I-ETO Sterilization Complete Guide: Imikhiqizo, Ukuqinisekisa, Ukupakisha & Imibuzo Evame Ukubuzwa
Imibuzo esebenzayo engu-20 ephendulwa onjiniyela bokuvala inzalo - okuvela kuyo imikhiqizo elungele i-ethylene oxide, kuye ukuthi imijikelezo yokuqinisekisa isebenza kanjani, ukukhetha kwezinto zokupakisha, ukuhlolwa kwe-bioburden, nempilo yeshelufu eyinyumba.
Buza nge-WhatsApp Buka umkhiqizo we-ETO SterilizerUkwenziwa inzalo kwe-Ethylene oxide (EO) kuyinqubo ekhethekile elawulwa ngokuqinile esetshenziswa kuwo wonke amadivayisi wezokwelapha, imithi, nemikhiqizo yezimboni. Ngenxa yokuthi ukusebenza kwawo kahle akukwazi ukuqinisekiswa ngokuhlolwa kwangemuva kokubulala inzalo kuphela, wonke umkhiqizo kufanele uqinisekiswe ngokusemthethweni ngaphambi kokucutshungulwa okujwayelekile. Umhlahlandlela olandelayo uphendula imibuzo evame kakhulu esiyithola kubakhiqizi abalungiselelayo Ukuvalwa kwe-ETO.
Amadivayisi Ezokwelapha
Isetshenziselwa kakhulu ipulasitiki, insimbi, kanye nemishini yezokwelapha engalukiwe ehlanganisa amasethi okumnika, amasirinji, amandla e-biopsy, ama-catheter ezokwelapha, izingubo zokuhlinza, imaski, nezinsimbi zokuhlinza.
Izimboni & Ezinye izinhlelo zokusebenza
Ifanele isikhumba, imikhiqizo kakotini, izindwangu zokwenziwa, amathuluzi anembayo, imikhiqizo yebhayoloji, iphepha, izincwadi, imibhalo, imithi ethile, nemikhiqizo yenjoloba — noma yini engezwani nokushisa engakwazi ukubulawa amagciwane ngezinye izindlela.
Ingabe umkhiqizo wami ungahlanzwa ngokushesha ngemva kokwakhiwa?
Cha. Ukusebenza kokuvimbela inzalo kwe-ETO akukwazi ukwahlulelwa ngokuhlola ubunyumba bangemva kokuvala inzalo kuphela — kuyinqubo ekhethekile edinga ukulawulwa okuqinile kwayo yonke inqubo. Lokhu kulawula kuvela ekwakhiweni kwepharamitha yokuvala inzalo ngokucophelela kanye nemiphumela yokuqinisekisa eqinisekisiwe. Ukusebenzisa inqubo yokuvala inzalo engaqinisekisiwe kubeka engcupheni ukuvala inzalo okwanele, okungaholela ekuthelelekeni ngamagciwane ezigulini. Ngalesi sizathu, izimiso emazweni amaningi zigunyaza ukuqinisekiswa kokuvala inzalo ngaphambi kokucubungula okujwayelekile.
Kuyini ngempela ukuqinisekiswa kokuvala inzalo?
Ngamagama alula, ukuqinisekiswa kusho ukuklama inqubo yokuvala inzalo kanye nemingcele yayo ukuze kuzuzwe umphumela wokuvala inzalo onqunywe kusengaphambili, bese usebenzisa izivivinyo eziningi ukuze kutholwe amapharamitha enqubo athembekile aqinisekisa umphumela. Lezi zivivinyo zisebenzisa izinjongo ezimbili: (1) ukuqinisekisa ukuthi izinga lokuqinisekiswa komkhiqizo (SAL) lihlangabezana nokuhlosiwe; (2) ukusungula amapharamitha ajwayelekile wokuvala inzalo nokwenza izidingo ezibhaliwe zokusebenza nokulawula.
Anginaso isiqiniseko sokuthi imuphi usayizi wegumbi ongawukhetha wokuvala inzalo.
