauv daim duab 1.
Kev taw qhia txog 8 qhov zoo tshaj plaws uas koj yuav tsum paub txog aseptic BFS tshuab filling tshuab.
1. Superior aseptic ntau lawm ib puag ncig tsim:
BFS tshuab yog tsim thiab ntsia raws li lub hauv paus ntsiab lus ntawm "dub thiab dawb muab faib". Tag nrho cov txheej txheem ntau lawm yog tswj los ntawm lub khoos phis tawj program, thiab cov txheej txheem tsis muaj kev ruaj ntseg thiab txhim khu kev qha. Qhov chaw ntim ntawm cov cuab yeej muaj kev tiv thaiv los ntawm A-theem laminar ntws, tsis muaj tus neeg teb xov tooj hauv chav ntim khoom thaum lub sijhawm tsim khoom, thiab tsis muaj cov pa phem hauv cov txheej txheem tsim khoom. Tag nrho cov txheej txheem kav dej (nrog rau cov txheej txheem npaj) hauv kev sib cuag nrog cov ntaub ntawv tuaj yeem paub CIP / SIP, thiab lub tshuab nqus tsev, ntim thiab sealing chaw nres tsheb yog tiv thaiv los ntawm A-theem cua da dej, cov khoom raug txiav tawm sab nraum chav ntim. Ib sab ntawm cov khoom xa tawm channel yog nyob rau hauv A-theem laminar ntws cheeb tsam thiab sab nraud yog nyob rau hauv qhov chaw tsim khoom, muaj qhov sib txawv siab tiv thaiv tsis pub tsawg dua 40Pa, thiab tag nrho cov txheej txheem muaj peev xwm lav aseptic muaj zog.
2. Super tus nqi txuag muaj peev xwm
Lub tshuab BFS ua rau lub thawv rau hauv lub xeev aseptic yam tsis tau ntxuav thiab ua kom tsis muaj menyuam, txuag cov txheej txheem dej thiab lub zog.
3. Cov khoom zoo thiab cov txiaj ntsig kev lag luam zoo
BFS tshuab txais kev tsim qauv, ib qho khoom siv zoo li lub Hoobkas me me, uas tuaj yeem ua tiav tag nrho cov txheej txheem thiab kev saib xyuas ntawm tshuab, filling thiab sealing. Cov khoom siv nyob hauv thaj chaw me me thiab siv lub zog tsawg dua hauv cov txheej txheem tsim khoom. Yog li ntawd, cov nqi tsim khoom ntawm BFS aseptic filling txheej txheem tsis siab dua li cov txheej txheem aseptic ib txwm ua, tab sis cov khoom lag luam zoo thiab cov txiaj ntsig kev lag luam muaj txiaj ntsig ntau dua li cov txheej txheem aseptic.
4. Ultra-siab technical cov ntsiab lus thiab cov khoom muaj nqis ntxiv
BFS tshuab tuaj yeem siv PP / PE2 cov ntaub ntawv raws li cov txheej txheem xav tau, cov nqi sib tw ntawm cov thawv ntim khoom yog tsawg, thiab cov khoom siv tshuab cov ntsiab lus thiab cov nqi ntxiv yog siab.
5. Kev tswj lub computer, kev nyab xeeb thiab txhim khu kev qha
BFS tshuab tuaj yeem ua tiav CIP / SIP raws li kev tswj hwm lub khoos phis tawj, nrog kev txhim kho txhim khu kev qha thiab kev nyab xeeb thiab txhim khu kev qha.
6. Haum rau kev tsim ntau hom aseptic filling khoom
BFS cov cuab yeej tuaj yeem paub aseptic filling yam tsis muaj qhov kub thiab txias, thiab cov khoom lag luam ruaj khov. Nws tuaj yeem siv rau ntau hom aseptic cov khoom ntim thiab tsim ntau yam aseptic ntim tsuas yog hloov cov pwm sib txawv.
7. Aseptic ntau lawm, siv aseptic, txuag nqi
Lub tshuab filling ntawm BFS cov cuab yeej tsim cov qauv "Luer interface" ntawm lub raj mis caj dab thaum cov khoom tau ntim. Lub "Luer interface" tuaj yeem txuas nrog cov koob txhaj tshuaj kom nruj. Thaum cov tshuaj tau muab rho tawm, cov huab cua sab nraud yuav tsis nkag mus rau hauv lub thawv, thiab cov khoom tuaj yeem paub txog aseptic ntau lawm, siv aseptic, thiab kev nyab xeeb zoo. Yas ntim cov khib nyiab yog yooj yim los lis thiab yuav tsis ua phem rau ib puag ncig.
