I-PQ yisigaba sokuqinisekiswa esisebenzisa igumbi lokubulala inzalo e-Ethylene oxide ukukhombisa ukuthi imishini yokuhlanza inzalo ye-ethylene oxide isebenza njalo ngokuya ngezinqubo zokwamukelwa ezinqunyelwe ngaphambili kanye nenqubo enezidingo ezibekiwe futhi ezihlangabezana nezidingo ezicacisiwe.

I-PQ kufanele yenziwe ngenqubo entsha ngayinye kanye/noma umkhiqizo ozoqinisekiswa ukuze ubonise ukuthi inqubo iyahambisana nemibandela yokwamukela ehlonziwe futhi iyakwazi ukuletha i-SAL edingekayo emkhiqizweni.I-PQ iqukethe kokubili ukufaneleka kokusebenza kwe-microbiological kanye nokusebenza ngokomzimba futhi yenziwa kumshini wokuvala inzalo we-Ethylene oxide osetshenziselwa ukuvala inzalo umkhiqizo.

Ngesikhathi senqubo ye-PQ, iphakheji yomkhiqizo kanye nemodi yokulayisha yomkhiqizo kufanele icaciswe; Khetha imikhiqizo emele noma izinto okupakishwa kwazo kanye nokwakheka kwezinto ezingamboza wonke umkhiqizo ozokwenziwa amagciwane noma wonke umndeni womkhiqizo.

Ngesikhathi senqubo ye-PQ, iphakheji yomkhiqizo kanye nemodi yokulayisha yomkhiqizo kufanele icaciswe; Khetha imikhiqizo emele noma izinto okupakishwa kwazo kanye nokwakheka kwezinto ezingamboza wonke umkhiqizo ozokwenziwa amagciwane noma wonke umndeni womkhiqizo.

Ngokuvamile, i-MPQ ne-PPQ zenziwa kanyekanye.Uma i-PPQ yenziwa ngokuhambisana okungenani nokugijima kwe-MPQ okuthathu, khona-ke ubuncane bokugijima kwe-PPQ eyodwa kuzokwenziwa kusetshenziswa ukucaciswa kwenqubo yomjikelezo ogcwele. I-Physical PQ (PPQ) izokhombisa ukuthi imibandela yokwamukela eshiwo iyahlangatshezwa kuwo wonke umthwalo ngesikhathi sokucaciswa kwenqubo yenkambiso ehlongozwayo.

I-PQ izokwenziwa lapho kwethulwa imikhiqizo emisha noma eguquliwe, ukupakishwa, ukucushwa komthwalo, igumbi le-Ethylene oxide sterilization noma imingcele yokucubungula ngaphandle uma ukulingana nomkhiqizo oqinisekisiwe ngaphambilini, ukupakishwa, ukucushwa komthwalo Igumbi le-Ethylene oxide sterilization noma inqubo ibhaliwe.

Ukuqinisekiswa kwe-PQ Inqubo yegumbi lokuvala inzalo ethylene oxide

Inqubo yokuqinisekisa i-PQ imvamisa ithi : yenza umjikelezo oyiqhezu kuqala, bese uhlola isimo sobunyumba somkhiqizo ngemva kwalokho.
ingxenye
cycle sterilization; compare the EO resistance relationship between IPCD, EPCD and representative products (the expected result is EPCD > IPCD > Product,); Refer to ISO-11737-2 for the test requirements involved in the fractional cycle.

Yenza uhhafu womjikelezo ukuze ufakazele ukuphindaphindeka kwenqubo yokuvala inzalo kanye nomphumela wokuvala inzalo; Uma kusetshenziswa indlela ye-overkill, akumele kube ne-IPCD ephozithivu ngesikhathi somjikelezo.I-EPCD enhle phakathi nohhafu womjikelezo iyamukeleka uma ikhombise ukumelana okukhulu kune-IPCD ehlinzeka
“
inselele yecala elibi kakhulu
”
ngokucubungula okujwayelekile.

Imingcele evamile yokuvala inzalo ivamise ukunqunywa amapharamitha omjikelezo ogcwele, ngakho izinselele eziyinsalela ngokuvamile zenziwa phakathi nomjikelezo ogcwele ukuze kutholwe isikhathi esifanele sokungenisa umoya. Njengoba ukuphumelela kwenqubo yokuvala inzalo kufakazelwe kumjikelezo wengxenyana kanye nohhafu womjikelezo, umphumela wokuvala inzalo ungaqinisekiswa yi-EPCD.

Uma, kunoma yikuphi kwalokhu kugijima, izidingo zokungazali noma ukusebenza komkhiqizo zingahlangatshezwana nazo, uphenyo kufanele lwenziwe ukuze kutholwe ukuthi kudingeka yini ukuqhutshwa kweziqu okwengeziwe. Uma amapharamitha enqubo engakwazi ukugcinwa ngaphakathi kwemikhawulo echaziwe, kufanele kwenziwe uphenyo. Uma kwenziwa izinguquko, ukugijima okwengeziwe kufanele kudingeke.

