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Nyocha nke isi mmalite nke ethylene oxide sterilization resides na ngwaọrụ ahụike

I. ndabere
N'ozuzu, a ga-enyocha ngwaọrụ ahụike na ethylene oxide na-enyocha ma nyochaa maka ihe fọdụrụ na post-sterilization, n'ihi na ọnụ ọgụgụ nke fọdụrụnụ nwere njikọ chiri anya na ahụike nke ndị ekpughere na ngwaọrụ ahụike.Ethylene oxide bụ ihe na-akpata nkụda mmụọ nke sistemu ụjọ.Ọ bụrụ na akpọtụrụ ya na akpụkpọ ahụ, acha ọbara ọbara na ọzịza na-apụta ngwa ngwa, ọnya na-apụta mgbe awa ole na ole gachara, na kọntaktị ugboro ugboro nwere ike ibute nghọta.Ịgbasa mmiri mmiri n'ime anya nwere ike ime ka ọkpụkpụ anụ ọkụ.N'ihe banyere ikpughe ogologo oge na obere ego, a na-ahụ ọrịa neurasthenia na ọrịa akwara vegetative.A kọwo na nnukwu ọnụ LD50 dị n'ime oke bụ 330 mg/kg, na ethylene oxide nwere ike ime ka ọnụọgụ nke chromosomes ụmị ọkpụkpụ dịkwuo elu na ụmụ oke [1].A kọwo ọnụ ọgụgụ dị elu nke ọrịa carcinogenicity na ọnwụ na ndị ọrụ kpughere ethylene oxide.[2] 2-Chloroethanol nwere ike ime ka anụ ahụ erythema ma ọ bụrụ na ọ na-emetụta akpụkpọ ahụ;enwere ike itinye ya na percutaneously ka ọ bute nsị.Iri ọnụ nwere ike igbu mmadụ.Mkpughe ogologo oge na-adịghị ala ala nwere ike imebi sistemu ụjọ nke etiti, sistem obi na akwara ozi na ngụgụ.Nsonaazụ nyocha nke ụlọ na nke mba ofesi na ethylene glycol kwenyere na nsi nke ya dị ntakịrị.Usoro metabolism ya n'ime ahụ bụ otu nke ethanol, site na metabolism nke ethanol dehydrogenase na acetaldehyde dehydrogenase, ngwaahịa ndị bụ isi bụ glycoxalic acid, oxalic acid na lactic acid, nke nwere oke nsi.Ya mere, ọtụtụ ụkpụrụ nwere ihe ndị a kapịrị ọnụ maka ihe ndị fọdụrụ mgbe sterilized site na ethylene oxide.Dịka ọmụmaatụ, GB/T 16886.7-2015 "Nnyocha ihe ndị dị ndụ nke ngwaọrụ ahụike Nkebi 7: Ethylene Oxide Sterilization Residues", YY0290.8-2008 "Ophthalmic Optics Artificial Lens Part 8: Basic Requirements", na ụkpụrụ ndị ọzọ nwere nkọwa zuru ezu maka ihe ndị a chọrọ maka njedebe. nke residues nke ethylene oxide na 2-chloroethanol.GB/T 16886.7-2015 na-ekwu n'ụzọ doro anya na mgbe ị na-eji GB/T 16886.7-2015, e kwuru n'ụzọ doro anya na mgbe 2-chloroethanol dị na ọgwụ ngwaọrụ igba ogwu site ethylene oxide, ya kacha ekwe resided. bụkwa n'ụzọ doro anya oke.Ya mere, ọ dị mkpa iji nyochaa nke ọma mmepụta nke ihe ndị a na-ahụkarị (ethylene oxide, 2-chloroethanol, ethylene glycol) site na mmepụta, njem na nchekwa nke ethylene oxide, mmepụta nke ngwaọrụ ahụike, na usoro nkwụsị.