BFS aseptic filling txheej txheem muaj keeb kwm ze li ntawm 50 xyoo. Vim muaj qhov zoo ntawm kev muaj zog tsis muaj zog lav nyob rau hauv cov txheej txheem ntawm kev tsim thiab siv, nws tau dhau los ua ib qho qauv los hloov cov iav ampoule ntau lawm txheej txheem ntawm kev ntxuav, sau, sealing thiab sterilization thiab cov txheej txheem iav fwj infusion nrog BFS aseptic filling txheej txheem. Cov khoom ntim aseptic saj zawg zog muaj qhov zoo tsis tuaj yeem hloov pauv hauv cov haujlwm tshwj xeeb xws li kev npaj kev sib ntaus sib tua thiab kev puas tsuaj.
8. Cov txheej txheem BFS yog qhov tsim nyog rau kev tsim cov tshuaj kub-rhiab, kev npaj biochemical, tshuaj tiv thaiv thiab lwm yam khoom.
Thaum lub sij hawm tsim cov txheej txheem, cov pwm tsim tshwj xeeb ua rau kev tsim thiab txias ntawm cov ampoules ua tiav yuav luag ib txhij. Txawm hais tias qhov kub ntawm cov khoom nce me ntsis thaum pib ntawm kev sau, nws tsis txaus los cuam tshuam rau qhov zoo ntawm cov tshuaj.
Txheej txheem aseptic Filling:
Hauv cov txheej txheem aseptic ib txwm siv, vim tias cov cuab yeej tsis tuaj yeem paub tseeb CIP / SIP, tshwj xeeb tshaj yog cov khoom tseem ceeb ntawm cov cuab yeej yuav tsum tau sib sau ua ke thiab debugged ua ntej siv, uas yuav ua rau muaj kuab paug rau cov cuab yeej thiab thaj chaw aseptic. Cov thawv ntim khoom thiab cov khoom siv yog yuav los ntawm sab nraud, thiab lawv yuav tsum tau muab ntxuav thiab ua kom tsis muaj menyuam sib cais, thiab tom qab ntawd muab tso ua ke. Muaj kev pheej hmoo ntawm kev kis kab mob hauv txhua qhov txuas, thiab nws tsis tuaj yeem ua kom tau raws li qhov yuav tsum tau muaj kev ruaj ntseg kom tsis muaj menyuam thoob plaws hauv cov txheej txheem.
Cov txheej txheem tsim khoom tiag kuj tau lees paub qhov tsis xws luag ntawm cov tshuaj aseptic filling. Piv txwv li, kev ntxuav, sau, sealing thiab sterilization txheej txheem ntawm me me ntim iav ampoules muaj cov nram qab no tsis xws luag:
1. Tus nqi siab:
(1) Rau cov iav ampoules outsourced, nws yog ib qho tsim nyog los tsim lub tsev rau khoom loj dua rau cov khoom ntim sab hauv.
(2) Muaj ntau yam kev ntxuav, txhaws, sealing, sterilizing thiab tom qab ua tiav cov khoom siv, cov kab ntau lawm ntev, qhov chaw ua haujlwm yog loj, thiab cov nqi tsim khoom yog siab.
(3) Qhov chaw tsim khoom huv si yog qhov loj, qhov chaw faib khoom yog qhov nyuaj, thiab kev tswj xyuas thiab kev kuaj xyuas yog qhov nyuaj.
(4) Cov txheej txheem ntxuav lub raj mis yuav tsum muaj dej ntau, thiab cov ntim khoom thiab cov khoom tiav yuav tsum tau ua kom tsis muaj menyuam ob zaug, uas siv ntau lub zog.
(5) Muaj ntau txoj haujlwm ua haujlwm, thiab kev tswj hwm kev pheej hmoo siab.
(6) Cov khoom tawg yooj yim, thiab cov nqi ntim khoom thiab kev thauj mus los yog siab.
Tus nqi tag nrho ntawm cov txheej txheem aseptic ib txwm muaj siab dua li ntawm BFS aseptic filling txheej txheem.
