Hauv cov khoom lag luam nrog cov kev cai huv huv siab heev, cov khoom siv lim dej yog cov khoom siv tseem ceeb kom ntseeg tau cov khoom tsis muaj menyuam thiab purity. Capsule cov ntxaij lim dej, nrog rau lawv cov kev hloov pauv siab, ua raws, thiab tus nqi- ua tau zoo, tau dhau los ua cov cuab yeej txheem hauv kev lag luam loj -.
Hangzhou HZK Purification Equipment Co., Ltd.(tom qab no hu ua "HZK") muaj ntau xyoo ntawm kev paub hauv kev lag luam pom, muaj peev xwm ntau lawm, tag nrho - chain serviceability, thiab customized technology.
HZK Capsule Filters: Tshuab thiab Lub Hoobkas Lub zog txhawb nqa los ntawm 20 Xyoos ntawm Cov Khoom
Txij li thaum nws tsim, HZK tau tsom mus tas li los tsim cov khoom siv ruaj khov, txhim khu kev qha, thiab ruaj khov. Nrog 20 xyoo ntawm kev lag luam kev lag luam, ntau dua 1,280 ua tiav cov haujlwm, thiab ntau dua 15,000 tus neeg siv khoom thoob ntiaj teb kev koom tes, nws tau tsim lub kaw - lub voj voog muaj peev xwm npog R & D, ntau lawm, thiab kev pabcuam. Cov kev sib tw tseem ceeb ntawm nws cov tshuaj ntsiav tshuaj lim dej yog qhov hnyav ntawm peb lub zog nyuaj ntawm lub Hoobkas:
Tag Nrho -Txoj Kev Tswj Xyuas Zoo: Cov qauv nruj los ntawm cov khoom siv raw mus rau cov khoom tiav
HZK tau tsim kom muaj tag nrho - txuas kev tswj hwm qhov system ntawm "raws li cov ntaub ntawv - ua - sib dhos - kev sim" hauv kev tsim cov tshuaj ntsiav tshuaj kom ntseeg tau tias txhua yam khoom ua tau raws li cov qauv kev lag luam siab tshaj plaws:
- Rigorous raw khoom xaiv:Procures kho mob-qib polypropylene hais thiab imported pleated lim membranes nrog pore loj qhov tseeb yuam kev tsawg dua los yog sib npaug rau 0.01μm. Tag nrho cov ntaub ntawv raw tau txais kev tshuaj ntsuam xyuas muaj pes tsawg leeg, kev ntsuas kev ua tau zoo, thiab kev sim extractable. Tsuas yog cov ntaub ntawv pov thawj los ntawm cov kev cai thoob ntiaj teb xws li USP<665>thiab EP 3.1.6 raug xaiv los tshem tawm cov kev pheej hmoo kis kab mob los ntawm qhov chaw.
- Precision processing peev xwm:Txais cov thev naus laus zis xws li laser txiav, CNC xuas nrig ntaus, thiab argon arc vuam rau txheej txheem lim vaj tsev thiab lub hau kawg. Qhov tseeb qhov tseeb ntawm cov khoom yog tswj nyob rau hauv ± 0.02mm los xyuas kom meej haum zoo ntawm cov lim membranes thiab vaj tse, tsis txhob xau los ntawm cov qauv sib txawv.
- Kev ntsuas kev ua tau zoo ntawm cov khoom tiav:Txhua batch ntawm cov tshuaj ntsiav lim tau dhau peb qhov kev sim ua ntej tawm hauv lub Hoobkas - kev ntsuas siab (tso tawm 0.15MPa yam tsis muaj kev sib tsoo), kev ntsuas nruj (txo qis dua lossis sib npaug rau 0.01%), thiab ntsuas qhov tseeb (kev tuav pov hwm zoo dua lossis sib npaug rau 99.99%). Cov ntaub ntawv xeem tau muab tso rau hauv tiag tiag-lub sijhawm rau HZK tus kheej tsim cov txheej txheem taug qab kom zoo, tso cai rau cov neeg siv khoom nug txog kev tsim khoom thiab kuaj cov ntaub ntawv ntawm txhua lub cuab yeej txhua lub sijhawm.