Usayizi wegumbi uncike kakhulu kuvolumu yakho yokuvala inzalo kanye nezidingo zomjikelezo wokulethwa. Amakamelo amakhulu ahlinzeka ngokuphuma okuphezulu kodwa adinga indawo yaphansi eyengeziwe kanye nezinsiza. Sincoma ukuthi uhlole ivolumu yakho yonyaka ehlongozwayo, usayizi weqoqo, nesikhathi sokushintsha ngaphambi kokukhetha imodeli.
Yini i-SAL? Ileveli yokuqinisekisa ukuzala amathuba okuthola i-microorganism esebenzayo eyunithi yomkhiqizo owodwa ngemva kokuvalwa inzalo. Ngokuvamile ivezwa njenge-10-6 noma 10-3. Uma isetshenziselwa i-SAL, i-10-6 imele amathuba aphansi (angcono) kunangu-10-3 — okusho ukuthi umkhiqizo uphephe kakhudlwana. Ochwepheshe bokulawula emhlabeni wonke bacabangela amathuba ayi-10-6 ukuze uphephe ngokusekelwe ekuhlaziyeni ubungozi.
Ngingakwazi ukwenza ukuhlolwa kobunyumba ngemva kokuvalwa inzalo esikhundleni sokuqinisekisa?
Cha. Ake sithi iqoqo lokuvala inzalo liqukethe amabhokisi ayi-100 anamayunithi ayi-100 lilinye — inani lamayunithi ayi-10,000. Ukubonisana ne-GB2828, umkhawulo ophezulu we-AQL ngu-0.01, okusho ukuthi ukulawula amasampula kungaqinisekisa kuphela ileveli yekhwalithi engu-1/10,000. A 10-6 imfuneko ayibonakali ngokuyisisekelo. Ngisho nasezingeni elingu-0.01, amasampula angu-1,250 [0 1] azodinga ukukhishwa futhi wonke angabi namagciwane ukuze kwahlulelwe amayunithi ayi-10,000 njengamukelekile. Izindleko kanye nengozi kubi kakhulu. Ukuzihlolela ubunyumba ngokwako kunesilinganiso samanga esingaba ngu-1/100. Kokubili ithiyori nokusebenza, ukuhlolwa kobunyumba ngemva kokuvalwa inzalo akukwazi ukufaka esikhundleni sokuqinisekisa.
Kuthatha isikhathi esingakanani ukuqinisekiswa kokuvala inzalo?
Okungenani izinsuku ezingama-45. Ukuqinisekisa kokuqala kuvame ukusebenzisa imijikelezo engu-7: imijikelezo enguhhafu engu-4, umjikelezo omfushane ongu-1, nemijikelezo emi-2 egcwele. Umjikelezo ngamunye oyingxenye kanye nomjikelezo omfushane udinga ukupholisa kusengaphambili umkhiqizo amahora angu-48 ukuze wehlise ku-0°C, bese usebenzisa ukufakwa kwe-preconditioning, inzalo, kanye nokufaka umoya cishe amahora angu-24. Kubandakanya ukulungiswa kwama-BI nezinzwa, umjikelezo owodwa uthatha cishe izinsuku ezi-4, ngakho imijikelezo eyi-7 ithatha cishe izinsuku ezingama-28. Ukwengeza isikhathi sokuhlola nokulungiselela umbiko, izinsuku ezingama-45 zincane. Ukuchezuka noma imiphumela engalindelekile idinga ukulungiswa kabusha kwemingcele nokusebenzisa imijikelezo eyengeziwe, futhi njengoba isibulala-magciwane siphinde siphathe ukukhiqizwa okujwayelekile, ukuqinisekiswa kwangempela kuvame ukuthatha izinsuku ezingama-60–90. Imikhiqizo eyinkimbinkimbi ingase idinge isikhathi esengeziwe.
Iyini inhloso yomjikelezo wesigamu ekuqinisekiseni?
