Sterilization yog dab tsi?

Yog li koj qhov yuav tsum tsis muaj menyuam. Zoo heev. Txoj kev ua kom tsis muaj menyuam twg? Qhov ntawd yog lo lus nug tsis muaj leej twg nug txog lig dhau lawm.

Sterilization tuaj tom qab Tooling -Lub tswv yim phem

Cov neeg feem coob ua qhov no rov qab. Lawv tsim ib feem, xaiv cov resin, tau txais cov cuab yeej hais, qee zaum txawm txiav hlau. Tom qab ntawd ib tug neeg hauv kev tswj hwm hais tias tos, peb yuav ua li cas kom tsis txhob muaj qhov no?

Tam sim no koj nyob nraum daig. Cov resin koj khaws tsis muaj sia nyob gamma. Los yog nws tawm - gasses ntau dhau rau EO. Los yog nws warps nyob rau hauv autoclave.

Yuav tsum tau tham nrog koj tus kws kho mob txhaj tshuaj molding txog qhov no rau hnub ib. Tsis yog hnub cuaj caum.

Plaub Txoj Kev Tua Kab

EO. Gamma. E-nqe. Autoclave. Qhov ntawd yog qhov pib nws rau plastics.

EO (ethylene oxide)- Gas sterilization. Tsawg kub, 37-63℃ntau yam. Gas nkag mus rau hauv txhua qhov tawg thiab crevice. Ua haujlwm ntawm yuav luag txhua yam thermoplastic. PP, PC, ABS, acetal, xijpeem. downside? Siv mus ib txhis. Ob hnub yam tsawg kawg nkaus nrog aeration, qee zaum plaub. Cov pa roj yog tshuaj lom yog li nws yuav tsum tau tawm roj mus rau qis dua 25 ppm ua ntej koj tuaj yeem nkoj. Daim ntawv cog lus sterilizers hauv Midwest tau rov qab rau lub lis piam qee zaum.

Gamma- Cobalt-60 hluav taws xob. Ceev ceev. Tag nrho pallet ua tiav hauv ib teev. Tsis muaj residue, tsis muaj aeration. Tab sis gamma rhuav tshem tej yam yas. Acetal? Tsis nco qab lawm. Hloov mus rau chalk. Txheem PP tau nkig thiab daj hauv lub hlis. Polycarbonate yellows ib yam nkaus, txawm tias qee cov neeg siv khoom tsis quav ntsej txog cov tshuaj pleev ib ce.

Muaj hluav taws xob -stabilized PP. Tus nqi ntau dua. Borealis thiab LyondellBasell ob leeg ua cov qhab nia rau qhov no. Koj lub chaw tsim tshuaj molding yuav tsum paub qhov twg. Yog tias lawv hais koj Pro-fax 6323 rau ib qho gamma-sterilized part, nrhiav lwm tus.

E-nqe- Electrons tsis yog gamma rays. Cov kev txwv zoo sib xws. Tsis nkag mus li tob, yog li phab ntsa thickness tseem ceeb. Ua haujlwm zoo rau cov khoom nyias. Catheters, tubing, ntim. Fast throughput. Qee qhov chaw khiav 24/7 tam sim no vim qhov kev thov tau nce tom qab Covid.

Autoclave- Chav ntawm 121℃lossis 134℃. Txoj kev qub. Cov tsev kho mob ua qhov no hauv -tsev. Tsis muaj daim ntawv cog lus sterilizer xav tau. Tab sis koj cov yas yuav tsum ua kom sov. PP softens. HDPE softens. ABS cov ntaub ntawv. Koj xav tau PEEK, PPSU, PSU, Ultem, lossis ib lub iav - puv nylon. Thiab txawm tias tom qab ntawd, 500 lub voj voog yuav qhia koj yog tias qhov kev tsim qauv yog qhov raug.

Resin Compatibility yam

Saib, txhua tus xav tau daim ntawv qhia yooj yim. Qhov no resin ua haujlwm nrog txoj kev no, uas tsis yog. Kev muaj tiag yog messier.

Sabic muaj polycarbonate uas ua haujlwm zoo gamma. Generic PC los ntawm ib co random compounder? Tej zaum tsis yog. Cov pob stabilizer tseem ceeb. Cov xim tseem ceeb. TiO2 dawb tuav tau zoo dua li cov organic pigments nyob rau hauv hluav taws xob. Carbon dub yeej tiv thaiv qee cov polymers.

Ib feem yuav dhau ntawm 25 kGy thiab poob ntawm 40 kGy. Koj cov koob tshuaj nyob ntawm bioburden thiab ntim ntim. Yog li koj tsis tuaj yeem saib daim duab xwb.

Tham nrog tus neeg muag khoom resin. Tau txais lawv daim ntawv qhia txog kev ua kom tsis muaj menyuam. Khiav cov qauv ntawm 1.5x koj lub hom phiaj koob tshuaj. Qhov no tsis yog xaiv tau yog tias gamma lossis e-beam yog txoj kev npaj.

