I. Bayani
Gabaɗaya, yakamata a bincika na'urorin likitancin da aka haifuwa tare da ethylene oxide kuma a kimanta su don ragowar bayan haifuwa, saboda adadin ragowar yana da alaƙa da lafiyar waɗanda aka fallasa ga na'urar.Ethylene oxide ne na tsakiya m tsarin depressant.Idan an tuntube shi da fata, ja da kumburi suna faruwa da sauri, blister yana faruwa bayan ƴan sa'o'i kaɗan, kuma maimaita lamba na iya haifar da hankali.Fasa ruwa a cikin idanu na iya haifar da konewar corneal.A cikin yanayin tsawaitawa ga ƙananan adadin, ana iya ganin ciwon neurasthenia da cututtuka na ciyayi.An bayar da rahoton cewa m LD50 na baka a cikin berayen shine 330 mg/kg, kuma ethylene oxide na iya ƙara yawan raguwar ƙwayoyin chromosomes na kasusuwa a cikin mice [1].An ba da rahoton mafi girman adadin cutar sankara da mace-mace a cikin ma'aikatan da aka fallasa ga ethylene oxide.[2] 2-Chloroethanol zai iya haifar da erythema fata idan yana hulɗa da fata;ana iya shayar da shi har abada don haifar da guba.Ciwon baki na iya zama m.Bayyanar lokaci mai tsawo na iya haifar da lalacewa ga tsarin juyayi na tsakiya, tsarin zuciya da jijiyoyin jini da huhu.Sakamakon bincike na cikin gida da na waje akan ethylene glycol sun yarda cewa gubar nata ba ta da yawa.Tsarinsa na metabolism a cikin jiki daidai yake da na ethanol, ta hanyar metabolism na ethanol dehydrogenase da acetaldehyde dehydrogenase, manyan samfurori sune glycoxalic acid, oxalic acid da lactic acid, wanda ke da yawan guba.Saboda haka, adadin ma'auni suna da takamaiman buƙatu don ragowar bayan haifuwa ta hanyar ethylene oxide.Misali, GB/T 16886.7-2015 "Biological Evaluation of Medical Devices Part 7: Ethylene Oxide Sterilization Residues", YY0290.8-2008 "Ophthalmic Optics Artificial Lens Part 8: Basic Bukatun", da sauran ka'idoji suna da cikakkun buƙatu don ƙa'idodi. na ragowar ethylene oxide da 2-chloroethanol.GB/T 16886.7-2015 a fili ya bayyana cewa lokacin amfani da GB/T 16886.7-2015, an bayyana karara cewa lokacin da 2-chloroethanol ya kasance a cikin na'urorin kiwon lafiya da aka haifuwa ta hanyar ethylene oxide, iyakar abin da za a iya barin shi. Hakanan yana da iyaka a sarari.Sabili da haka, ya zama dole a cikakken nazari akan samar da ragowar gama gari (ethylene oxide, 2-chloroethanol, ethylene glycol) daga samarwa, sufuri da ajiyar ethylene oxide, samar da na'urorin likitanci, da tsarin haifuwa.
II.Binciken ragowar haifuwa
An raba tsarin samar da ethylene oxide zuwa hanyar chlorohydrin da hanyar oxidation.Daga cikin su, hanyar chlorohydrin ita ce hanyar samar da ethylene oxide na farko.Ya ƙunshi matakai guda biyu: mataki na farko: C2H4 + HClO - CH2Cl - CH2OH;mataki na biyu: CH2Cl – CH2OH + CaOH2 – C2H4O + CaCl2 + H2O.Tsarin amsawarsa Matsakaicin samfurin shine 2-chloroethanol (CH2Cl-CH2OH).Saboda fasaha na baya-bayan nan na hanyar chlorohydrin, mummunar gurɓataccen yanayi, tare da samfurin mummunan lalata na kayan aiki, yawancin masana'antun an kawar da su [4].Hanyar oxidation [3] an raba shi zuwa hanyoyin iska da oxygen.Dangane da tsaftar iskar oxygen daban-daban, samar da babban ya ƙunshi matakai guda biyu: mataki na farko: 2C2H4 + O2 - 2C2H4O;mataki na biyu: C2H4 + 3O2 – 2CO2 + H2O.A halin yanzu, samar da masana'antu na ethylene oxide A halin yanzu, samar da masana'antu na ethylene oxide galibi yana ɗaukar tsarin iskar oxygen na ethylene kai tsaye tare da azurfa a matsayin mai haɓakawa.Saboda haka, tsarin samar da ethylene oxide wani abu ne wanda ke ƙayyade ƙimar 2-chlorethanol bayan haifuwa.