Cov Txheej Txheem Ntau Lawm Kev sib xyaw ua ke loj - Nplai thiab Customized Capabilities
HZK lub Hoobkas tau nruab nrog ntau cov kab ntau lawm, muaj peev xwm ua tau raws li cov khoom loj ntawm cov qauv tshuaj ntsiav lim thiab muab cov kev daws teeb meem rau cov neeg siv khoom hauv kev lag luam sib txawv nyob ntawm ntau dua 92 daim ntawv pov thawj kev lag luam thiab patented technologies:
- Standardized ntau lawm xyuas kom meej tus me nyuam efficiency:Txais MES (Manufacturing Execution System) rau kev soj ntsuam digital ntawm tag nrho cov txheej txheem tsim khoom. Cov cuab yeej siv hluav taws xob koom nrog hauv txhua qhov txuas los ntawm daim nyias nyias pleating, vaj tsev txhaj tshuaj molding rau kev sib dhos thiab kev sim, ua kom luv lub voj voog ntau lawm rau 3-5 hnub thaum ua kom muaj kev ua tau zoo ntawm cov khoom hauv tib batch.
- Cov kev pabcuam Customized hloov mus rau ntau yam kev xav tau:Customizes capsule filters nrog PFA-coated vaj tse rau siab-corrosive chemical filtration scenarios hauv kev lag luam kws tshuaj; txhim kho 121℃siab-kub resistant polypropylene lim rau siab -kub kua ua kev xav tau nyob rau hauv cov zaub mov thiab dej haus kev lag luam. Nws kuj tseem txhawb nqa tus kheej tsim cov qauv lim raws li cov neeg siv khoom txaus, kev sib txuas lus tshwj xeeb, thiab pom qhov tseeb, ua tiav tiag tiag ntawm - kev thov kev hloov kho.
Cov txiaj ntsig tseem ceeb ntawm HZK Capsule Lim: Kev daws teeb meem zoo rau ntau qhov kev lag luam
Rov qab los ntawm lub Hoobkas lub zog thiab kev tsim khoom, HZK capsule cov ntxaij lim dej tsim cov txiaj ntsig sib txawv hauv peb qhov loj me -kev ua tau zoo, kev nyab xeeb, thiab tus nqi- ua kom haum raws li cov kev cai nruj ntawm kev siv tshuaj, zaub mov, hluav taws xob, thiab lwm yam lag luam:
High Filtration Efficiency rau Precision Scenarios
Txais HZK nws tus kheej optimized multi- txheej pleated membrane qauv, ua kom pom qhov zoo ntawm 3-5 zaug piv nrog cov pav ca daim nyias nyias. Nws tuaj yeem khaws cov kab mob, mycoplasma, submicron hais, thiab lwm yam kuab paug. Nyob rau hauv lub cell kab lis kev cai kua clarification scenario ntawm biopharmaceuticals, nws muaj peev xwm ua kom tiav qhov pom ntawm 100L kab lis kev cai kua nyob rau hauv 30 feeb, nrog lub turbidity ntawm lim kua tsawg dua los yog sib npaug zos rau 0.5NTU. Nyob rau hauv lub davhlau ya nyob twg sterilizing filtration ntawm sterile injectables, lub retention efficiency rau 0.2μm hais txog 99.999%, deb tshaj qhov nruab nrab kev lag luam.
Khoom siv kev nyab xeeb ua raws li kev cai thoob ntiaj teb cov qauv
Ob lub vaj tse thiab cov khoom siv lim dej ntawm HZK capsule lim yog ua los ntawm kev kho mob -qib nkauj xwb polypropylene yam tsis muaj cov nplaum los yog cov yas yas, tsis muaj tshuaj lom neeg ntxiv thaum tsim khoom. Kev txheeb xyuas los ntawm thib peb-cov koom haum xeem thib peb, lawv cov ntsiab lus tau txais txiaj ntsig tsawg dua li qhov kev nyab xeeb tau teev tseg hauv USP<665>. Cov khoom lag luam tau dhau daim ntawv pov thawj xws li SGS thiab CQC, thiab tuaj yeem siv ncaj qha rau hauv cov chaw ua haujlwm tshuaj raws li FDA saib xyuas yam tsis muaj cov ntaub ntawv pov thawj ntxiv, pab cov neeg siv khoom luv luv ua haujlwm.
