I-ETO Sterilization Chamber Testing

Ukuhlola Ukusabalalisa Izinga lokushisa Nomswakama

Ibanga lokusetha izinga lokushisa le-ETO Sterilization Chamber kufanele libe phakathi kuka-30-60°C. Kunconywa ukwenza ukuhlolwa kokusatshalaliswa kwezinga lokushisa kwendawo yangaphakathi yesibulala-magciwane kanye nokuhlola izinga lokushisa kanye nomswakama wokusabalalisa ngaphakathi kwegumbi lokuvala inzalo ukuze kuqinisekiswe ukusebenza kahle kwezinhlelo zokushisisa nokuswakama.

a) Ukuhlolwa Kwezinga Lokushisa Komhlaba Kwangaphakathi kwe-ETO Sterilization Chamber:

Ngesikhathi sokuhlolwa, igumbi lokuvala inzalo kufanele lingabi nalutho, kodwa izisetshenziswa ezisizayo ezidingekayo ukuze kubulawe inzalo zingafakwa. Umnyango wegumbi lokuvala inzalo kufanele uvalwe.
Izinga lokushisa lanoma yisiphi isiteji sokushisa njengoba lishiwo ngumkhiqizi wezibulali magciwane kufanele kurekhodwe. Izinga lokushisa lazo zonke izindawo zangaphakathi zegumbi lokuvala inzalo akufanele lidlule izinga lokushisa elimisiwe lesigaba sokuvala inzalo ngo-±5°C.

b) Ukuhlolwa Kwezinga Lokushisa Nokuswakama e-ETO Sterilization Chamber:

Ngesikhathi sokuhlolwa, i-ETO Sterilization Chamber kufanele ingabi nalutho, kodwa izisetshenziswa ezisizayo ezidingekayo ukuze kubulawe inzalo zingafakwa. Umnyango wegumbi lokuvala inzalo kufanele uvalwe.
Sebenzisa izinzwa zezinga lokushisa kanye nomswakamo ezibekwe ezindaweni ezithile ukuze uqhathanise nezinga lokushisa lokulawula ngaphakathi kwegumbi. Izinzwa zokushisa kufanele zibekwe ezindaweni okungenzeka zimelele umehluko omkhulu wezinga lokushisa, njengezingxenye ezingashisiwe zegumbi, eduze kweminyango yekhabethe, kanye eduze nezindawo zokungena zesitimu noma zegesi. Ezinye izinzwa kufanele zisatshalaliswe ngokulinganayo kuyo yonke ivolumu esebenzisekayo yegumbi lokuvala inzalo, okuhlanganisa phakathi, phezulu, phansi, ngaphambili, nangemuva. Inombolo yezinzwa kufanele ihlangabezane nezidingo ku-Appendix C ye-GB18279.1.
Indawo yesilinganiso ngasinye kufanele irekhodwe, futhi izinga lokushisa kanye nomswakama ezindaweni ezahlukene zegumbi lokuvala inzalo kufanele kurekhodwe ukuze kubonakale izindawo ezishisayo ezingaba khona kanye nezindawo ezibandayo.
Izinga lokushisa elingaphakathi endlini legumbi lokuvala inzalo uma lingenalutho akufanele lidlule u-±2°C wezinga lokushisa elimisiwe noma ±3°C wezinga lokushisa elimaphakathi ngaphakathi kwegumbi.

I-Vacuum Pumping Rate

Isistimu ye-vacuum ngesikhathi sesigaba sokumpompa i-vacuum kufanele ikwazi ukukhipha igumbi lokuvala inzalo elingenalutho liye ku- -75 kPa noma ngaphansi. Igeji yokucindezela kufanele ixhunywe endaweni yokuhlola ye-vacuum ukuze kubhekwe ukuthi iyahlangabezana yini nezinga elidingekayo.
Umkhiqizi kufanele aqinisekise isikhathi esidingekayo ukuze kufinyelele -50 kPa kanye -75 kPa ngaphansi kwezimo ezingenalutho zokulayisha. Idivayisi yesikhathi ingasetshenziswa ukuqapha isigaba sokumpompa ivacuum, futhi imingcele esethiwe kufanele ifinyelelwe phakathi nesikhathi esishiwo.

Ukuhlolwa kokuvuza kweKhabhinethi ye-ETO Sterilization

Ukuhlolwa kokuvuza kweKhabhinethi ye-ETO Sterilization kuhlanganisa kokubili ukuhlolwa kokuvuza kwe-vacuum (ingcindezi embi) kanye nengcindezi (ingcindezi enhle) ukuhlola ukuvuza (uma kusebenza). Uma ukucindezela kokusebenza kwesibulala-magciwane kungaphezu kuka-5 kPa, kufanele kwenziwe ukuhlolwa kokuvuza kwengcindezi (ingcindezi enhle).