Dangane da abubuwan da suka dace a cikin GB / T 16886.7-2015 misali don aiwatar da tabbatarwa da haɓaka tsarin haifuwa na ethylene oxide, bisa ga kaddarorin physicochemical na ethylene oxide, yawancin ragowar sun kasance a cikin asali na asali bayan haifuwa.Abubuwan da ke shafar adadin ragowar sun haɗa da adsorption na ethylene oxide ta na'urorin likitanci, kayan marufi da kauri, zafin jiki da zafi kafin da bayan haifuwa, lokacin aikin haifuwa da lokacin ƙuduri, yanayin ajiya, da dai sauransu, kuma abubuwan da ke sama suna ƙayyade gudun hijira. ikon ethylene oxide.An ba da rahoto a cikin wallafe-wallafen [5] cewa yawancin haifuwa na ethylene oxide yawanci ana zaba a matsayin 300-1000mg.L-1.Abubuwan da ke haifar da asarar ethylene oxide lokacin haifuwa sun haɗa da: adsorption na na'urorin likita, hydrolysis a ƙarƙashin wasu yanayin zafi, da sauransu.Matsakaicin 500-600mg.L-1 yana da ƙarancin tattalin arziki da tasiri, rage yawan amfani da ethylene oxide da ragowar akan abubuwan da aka haifuwa, adana farashin haifuwa.
Chlorine yana da aikace-aikace masu yawa a cikin masana'antar sinadarai, yawancin samfurori suna da alaƙa da mu.Ana iya amfani da shi azaman matsakaici, kamar vinyl chloride, ko azaman samfurin ƙarshe, kamar bleach.A lokaci guda kuma, sinadarin chlorine yana wanzuwa a cikin iska, ruwa da sauran muhallai, cutar da jikin ɗan adam ma a bayyane take.Sabili da haka, lokacin da na'urorin likitancin da suka dace suna haifuwa ta hanyar ethylene oxide, ya kamata a yi la'akari da cikakken bincike na samarwa, haifuwa, ajiya da sauran abubuwan samfurin, kuma yakamata a ɗauki matakan da aka yi niyya don sarrafa ragowar adadin 2-chloroethanol.
An ba da rahoto a cikin wallafe-wallafen [6] cewa abun ciki na 2-chloroethanol ya kai kusan 150 μg / yanki bayan sa'o'i 72 na ƙudurin facin taimakon bandeji wanda aka lalata ta hanyar ethylene oxide, kuma dangane da na'urorin tuntuɓar ɗan gajeren lokaci da aka ƙayyade. a cikin ma'auni na GB/T16886.7-2015, matsakaicin adadin yau da kullun na 2-chloroethanol ga mai haƙuri bai kamata ya zama fiye da 9 MG ba, kuma ragowar adadinsa yana da ƙasa da ƙimar iyaka a cikin ma'auni.
