I. Kaula
Ma keʻano laulā, pono e nānā ʻia a loiloi ʻia nā mea lapaʻau i hoʻomaʻemaʻe ʻia me ka ethylene oxide no nā koena post-sterilization, no ka mea, pili loa ka nui o ke koena i ke olakino o ka poʻe i ʻike ʻia i ka mea lapaʻau.ʻO ka Ethylene oxide kahi mea hoʻohaʻahaʻa i ka ʻōnaehana nerve waena.Inā pili me ka ʻili, hiki wawe ka ʻulaʻula a me ka pehu ʻana, hiki mai ka pehu ma hope o kekahi mau hola, a hiki i ka hoʻopili pinepine ʻana ke hoʻoulu i ka sensitization.ʻO ka pīpī ʻana i ka wai i loko o nā maka hiki ke hoʻomake i ka ʻāʻī.I ka loaʻa ʻana o ka liʻiliʻi liʻiliʻi, hiki ke ʻike ʻia ka maʻi neurasthenia a me nā maʻi nerve vegetative.Ua hōʻike ʻia he 330 mg/Kg ka LD50 waha waha ma nā ʻiole, a hiki i ka ethylene oxide ke hoʻonui i ka nui o nā aberrations o nā chromosomes iwi ma nā ʻiole [1].Ua hōʻike ʻia nā helu kiʻekiʻe o ka carcinogenicity a me ka make i nā limahana i ʻike ʻia i ka ethylene oxide.[2] 2-Hiki i ka Chloroethanol ke hoʻoulu i ka erythema o ka ʻili inā pili me ka ʻili;hiki ke hoʻomoʻa ʻia i ke kino e hoʻomake ai.Hiki ke make ma ka waha.Hiki ke hoʻopōʻino i ka ʻōnaehana nerve waena, ka ʻōnaehana cardiovascular a me nā māmā.Ua ʻae nā hopena noiʻi kūloko a me nā ʻāina ʻē e pili ana i ka ethylene glycol he haʻahaʻa kona ʻona ponoʻī.ʻO kāna kaʻina hana metabolism i loko o ke kino e like me ka ethanol, ma o ka metabolism o ka ethanol dehydrogenase a me ka acetaldehyde dehydrogenase, nā huahana nui he glyoxalic acid, oxalic acid a me ka lactic acid, ʻoi aku ka nui o ka toxicity.No laila, loaʻa i kekahi mau maʻamau nā koi kikoʻī no nā koena ma hope o ka sterilization e ka ethylene oxide.No ka laʻana, 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: Nā Pono Pono", a me nā kūlana ʻē aʻe nā koi kikoʻī no nā palena. ʻO nā koena o ka ethylene oxide a me 2-chloroethanol.GB/T 16886.7-2015 e ʻōlelo maopopo ana i ka wā e hoʻohana ai i ka GB/T 16886.7-2015, ua ʻōlelo maopopo ʻia i ka wā e loaʻa ai ka 2-chloroethanol i nā mea lapaʻau i sterilized e ka ethylene oxide, ʻo kona koena ʻae ʻia. ua maopopo ka palena.No laila, pono e hoʻopili piha i ka hana ʻana o nā koena maʻamau (ethylene oxide, 2-chloroethanol, ethylene glycol) mai ka hana ʻana, ka lawe ʻana a me ka mālama ʻana i ka ethylene oxide, ka hana ʻana o nā mea lapaʻau, a me ke kaʻina hana sterilization.
II.Ka nānā 'ana i nā koena sterilization
Hoʻokaʻawale ʻia ke kaʻina hana o ka ethylene oxide i ke ʻano chlorohydrin a me ke ʻano oxidation.I waena o lākou, ʻo ke ʻano chlorohydrin ke ʻano hana mua o ka ethylene oxide.Loaʻa ka nui o nā kaʻina hana ʻelua: ka hana mua: C2H4 + HClO – CH2Cl – CH2OH;ka ʻanuʻu ʻelua: CH2Cl – CH2OH + CaOH2 – C2H4O + CaCl2 + H2O.kona kaʻina hana ʻana ʻO ka huahana waena he 2-chloroethanol (CH2Cl-CH2OH).Ma muli o ka ʻenehana hope o ke ʻano chlorohydrin, ka haumia koʻikoʻi o ke kaiapuni, i hui pū ʻia me ka huahana o ka corrosion koʻikoʻi o nā mea hana, ua hoʻopau ʻia ka hapa nui o nā mea hana [4].Hoʻokaʻawale ʻia ke ʻano oxidation [3] i nā ʻano ea a me ka oxygen.Wahi a ka maʻemaʻe like ʻole o ka oxygen, ʻo ka hana ʻana o ka mea nui he ʻelua kaʻina hana: ka hana mua: 2C2H4 + O2 - 2C2H4O;ʻo ka lua o ka ʻanuʻu: C2H4 + 3O2 – 2CO2 + H2O.i kēia manawa, ka hana ʻenehana o ka ethylene oxide I kēia manawa, ʻo ka hana ʻoihana o ka ethylene oxide ka mea nui e hoʻohana i ka ethylene direct oxidation kaʻina me ke kālā e like me ka catalyst.No laila, ʻo ke kaʻina hana o ka ethylene oxide kahi mea e hoʻoholo ai i ka loiloi o 2-chloroethanol ma hope o ka sterilization.
