Roj hmab ntsaws ruaj ruaj yog dav siv nyob rau hauv cov khoom noj thiab kev kho mob industries, uas yuav tsum tau nruj me ntsis kev cai thiab yuav tsum tau ua raws li nruj me ntsis kev cai thiab kev nyab xeeb cov qauv. Yog li ntawd, txhua yam khoom siv hauv kev ua, ntim khoom, lossis khaws cia cov khoom noj thiab cov khoom siv kho mob yuav tsum ua raws li cov lus qhia meej kom tsis txhob muaj kev sib kis.
Kab lus no tsom mus rau qhov tseem ceeb ntawm FDA-pom zoo roj hmab foob hauv kev lag luam khoom noj.
Khoom noj khoom haus qib roj hmab yog dab tsi?
Khoom noj khoom haus qib roj hmab yog hais txog cov khoom siv roj hmab uas muaj kev nyab xeeb rau kev siv hauv txhua daim ntawv thov cuam tshuam nrog kev tsim khoom noj, kev ua, kev cia khoom, thiab ntim khoom. Khoom noj khoom haus qib roj hmab yog tsim tshwj xeeb thiab kuaj xyuas kom ntseeg tau tias lawv tsis muaj cov tshuaj phem lossis cov kab mob uas tuaj yeem hloov mus rau hauv cov zaub mov thiab cuam tshuam nws txoj kev nyab xeeb. Cov khoom ntim khoom noj yuav tsum thaiv cov kab mob thiab lwm yam kab mob los ntawm kev nkag mus rau hauv cov zaub mov lossis ntim khoom noj.
Roj hmab foob rau kev lag luam khoom noj khoom haus yuav tsum tau sib haum nrog kev lag luam kom nyob ruaj khov thiab ua haujlwm zoo. Cov ntsaws ruaj ruaj thiab lwm yam khoom siv roj hmab yuav tsum tau tsim los tiv thaiv cov xwm txheej hnyav ntawm ib puag ncig kev lag luam, uas tuaj yeem suav nrog qhov kub thiab txias thiab kev ua kom nruj heev.
Cov khoom noj khoom haus qib roj hmab siv nyob qhov twg?
Cov khoom siv roj hmab zoo li O-rings lossis cov ntsaws ruaj ruaj tuaj yeem pom nyob hauv ntau daim ntawv thov suav nrog kev tsim khoom noj. Piv txwv li, cov khoom siv roj hmab yuav tsum tau ua hauv cov khoom noj khoom haus thiab cov khoom ntim khoom. Yog li ntawd nws yog ib qho tseem ceeb los xyuas kom meej tias cov khoom siv roj hmab no yog tsim los ntawm FDA-pom zoo sib txuas. Ib qho piv txwv hauv tsev niaj hnub ntawm cov khoom siv roj hmab no yog cov thawv ntim khoom noj uas muaj lub hau airtight.
Vim li cas koj thiaj xav tau FDA-pom zoo seals?
FDA yog lub koomhaum tseemfwv Meskas rau kev tiv thaiv pej xeem kev noj qab haus huv los ntawm kev ua kom muaj kev nyab xeeb thiab zoo ntawm cov zaub mov, tshuaj, thiab lwm yam khoom. FDA txoj cai txwv rau Tebchaws Meskas, tab sis nws cov kev cai feem ntau suav hais tias yog cov qauv zoo thoob ntiaj teb.
FDA tau lees paub thoob ntiaj teb ua lub koom haum saib xyuas zaub mov thiab tshuaj noj thiab yog lub koom haum tswj hwm nruj tshaj plaws. FDA pom zoo qhia tias cov khoom tau dhau los ua cov txheej txheem tshuaj xyuas nruj thiab tau ua pov thawj tias muaj kev nyab xeeb. FDA tswj xyuas cov npe ntawm cov tshuaj thiab cov tshuaj tso cai rau kev sib cuag nrog cov khoom noj los ntawm nws Cov Cai Tswjfwm Ntiag Tug.
Puas yog FDA txoj cai npog cov ntsaws ruaj ruaj?
Nyob rau hauv cov ntaub ntawv ntawm cov roj hmab foob, cov kev cai FDA cuam tshuam yog Txoj Cai Tswjfwm Ntiag Tug (npe 21), ntu tus lej 177.2600 (CFR 21.177.2600). TIAB SA 21.177. 2600 tau teeb tsa "Dawb Daim Ntawv Teev Npe" ntawm cov khoom xyaw roj hmab zoo rau kev sib cuag nrog cov khoom noj thiab lawv qhov txwv kom muaj nuj nqis. TIAB SA 21.177. 2600 kuj tseem muaj cov lus qhia tshwj xeeb los txwv cov khoom siv roj hmab uas xav tau rov siv dua hauv kev sib cuag nrog dej lossis cov khoom noj rog. Extractables yog cov tshuaj uas tuaj yeem tso tawm los ntawm qhov chaw ntawm cov khoom siv hauv kev tsim khoom lossis khaws cov khoom noj lossis tshuaj thaum raug rau qee yam kua thiab kub.
FDA CFR 21.177.2600 kab lus A txog D qhia txog cov kev cai rau "cov khoom siv roj hmab rau rov siv dua" hauv kev lag luam khoom noj. Hauv cov kab lus no, FDA teev cov ntaub ntawv elastomer, cov ntaub ntawv vulcanization, thiab lwm yam additives pom zoo siv rau kev sib cuag nrog zaub mov. Daim ntawv teev npe kuj qhia txog qhov txwv ntau rau txhua hom khoom. Cov nqe lus E thiab F qhia cov lus qhia kom txwv tsis pub rho tawm ntawm cov khoom siv roj hmab uas xav tau rov siv dua hauv kev sib cuag nrog cov khoom noj ua kua lossis rog. Kab lus g kuj ntxiv tias cov khoom siv roj hmab hauv cov ntawv thov tuav cov zaub mov yuav tsum tau ntxuav ua ntej siv thawj zaug.
Dab tsi Linde Polymer muab
Ntawm Linde Polymer, peb muab ntau yam khoom uas muaj kev ntseeg siab thiab txhim khu kev qha uas ua tau raws li qhov xav tau ntawm koj lub hom phiaj kev lag luam. Peb cov khoom muaj xws li cov khoom siv roj hmab hauv zos thiab cov khoom siv raw khoom, kom ua tau raws li cov cai thiab cov qauv tsim nyog.
Nws yog ib qho tseem ceeb uas yuav tsum nco ntsoov tias tsuas yog siv cov khoom siv los ntawm FDA-pom zoo roj hmab tsis tas yuav tsim nyog rau nws txoj kev siv. Linde Polymer tuaj yeem pab koj nrhiav FDA-raws li cov roj hmab sib txuas uas ua tau raws li koj cov kev xav tau tshwj xeeb.
Linde Polymer muaj kev paub dhau los nrog FDA pom zoo cov txheej txheem thiab cov cai. Peb pab neeg ua tib zoo tswj hwm thiab tswj txhua cov ntaub ntawv ntsig txog peb cov khoom, suav nrog FDA daim ntawv pov thawj, kom ntseeg tau tias tag nrho cov ntawv pov thawj siv tau thiab hloov tshiab.
Puas yog koj tab tom nrhiav FDA-pom zoo roj hmab foob rau kev lag luam khoom noj? Hu rau peb cov kws tshaj lij ntawm Linde Polymer hnub no. Lawv yuav muab cov kev daws teeb meem uas haum rau koj cov kev xav tau tshwj xeeb.