Kev Tsim Nyog Rau Kev Txo Nqi, Kev Txhim Kho Kom Zoo, thiab Kev Ua Raws Cai
Cov qauv pov tseg ntawm HZK capsule lim zoo kawg nkaus ua tau raws li tus nqi txo thiab kev txhim kho kev xav tau ntawm kev lag luam niaj hnub no:
- Txo kev nqis peev thawj zaug: Tsis xav tau tshwj xeeb lim cartridges, ntsaws ruaj ruaj, lossis lwm yam khoom siv pabcuam. Kev teeb tsa tuaj yeem ua tiav los ntawm ib tus neeg hauv 5 feeb, txuag ntau dua 60% ntawm cov khoom siv khoom siv piv nrog cov lim dej uas siv tau.
- Tsis txhob ntxuav cov nqi siv hluav taws xob: Raws li HZK cov neeg siv khoom txheeb cais, tom qab siv cov tshuaj ntsiav tshuaj pov tseg, lub voj voog kev ua haujlwm ntawm cov tuam txhab tshuaj tau luv luv los ntawm 2-3 lub hlis mus rau tsawg dua 1 lub lis piam, nrog rau cov nqi siv tau raug txo los ntawm 40%, thaum zam kev cuam tshuam cov kab mob sib kis los ntawm kev tu tsis tiav.
- Kho kom haum rau kev tsim khoom tas mus li: Kev cog lus me me (cov qauv tsis tu ncua tsuas yog xib teg- loj), tuaj yeem ncaj qha mus rau hauv cov kav dej txuas ntxiv (CPP). Cov khoom lim dej poob qis dua 0.5%, txhawb nqa 24/7 tsis cuam tshuam kev ua haujlwm thiab tsis ncaj qha txhim kho kev siv cov kab ntau lawm.
Capsule Filter Integrity Testing: HZK's Upgraded "Quality Inspection Checkpoint" Solution
Filter kev ncaj ncees yog lub neej ntawm cov txheej txheem aseptic. Pinholes los yog kev puas tsuaj rau lub lim membrane yuav ncaj qha ua rau aseptic tsis ua hauj lwm. HZK tsis yog tsuas yog muab cov kev pabcuam kev sib txawv ntawm cov dej ntws tawm xwb tab sis kuj tseem muaj cov kev pabcuam pov thawj rau cov neeg siv khoom uas tso siab rau lub Hoobkas CNAS- qhov chaw kuaj pom zoo:
Standardized Diffusion Flow Testing Services
HZK siv nws tus kheej tsim cov neeg soj ntsuam kev ncaj ncees thiab nruj me ntsis siv kev sim raws li cov txheej txheem hauv qab no:
- Kev sim lub hauv paus ntsiab lus: Hauv kev teeb tsa siab (feem ntau yog 80% ntawm cov npuas npuas taw tes siab), saib xyuas qhov sib txawv ntawm cov roj los ntawm cov kua theem txheej ntawm daim nyias nyias. Yog tias qhov ntsuas tus nqi qis dua HZK qhov chaw pib ua ntej (kev hloov kho raws li daim nyias nyias pore loj, piv txwv li, Tsawg dua lossis sib npaug li 5mL / min rau 0.2μm lim), nws raug txiav txim tias tsim nyog.
- HZK qhov kev ua kom zoo tshaj plaws: Nruab nrog qhov ntsuas kub tsis tu ncua (kub hloov pauv ± 0.5 degree) kom tsis txhob muaj qhov sib txawv ntawm qhov ntsuas kub ib puag ncig. Nws kuj tseem txhawb nqa cov ntaub ntawv xa tawm tsis siv neeg thiab cov ntawv tshaj tawm PDF kom tau raws li GMP kev tshawb xyuas cov kev xav tau ntawm cov tuam txhab tshuaj.
