Shanghai JPS Medical Co., Ltd.

I-Ethylene Oxide Sterilization Biological Indicator

Incazelo emfushane:

I-Ethylene Oxide Sterilization Biological Indicators zingamathuluzi abalulekile okuqinisekisa ukusebenza kahle kwezinqubo zokuvala inzalo ze-EtO. Ngokusebenzisa izinhlayiya zebhaktheriya ezimelana kakhulu, zinikeza indlela eqinile nethembekile yokuqinisekisa ukuthi izimo zokuvala inzalo ziyahlangatshezwa, okunomthelela ekulawuleni ukutheleleka okuphumelelayo kanye nokuhambisana nomthetho.

Inqubo: I-Ethylene oxide

I-Microorganism: Bacillus atrophaeus(ATCCR@ 9372)

Inani labantu: 10^6 Spores/umthwali

Isikhathi Sokufunda: 3 hr, 24 Hr, 48 hr

Imithethonqubo: ISO13485:2016/NS-EN ISO13485:2016ISO 11138-1:2017; ISO 11138-2:2017; ISO 11138-8:2021


Imininingwane Yomkhiqizo

Omaka bomkhiqizo

Imikhiqizo

I-PRDUCTS ISIKHATHI INDLELA
I-Ethylene Oxide Sterilization Biological Indicator (Ukufunda Ngokushesha) 3 ihora JPE180
I-Ethylene Oxide Sterilization Biological Indicator amahora 48 JPE288

Izingxenye Ezibalulekile

Ama-Microorganisms:

Ama-BI aqukethe izinhlamvu zamagciwane amelana kakhulu, ngokuvamile i-Bacillus atrophaeus noma i-Geobacillus stearothermophilus.

Lezi zinhlamvu zikhethwa ngenxa yokumelana kwazo okwaziwayo ku-ethylene oxide, okuzenza zilungele ukuqinisekisa inqubo yokuvala inzalo.

Inkampani yenethiwekhi:

Ama-spores asetshenziswa ezintweni ezithwala njengephepha, idiski yensimbi engagqwali, noma umucu wepulasitiki.

Isithwali sivalelwe kuphakheji elivikelayo elivumela igesi ye-EtO ukuthi ingene ngenkathi igcina ubuqotho bezinhlamvu.

Ukupakisha Okuyinhloko:

Ama-BI avalelwe ezintweni eziqinisekisa ukuthi angaphathwa kalula futhi afakwe ngaphakathi komthwalo wokuvala inzalo.

Iphakheji iklanyelwe ukuthi ingene kugesi ye-ethylene oxide kodwa ingangenwa ukungcola okuvela endaweni.

Ukusetshenziswa

Ukubekwa:

Ama-BI abekwe ezindaweni ezingaphakathi kwegumbi lokuvala inzalo lapho ukungena kwegesi okulindeleke ukuba kube inselele enkulu, njengendawo emaphakathi yamaphakethe aminyene noma amathuluzi angaphakathi ayinkimbinkimbi.

Izinkomba eziningi zivame ukusetshenziswa ezindaweni ezihlukene ukuze kuqinisekiswe ukusatshalaliswa kwegesi okufanayo.

Umjikelezo Wokuvula Inzalo:

Isibulala-magciwane siqhutshwa ngomjikelezo ojwayelekile, ovame ukubandakanya igesi ye-EtO ezindaweni ezithile ezigxilile, amazinga okushisa, namazinga womswakamo isikhathi esinqunyiwe kusengaphambili.

Ama-BI abhekene nezimo ezifanayo nezinto ezihlanzwa amagciwane.

Ukufukamela:

Ngemva komjikelezo wokuvala inzalo, ama-BI ayasuswa futhi afakwe ngaphansi kwezimo ezivumayo ekukhuleni kwento ephilayo yokuhlola (isb, 37°C ye-Bacillus atrophaeus).

Isikhathi sokufukamela ngokuvamile sithatha phakathi kwamahora angu-24 kuya kwangu-48.

Imiphumela yokufunda:

Ngemva kokufukamela, ama-BI ahlolelwa izimpawu zokukhula kwamagciwane. Akukho ukukhula okubonisa ukuthi inqubo yokuvala inzalo yayisebenza kahle ekubulaleni izinhlamvu, kuyilapho ukukhula kubonisa ukwehluleka.

Imiphumela ingaboniswa ngokushintsha kombala endaweni yokukhula noma nge-turbidity.

Ukubaluleka

Ukuqinisekisa Nokuqapha:

Ama-BI ahlinzeka ngendlela enokwethenjelwa neqondile yokuqinisekisa ukusebenza kahle kwezinqubo zokuvala inzalo ze-EtO.

Basiza ukuqinisekisa ukuthi zonke izingxenye zomthwalo ovalelwe amagciwane zifinyelele izimo ezidingekayo ukuze kuzuzwe inzalo.

Ukuthobela Umthetho:

Ukusetshenziswa kwama-BI ngokuvamile kudingwa ngamazinga okulawula nemihlahlandlela (isb, ISO 11135, ANSI/AAMI ST41) ukuze kuqinisekiswe futhi kuqashwe izinqubo zokuvala inzalo.

Ama-BI ayingxenye ebalulekile yezinhlelo zokuqinisekisa ikhwalithi ekunakekelweni kwezempilo nezimboni, eziqinisekisa ukuphepha kwesiguli kanye nabathengi.

Ukuqinisekisa ikhwalithi:

Ukusebenzisa njalo ama-BI kusiza ukugcina amazinga aphezulu okulawula ukutheleleka ngokunikeza ukuqinisekiswa okuqhubekayo kokusebenza kwesibulala-magciwane.

Ziyingxenye yohlelo olubanzi lokuqapha ukuvala inzalo okungase kuhlanganise izinkomba zamakhemikhali kanye nemishini yokuqapha ngokomzimba.

Izinhlobo ze-Ethylene Oxide Sterilization Biological Indicators

Izinkomba Zebhayoloji Ezizimele (ama-SCBI):

Lokhu kufaka phakathi i-spore carrier, indawo yokukhula, kanye nesistimu ye-incubation eyunithi eyodwa.

Ngemva kokuchayeka emjikelezweni wokuvala inzalo, i-SCBI ingenziwa isebenze futhi ifakwe ngqo ngaphandle kokuphatha okwengeziwe.

Izinkomba Zebhayoloji Yendabuko:

Lokhu kuvame ukuhlanganisa umucu we-spore ngaphakathi kwemvilophu yengilazi noma ibhodlela.

Lokhu kudinga ukudluliselwa endaweni yokukhula ngemva komjikelezo wokuvala inzalo ukuze kufakwe incubation kanye nokuchazwa kwemiphumela.

Izinzuzo Zokusebenzisa ama-BI ku-EtO Sterilization

Ukuzwela Okuphezulu:

Ama-BI athola ukuba khona kwezinhlamvu zebhaktheriya ezimelana kakhulu, enikeza ukuhlolwa okuqinile kwenqubo yokuvala inzalo.

Ukuqinisekisa Okuphelele:

Ama-BI aqinisekisa yonke inqubo yokuvala inzalo, okuhlanganisa ukungena kwegesi, isikhathi sokuchayeka, izinga lokushisa, kanye nomswakama.

Isiqiniseko Sokuphepha:

Baqinisekisa ukuthi imikhiqizo evalwe inzalo iphephile ukusetshenziswa, ayinazo ama-microorganisms aphilayo.


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