Wani bincike [7] ya auna ragowar ethylene oxide da 2-chloroethanol a cikin nau'ikan zaren suture guda uku, kuma sakamakon ethylene oxide ba a iya gano shi ba kuma 2-chloroethanol ya kasance 53.7 µg.g-1 don zaren suture tare da zaren nailan. .YY 0167-2005 yana ƙayyadad da iyakacin ganowa don ethylene oxide don suturar tiyata mara amfani, kuma babu wani sharadi na 2-chloroethanol.Sutures suna da damar samun ruwa mai yawa na masana'antu a cikin tsarin samarwa.Rukunin nau'ikan nau'ikan ruwa guda huɗu na ingancin ruwan mu na ƙasa suna amfani da yankin kariyar masana'antu na gabaɗaya kuma jikin ɗan adam ba kai tsaye hulɗa da yankin ruwa ba, gabaɗaya ana bi da su tare da bleach, na iya sarrafa algae da ƙananan ƙwayoyin cuta a cikin ruwa, ana amfani da su don hana haifuwa da rigakafin cutar sankara. .Babban abin da ke aiki da shi shine calcium hypochlorite, wanda ake samarwa ta hanyar wucewar iskar chlorine ta cikin dutsen farar ƙasa.Calcium hypochlorite yana sauƙaƙa ƙasƙanci a cikin iska, babban tsarin amsawa shine: Ca (ClO) 2+ CO2+H2O-CaCO3+2HClO.Ana samun sauƙin bazuwar hypochlorite zuwa hydrochloric acid da ruwa ƙarƙashin haske, babban tsarin amsawa shine: 2HClO+light—2HCl+O2.2HCl + O2.Chlorine korau ions ana sauƙaƙe a cikin sutures, kuma a ƙarƙashin wasu yanayi marasa ƙarfi na acidic ko alkaline, ethylene oxide yana buɗe zobe tare da shi don samar da 2-chloroethanol.
An ba da rahoto a cikin wallafe-wallafen [8] cewa ragowar 2-chloroethanol akan samfuran IOL an fitar da su ta hanyar cirewar ultrasonic tare da acetone kuma an ƙaddara ta gas chromatography-mass spectrometry, amma ba a gano shi ba.YY0290.8-2008 "Ophthalmic Optics Artificial Lens Sashe na 8: Abubuwan Bukatu na asali" ya bayyana cewa ragowar adadin 2-chloroethanol akan IOL bai kamata ya wuce 2.0µg kowace rana a kowane ruwan tabarau ba, kuma jimlar kowane ruwan tabarau kada ya wuce 5.0 GB/T16886. Ƙididdigar 7-2015 ya ambaci cewa ƙwayar ido da ke haifar da ragowar 2-chloroethanol ya ninka sau 4 fiye da wanda ya haifar da wannan matakin na ethylene oxide.
A taƙaice, lokacin da ake kimanta ragowar na'urorin likitanci bayan haifuwa ta hanyar ethylene oxide, ethylene oxide da 2-chloroethanol yakamata a mai da hankali akai, amma ragowar su kuma yakamata a bincika gabaɗaya bisa ga ainihin halin da ake ciki.
A lokacin haifuwa na na'urorin likitanci, wasu daga cikin albarkatun na'urorin likitanci masu amfani guda ɗaya ko kayan marufi sun haɗa da polyvinyl chloride (PVC), da ƙaramin adadin vinyl chloride monomer (VCM) kuma za a samar da shi ta hanyar bazuwar guduro na PVC. yayin sarrafawa.GB10010-2009 bututun PVC masu laushi na likita sun nuna cewa abun ciki na VCM ba zai iya wuce 1µg.g-1 ba.VCM a sauƙaƙe ana yin polymerized ƙarƙashin aikin masu kara kuzari (peroxides, da sauransu) ko haske da zafi don samar da guduro na polyvinyl chloride, tare da aka sani da resin vinyl chloride.Vinyl chloride yana da sauƙi polymerized a ƙarƙashin aikin mai kara kuzari (peroxide, da dai sauransu) ko haske da zafi don samar da polyvinyl chloride, wanda aka fi sani da resin vinyl chloride.Lokacin da polyvinyl chloride yayi zafi sama da 100 ° C ko kuma ya fallasa shi zuwa hasken ultraviolet, akwai yuwuwar iskar hydrogen chloride zai iya tserewa.Sannan hadewar iskar hydrogen chloride da ethylene oxide a cikin kunshin zai samar da wani adadin 2-chlorethanol.