Kev daws teeb meem ceev ceev thiab kev daws teeb meem rau kev ua tsis tiav
Rau cov teeb meem kev sim ua tsis tiav uas tau ntsib los ntawm cov neeg siv khoom hauv kev xyaum, HZK muab qhov tseeb - cov kev pabcuam daws teebmeem nyob rau hauv pab pawg kws tshaj lij (nrog cov kev paub dhau los hauv ntau dua 1,280 qhov haujlwm):
- Yog tias cov dej ntws tawm siab dhau lawm: Ua ntej kuaj xyuas seb lub lim puas raug khawb los ntawm cov khoom ntse thaum lub sijhawm thauj mus los (HZK siv cov npuas tuab + ntoo lub thawv ntim, nrog qhov kev puas tsuaj tsawg dua lossis sib npaug li 0.1%) lossis yog tias ntub dej txaus (tshwj xeeb 70% isopropyl cawv wetting tus neeg saib xyuas tuaj yeem muab los ua kom tiav daim nyias nyias wetting).
- Yog tias tsis muaj qhov ntws tawm: Pab tshawb xyuas qhov nruj ntawm cov kav xa dej los yog muab rau ntawm -cov kev pabcuam calibration los xyuas kom meej cov neeg kuaj xyuas qhov tseeb (txhua xyoo calibration yuam kev ntawm HZK testers tsawg dua lossis sib npaug li 0.1%).
Cov txheej txheem kom tsis muaj menyuam tag nrho ntawm HZK Capsule Lim: Dual Guarantee ntawm Kev Ua Raws Cai thiab Kev Nyab Xeeb
Lub tsev ntawm cov tshuaj ntsiav lim muaj qhov ntsuas kub thiab siab tsis kam (feem ntau yog 121℃/ 0.1MPa), yog li siab -siab ua kom tsis muaj menyuam (Autoclave) yog txoj kev ua kom tsis muaj menyuam ntau tshaj plaws. Rau hauv - kab sterilization (SIP), HZK tuaj yeem muab cov kev daws teeb meem sib xyaw ua ke nrog lub peev xwm hloov kho lub Hoobkas.
Siab -Nias Chav Sterilization
Ua ntej-Kev Npaj Ua kom tsis muaj menyuam
- Interface thiab valve preprocessing:Lub qhov tso pa tawm thiab cov dej ntws tawm ntawm HZK capsule lim tau txais kev tsim sai sai -tso tawm, uas tuaj yeem tig ncaj qha mus rau lub xeev qhib tag nrho kom ua tiav chav nkag. Nyob rau tib lub sijhawm, tshwj xeeb silicone gaskets (tiv taus rau 121℃siab kub) yog muab kom tsis txhob degradation ntawm sealing kev ua tau zoo tom qab sterilization.
- Sterile ntim specifications:Nruab nrog siab - lub hnab ntim kom tsis muaj menyuam nrog lub qhov cua (ua los ntawm kev kho mob- qib PET, tiv taus qhov kub ntawm 134 degrees). Txuag 2-3cm ntawm qhov chaw xoob thaum lub sijhawm ntim khoom kom tsis txhob muaj kev cuam tshuam ntawm cov pa ncig-qhov ntim no yog tsim los ntawm HZK lub Hoobkas thiab tau dhau qhov kev kuaj kab mob microbial.
- Hose matching cov kev xav tau:Muab cov khoom noj- qib silicone hoses nrog inner diameter Ntau dua los yog sib npaug li 8 hli (adapting to filter interfaces), cim nrog "siab kub resistant 121 degree" ntawm lub raj lub cev kom tsis txhob melting los ntawm cov neeg siv khoom siv cov hoses tsis zoo.
Ntsiab Cai Thaum Sterilization
- Kev taw qhia qhov chaw:Lub xub taw qhia ua kua yog cim rau ntawm lub tsev ntawm HZK capsule lim. Nws raug nquahu kom kho vertically nrog lub qhov hluav taws xob tig mus rau tso cov dej condensed los ntawm lub ntiajteb txawj nqus, zam kev ua haujlwm degradation los ntawm qhov ntev - lub sij hawm membrane immersion.