2. Kev pheej hmoo kis kab mob:
(1) Nplaim kub-melt sealing, tsis zoo siab yuav raug tsim nyob rau hauv ampoule thaum nws txias, thiab ib tug loj npaum li cas ntawm zoo iav chips yuav nkag mus rau hauv cov kua nyob rau hauv qhov kev txiav txim ntawm tsis zoo siab, uas yuav paug cov khoom thaum siv, thiab insoluble hais yuav ua rau muaj kev puas tsuaj rau cov neeg siv. Muaj kev pheej hmoo ntawm kev siv cov khoom.
(2) Ntse iav ampoule tawg tuaj yeem ua rau raug mob rau tus neeg teb xov tooj.
3. Kev pheej hmoo tseem muaj nyob rau hauv qhov kub thiab txias kom tsis muaj menyuam:
(1) Cov txheej txheem ua kom tsis muaj qhov kub thiab txias yuav hloov cov khoom xyaw nquag ntawm qee cov tshuaj, thiab tib lub sijhawm tsim "cov tshuaj tshiab", ua rau cov xwm txheej phytotoxic.
(2) Qee cov khoom tsis tuaj yeem ua kom tsis muaj menyuam nyob rau qhov kub thiab txias vim qhov kev txwv ntawm cov khoom siv raw thiab cov txheej txheem, thiab tsis ua raws li cov kev cai ntawm cov txheej txheem tsim tshuaj tsis muaj menyuam.
(3) Circulation steam sterilization" nws tus kheej yog txheej txheem txaus ntshai heev.
4. Lwm yam tsis zoo
(1) Cov khoom siv thiab cov txheej txheem kav dej, tshwj xeeb tshaj yog cov khoom siv thiab cov kav xa dej tom qab ua kom tsis muaj menyuam thiab pom, tsis tuaj yeem ua tiav CIP / SIP.
(2) Lub Cheebtsam ntawm cov khoom ua ntej filling yuav tsum tau manually assembled thiab debugged, thiab lub filling cheeb tsam yuav tsum tau ua los ntawm cov neeg ua haujlwm. Muaj ntau yam tsis tuaj yeem tswj tau, thiab aseptic lav muaj peev xwm tsis zoo.
(3) Cov pov tseg uas tsis tuaj yeem degradable yuav ua rau ib puag ncig tsis zoo thiab ua tsis tau raws li qhov xav tau ntawm cov neeg siv kev nyab xeeb, tus neeg siv kev nyab xeeb thiab kev nyab xeeb ib puag ncig.
Txias kom qhuav txheej txheem
Ntau yam khoom tsis tuaj yeem ua tiav qhov kev ua kom tsis muaj menyuam vim muaj cua sov, yog li lawv yuav tsum xaiv cov txheej txheem khov-qhuav. BFS aseptic filling txheej txheem thiab khov-drying txheej txheem yog ob qho tib si uas tsis yog-terminal sterilization txheej txheem. Los ntawm kev sib piv cov aseptic guarantee muaj peev xwm, ntau lawm efficiency thiab ntau lawm cov txiaj ntsig ntawm cov txheej txheem ntau lawm, nws tuaj yeem pom tau tias BFS aseptic filling txheej txheem muaj cov khoom lag luam zoo thiab cov txiaj ntsig thev naus laus zis tsis sib xws piv nrog cov txheej txheem kom qhuav.
Cov txheej txheem yooj yim ntawm kev siv lub tshuab ziab khaub ncaws: vial fwj thiab roj hmab tu thiab sterilizing → khoom ntim → semi-stoppering → lub sij hawm ntev freezing sublimation nyob rau hauv lub freeze dryer, nias stopper → tawm ntawm lub freeze dryer → capping aluminium cap → labeling thiab ntim.
Kev tsim cov khoom khov-qhuav yuav tsum tau yuav cov vials, roj hmab stoppers, thiab txhuas lub hau, thiab yuav tsum muaj thaj tsam loj ntawm lub tsev rau khoom cia. Cov txheej txheem khov-drying muaj ntau yam khoom siv, qib high-qib huv rhiav nyob rau hauv ib cheeb tsam loj, kev xav tau siab, kev tswj tsis yooj yim, thiab kev nqis peev loj. Cov txheej txheem khov-drying yog ntev, cov txheej txheem ntau lawm tsis tuaj yeem ua tsis tau, cov khoom tsis tuaj yeem ua kom zoo, thiab tsis tuaj yeem kuaj pom cov khoom tsis zoo. Muaj ntau qhov txuas thiab muaj kev pheej hmoo siab; Lub voj voog ntev ntau lawm, tus nqi siab, cov zis qis thiab cov txiaj ntsig kev lag luam.