E pili ana i nā mea kūpono i loko o ka maʻamau GB / T 16886.7-2015 e hoʻokō i ka hōʻoia a me ka hoʻomohala ʻana i ke kaʻina hana sterilization ethylene oxide, e like me nā waiwai physicochemical o ka ethylene oxide, ʻo ka hapa nui o nā koena i loko o ke ʻano kumu ma hope o ka sterilization.ʻO nā mea e pili ana i ka nui o ke koena ka nui o ka adsorption o ka ethylene oxide e nā lāʻau lapaʻau, nā mea hoʻopihapiha a me ka mānoanoa, ka mahana a me ka haʻahaʻa ma mua a ma hope o ka sterilization, ka manawa hana sterilization a me ka manawa hoʻonā, nā kūlana mālama, a me nā mea i luna e hoʻoholo ai i ka pakele. hiki i ka ethylene oxide.Ua hōʻike ʻia ma ka palapala [5] e koho maʻamau ʻia ka ʻike o ka ethylene oxide sterilization e like me 300-1000mg.L-1.ʻO nā kumu nalowale o ka ethylene oxide i ka wā sterilization ka mea nui: adsorption o nā mea lapaʻau, hydrolysis ma lalo o kekahi mau kūlana haʻahaʻa, a pēlā aku.ʻO ka manaʻo o ka 500-600mg.L-1 he mea waiwai a maikaʻi hoʻi, e hoʻemi ana i ka hoʻohanaʻana i ka ethylene oxide a me ke koena o nā mea i hoʻopiliʻia, e mālama i ke kumukūʻai sterilization.
He nui nā noi o Chlorine i ka ʻoihana kemika, nui nā huahana pili pili iā mākou.Hiki ke hoʻohana ʻia ma ke ʻano he waena, e like me ka vinyl chloride, a i ʻole ka hopena hopena, e like me ka bleach.I ka manawa like, aia ka chlorine i ka lewa, ka wai a me nā wahi ʻē aʻe, ʻike ʻia ka pōʻino i ke kino kanaka.No laila, i ka wā e hoʻomaʻamaʻa ʻia ai nā lāʻau lapaʻau e pili ana i ka ethylene oxide, pono e noʻonoʻo ʻia kahi loiloi piha o ka hana ʻana, sterilization, mālama a me nā mea ʻē aʻe o ka huahana, a pono e lawe ʻia nā hana i manaʻo ʻia e kāohi i ke koena o 2-chloroethanol.
Ua hōʻike ʻia ma ka palapala [6] ua hiki ka ʻike o 2-chloroethanol ma kahi o 150 µg/ʻāpana ma hope o 72 mau hola o ka hoʻonā ʻana o kahi pā-aid patch i hoʻopaʻa ʻia e ka ethylene oxide, a me ka pili ʻana i nā mea pili i ka wā pōkole i kuhikuhi ʻia. ma ke kūlana o GB / T16886.7-2015, ka awelika o kēlā me kēia lā o ka 2-chloroethanol i ka mea maʻi ʻaʻole pono e ʻoi aku ma mua o 9 mg, a ʻoi aku ka haʻahaʻa o kona koena ma mua o ka palena o ka waiwai.