- Sterilization program xaiv:Rau cov khoom yam ntxwv ntawm HZK cov ntxaij lim dej, nws raug nquahu kom siv lub tshuab nqus tsev nqus kom tsis muaj menyuam (3 lub tshuab nqus tsev twj tso kua mis-steam txhaj tshuaj). Cov kev ua kom tsis muaj menyuam yog teem rau 121℃/ 20 feeb, uas tuaj yeem ua kom cov cua txias seem hauv cov lim dej tsawg dua lossis sib npaug li 0.5%.
- Cov lus ceeb toom ntawm kev sib txuas kom tsis muaj menyuam nrog cov txheej txheem tso tsheb hlau luam:Yog hais tias lub lim twb txuas nrog cov txheej txheem tank, HZK tuaj yeem muab cov pob qij txha hauv nruab nrab (ua los ntawm 316L stainless hlau) kom tsis txhob lim deformation vim lub siab thaum ua kom tsis muaj menyuam, thiab txhawb nqa ntawm - qhov chaw qhia kev teeb tsa.
Hauv -Line Sterilization
Yog tias cov txheej txheem tsim khoom xav tau nyob rau hauv -kab chav ua kom tsis muaj menyuam ntawm cov tshuaj ntsiav tshuaj txuas nrog cov lim dej, HZK tuaj yeem muab tag nrho - cov txheej txheem kev daws teeb meem uas vam khom lub Hoobkas muaj peev xwm hloov kho:
- Kev ntsuas kub thiab siab sib txawv:Kev koom ua ke HZK tus kheej tsim qhov ntsuas kub ntawm nws tus kheej (qhov tseeb ± 0.1 degree) thiab cov ntsuas ntsuas siab ntws thiab qis ntawm cov lim mus rau qhov tiag - lub sijhawm saib xyuas qhov kub thiab txias qhov sib txawv (tswj tsis pub dhau 0.05MPa) thaum ua kom tsis muaj menyuam, zam kev puas tsuaj rau daim nyias nyias.
- Condensed dej paug optimization:Tsim ib qho kev ywj pheej condensed dej tawm pipeline (nruab nrog lub tshuab nqus tsev vacuum) thiab teem ib lub qhov dej phwj tuaj ntawm qhov qis tshaj ntawm lub lim. Qhib nws ib zaug txhua 5 feeb thaum tsis muaj menyuam (10 vib nas this txhua lub sijhawm) kom tsis txhob muaj cov dej sib xyaw ua ke.
- Aseptic ciam teb tiv thaiv:Muab cov txheej txheem tsim cov raj xa dej rau ib qho -txoj kev ntws ntws, ua tiav SIP hauv ob kauj ruam -preheating-sterilization-txias. Nyob rau tib lub sijhawm, nruab nrog cov tshuab ua pa kom tsis muaj menyuam los tiv thaiv cov pa phem thib ob tom qab ua kom tsis muaj menyuam.
Cov ntawv thov kev lag luam ntawm HZK Capsule Lim: 20 Xyoo ntawm Kev Ua Haujlwm Txhim Kho Kev Tsim Nyog Hauv Ntau Qhov
Rov qab los ntawm lub Hoobkas muaj zog thiab muaj peev xwm kho tau, HZK capsule lim tau siv dav hauv kev siv tshuaj, khoom noj thiab dej haus, hluav taws xob, thiab lwm yam, dhau los ua kev ntseeg siab ntawm ntau dua 15,000 cov neeg siv khoom:
Biopharmaceutical Industry Applications
Hanzhikang capsule lim yog tsim rau aseptic thiab pom tseeb ntawm cov kua tseem ceeb xws li kab lis kev cai xov xwm, tsis muaj kev daws teeb meem, thiab fermentation broths, txo qhov kev pheej hmoo ntawm microbial thiab cov kab mob sib kis. Ntau cov ntaub ntawv hauv daim nyias nyias ua tau raws li kev ua kom huv thiab dhau los ntawm cov tshuaj tiv thaiv, tshuaj tiv thaiv kab mob, thiab cov khoom lag luam muaj txiaj ntsig zoo, txhawb kev hloov pauv sai rau cov tshuab pov tseg.