Ukuhlolwa kokuvuza kwe-vacuum kufanele kwenziwe ngaphambi kwesigaba somjovo obulalayo kanye nesigaba sokuswakama, ngendlela yokuhlola elandela izinhlinzeko zeSithasiselo D.1 se-YY0503. Ingcindezi esethiwe ngesikhathi sokuhlolwa kufanele ibe ngaphansi kuka -20 kPa futhi okungenani ibe ngaphansi kuka-20 kPa kunengcindezi yokuvala inzalo esethiwe. Uma ukucindezela okusethiwe sekufinyelelwe, wonke amavalvu axhunywe egumbini lokuvala inzalo kufanele avalwe, futhi iphampu yevacuum kufanele iyeke ukusebenza. Ukucindezela ekamelweni lokuvala inzalo kufanele kuqashelwe, futhi ukuphakama kwengcindezi kungakapheli imizuzu emi-5 akufanele kudlule i-0.3 kPa/min. Ukuhluka kwengcindezi phakathi nakho konke ukuhlolwa akufanele kudlule ku-0.1 kPa/min.
Ukuhlolwa kokuvuza kwengcindezi enhle (uma kusebenza) kufanele kwenziwe ngaphambi kwesigaba sokumpompa i-vacuum. Ingcindezi esethiwe yokuhlolwa kufanele ibe phakathi kuka-10% wengcindezi yokusebenza esethiwe yesibulala-magciwane. Ukwehla kwengcindezi kungakapheli imizuzu emi-5 akufanele kudlule ku-0.3 kPa/min. Ngesikhathi esifanayo, ngokwendlela eseSithasiselweni D.2 sika-YY0503, isikhathi sokuvala inzalo kufanele simiswe okungenani sibe imizuzu engama-65, kusetshenziswa igesi engasebenzi (efana nomoya) ukuze kungene igesi ye-EO futhi kuqhube umjikelezo ojwayelekile wokuvala inzalo. Ngemuva kokuthi isigaba sokuvala inzalo sifinyelele ukuzinza kwezinga lokushisa imizuzu emi-2, ukucindezela ekamelweni lokuvala inzalo kufanele kurekhodwe. Kufanele kurekhodwe futhi ngemva kwemizuzu engama-60 ± 1 iminithi. Izinga lokushintsha kwengcindezi akufanele lidlule ku-0.1 kPa/min.Ukuqinisekiswa Kwesistimu Esizayo

Ngesikhathi sokuqinisekiswa kokusebenza, ukusebenza kwezinhlelo ezisizayo ezihlobene kufanele kuqinisekiswe, okuhlanganisa kodwa kungagcini nje kulokhu: ikhwalithi yesitimu enikeziwe, ikhono le-EO vaporizer ukufinyelela izinga lokushisa elincane lokufakwa kwegesi, ukwethembeka kokuhlunga komoya kwe-sterilizer kanye nezinhlelo zokuphakelwa kwamanzi, kanye nekhono lejeneretha yesitimu ukugcina ikhwalithi yokuhlinzeka edingekayo ngaphansi kwezimo eziphezulu zokulayisha inzalo.

Izibonelo zokusebenza okwamukelekayo kwesistimu yokusiza: a) Uma isitimu sijovwa phakathi nesigaba sokucubungula, umswakamo osegunjini lokuvala inzalo kufanele ubonise ushintsho olubonakalayo, futhi igumbi kufanele ligcine ukucindezela phakathi kuka-±2.5 kPa wengcindezi emisiwe. b) Izinga lokushisa legesi ye-EO ejovwe kufanele libe ngaphezu kwenani eliphansi elibekiwe le-vaporizer (ngokuvamile libe ngu-10.7°C emkhathini wokucindezela) ukuze kuqinisekiswe ukuthi i-EO ejovwe isesimweni segesi, hhayi uketshezi. c) Ukusebenza kahle kokuhlunga kwesistimu yokuhlunga komoya kufanele kuhlangabezane nemfuneko yesilinganiso sokuhlunga okungenani esingu-99.5% wezinhlayiya ezingaphezu kuka-0.3 microns. d) Uhlelo lokuhlinzeka ngamanzi kufanele lusebenzise amanzi ahlanzekile ahlangabezana nezidingo zohlelo lwango-2020 lwe-Chinese Pharmacopoeia. e) Umfutho womhwamuko osetshenziselwa ukuhwamisa kusibulala-magciwane akufanele udlule ku-50 kPa.

Isoftware yeKhabhinethi ye-ETO Sterilization

Ngesikhathi senqubo yokuvala inzalo, isofthiwe yemishini yokuvala inzalo izolawula futhi iqaphe inqubo yokuvala inzalo futhi ihlole imingcele yomjikelezo wokuvala inzalo. Ngakho-ke, ngesikhathi senqubo yokusebenza yokufaneleka, isofthiwe yemishini yokuvala inzalo kufanele ihlolwe ngaphansi kwazo zonke izimo zokwehluleka (ezifana nezinhlelo zokukala nezinhlelo zokulawula ngekhompuyutha). Bheka kumanuwali yomsebenzisi obulalayo kanye nezichasiselo zemishini, futhi uhlole imisebenzi yesistimu yesofthiwe ezindaweni ezifana nokubamba i-alamu, ukucubungula amaphutha, ukuphathwa kolwazi, izilungiselelo zepharamitha, ukuxhumana okurekhodiwe okungokomlando, ukulawulwa kwezinzwa nokuqapha, nokulawula ukusebenza nokuqapha ngaphansi kwezimo ezibekela inselele imikhawulo yokusebenza kwemishini.