Ua ana kekahi haʻawina [7] i nā koena o ka ethylene oxide a me 2-chloroethanol i ʻekolu ʻano o nā loina humuhumu, a ʻaʻole hiki ke ʻike ʻia nā hopena o ka ethylene oxide a ʻo 2-chloroethanol he 53.7 µg.g-1 no ke kaula humuhumu me ke kaula nylon. .ʻO YY 0167-2005 ka palena o ka ʻike ʻana no ka ethylene oxide no nā ʻokiʻoki hiki ʻole ke hoʻopili ʻia, a ʻaʻohe ʻōlelo no ka 2-chloroethanol.Hiki i nā sutures ka nui o ka wai ʻoihana i ka hana hana.ʻO nā ʻano ʻehā o ka maikaʻi o ka wai o kā mākou wai lepo e pili ana i ka wahi palekana o ka ʻoihana a me ke kino o ke kanaka i pili ʻole me ka wai, mālama ʻia me ka bleach, hiki ke hoʻomalu i nā algae a me nā microorganism i ka wai, hoʻohana ʻia no ka sterilization a me ka pale ʻana i ka maʻi maʻi maʻi. .ʻO kāna mea hana nui ʻo ka calcium hypochlorite, ka mea i hana ʻia ma ke kahe ʻana i ke kinoea chlorine ma o ka limestone.Hiki ke hoʻohaʻahaʻa ʻia ka calcium hypochlorite i ka lewa, ʻo ke kumu hoʻohālikelike nui: Ca(ClO)2+CO2+H2O–CaCO3+2HClO.ʻO ka hypochlorite hiki ke hoʻoheheʻe ʻia i loko o ka waika hydrochloric a me ka wai ma lalo o ke kukui, ʻo ke kumu hoʻohālikelike nui: 2HClO+light—2HCl+O2.2HCl+O2. Hiki ke hoʻopili maʻalahi ʻia nā ʻona ʻino ʻole o ka chlorine i nā sutures, a ma lalo o kekahi mau kaiapuni nāwaliwali a alkaline, wehe ka ethylene oxide i ke apo me ia e hana ai i 2-chloroethanol.
Ua hōʻike 'ia i loko o ka palapala [8] i ke koena 2-chloroethanol ma IOL laʻana ua extracted e kani ultrasonic unuhi me ka acetone a hoʻoholo 'ia e ke kinoea chromatography-mass spectrometry, akā, 'aʻole i ike.YY0290.8-2008 "Ophthalmic Optics Artificial Lens Part 8: Nā Koina Kuleana" ʻōlelo ʻo ka nui o ke koena o 2-chloroethanol ma ka IOL ʻaʻole pono e ʻoi aku ma mua o 2.0µg i kēlā me kēia lā no kēlā me kēia lens, a ʻaʻole pono e ʻoi aku ka nui o kēlā me kēia lens ma mua o 5.0 The GB/T16886. Ua ʻōlelo ʻo 7-2015 maʻamau ʻo ka ʻona ocular i hoʻokumu ʻia e ke koena 2-chloroethanol he 4 mau manawa kiʻekiʻe ma mua o ka mea i hoʻokumu ʻia e ka pae like o ka ethylene oxide.
I ka hōʻuluʻulu ʻana, i ka loiloi ʻana i nā koena o nā lāʻau lapaʻau ma hope o ka sterilization e ka ethylene oxide, ethylene oxide a me 2-chloroethanol e nānā pono ʻia, akā pono e nānā ʻia ko lākou mau koena e like me ke kūlana maoli.
I ka wā o ka sterilization o nā lāʻau lapaʻau, ʻo kekahi o nā mea maka no nā lāʻau lapaʻau hoʻohana hoʻokahi a i ʻole nā mea hoʻopihapiha e loaʻa ai ka polyvinyl chloride (PVC), a me kahi mea liʻiliʻi loa o ka vinyl chloride monomer (VCM) e hana pū ʻia e ka decomposition o PVC resin. i ka wā e hana ai.GB10010-2009 ʻo nā paipu PVC palupalu olakino ʻaʻole hiki ke ʻoi aku ka nui o ka VCM ma mua o 1µg.g-1.Hoʻopili maʻalahi ʻia ʻo VCM ma lalo o ka hana a nā catalysts (peroxides, etc.) a i ʻole māmā a me ka wela e hana ai i ka resin polyvinyl chloride, i hui pū ʻia ʻo vinyl chloride resin.Hoʻopili maʻalahi ʻia ka Vinyl chloride ma lalo o ka hana o ka catalyst (peroxide, etc.) a i ʻole ka māmā a me ka wela e hana ai i ka polyvinyl chloride, i kapa ʻia ʻo vinyl chloride resin.Ke hoʻomehana ʻia ka polyvinyl chloride ma luna o 100°C a i ʻole i ʻike ʻia i ka radiation ultraviolet, aia kahi hiki ke pakele ke kinoea hydrogen chloride.A laila ʻo ka hui pū ʻana o ke kinoea hydrogen chloride a me ka ethylene oxide i loko o ka pūʻolo e hoʻohua i kahi nui o 2-chloroethanol.