 

II.Nyocha nke ihe fọdụrụ sterilization
A na-ekewa usoro mmepụta nke ethylene oxide na usoro chlorohydrin na usoro oxidation.N'ime ha, usoro chlorohydrin bụ ụzọ mmepụta ethylene oxide mbụ.Ọ kachasị nwere usoro mmeghachi omume abụọ: nzọụkwụ mbụ: C2H4 + HClO - CH2Cl - CH2OH;nzọụkwụ nke abụọ: CH2Cl - CH2OH + CaOH2 - C2H4O + CaCl2 + H2O.Usoro mmeghachi omume ya Ngwaahịa etiti bụ 2-chloroethanol (CH2Cl-CH2OH).N'ihi nkà na ụzụ azụ azụ nke usoro chlorohydrin, mmetọ dị egwu nke gburugburu ebe obibi, yana ngwaahịa nke nnukwu mmebi nke akụrụngwa, ekpochapụla ọtụtụ ndị na-emepụta [4].A na-ekewa usoro oxidation [3] na ụzọ ikuku na ikuku oxygen.Dị ka ịdị ọcha dị iche iche nke oxygen si dị, mmepụta nke isi nwere usoro mmeghachi omume abụọ: nzọụkwụ mbụ: 2C2H4 + O2 - 2C2H4O;nzọụkwụ nke abụọ: C2H4 + 3O2 - 2CO2 + H2O.Ka ọ dị ugbu a, mmepụta nke ethylene oxide nke ụlọ ọrụ mmepụta ihe ugbu a, mmepụta mmepụta nke ethylene oxide na-ejikarị ethylene oxide na ọlaọcha eme ihe.Ya mere, usoro mmepụta nke ethylene oxide bụ ihe na-ekpebi nyocha nke 2-chlorethanol mgbe emechara ọgwụ mgbochi.
N'izo aka na ndokwa ndị dị mkpa na GB / T 16886.7-2015 ọkọlọtọ iji mezuo nkwenye na mmepe nke usoro nkwụsị nke ethylene oxide, dị ka physicochemical Njirimara nke ethylene oxide, ọtụtụ n'ime ihe ndị fọdụrụ na-adị n'ụdị mbụ mgbe sterilization gasịrị.Ihe ndị na-emetụta ọnụ ọgụgụ nke fọdụrụnụ na-agụnye mgbasa ozi nke ethylene oxide site na ngwaọrụ ahụike, ihe nkwakọ ngwaahịa na ọkpụrụkpụ, okpomọkụ na iru mmiri tupu na mgbe sterilization, sterilization edinam oge na mkpebi oge, ọnọdụ nchekwa, wdg, na ihe ndị dị n'elu na-ekpebi ụzọ mgbapụ. ike nke ethylene oxide.A kọwala ya na akwụkwọ [5] na a na-ahọrọkarị ntinye nke ethylene oxide sterilization dị ka 300-1000mg.L-1.Ihe na-efunahụ ethylene oxide n'oge igba ogwu na-agụnye: mgbasa ozi nke ngwaọrụ ahụike, hydrolysis n'okpuru ụfọdụ ọnọdụ iru mmiri, na ihe ndị ọzọ.Ntụle nke 500-600mg.L-1 dị oke ọnụ ahịa ma dị irè, na-ebelata oriri nke ethylene oxide na ihe fọdụrụ na ihe ndị a na-emepụta ihe, na-echekwa ego nkwụsị.
Chlorine nwere ọtụtụ ngwa ngwa na ụlọ ọrụ kemịkalụ, ọtụtụ ngwaahịa nwere njikọ chiri anya anyị.Enwere ike iji ya dị ka etiti, dị ka vinyl chloride, ma ọ bụ dị ka ngwaahịa njedebe, dị ka ịcha ọcha.N'otu oge ahụ, chlorine dịkwa n'ikuku, mmiri na gburugburu ebe ndị ọzọ, mmerụ ahụ na ahụ mmadụ pụtakwara ìhè.Ya mere, mgbe ngwaọrụ ahụike dị mkpa na-agbaze site na ethylene oxide, a ga-atụle nyocha zuru oke nke mmepụta, igba ogwu, nchekwa na akụkụ ndị ọzọ nke ngwaahịa ahụ, a ga-emekwa ihe ndị ezubere iche iji chịkwaa ihe fọdụrụ nke 2-chloroethanol.