Thaum EO Ua Siab Zoo

Thaum tshav kub kub-sensitive qhov chaw. Complex geometry nrog cov channel sab hauv. Txhua yam nrog nyias nyias los yog lim. Ntau- cov khoom sib dhos uas ib feem tsis tuaj yeem siv hluav taws xob.

EO zam txim. Lub voj voog tom qab lub voj voog, feem ntau cov yas tsis degrade. Yog vim li cas cov tsev kho mob siv EO rau cov kev siv thiab cov cuab yeej siv rov qab tau.

Txawm li cas los xij, EPA tau ua nruj me ntsis rau cov kev cai emissions. Qee qhov chaw raug kaw. Muaj peev xwm nruj dua li tsib xyoos dhau los. Koj lub tuam txhab kev cai txhaj tshuaj molding yuav tsum ua lub sijhawm ua haujlwm rau lub sijhawm ua haujlwm.

Thaum Gamma los yog E-beam Ua rau Sense

High ntim pov tseg. Cov khoom uas xa los ntawm lub tsheb thauj khoom. Cov koob txhaj tshuaj, cov hlab ntshav sau, cov khoom siv IV. Ceev tseem ceeb thaum koj ua tau ntau lab.

Gamma cov chaw feem ntau yog nyob rau hauv Midwest thiab Southeast. Sterigenics, Nordion, ob peb lwm yam. E-beam muaj peev xwm loj tuaj. Cov hneev taw me me, tso cai yooj yim dua.

Txawm li cas los xij, cov khoom yuav tsum yog. Tau qhov no tsis raug thiab koj tab tom ua rov qab.

Autoclave yog nws lub ntiaj teb

Cov cuab yeej phais. Reusable ntaus ntawv vaj tse. Txhua yam uas rov qab mus rau hauv lub sterilizer ntawm cov neeg mob.

PEEK yog tus qauv kub. kim tab sis mos mos. PPSU yog pheej yig dua, tseem zoo rau ntau pua lub voj voog. Ultem (PEI) ua haujlwm tab sis nws nkig. Iav - puv PA66 tuaj yeem ua tau yog tias koj tsim qhov zoo.

Phab ntsa thickness uniformity tseem ceeb tshaj rau autoclave dua lwm txoj kev. Nyias me ntsis warp. Cov tawv nqaij tawv yuav siv sijhawm ntev dua kom sov thiab txias. Ib tug kws kho mob txhaj tshuaj molding tus khub yuav thawb rov qab rau ntawm koj phab ntsa tuab yog tias nws yuav ua rau muaj teeb meem.

Validation yog Slog

Kev kuaj Bioburden. Daim ntawv qhia koob. Kev kuaj tsis muaj menyuam. Kev tshawb fawb txog kev ruaj ntseg. Tom qab ntawd koj sau tag nrho rau koj 510 (k) lossis koj Cov Ntaub Ntawv Keeb Kwm Tsim.

Hloov cov resin? Rov ua dua. Hloov qhov chaw ua kom tsis muaj menyuam? Rov ua dua. Hloov lub ntim? Tej zaum yuav tau rov siv dua.

Cov peev nyiaj tsawg kawg rau lub hlis. Tej zaum ntau. Daim ntawv cog lus sterilizer ua validation khiav ntawm lawv lub sijhawm, tsis yog koj li.

Nqe Lus Nug

Ua ntej koj tham nrog ib tus kws kho mob txhaj tshuaj molding, xyuas seb koj lub cuab yeej siv qhov twg.

Ib leeg - siv pov tseg mus rau tsev kho mob uas tsis muaj autoclaves? Gamma los yog e-beam tej zaum.

Reusable ntaus ntawv? Autoclave- cov ntaub ntawv sib xws, tus nqi siab dua.

Tsawg ntim, geometry nyuaj, cua sov-sensitive? EO.

Cov ntim siab, geometry yooj yim, hluav taws xob- cov khoom ruaj khov? Gamma rau nqi, e-beam yog lub chaw nyob ze dua.

Koj tus neeg muag khoom yas txhaj tshuaj tuaj yeem pab txo qhov no yog tias lawv tau ua haujlwm kho mob ua ntej. Cov uas tsis tau yuav cia li hais dab tsi resin yog pheej yig tshaj thiab cia koj txiav txim kom tsis muaj menyuam tom qab. Qhov ntawd yog li cas cov phiaj xwm mus rau sab.

Qhwv

Sterilization tsis nyuaj. Plaub txoj kev, txhua tus nrog kev sib pauv. Xaiv koj cov resin raws li qhov yuav tsum tau ua thiab qhov ua kom tsis muaj menyuam yuav tsum muaj sia nyob. Tsis yog lwm txoj hauv kev.

Tham nrog koj tus neeg muab khoom siv thaum ntxov. Tham nrog daim ntawv cog lus sterilizer ntxov. Tsis txhob tos kom txog thaum koj twb txiav steel lawm. Qhov ntawd yog thaum qhov kev xav tsis thoob kim tshwm sim.