ʻO ka Ethylene glycol, paʻa i ke ʻano, ʻaʻole hiki ke hoʻololi.ʻO ka ʻātoma oxygen i loko o ka ethylene oxide e lawe i ʻelua mau paʻa electrons a he hydrophilicity ikaika, kahi e maʻalahi ai ka hana ʻana i ka ethylene glycol ke noho pū me nā ion chloride maikaʻi ʻole.No ka laʻana: C2H4O + NaCl + H2O – CH2Cl – CH2OH + NaOH.He haʻahaʻa loa kēia kaʻina hana ma ka hopena reactive a me ke kumu ikaika ma ka hopena generative, a he haʻahaʻa ka hopena o kēia pane.ʻO ka hopena kiʻekiʻe ka hana ʻana o ka ethylene glycol mai ka ethylene oxide e pili ana me ka wai: C2H4O + H2O - CH2OH - CH2OH, a ʻo ka hydration o ka ethylene oxide e pale ai i kona hoʻopaʻa ʻana i nā ion ʻino chlorine manuahi.
Inā hoʻokomo ʻia nā ion chlorine maikaʻi ʻole i ka hana ʻana, sterilization, mālama ʻana, ka lawe ʻana a me ka hoʻohana ʻana i nā mea lapaʻau, aia ka mea hiki ke hana ʻia ka ethylene oxide me lākou e hana i ka 2-chloroethanol.Ma muli o ka hoʻopau ʻia ʻana o ke ʻano chlorohydrin mai ke kaʻina hana, ʻaʻole e loaʻa kāna huahana waena, 2-chloroethanol, i ke ʻano o ka oxidation pololei.I ka hana ʻana i nā lāʻau lapaʻau, loaʻa i kekahi mau mea maka nā waiwai adsorption ikaika no ka ethylene oxide a me 2-chloroethanol, no laila pono e noʻonoʻo ʻia ka mana o kā lākou mau koena i ka wā e nānā ai iā lākou ma hope o ka sterilization.Eia kekahi, i ka wā o ka hana ʻana i nā lāʻau lapaʻau, nā mea maka, nā mea hoʻohui, nā mea hoʻopiʻi hopena, a me nā mea ʻē aʻe i loko o nā paʻakai inorganic i ke ʻano o nā chlorides, a i ka wā sterilized, hiki i ka ethylene oxide ke wehe i ke apo ma lalo o nā kūlana acidic a alkaline paha, e loaʻa i ka SN2. pono e noʻonoʻo ʻia ka hopena, a me ka hui pū ʻana me ka chlorine manuahi e hoʻohua ai i ka 2-chloroethanol.
I kēia manawa, ʻo ke ʻano hana maʻamau no ka ʻike ʻana i ka ethylene oxide, 2-chloroethanol a me ka ethylene glycol ʻo ia ke ʻano hana kinoea.Hiki ke ʻike ʻia ka Ethylene oxide e ke ʻano colorimetric me ka hoʻohana ʻana i ka solution test sulfite ʻulaʻula ʻulaʻula, akā ʻo kona hemahema ʻo ia ka hopena o ka ʻoiaʻiʻo o nā hopena hōʻike e nā mea hou aʻe i nā kūlana hoʻokolohua, e like me ka hōʻoia ʻana i ka mahana mau o 37°C i ka kaiapuni hoʻokolohua e hoʻomalu i ka hopena o ka ethylene glycol, a me ka manawa o ka waiho ʻana i ka hopena e hoʻāʻo ʻia ma hope o ke kaʻina hoʻomohala kala.No laila, ʻo ka hoʻopaʻa ʻana i ke ʻano hana (me ka pololei, ka pololei, ka linearity, sensitivity, etc.) i loko o kahi keʻena hana kūpono he mea nui ia no ka ʻike nui o nā koena.
III.Nā noʻonoʻo e pili ana i ke kaʻina loiloi
ʻO ka Ethylene oxide, 2-chloroethanol a me ka ethylene glycol nā koena maʻamau ma hope o ka sterilization o ka ethylene oxide o nā mea lapaʻau.No ka hoʻokō ʻana i ke koena loiloi, pono e noʻonoʻo ʻia ka hoʻokomo ʻana o nā mea pili i ka hana ʻana a me ka mālama ʻana i ka ethylene oxide, ka hana ʻana a me ka sterilization o nā mea lapaʻau.
