PFS Nqus Filling thiab Stoppering Tshuab - Cov Lus Nug Nquag (FAQ)
Hais txog cov khoom ntim
Cov ntaub ntawv dab tsi tau tshaj?
Cov khoom siv iav thiab COP (Cyclic Olefin Polymer) yas.
Nws puas tuaj yeem tuav cov koob txhaj tshuaj ntawm qhov sib txawv / qhov tshwj xeeb?
Yog lawm. Raws li cov kev qhia tshwj xeeb uas muab los ntawm tus neeg siv khoom, peb tuaj yeem teev cov kev hloov pauv uas yuav tsum tau ua (piv txwv li, lub hnub qub log, ntim cov kab ke, lub thawv ntim khoom, lub tais ntim khoom). Yog hais tias lub ntim ntim ntau loj, yuav tsum tau hloov lub twj tso kua mis ceramic.Qhov ntau thiab tsawg tuaj yeem haum.
Nws puas tuaj yeem sau PFS thiab Cartridges?
Yog, siv tus qauv combo. Hloov ntawm Cartridges thiab PFS yog ua tiav los ntawm kev hloov cov ntsiab lus tshwj xeeb / hloov qhov chaw).
Nws puas tuaj yeem sau dual -chamber PFS?
Yog, nws tuaj yeem sau rau lawv. Qhov no yuav tsum muaj ob lub tshuab filling thiab nres ua kom tiav.
Dab tsi yog hom filling twj siv? Nws puas tuaj yeem txhawb nqa peristaltic lossis piston twj?
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Peb tuaj yeem txais cov neeg siv khoom- cov twj tso kua mis. Peb lub tshuab txheem siv lub siab -precision ceramic twj tso kua mis, haum rau ob qho tib si siab -viscosity thiab aqueous tshuaj.Yog tias yuav tsum siv lub twj tso kua mis peristaltic lossis piston, peb yuav tsum nkag siab txog qhov viscosity lossis ntws yam ntxwv ntawm tus neeg siv khoom ua ntej. |
Qhov tseeb filling yog dab tsi?
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Ceramic twj tso kua mis muaj qhov ua tiav qhov tseeb txog li ± 1%. Yog tias tus neeg siv khoom xav tau qhov raug siab dua, peb tuaj yeem muab cov khoom tiav cov ntawv xeem los ntawm cov neeg siv khoom yav dhau los nrog cov ntaub ntawv zoo sib xws rau kev siv, nyob ntawm cov khoom tshwj xeeb.
Puas yog lub puab tsaig thiab lub plunger pas nrig ntxiv tom qab sau?
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Stopper insertion yog tsis siv neeg. Lub plunger pas nrig kuj tuaj yeem muab ntxiv tau, tab sis qhov no feem ntau yog cov khoom sib cais, cov khoom siv ywj pheej.
Lub tshuab nqus tsev filling puas tuaj yeem ua tiav? Puas yog nws tsim nyog rausiab - cov ntaub ntawv viscosity?
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Yog lawm, nws ua tau. Peb lub tshuab nta lub tshuab nqus tsev dual (lub tshuab nqus tsev filling thiab lub tshuab nqus tsev vacuum), haum rau siab - cov ntaub ntawv viscosity. Peb txhawb kev sim nrog cov neeg siv khoom kuaj.
Nws puas txhawb kev sau nrog npuas tswj (piv txwv li, tsis txhob muaj npuas, nws pib-deaeration)?
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ntau yam. Ua ntej, tus neeg siv khoom nws tus kheej yuav xav tau ua ntej - kho rau deaeration (xws li, nqus degassing, centrifuge). Ua ke nrog peb lub tshuab nqus tsev dual, npuas - pub dawb puv thiab nres tuaj yeem ua tiav.Peb lub tshuab nqus tsev ob lub tshuab ua kom tsis muaj npuas tsimthaumtxheej txheem filling. Yog hais tias tus neeg siv khoom cov khoom muaj npuas thiab tsis ua ntej- kho (xws li, los ntawm lub tshuab nqus tsev centrifuge), lub tshuab ceev yuav tsum tau txo qis me ntsis kom tso sijhawm ntau rau lub tshuab nqus tsev ua haujlwm.
Hais txog Filling Aspects
Cov khoom puas tuaj yeem pab txhawb cov kua cua sov lossis sib tov ua ntej sau?
Nws tuaj yeem txhawb nqa, nyob ntawm cov khoom siv tshwj xeeb. Yog hais tias cov khoom yog degradation los yog poob ntawm kev ua tau zoo vim qhov kub thiab txias, nws yuav tsum tsis txhob siv. Peb pom zoo kom cov neeg siv khoom npaj cov khoom (rhuab / sib xyaw) ua ntej ua ntej sau thiab nres ntawm lub tshuab.
Puas yog dual -pump filling txaus? (piv txwv li, cov kua sib txawv tau ntim ib txhij rau hauv ob lub-chamber syringe)
Dual filling / stoppering tshuab tau txais kev txhawb nqa. Txawm li cas los xij, cov kua sib txawv tsis tuaj yeem sauib txhijnyob rau hauv ib tug dual -chamber syringe. Txij li nws yog dual -chamber, cov ntaub ntawv zoo li tsis tuaj yeem sib xyaw. Cov txheej txheem yuav koom nrog kev sau thiab sealing thawj chamber, tom qab ntawd ua ntu zus thiab sib khi lub chamber thib ob.
Puas yog HMI system txhawb 21 CFR Part 11?
Nws tuaj yeem txhawb nqa 21 CFR Part 11. (Ceeb Toom: Qhov no muaj ntau dua ntawm cov kab tshuab combo. Standalone PFS cov cav tov muaj cov haujlwm yooj yim xws li lub sijhawm-raws li cov ntaub ntawv ua haujlwm, suav ntau lawm, thiab khaws daim ntawv qhia.)
Nws puas ua raws li cov cai xws li GMP, CE?
Yog, nws ua raws.
Hais txog FAQs txogprefilled filling tshuab, thov ua raws li peb thiab peb yuav qhia lawv ntxiv rau lwm zaus