Daim ntawv thov kev lag luam tshuaj pleev ib ce thiab tshuaj txhua hnub
Siv rau kev tshem tawm impurity, clarification, thiab stability tswj nyob rau hauv cov khoom xws li emulsions, serums, thiab fragrances, zoo tshem tawm particulates, gels, thiab undissolved raw cov ntaub ntawv, txhim kho cov tsos ntawm cov khoom tiav. Cov qauv tshuaj ntsiav yog tsim rau cov khoom siv tau yooj yim, tso cai rau kev hloov lim sai thiab ua tau raws li qhov xav tau ntawm ntau cov qauv, cov khoom me me, thiab ntau SKUs.
Kev kho dej thiab kev tiv thaiv ib puag ncig kev lag luam daim ntawv thov
Siv rau cov dej ntshiab huv, RO ua ntej - lim kev tiv thaiv, qhov dej turbidity tshem tawm, thiab greywater rov siv dua, nws ruaj khov tshem tawm cov khib nyiab, colloids, thiab qee cov kab mob, txhim kho kev ua haujlwm ntawm cov dej hauv qab. Qhov tsim kaw yuav txo qhov kev pheej hmoo ntawm kev kis kab mob thaum hloov pauv, ua rau nws tsim nyog rau kev sim, kev lag luam, thiab kev kho mob hauv nroog.
HZK's Tag Nrho -Chain Services: Kev txhawj xeeb-Dawb Guarantee los ntawm Tsim rau Tom Qab- Muag
Ntxiv rau lub Hoobkas lub zog nyuaj, HZK tseem muab cov neeg siv khoom nrog tag nrho - cov kev pabcuam hauv lub voj voog ntawm "kev tsim qauv tsim - ntawm- qhov chaw teeb tsa - tom qab- kev muag khoom" rau cov ntxaij lim dej:
- Customized design: Muab cov lim dej tshwj xeeb raws li cov neeg siv khoom txaus (0.1-100m³ / h), pom qhov tseeb (0.1-10μm), thiab cov yam ntxwv nruab nrab (acidic/alkaline/corrosive), xws li customizing PFA-coated filters rau high-corrosive chemical scenarios.
- Ntawm -kev teeb tsa thiab commissioning: Xa cov kws tshaj lij pab pawg (nrog rau qhov nruab nrab ntawm ntau dua 8 xyoo ntawm kev lag luam kev paub) los muab rau ntawm - kev taw qhia kev teeb tsa ntawm qhov chaw, ua kom muaj kev hloov pauv zoo ntawm cov lim dej rau cov kav dej uas twb muaj lawm. Nyob rau tib lub sijhawm, ua kev cob qhia ua haujlwm kom txo tau qhov pib rau cov neeg ua haujlwm siv.
- Tom qab- kev txhawb nqa muag: Muab lub sijhawm lav 1-xyoo, thaum lub sijhawm kho dawb thiab kev pabcuam hloov khoom siv. Nws tseem tsim kom muaj 24-teev teb mechanism. Thaum cov neeg siv khoom ntsib teeb meem, cov kws tshaj lij tuaj yeem muab cov kev daws teeb meem hauv 4 teev kom ntseeg tau tias tsis muaj kev cuam tshuam ntau lawm.
Nrog rau xyoo ntawm lub Hoobkas tsub zuj zuj, tag nrho - txheej txheem tswj kev muaj peev xwm, thiab cov kev pabcuam customized, HZK tau hloov kho cov tshuaj ntsiav tshuaj los ntawm - cov khoom siv rau cov kev daws teeb meem zoo rau kev lag luam xav tau. Txawm hais tias nws yog cov kev cai nruj nruj ntawm kev lag luam kws tshuaj lossis cov kev xav tau ntawm tus kheej ntawm cov khoom noj thiab cov khoom siv hluav taws xob, HZK tuaj yeem muab cov khoom siv ruaj khov, txhim khu kev qha, thiab ruaj khov thiab cov kev pabcuam txhawb nqa los ntawm lub Hoobkas muaj zog.
Hu rau Hanzhikang pawg neeg ua haujlwm rau kev daws teeb meem.