A kọwo n'ime akwụkwọ [6] na ọdịnaya nke 2-chlorethanol ruru ihe fọrọ nke nta ka ọ bụrụ 150 µg/ibe ka awa 72 gachara mkpebi nke ihe mgbochi bandeji nke ethylene oxide gbasiri ike, yana n'izo aka na ngwaọrụ kọntaktị obere oge akọwapụtara. na ọkọlọtọ GB/T16886.7-2015, nkezi kwa ụbọchị nke 2-chlorethanol na onye ọrịa ekwesịghị ịbụ ihe karịrị 9 mg, na ihe fọdụrụnụ dị nnọọ ala karịa oke uru na ọkọlọtọ.
Otu nnyocha [7] tụrụ ihe fọdụrụ nke ethylene oxide na 2-chloroethanol n'ụdị eriri suture atọ, na nsonaazụ ethylene oxide bụ ihe a na-apụghị ịchọpụta na 2-chloroethanol bụ 53.7 µg.g-1 maka eriri suture na eri nylon. .YY 0167-2005 kwuputara oke nchọta maka ethylene oxide maka suture ịwa ahụ anaghị amị amị, ọ nweghịkwa iwu maka 2-chloroethanol.Sutures nwere ikike maka nnukwu mmiri mmepụta ihe na usoro mmepụta.The anọ edemede nke mmiri àgwà nke ala mmiri anyị na ọdabara na izugbe ụlọ ọrụ nchebe ebe na ahụ mmadụ na-abụghị kpọmkwem kọntaktị na mpaghara mmiri, n'ozuzu na-emeso na ịcha ọcha, nwere ike ịchịkwa algae na microorganisms na mmiri, na-eji sterilization na ịdị ọcha ọrịa mgbochi. .Isi ihe na-arụ ọrụ ya bụ calcium hypochlorite, nke a na-emepụta site na ibufe gas chlorine site na nkume nzu.Calcium hypochlorite na-eweda ngwa ngwa na ikuku, usoro mmeghachi omume bụ isi bụ: Ca (ClO) 2+ CO2+H2O-CaCO3+2HClO.A na-agbaji hypochlorite ngwa ngwa n'ime hydrochloric acid na mmiri n'okpuru ìhè, usoro mmeghachi omume bụ isi bụ: 2HClO+light-2HCl+O2.2HCl + O2.Chlorine ọjọọ ion na-adị mfe adsorbed na sutures, na n'okpuru ụfọdụ adịghị ike acidic ma ọ bụ alkaline gburugburu, ethylene oxide meghere mgbanaka na ya na-emepụta 2-chloroethanol.
A kọwapụtara ya n'akwụkwọ [8] na ihe fọdụrụ 2-chloroethanol dị na nlele IOL bụ nke ultrasonic mmịpụta na acetone wee kpebie site na gas chromatography-mass spectrometry, mana achọpụtaghị ya.YY0290.8-2008 “Ophthalmic Optics Artificial Lens Nkebi 8: Ihe ndị dị mkpa” na-ekwu na ego fọdụrụ nke 2-chloroethanol na IOL ekwesịghị ịbụ ihe karịrị 2.0µg kwa ụbọchị kwa oghere, yana na mkpokọta oghere nke ọ bụla ekwesịghị ịbụ ihe karịrị 5.0 GB/T16886. Ọkọlọtọ 7-2015 kwuru na nsi anya nke 2-chloroethanol residue kpatara dị okpukpu anọ karịa nke otu ọkwa ethylene oxide kpatara.
Na nchịkọta, mgbe ị na-enyocha ihe ndị fọdụrụ nke ngwaọrụ ahụike mgbe sterilization site na ethylene oxide, ethylene oxide na 2-chloroethanol kwesịrị ilekwasị anya na ya, mana ekwesịrị nyochaa ihe fọdụrụ ha n'ụzọ zuru ezu dịka ọnọdụ dị adị.