Ingxenye yomjikelezo ingenye yezindlela ezishiwo ku-ISO 11135 ukubonisa i-SAL = 10-6. Ngayo yonke imingcele yokuvala inzalo engashintshiwe ngaphandle kwesikhathi sokuchayeka, inquma isikhathi esifushane kakhulu sokuchayeka ku-EO esingakhiqizi ama-microorganisms aphilayo. Ukuphinda kabili leso sikhathi ngaphansi kwezimo ezifanayo kunikeza umjikelezo ogcwele, okulindeleke ukuthi uzuze i-SAL = 10-6. Imigijimo emithathu eyimpinda iyadingeka ngokwezinga.
Iyini inhloso yomjikelezo omfushane wokuqinisekisa?
Umjikelezo omfushane uhlola ubudlelwano bokumelana phakathi kwe-IPCD, EPCD, kanye nomkhiqizo ngokwawo. Ngomjikelezo omfushane, imfuneko iwukumelana ne-EPCD? Ukumelana ne-IPCD ? ukumelana nomkhiqizo. Umkhiqizo kufanele uphumelele zonke izivivinyo zokungabi nzalo (kunconyiwe ngokwezidingo zekhemisi).
Iyini inhloso yomjikelezo ogcwele wokuqinisekisa?
Umjikelezo ogcwele ubeka imingcele yepharamitha engaphezulu yenqubo yokuvala inzalo, inselele izakhiwo ezingokomzimba nezamakhemikhali zomkhiqizo (okuhlanganisa nezinsalela ezibulalayo). Ikakhulukazi, elinye lamasampula angemuva kokuvalwa inzalo lingaphansi komjikelezo wesibili wokuvala inzalo ukuze inselele ukwethembeka kokuvala inzalo okuphindwe kabili. Izinto zokuhlola ukusebenza komkhiqizo, amanani, nezindlela kunqunywa ikhasimende. Singahlola i-EO/ECH sisebenzisa i-gas chromatography, kodwa asiyona ilabhorethri egunyaziwe. Uma ukuhlolwa okugunyaziwe kuyadingeka, kufanele kukhishwe ngaphandle. Ukuhlolwa kwe-EO/ECH kunezingqinamba zesikhathi - amasampula akhishwe ngaphandle kufanele athunyelwe eqhweni elomile, futhi ilabhorethri kufanele igcine iphakethe eqhweni elomile lapho ilivula.
Ingabe ukuhlolwa kwe-bioburden kuyadingeka kumasampuli okuqinisekisa?
Yebo. Zonke izisetshenziswa zezokwelapha eziyinyumba kufanele zihlolwe i-bioburden yazo ngezikhathi ezithile. Amasampula okuqinisekisa kufanele ahambisane nombiko wokuhlolwa kwe-bioburden ovela kumkhiqizo owenziwe ngaphansi kwezimo ezijwayelekile zokukhiqiza. Lo msebenzi wenziwa ngumkhiqizi womkhiqizo.
Ingabe kufanele amasampula e-bioburden akhiqizwe endlini ehlanzekile?
Amasampula okuhlolwa kwe-Bioburden kufanele aqhamuke enqubweni evamile yokukhiqiza - inqubo efanayo ncamashi nemikhiqizo evamise ukuvalwa inzalo. Wonke amasampula asetshenziselwa ukuhlola kwangempela kufanele akhiqizwe ngenqubo efana nokukhiqizwa kokuvala inzalo okujwayelekile.
Umkhiqizo wami upakishwe ngepulasitiki (PE film). Ingabe ingenziwa inzalo nge-EO?
I-ISO 11135 ayikuvumeli ukuvala inzalo kwe-EO emikhiqizweni esephaketheni lezikhwama zepulasitiki futhi incoma izikhwama ze-dialysis zephepha-plastiki esikhundleni salokho. Kodwa-ke, amanye amazwe awanayo imithetho ecacile kulokhu, futhi empeleni, imikhiqizo epakishwe izikhwama zepulasitiki isafakwe inzalo ye-EO ngemingcele elungiselelwe ngokukhethekile. I-aeration inzima kakhulu ekufakweni kwezikhwama zepulasitiki, ngokuvamile kudinga izinsuku eziyishumi noma ngaphezulu. Sincoma ukusebenzisa izinto zokupakisha ezinekhono lokungenisa umoya.