ʻElua mau pilikia ʻē aʻe e pono ke kālele ʻia ma ka hana loiloi mea lapaʻau maoli: 1. Inā pono e hoʻokō i ka hoʻāʻo ʻana i nā koena o 2-chloroethanol.I ka hana ʻana o ka ethylene oxide, inā hoʻohana ʻia ke ʻano chlorohydrin kuʻuna, ʻoiai e hoʻohana ʻia ka hoʻomaʻemaʻe, kānana a me nā ʻano hana ʻē aʻe i ke kaʻina hana, e loaʻa mau ke kinoea ethylene oxide i ka huahana waena 2-chloroethanol i kekahi ʻano, a me kona koena nui. pono e loiloi.Inā hoʻohana ʻia ke ʻano o ka oxidation, ʻaʻohe hoʻokomo o 2-chloroethanol, akā pono e noʻonoʻo ʻia ke koena o nā mea hoʻopiʻi kūpono, catalysts, etc.Hoʻohana nā lāʻau lapaʻau i ka nui o ka wai ʻenehana i ke kaʻina hana, a ua hoʻopili ʻia kekahi nui o ka hypochlorite a me ka chlorine ion i loko o ka huahana i hoʻopau ʻia, ʻo ia ke kumu o ka hiki ʻana o 2-chloroethanol i ke koena.Aia kekahi mau hihia ʻo nā mea maka a me ka hoʻopili ʻana o nā lāʻau lapaʻau he paʻakai inorganic i loaʻa nā elemental chlorine a i ʻole nā mea polymer me ka paʻa paʻa a ʻaʻole maʻalahi e wāwahi i ka paʻa, a me nā mea ʻē aʻe. Pono e ho'āʻoʻia ke koena no ka loiloiʻana, a inā he lawa nā hōʻike e hōʻike aiʻaʻole e hoʻokomoʻia i loko o ka 2-chloroethanol a iʻole ka haʻahaʻa ma mua o ka palenaʻike o keʻanoʻike, hiki ke mālamaʻoleʻia ka ho'āʻo no ka mālamaʻana i ka pilikia o ia.2. No ka ethylene glycol Analytical loiloi o nā koena.Ke hoʻohālikelike ʻia me ka ethylene oxide a me ka 2-chloroethanol, ʻoi aku ka haʻahaʻa o ka hoʻopili ʻana o nā koena o ka ethylene glycol, akā no ka mea e ʻike pū ʻia ka hana ʻana a me ka hoʻohana ʻana i ka ethylene oxide i ke kalapona a me ka wai, a ʻo ka ethylene oxide a me ka wai e hiki ke hana i ka ethylene glycol, a me ka ʻO ka maʻiʻo o ka ethylene glycol ma hope o ka sterilization e pili ana i ka maʻemaʻe o ka ethylene oxide, a pili pū hoʻi i ka ʻeke, ka wai i nā microorganisms, a me ka mahana a me ka haʻahaʻa o ka sterilization, no laila, pono e noʻonoʻo ʻia ka ethylene glycol e like me nā kūlana maoli. .Loiloi.
ʻO nā maʻamau kekahi o nā mea hana no ka loiloi ʻenehana o nā mea lapaʻau, ʻo ka loiloi ʻenehana o nā mea lapaʻau pono e kau pono i nā koi kumu o ka palekana a me ka pono o ka hoʻolālā huahana a me ka hoʻomohala ʻana, ka hana ʻana, ka mālama ʻana, ka hoʻohana ʻana a me nā ʻano ʻē aʻe o ka loiloi piha o nā mea e pili ana. ka palekana a me ka pono o ka manaʻo a me ka hana, e pili ana i ka ʻepekema, e pili ana i nā ʻoiaʻiʻo, ma mua o ka kuhikuhi pololei ʻana i ka maʻamau, wehe ʻia mai ke kūlana maoli o ka hoʻolālā huahana, noiʻi a me ka hoʻomohala ʻana, hana a hoʻohana.Pono ka nānā ʻana i ka hana loiloi i ka ʻōnaehana ʻoi aku ka maikaʻi o nā mea lapaʻau no ka mālama ʻana i nā loulou pili, i ka manawa like ʻo ka loiloi ma ka pūnaewele pono e "pilikia", e hāʻawi i ka pāʻani piha i ke kuleana o nā "maka" i hoʻomaikaʻi i ka maikaʻi o ka loiloi, ke kumu o ka loiloi ʻepekema.
Puna: Center for Technical Review of Medical Devices, State Drug Administration (SDA)
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Ka manawa hoʻouna: Sep-21-2023