 

N'oge ịgba ọgwụ mgbochi ọrịa nke ngwaọrụ ahụike, ụfọdụ akụrụngwa maka ngwaọrụ ahụike na-eji otu ma ọ bụ ihe nkwakọ ngwaahịa gụnyere polyvinyl chloride (PVC), na obere ego nke vinyl chloride monomer (VCM) ga-emepụtakwa site na mwepu nke resin PVC. n'oge nhazi.GB10010-2009 ọgwụ dị nro PVC ọkpọkọ na-egosi na ọdịnaya nke VCM enweghị ike gafere 1µg.g-1.A na-eme ka VCM dị mfe polymerized n'okpuru ọrụ nke ihe na-akpata (peroxides, wdg) ma ọ bụ ọkụ na okpomọkụ iji mepụta resin polyvinyl chloride, nke a na-akpọkọ ọnụ dị ka resin vinyl chloride.Vinyl chloride na-adị mfe polymerized n'okpuru ọrụ nke catalyst (peroxide, wdg) ma ọ bụ ọkụ na okpomọkụ iji mepụta polyvinyl chloride, nke a na-akpọkọta ọnụ dị ka resin vinyl chloride.Mgbe polyvinyl chloride na-ekpo ọkụ karịa 100 Celsius ma ọ bụ kpughee na radieshon ultraviolet, enwere ike na gas hydrogen chloride nwere ike ịgbapụ.Mgbe ahụ nchikota hydrogen chloride gas na ethylene oxide n'ime ngwugwu ga-emepụta ụfọdụ 2-chlorethanol.
Ethylene glycol, kwụsiri ike na okike, anaghị agbanwe agbanwe.Atọm oxygen dị na ethylene oxide na-ebu ụzọ abụọ abụọ nke eletrọn ma nwee hydrophilicity siri ike, nke na-eme ka ọ dịkwuo mfe ịmepụta ethylene glycol mgbe ha na ion chloride na-adịghị mma na-ebikọ ọnụ.Dịka ọmụmaatụ: C2H4O + NaCl + H2O - CH2Cl - CH2OH + NaOH.Usoro a na-esighi ike na njedebe na-emeghachi omume na nke siri ike na njedebe generative, na omume nke mmeghachi omume a dị ala.Ihe kachasị elu bụ nhazi ethylene glycol site na ethylene oxide na kọntaktị na mmiri: C2H4O + H2O - CH2OH - CH2OH, na hydration nke ethylene oxide na-egbochi njikọ ya na ion na-adịghị mma chlorine.
Ọ bụrụ na ewebata ion na-adịghị mma nke chlorine na mmepụta, igba ogwu, nchekwa, njem na ojiji nke ngwaọrụ ahụike, enwere ike na ethylene oxide ga-emeghachi omume na ha iji mepụta 2-chlorethanol.Ebe ọ bụ na ekpochapụla usoro chlorohydrin na usoro mmepụta ya, ngwaahịa dị n'etiti ya, 2-chlorethanol, agaghị eme na usoro oxidation kpọmkwem.N'ime mmepụta nke ngwaọrụ ahụike, ụfọdụ akụrụngwa nwere akụrụngwa adsorption siri ike maka ethylene oxide na 2-chlorethanol, yabụ, a ga-atụle njikwa nke ihe fọdụrụ ha mgbe ị na-enyocha ha mgbe emechara ọgwụ mgbochi.Tụkwasị na nke ahụ, n'oge mmepụta nke ngwaọrụ ahụike, akụrụngwa, ihe mgbakwunye, mmeghachi omume mmeghachi omume, wdg nwere nnu inorganic n'ụdị chlorides, na mgbe ịgba ọgwụ mgbochi ahụ, ohere na ethylene oxide na-emepe mgbanaka n'okpuru ọnọdụ acidic ma ọ bụ alkaline, na-enweta SN2. mmeghachi omume, ma jikọta ya na ion adịghị mma chlorine n'efu iji mepụta 2-chlorethanol kwesịrị ịtụle.
Ugbu a, usoro a na-ejikarị achọpụta ethylene oxide, 2-chlorethanol na ethylene glycol bụ usoro nke gas.Ethylene oxide nwekwara ike ịchọpụta site na usoro colorimetric site na iji pinched red sulfite test solution, ma mwepu ya bụ na eziokwu nke nsonaazụ ule na-emetụta ihe ndị ọzọ na ọnọdụ nnwale, dị ka ịhụ na okpomọkụ nke 37 ° C na-adịgide adịgide. ebe nnwale iji chịkwaa mmeghachi omume nke ethylene glycol, na oge itinye ihe ngwọta a ga-anwale mgbe usoro mmepe agba.Ya mere, nkwenye usoro akwadoro (gụnyere izi ezi, nkenke, linearity, sensitivity, wdg) n'ime ụlọ nyocha tozuru oke bụ ihe dị mkpa maka nchọta ọnụọgụgụ nke fọduru.