Umkhiqizo wami awukwazi ukumelana nokushisa. Ingabe i-EO-sterilized?
Imingcele yethu yokuvala inzalo ngokuvamile isebenza ku-40–60°C. Sincoma ukuthi izinto zokwakha, ukupakishwa, nezisizi zokucubungula zimelane namazinga okushisa angaphezu kuka-60°C ukuze kugwenywe ukulimala komkhiqizo. Uma umkhiqizo unemikhawulo ekhethekile yokushisa, ukuvala inzalo kwezinga lokushisa eliphansi kufanele kuqinisekiswe ngokukhethekile.
Ngemuva kokufakwa inzalo kwe-EO, ezinye izindawo eziboshiwe ziye zaxega noma zikhubazekile (ukugoba, ukuphakamisa amakhona, njll.). Yini ebangela lokhu?
Ukuvalwa inzalo kwe-EO kudinga amazinga okushisa athile, ngokuvamile acishe abe ngu-54°C. Eminye imikhiqizo inokumelana nokushisa okungekuhle, futhi amazinga okushisa kuma-50s anganciphisa izakhiwo ezingokomzimba njengamandla ebhondi, okubangela lezi zenzakalo. Yingakho ukuqinisekiswa kokuvala inzalo komkhiqizo kubalulekile - ukuqinisekisa indlela efanelekile yokuvala inzalo kanye nemingcele lapho umkhiqizo uthola i-SAL edingekayo kuyilapho ulondoloza izici ezihlosiwe.
Ingabe ukuvala inzalo okujwayelekile kudinga ukuhlolwa kobunyumba komkhiqizo?
Akunjalo. Ngokwezinga le-ISO, ukuhlolwa kobunyumba komkhiqizo ngokuvamile akudingekile ukuze kukhishwe okuvamile. Inqobo nje uma ukuqinisekiswa kwenziwa nge-ISO 11135 ngayinye kanye nokuvalwa inzalo okujwayelekile kulandela izinga, ukukhululwa kwe-aseptic kuyamukeleka. Kodwa-ke, e-China, ukukhishwa komkhiqizo oyinyumba kufanele futhi kwenelise izinga lokubhaliswa komkhiqizo - izinga inkampani eyalisungula lapho ifaka isicelo sesitifiketi sayo sokubhaliswa ne-NMPA. Izinkampani eziningi, lapho zibhala izinga lazo lokubhalisa, zalandela indlela yakudala yokudinga ukuhlolwa kwe-batch-by-batch sterility. Njengoba inkampani ngokwayo ikucacisile, kufanele yenziwe.
Ingabe ukuvala inzalo okujwayelekile kudinga ukuhlolwa kwezinsalela ze-EO/ECH?
Akunjalo. Ngokwezinga le-ISO, ukuhlolwa kwensalela ye-EO/ECH okujwayelekile ngokuvamile akudingekile. Inqobo nje uma ukuqinisekiswa kokukhishwa kwezinsalela kwenziwa nge-ISO 10993-7 ngayinye kanye nokufaka umoya okuvamile kulandela izinga, kuyamukeleka. Kodwa-ke, e-China, ukukhishwa komkhiqizo oyinyumba kufanele futhi kwenelise izinga lokubhaliswa komkhiqizo. Izinkampani eziningi zicacise ukuhlolwa kwezinsalela ze-batch-by-batch ze-EO/ECH ezingeni labo lokubhalisa, ngakho kufanele kwenziwe.
Ngemva kokuqedwa kombiko wokuqinisekisa, ukuvala inzalo kungaqala ngokushesha kangakanani?
Uma umbiko wokuqinisekisa usuqediwe, ikhasimende kufanele liwugunyaze. Ukuvala inzalo kungaqala ngokushesha ngemva kokugunyazwa. Uma ukuvala inzalo kuphuthuma, imikhiqizo ingathunyelwa kuqala futhi ivalwe amagciwane, kodwa ayikwazi ukukhishwa kuze kube izinhlangothi zombili zivumelana ngemiphumela yokuqinisekisa futhi wonke amadokhumenti angemuva kokuvalwa inzalo ahlangabezana ngokugcwele nezimfuneko ezishiwo.