I-PQ Yonyaka kunqubo yegumbi le-Ethylene oxide sterilization

Ukubuyekezwa kwe-PQ kufanele kuhlole ukuthi inqubo yokuvala inzalo ihlala isemthethweni kumkhiqizo oqokiwe.I-MPQ/PPQ encishisiwe ingadingeka ezimeni ezithile, isb. ukuqinisekisa ukufaneleka okuqhubekayo kokumelana kwe-PCD yangaphakathi emthwalweni womkhiqizo ukumelana ne-bioburden yomkhiqizo, noma, ngemva kwesikhashana esinqunyiwe, ukunikeza ubufakazi bokuthi akubanga khona ushintsho olungaqondile kusukela ocwaningweni lwangaphambilini lokufaneleka. Lokhu ngokuvamile kuzobandakanya, kancane, ukuchayeka komjikelezo okuyingxenye noma okuyingxenye okuhlanganisa izinga lokushisa lomthwalo nezilinganiso zomswakama. Imijikelezo yezingxenye ezincane ekamelweni elithuthukisayo ingasetshenziswa futhi ukusekela uhlelo lokufaneleka, kodwa ukufaneleka kabusha kwegumbi lokukhiqiza kufanele kwenziwe ekamelweni lokukhiqiza.

Ukuhlolwa kokulingana

1.Process Equivalence?Imishini yokuvala inzalo ye-Ethylene oxide eletha amapharamitha enqubo efanayo, esedlule. I-IQ futhi OQ, uzofaneleka noma.

2. ngendlela efanayo negumbi lokuqala, noma kusetshenziswa i-MPQ encishisiwe ebonisa ukulethwa kwezinga elidingekayo le-microbiological lethality kanye ne-PPQ ukukhombisa izinga lokushisa nokuswakama okufanayo komthwalo nokulawulwa yigumbi lokukhiqiza. Isizathu salesi siqinisekiso esincishisiwe sizorekhodwa futhi sibhalwe phansi.

3. Umthelela wezindawo ezihlukene zezindawo kumkhiqizo noma izakhiwo zomthwalo uzonqunywa.

4. Ukulinganisa kwenqubo kuyindlela esetshenziselwa ukubonisa ukuthi inqubo efanayo yokuvala inzalo eqinisekisiwe ilethwa izingcezu ezimbili noma ngaphezulu noma amasethi wemishini yokuvala inzalo ye-Ethylene oxide. Akudingi ukuthi okokusebenza kufane ngokomzimba. Ngisho noma amapharamitha alethwa okokusebenza awafani ngokwezibalo, izinqubo ezilethiwe zisengalingana uma zonke zikwazi ukuqalisa inqubo ngaphakathi kwemikhawulo yenqubo echaziwe, eqinisekisiwe.

5. Ukulingana kwenqubo phakathi kwezingcezu eziningi zemishini kuhloswe ngayo ukunciphisa inani lokuhlola elidingekayo ukuze kusetshenziswe inqubo. Inqubo yokuvala inzalo kufanele iqinisekiswe ekamelweni elilodwa. Izisetshenziswa ezisele zingabhekana ne-PQ encishisiwe uma okokusebenza okusele kwenze iziqu zokufakwa (IQ) kanye neziqu zokusebenza (OQ) (bheka u-9.2 no-9.3). Ukulingana kungasetshenziswa futhi ukunciphisa ukufaneleka kwezingcezu ezimbalwa zemishini. Okokusebenza okusetshenziselwa ukuletha inqubo yokuvala inzalo kuvame ukuba negumbi noma igumbi kanye nezinhlelo zokulawula ezisizayo. Impahla yenqubo yokuvala inzalo ingase ibekwe endaweni ethile yokucubungula noma phakathi kwezindawo ezimbalwa. Lokhu okokusebenza kungasetshenziswa ngokuzimela ukuletha izimo zenqubo efanayo futhi kungase kufane ncamashi nomklamo ofanayo noma kungase kuhluke ngobukhulu noma ngezinga lempahla ehambisanayo.

6. Ukulingana kwenqubo phakathi kwezingcezu eziningi zemishini kuhloswe ngayo ukunciphisa inani lokuhlola elidingekayo ukuze kusetshenziswe inqubo. Inqubo yokuvala inzalo kufanele iqinisekiswe ekamelweni elilodwa. Izisetshenziswa ezisele zingabhekana ne-PQ encishisiwe uma okokusebenza okusele kwenze iziqu zokufakwa (IQ) kanye neziqu zokusebenza (OQ) (bheka u-9.2 no-9.3). Ukulingana kungasetshenziswa futhi ukunciphisa ukufaneleka kwezingcezu ezimbalwa zemishini. Okokusebenza okusetshenziselwa ukuletha inqubo yokuvala inzalo kuvame ukuba negumbi noma igumbi kanye nezinhlelo zokulawula ezisizayo. Impahla yenqubo yokuvala inzalo ingase ibekwe endaweni ethile yokucubungula noma phakathi kwezindawo ezimbalwa. Lokhu okokusebenza kungasetshenziswa ngokuzimela ukuletha izimo zenqubo efanayo futhi kungase kufane ncamashi nomklamo ofanayo noma kungase kuhluke ngobukhulu noma ngezinga lempahla ehambisanayo.

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