 

III.Ntụleghachi na usoro nyocha
Ethylene oxide, 2-chloroethanol na ethylene glycol bụ ihe ndị a na-ahụkarị mgbe ethylene oxide sterilization nke ngwaọrụ ahụike.Iji mee nyocha nke fọdụrụ, ekwesịrị ịtụle iwebata ihe ndị dị mkpa na mmepụta na nchekwa nke ethylene oxide, mmepụta na igba ogwu nke ngwaọrụ ahụike.
Enwere okwu abụọ ọzọ kwesịrị ilekwasị anya na ọrụ nyocha ngwaọrụ ahụike n'ezie: 1. Ma ọ dị mkpa iji mee nnwale nke residues nke 2-chlorethanol.N'ime mmepụta nke ethylene oxide, ọ bụrụ na ejiri usoro chlorohydrin omenala mee ihe, ọ bụ ezie na a ga-anakwere ịdị ọcha, nzacha na ụzọ ndị ọzọ na usoro mmepụta, ethylene oxide gas ka ga-enwe ngwaahịa etiti 2-chloroethanol ruo n'ókè ụfọdụ, na ego fọdụrụnụ ya. kwesịrị ịtụle.Ọ bụrụ na a na-eji usoro oxidation, ọ dịghị iwebata 2-chloroethanol, ma ihe fọdụrụnụ nke ndị na-emechi ihe dị mkpa, ihe na-eme ka ọ dị mkpa, na ihe ndị ọzọ dị na ethylene oxide mmeghachi omume kwesịrị ịtụle.Ngwá ọrụ ahụike na-eji nnukwu mmiri nke ụlọ ọrụ mmepụta ihe na usoro mmepụta ihe, a na-etinyekwa ụfọdụ hypochlorite na ion chlorine na-adịghị mma na ngwaahịa emechara, nke bụ ihe kpatara enwere ike ịnweta 2-chloroethanol na ihe fọdụrụnụ.E nwekwara ikpe na akụrụngwa na nkwakọ ngwaahịa ọgwụ bụ inorganic salts nwere elemental chlorine ma ọ bụ polymer ihe na ike Ọdịdị na adịghị mfe imebi nkekọ, wdg Ya mere, ọ dị mkpa ka comprehensively nyochaa ma ihe ize ndụ nke 2-chloroethanol. A ga-anwale ihe fọdụrụ maka nyocha, ma ọ bụrụ na enwere ihe akaebe zuru oke iji gosi na agaghị ewebata ya na 2-chloroethanol ma ọ bụ dị ala karịa njedebe nchọpụta nke usoro nchọpụta ahụ, enwere ike ileghara ule ahụ anya iji chịkwaa ihe ize ndụ nke ya.2. N'ihi na ethylene glycol Analytical nwale nke residues.E jiri ya tụnyere ethylene oxide na 2-chloroethanol, kọntaktị toxicity nke ethylene glycol residues dị ala, ma n'ihi na ethylene oxide mmepụta na ojiji a ga-ekpughere na carbon dioxide na mmiri, na ethylene oxide na mmiri na-adịkarị mfe imepụta ethylene glycol, na Ọdịnaya nke ethylene glycol mgbe ịgba ọgwụ mgbochi ọrịa metụtara ịdị ọcha nke ethylene oxide, yana metụtara nkwakọ ngwaahịa, mmiri dị na microorganisms, yana ọnọdụ okpomọkụ na iru mmiri nke sterilization, yabụ, ekwesịrị ịtụle ethylene glycol dabere n'ọnọdụ ndị dị adị. .Nlele.
Standardskpụrụ bụ otu n'ime ngwaọrụ maka nyocha teknụzụ nke ngwaọrụ ahụike, nyocha teknụzụ nke ngwaọrụ ahụike kwesịrị ilekwasị anya na isi chọrọ nchekwa na ịdị irè nke imepụta ngwaahịa na mmepe, mmepụta, nchekwa, ojiji na akụkụ ndị ọzọ nke nyocha zuru oke nke ihe ndị na-emetụta. nchekwa na ịdị irè nke tiori na omume, dabere na sayensị, dabere na eziokwu, kama ịre aka kpọmkwem na ọkọlọtọ, kewapụrụ n'ezie ọnọdụ nke mmepụta ngwaahịa, nchọpụta na mmepe, mmepụta na ojiji.Ọrụ nyocha kwesịrị itinyekwu uche na usoro nrụpụta ngwaọrụ ahụike maka njikwa njikọ ndị dị mkpa, n'otu oge nyocha na saịtị kwesịkwara ịbụ "nsogbu" gbakwasara, nye egwuregwu zuru oke na ọrụ nke "anya" ka. melite ogo nyocha, ebumnuche nyocha sayensị.

Isi mmalite: Center for Technical Review of Medical Devices, State Drug Administration (SDA)

 

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Oge nzipu: Sep-21-2023