Ingabe umkhiqizo wami ungagcinwa isikhathi esingakanani ngemva kokuvalwa kwe-EO?
Ukwenziwa inzalo kwe-EO kuyinqubo yokubulala amagciwane. Uma imvelo ngemva kokuvala inzalo ihlala iyinyumba, umkhiqizo uhlala uyinyumba unomphela - inqobo nje uma imvelo ingashintshi. Eqinisweni, impilo yeshelufu eyinyumba yomkhiqizo ayihlobene kancane nenqubo ye-EO yokuvala inzalo ngokwayo. Ukugcina impilo eyinyumba kuncike ekufakweni kokuqala (okubizwa nangokuthi ukupakisha oyinyumba noma umgoqo oyinyumba). Izinto ze-Tyvek ngokuvamile zigcina ubunyumba isikhathi esingaphezu kweminyaka emi-5, kuyilapho iphepha elivamile le-dialysis lezokwelapha ligcina cishe iminyaka emi-2. Impilo yeshelufu yokupakishwa oyinyumba kufanele kuphikiswe - bheka i-ISO 11607 kanye ne-ASTM 1989. Qaphela ukuthi kokubili i-EO kanye nokuvalwa kwe-irradiation inselele kusistimu yokupakisha eyinyumba. Uma isistimu yokupakisha ingaqinile ngokwanele, ingalimala ngemva kokuvalwa inzalo, futhi umkhiqizo uzongcoliswa ngokushesha ngemva kokuvalwa inzalo.
After sterilization, my customer’s testing found the product non-sterile. Does this mean sterilization failed?
A non-sterile test result can have many causes: (1) false positive — a retest is usually needed to confirm; (2) weak pouch seal or poor microbial barrier of the material; (3) sterilization parameter deviation; (4) load pattern change; (5) packaging material change; (6) transportation damage compromising seal integrity; (7) bioburden deviation, such as unusually high counts with increased resistance; (8) product structure trapping microorganisms internally, while testing uses a cutting method — EO sterilization is a surface sterilization process.
Ngemva kokuvala inzalo, ilebula yokushintsha umbala (inkomba yamakhemikhali) ibonisa ukushintsha kombala okungalingani noma okungaphelele. Ingabe lokhu ukwehluleka kokuvala inzalo?
Ukushintsha kombala ongalingani kulebula yenkomba kunezimbangela eziningi futhi kuhluke ngokuphelele ekuhlulekeni kokuvala inzalo. Izinkomba zamakhemikhali zisabela ezimweni ezithile ezifana nezinga lokushisa, umswakama, nokugxila kwe-EO; ukushintsha kombala okungalingani ngokuvamile kubonisa ukusatshalaliswa okungalingani kwalezo zimo ngaphakathi komthwalo kunokuba yingozi enganele. Ukuhumusha okulungile kudinga ukubuyekeza amarekhodi omjikelezo ogcwele kanye nemiphumela yezinkomba zezinto eziphilayo.
Unemibuzo Eminye Nge-ETO Sterilization?
Ithimba lethu lonjiniyela lingakusiza ukuthi uhlole ukufaneleka komkhiqizo, izivumelwano zokuqinisekisa ukuklama, ukhethe izinto zokupakisha, futhi uhlele ukuhamba kwakho kokuvala inzalo. Xhumana nathi ukuze uxoxe ngezidingo zakho ezithile.
Xoxa ku-WhatsAppUmshwana wokuzihlangula: Lesi sihloko sifinyeza imibuzo evamile yokuvala inzalo ye-ETO ngezinjongo zemfundo. Ngaso sonke isikhathi ubhekisele ku-ISO 11135, ISO 10993-7, ISO 11607, kanye nezimfuneko zokulawula ezisebenzayo zokuqinisekisa okukhethekile kanye nokukhishwa kwezivumelwano.