Ethylene glycol, barga a cikin yanayi, ba maras tabbas ba.Atom ɗin oxygen a cikin ethylene oxide yana ɗaukar nau'i-nau'i guda biyu na electrons kuma yana da karfi mai karfi, wanda ya sa ya fi sauƙi don samar da ethylene glycol lokacin da yake tare da ions chloride mara kyau.Misali: C2H4O + NaCl + H2O – CH2Cl – CH2OH + NaOH.Wannan tsari yana da rauni na asali a ƙarshen amsawa kuma yana da ƙarfi sosai a ƙarshen haɓakawa, kuma abin da ya faru na wannan dauki yayi ƙasa.Babban abin da ya fi girma shine samuwar ethylene glycol daga ethylene oxide a cikin hulɗa da ruwa: C2H4O + H2O - CH2OH - CH2OH, kuma hydration na ethylene oxide yana hana haɗin kai ga ions chlorine kyauta.
Idan chlorine korau ions aka gabatar a cikin samarwa, haifuwa, ajiya, sufuri da kuma amfani da na'urorin kiwon lafiya, akwai yiwuwar ethylene oxide zai amsa tare da su don samar da 2-chloroethanol.Tun lokacin da aka kawar da hanyar chlorohydrin daga tsarin samarwa, samfurinsa na tsaka-tsaki, 2-chloroethanol, ba zai faru a cikin hanyar oxidation kai tsaye ba.A cikin samar da na'urorin likitanci, wasu albarkatun ƙasa suna da ƙaƙƙarfan kaddarorin adsorption don ethylene oxide da 2-chloroethanol, don haka dole ne a yi la'akari da sarrafa ragowar adadin su yayin nazarin su bayan haifuwa.Bugu da ƙari, a lokacin samar da na'urorin kiwon lafiya, albarkatun kasa, additives, masu hana amsawa, da dai sauransu sun ƙunshi salts inorganic a cikin nau'i na chlorides, kuma lokacin da aka haifuwa, yiwuwar ethylene oxide ya buɗe zobe a ƙarƙashin yanayin acidic ko alkaline, yana jurewa SN2. dauki, da kuma hadawa da free chlorine korau ions don samar da 2-chloroethanol dole ne a yi la'akari.
A halin yanzu, hanyar da aka saba amfani da ita don gano ethylene oxide, 2-chloroethanol da ethylene glycol ita ce hanyar lokaci na iskar gas.Hakanan za'a iya gano Ethylene oxide ta hanyar launi ta hanyar amfani da maganin gwajin gwajin sulfite ja, amma rashin amfanin sa shine cewa ingantaccen sakamakon gwajin yana shafar ƙarin abubuwa a cikin yanayin gwaji, kamar tabbatar da yawan zafin jiki na 37 ° C a cikin yanayin gwaji don sarrafa tasirin ethylene glycol, da lokacin sanya maganin da za a gwada bayan tsarin haɓaka launi.Don haka, tabbatar da ingantacciyar hanya (gami da daidaito, daidaito, layi, hankali, da sauransu) a cikin ƙwararrun dakin gwaje-gwaje yana da mahimmanci ga gano ƙididdiga na ragowar.
III.Tunani akan tsarin bita
Ethylene oxide, 2-chloroethanol da ethylene glycol sune abubuwan da suka faru na yau da kullun bayan haifuwar ethylene oxide na na'urorin likita.Don aiwatar da ragowar kimantawa, ƙaddamar da abubuwan da suka dace a cikin samarwa da adana ethylene oxide, samarwa da haifuwa na na'urorin likitanci yakamata a yi la'akari da su.
