Imicaba engenakho ukusebenzisa kabusho kufanele ibalise amathuluzo amathathu okokubalwa kwezicaba zokudla:
Isicelo sengu-2021 kwi- Isikhathi-soludwana sokudokotela e-Mikrobiyoloji kutholwe izinhlayo ezingenakho umoya ezibonisa ukuthenga kwezinhlobo zokulayisha izimpawu ngama-23% ngaphandle kwezinhlobo eziphambene nezinhlobo eziqine zokudla ezingenakho umoya kuzo zokusebenzisa i-PCR. Le mpikiswano yemiphumela ivumelana nezindlela ezahlukene ngokwemfundiso:
Umthawu | Cotton | Izinhlayo ezingenakho umoya |
---|---|---|
Ukugcina | Phezulu (200-300% yobunzima) | Ikulawuliwe (50-150%) |
Ukulayishwa kwezimpawu | 65-75% | 85-95% |
Ukuqondana nezichemikhali | Iphendula nge-solvents | Iyamelana nama-reagents amaningi |
Ingozi Yokuchitheka Kwe-Fiber | Kancane | Phantsi |
Ukotini we-pharmaceutical grade usakhethwa ekunakekeleni izilonda ngenxa yobumnene bawo bemvelo nokumunca kwawo uketshezi. Nokho, kuvela ukulinganiselwa ezimweni zokuxilonga:
Isihlelo esikhohliweyo 2022 sabona ukuthi 34% wezicwancwane zocotton zingeliphi kuityala le-fiber shedding ye-ISO kumatheweni wesembo lokuqala.
Amaphoyisa amamakheti we-polyester ne-nylon angaphendula izindlela zocotton ngokusebenzisa:
Ukusebenzisa imithi yokuflocka ukuthola amaceli 40% ngaphezulu kuka-cotton wokugcina nasopharyngeal sampling ( Imikrobiology Clinicale , 2023). Le ndawo ibaluleke kakhulu kuma:
Imibhovu yokuflocka iyasebenzisa imithi yokwenza isayithi esivumelane ukwakhiwa kwe-matrix enobungo obuphezulu. Le ndawo enobungo obuphezulu ikhuthaza:
Noma isampuli yamandla iyinjani, imithombo yekliniki ibonisa ukuthi ukwabiwa kweziphawu kunezimpawu ezinguquko kumaphethini wokuvavanya:
Inqanawa yemiphumela | Izibhobho zokulondoloza | Izihlahla eziqile |
---|---|---|
Ukuvuleka kweziphawu kahulumeni | 94% | 68% |
Isilinganiso sokuvuma engalungileyo | 2.1% | 5.7% |
Ukuphumelela kweselula | 89% | 63% |
Izilaborithile ezinamakhemikhali ezifuna ukuba ngezimalo ezenziwe ngokuhlamvanga zokuthola iziphumo ezinhle xa zisebenzisa izivivinyo nezinhlelo zokuthumela izivirusi.
Izimalo zokuthatha izivivinyo ezintsha zenzeke ngokuhlamvanga zinezici ezilandelayo:
Izivivinyo zokuvikisa zibonisa:
Ukuphepha ngegasi le-ethylene oxide (EtO) ligcwalisa iphakheji kepha kudinga ukulahla iphakheji ngama-24-48 iintsuku ukuze kufinyelelwe i-FDA thresholds (≤1 ppm). I-Gamma irradiation iyahlula amagugu kepha ingaba ingaqhelekanga - ingqalelo ye-2023 ye-ASTM yafuneko ukuba kukhuphela ukuphakama ngama-12% kumanye amafayibha e-nylon. Abasebenzisi bekuphakela bafuphakela i-ISO 11135 (EtO) kunye ne-ISO 11137 (gamma) izistanda.
