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Ethylene Oxide Sterilisation Biological egosi

Nkọwa dị mkpirikpi:

Ethylene Oxide Sterilisation Ngosi ihe ndị dị ndụ bụ ngwaọrụ dị mkpa maka ịchọpụta ịdị mma nke usoro igba ogwu EtO. Site n'iji nje nje bacteria na-eguzogide nke ukwuu, ha na-enye usoro siri ike na nke a pụrụ ịdabere na ya iji hụ na a na-ezute ọnọdụ sterilization, na-enye aka na njikwa ọrịa dị irè na nhazi usoro.

Usoro: Ethylene oxide

Microorganism: Bacillus atrophaeus (ATCCR@9372)

Ọnụ ọgụgụ ndị mmadụ: 10^6 Spores/ebu

Oge ngụcha: elekere 3, elekere 24, elekere 48

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


Nkọwa ngwaahịa

Mkpado ngwaahịa

Ngwaahịa

AKWỤKWỌ OGE Nlereanya
Ethylene Oxide Sterilisation Biological egosi (Ngụpụta ngwa ngwa) 3h JPE180
Ethylene Oxide Sterilisation Biological egosi 48h JPE288

Ngwa ngwa

Microorganisms:

BIs nwere spores nke nje bacteria na-eguzogide nke ukwuu, nke na-abụkarị Bacillus atrophaeus ma ọ bụ Geobacillus stearothermophilus.

A na-ahọrọ spores ndị a maka iguzogide ethylene oxide a maara nke ọma, na-eme ka ha dị mma maka ịkwado usoro nkwụsị ahụ.

Onye na-ebu:

A na-etinye spores ahụ n'ihe ndị na-ebu ihe dị ka mpempe akwụkwọ, diski igwe anaghị agba nchara, ma ọ bụ eriri plastik.

A na-etinye onye na-ebu ya na ngwugwu nchebe nke na-enye ohere ka gas EtO banye n'ime ka ọ na-ejigide iguzosi ike n'ezi ihe nke spores.

Nkwakọ ngwaahịa mbụ:

A na-etinye BIs n'ime ihe ndị na-ahụ na enwere ike ijikwa ha ngwa ngwa ma tinye ya n'ime ibu ọgwụ mgbochi.

Emebere nkwakọ ngwaahịa ahụ ka ọ bụrụ nke ga-adaba na gas ethylene oxide mana enweghị ike imerụ ihe ndị sitere na gburugburu ebe obibi.

Ojiji

Nkwanye:

A na-etinye BIs n'ebe dị n'ime ụlọ ịgba ọgwụ mgbochi ebe a na-atụ anya na ntinye gas ga-akacha sie ike, dị ka etiti nnukwu ngwugwu ma ọ bụ n'ime ngwa mgbagwoju anya.

A na-ejikarị ihe ngosi dị iche iche eme ihe n'ọnọdụ dị iche iche iji nyochaa nkesa otu gas.

okirikiri sterilization:

A na-agba ọsọ sterilizer site na okirikiri ọkọlọtọ, na-emetụtakarị gas EtO n'otu ọkwa, okpomọkụ na iru mmiri maka oge a kara aka.

A na-ekpughere BIs n'otu ọnọdụ dị ka ihe a na-agbaze.

Mmalite:

Mgbe usoro ịgba ọgwụ mgbochi ahụ gasịrị, a na-ewepụ BIs ma tinye ya n'okpuru ọnọdụ dị mma maka uto nke anụ ahụ ule (dịka, 37 Celsius C maka Bacillus atrophaeus).

Oge nnabata na-adịkarị n'etiti awa 24 ruo 48.

Nsonaazụ Ọgụgụ:

Mgbe emechara ya, a na-enyocha BI maka ihe ịrịba ama nke uto microbial. Enweghị uto na-egosi na usoro ịgba ọgwụ mgbochi ahụ dị irè n'igbu spores, ebe uto na-egosi ọdịda.

Enwere ike igosi nsonaazụ site na mgbanwe agba na etiti uto ma ọ bụ turbidity.

Ihe ọ pụtara

Nkwado na nlekota oru:

BIs na-enye usoro a pụrụ ịdabere na ya na nke a kapịrị ọnụ maka ịkwado ịdị irè nke usoro ịgba ọgwụ mgbochi EtO.

Ha na-enyere aka hụ na akụkụ niile nke ibu sterilized eruola ọnọdụ dị mkpa iji nweta ịmụ nwa.

Nrube isi n'usoro iwu:

A na-achọkarị iji BIs site na ụkpụrụ na ụkpụrụ nduzi (dịka, ISO 11135, ANSI/AAMI ST41) iji kwado na nyochaa usoro ịmụ nwa.

BI bụ akụkụ dị oke mkpa nke mmemme mmesi obi ike na nlekọta ahụike na ntọala ụlọ ọrụ, na-ahụ maka nchekwa ndị ọrịa na ndị ahịa.

Ntụkwasị obi ịdị mma:

Iji BI oge niile na-enyere aka idowe ụkpụrụ njikwa ọrịa dị elu site na ịnye nkwenye na-aga n'ihu nke arụmọrụ sterilizer.

Ha bụ akụkụ nke mmemme nleba anya ọgwụ mgbochi nwa nke nwekwara ike ịgụnye ihe nrịbama kemịkalụ na ngwaọrụ nleba anya anụ ahụ.

Ụdị nke Ethylene Oxide Sterilisation Biological egosi

Ngosipụta ihe ndị dị ndụ nwere onwe (SCBI):

Ndị a na-agụnye ihe na-ebu spore, onye na-eto eto, na usoro ntinye n'otu nkeji.

Mgbe ekpughere ya na okirikiri sterilization, SCBI nwere ike ịgbalite ma tinye ya ozugbo na-enweghị njikwa ọzọ.

Ngosipụta ndu ndu ọdịnala:

Ndị a na-enwekarị eriri spore n'ime envelopu glassine ma ọ bụ vial.

Ndị a na-achọ ịnyefe na usoro ntolite mgbe usoro ọgwụgwọ sterilization gasịrị maka incubation na nkọwa nsonaazụ.

Uru nke Iji BIs na EtO Sterilisation

Mmetụta dị elu:

BIs na-achọpụta ọnụnọ nke spores nje na-eguzogide nke ukwuu, na-enye nnwale siri ike nke usoro igba ogwu.

Nkwado zuru oke:

BIs na-akwado usoro ịgba ọgwụ mgbochi ọrịa niile, gụnyere ntinye gas, oge mkpughe, okpomọkụ, na iru mmiri.

Nkwado nchekwa:

Ha na-ahụ na ngwaahịa ndị gbasiri ike dị mma maka ojiji, na-enwere onwe ha pụọ ​​​​na microorganisms nwere ike ime.


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