Akwai wasu batutuwa guda biyu da ya kamata a mai da hankali a kansu a cikin ainihin aikin sake duba na'urar likita: 1. Ko yana da mahimmanci don aiwatar da gwajin ragowar 2-chloroethanol.A cikin samar da ethylene oxide, idan aka yi amfani da chlorohydrin na gargajiya hanya, ko da yake tsarkakewa, tacewa da sauran hanyoyin da za a dauka a cikin tsarin samar, ethylene oxide gas har yanzu zai ƙunshi matsakaici samfurin 2-chloroethanol zuwa wani m adadin, da ragowar adadin. yakamata a tantance.Idan an yi amfani da hanyar hadawan abu da iskar shaka, babu gabatarwar 2-chloroethanol, amma ragowar adadin masu hanawa, masu haɓakawa, da dai sauransu a cikin tsarin amsawar ethylene oxide ya kamata a yi la'akari.Na'urorin likitanci suna amfani da ruwa mai yawa na masana'antu a cikin tsarin samarwa, kuma ana sanya wasu adadin hypochlorite da chlorine korau ions a cikin samfuran da aka gama, waɗanda sune dalilan yuwuwar kasancewar 2-chloroethanol a cikin ragowar.Akwai kuma lokuta da cewa albarkatun kasa da marufi na likita na'urorin ne inorganic salts dauke da elemental chlorine ko polymer kayan tare da barga tsarin da kuma ba sauki karya bond, da dai sauransu. Saboda haka, wajibi ne a comprehensively bincika ko hadarin 2-chloroethanol. Dole ne a gwada ragowar don kimantawa, kuma idan akwai isassun shaidun da za su nuna cewa ba za a shigar da shi a cikin 2-chloroethanol ba ko kuma ƙasa da iyakar gano hanyar ganowa, za a iya yin watsi da gwajin don sarrafa haɗarinsa.2. Don ethylene glycol Analytical kimantawa na ragowar.Idan aka kwatanta da ethylene oxide da 2-chloroethanol, da lamba toxicity na ethylene glycol residues ne m, amma saboda ethylene oxide samar da kuma amfani da shi za a fallasa zuwa carbon dioxide da ruwa, da ethylene oxide da ruwa suna da wuya ga samar da ethylene glycol, da kuma abun ciki na ethylene glycol bayan haifuwa yana da alaƙa da tsabtar ethylene oxide, kuma yana da alaƙa da marufi, danshi a cikin ƙwayoyin cuta, da yanayin zafi da yanayin zafi na haifuwa, sabili da haka, yakamata a yi la'akari da ethylene glycol daidai da ainihin yanayin. .Kimantawa.
Ma'auni ɗaya ne daga cikin kayan aiki don nazarin fasaha na na'urorin kiwon lafiya, nazarin fasaha na na'urorin kiwon lafiya ya kamata ya mayar da hankali kan mahimman buƙatun aminci da tasiri na ƙirar samfuri da haɓakawa, samarwa, ajiya, amfani da sauran abubuwan da ke tattare da cikakken bincike na abubuwan da ke tasiri. aminci da tasiri na ka'idar da aiki, bisa ga kimiyya, bisa ga gaskiya, maimakon yin la'akari da kai tsaye ga ma'auni, ya rabu da ainihin halin da ake ciki na samfurin samfurin, bincike da ci gaba, samarwa da amfani.Aikin bita ya kamata ya ba da hankali sosai ga tsarin samar da kayan aikin likita don sarrafa hanyoyin haɗin gwiwar da suka dace, a lokaci guda bita kan shafin ya kamata kuma ya kasance "matsala" daidaitacce, ba da cikakken wasa ga rawar "idon" zuwa. inganta ingancin bita, manufar nazarin kimiyya.
Tushen: Cibiyar Nazarin Fasaha na Na'urorin Lafiya, Gudanar da Magunguna na Jiha (SDA)
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