Izimboniso ezingcono kakhulu kudinga i-Sterility Assurance Level (SAL) ≤10â»â¶. Kumaqo amaphoyisa, iziqwayiso kufanele zilinde isiqhelo esingcono kwezinsuku eziyi-30-90 ngaphandle kwezimo zokugcinwa zase-ISO 11607. I-Cleanrooms iyasebenza ngokwesiqhelo se-ISO 14644 Isihefu 7/8 (≤352,000 iphethini/m³).
Ukuqinisekiswa | Isigaba | Izidingo eziphambene |
---|---|---|
ISO 13485 | Ukuphatha Ukudabuka | Ukucimisa okuvumelekile, ukulandelana nezinhlobo |
FDA 510(k) | Ukuvunyelwa kwezwe le-United States | Ukuvumelana nezimboniso, imiphango yesililwane |
CE Marking | Ukuvumelana nezwe le-EU | Ukubaluleka kuka EN ISO 11737-1 |
Izindwandwe zika Nasopharyngeal zisebenzisa amaphoyisa amabi (3-4 mm) anezinhlango zokuphethela eziphethelene ne-nylon, zokugcina izinhlobo zeviral kancane 34% ngaphansi kwezifomu eziphambene. Izindwandwe zika Oropharyngeal zisebenzisa izinhlango eziphakeme eziphethelene ne-polyester ukuxhumana kuzindawo eziphakeme.
Izindwandwe zokudalela zinikeza inkimbinkimbi yokuthola - i-polyurethane engenakho ukutholwa kwezinhlobo kancane 92% ngaphansi kuka-cotton. Izinkinga eziphakeme kuzi zifumaneka:
Impahla | Ukuxhumana nezolvente | Imisebenzo Esheshayo |
---|---|---|
Polyester | Izilwane, acetone | Ukuthunyelwa kwe-DNA/RNA |
Rayon | Izinhlaya eziyinkimbinkimbi, izibizo | Izivivinyo zemiphefumulo |
PTFE | Izinhlaya eziphakeme | Ukuthenga kwe-HPLC |
Isibonelo esitholile 21% yezinhlaya ezithintekileyo eshishwa kwi-swab-solvent incompatibilities ngokwesibonelo esikhulu 2023.
Izindlela zokuhlukana kubantu:
Isici | Ezimali engaphindwanga | Ezimali zokugcina |
---|---|---|
Amakhotsi | Akukho | ISO 13485, FDA 21 CFR 820 |
Imiklankempu yezinto | Ayiphawuli | Amaphela aphakathi kwe-USP Class VI |
Ukugcinwa kwezimali | Akukhathiwe | Ukucima kwezinhlelo yokucima |
Isendvolo yokusebenzela | Ukuguqula kumasekhaya | Ukudluliselwa kwezilungiselelo |
Izindlela ze-CDC zomnyaka 2023 zilungise iindlela zokusebenzela kwezinhlelo zokucima zokuhlolwa kwe-FDA ngisho nezindlela zokuthutha kwezinhlelo zokucima kwezokudla ngokuthi kuzobonakala ukuthutha kwezinhlelo zokucima zokudla. Iizinhlelo eziqinisekileyo zokucima zenza ukuba kube 34% okuningi ukutholwa kwezinto zokuhlola kuzo zokucima kwe-nasopharyngeal.
Izinhlelo ezingenayo zokucima zenza ukuba kube izingxenye zokuthola izinto, ukungcola ukuthi zingatholanga izinkimbini, futhi zenza ukuba kube phezulu ukuthi kuzothathwa kwezimbewu, lokhu kwenza ukuba kube yimali kakhulu kuzo zokudlulisela.
Izinhlelo zokucima eziflockwe zenza umkhombandlela okuphezulu kwezinhlelo ngezimbewu ezivumelane, ukuthutha ukuthi kuzo zokutholwa, ukuthi kuzo zokuthola, futhi ukuthi kuzo zokutholwa kwezinto eziphakeme.
I-Ethylene oxide (EtO) igas faye i-gamma irradiation kuyindlela ejwayelekile yokupheka, nganye enenye le ndlela yokupheka inezimphakathi kanye nezinhawu zokugcina ubunzima bokwelaphi.