Intangiriro
Mu buryo bwa farumasi, icyumba gisukuye bivuga icyumba cyujuje ibyangombwa bya GMP. Bitewe n’ibisabwa bikenewe mu kuzamura ikoranabuhanga mu kongera umusaruro, icyumba gisukuye muri laboratoire kizwi kandi nk '"umurinzi w’inganda zo mu rwego rwo hejuru."
1. Icyumba gisukuye ni iki
Icyumba gisukuye, kizwi kandi nk'icyumba kitarimo ivumbi, ubusanzwe gikoreshwa mu rwego rwo gukora inganda zumwuga cyangwa ubushakashatsi bwa siyansi, harimo gukora imiti, imiti ihuriweho, CRT, LCD, OLED na micro LED yerekana, n'ibindi.
Icyumba gisukuye cyagenewe kubungabunga urwego ruto cyane, nk'umukungugu, ibinyabuzima byo mu kirere, cyangwa imyuka ihumeka. By'umwihariko, icyumba gisukuye gifite urwego rwanduye rwanduye, rusobanurwa numubare wibice kuri metero kibe ku bunini bwagenwe.
Icyumba gisukuye kirashobora kandi kwerekeza kumwanya uwo ariwo wose wabigenewe aho hashyizweho ingamba zo kugabanya kwanduza uduce no kugenzura ibindi bidukikije nkubushyuhe, ubushuhe n’umuvuduko. Mu buryo bwa farumasi, icyumba gisukuye nicyumba cyujuje ibyangombwa bisabwa na GMP byasobanuwe muri GMP aseptic. Ni ihuriro ryibishushanyo mbonera, gukora, kurangiza no kugenzura ibikorwa (ingamba zo kugenzura) bisabwa kugirango icyumba gisanzwe kibe icyumba gisukuye. Ibyumba bisukuye bikoreshwa mu nganda nyinshi, ahantu hose uduce duto dushobora kugira ingaruka mbi mubikorwa.
Ibyumba bisukuye biratandukanye mubunini no mubigoye kandi bikoreshwa cyane mubikorwa nko gukora semiconductor, farumasi, biotechnologie, ibikoresho byubuvuzi na siyanse yubuzima, hamwe ninganda zikomeye zikoreshwa mu kirere, optique, igisirikare n’ishami ry’ingufu.
2. Gutezimbere icyumba gisukuye
Icyumba cya kijyambere gisukuye cyavumbuwe n’umunyamerika w’umuhanga mu bya fiziki witwa Willis Whitfield. Whitfield, nk'umukozi wa Laboratwari y'igihugu ya Sandia, yateguye igishushanyo mbonera cy'icyumba gisukuye mu 1966. Mbere yuko Whitfield ivumburwa, icyumba gisukuye hakiri kare cyahuye n'ibibazo by'uduce duto ndetse n'umwuka utamenyekana.
Whitfield yateguye icyumba gisukuye hamwe nu mwuka uhoraho kandi ushungura cyane kugirango umuyaga ugire isuku. Byinshi mubikorwa byububiko byuzuzanya byuzuzanya mubibaya bya Silicon byubatswe namasosiyete atatu: MicroAire, PureAire, na Key Plastics. Bakoze amashanyarazi ya laminari, udusanduku twa gants, ibyumba bisukuye hamwe nogesha ikirere, hamwe na tanki yimiti hamwe nintebe yakazi yo kubaka "inzira itose" yo kubaka imiyoboro ihuriweho. Izi sosiyete uko ari eshatu nazo zabaye intangarugero mu gukoresha Teflon mu mbunda zo mu kirere, pompe y’imiti, scrubbers, imbunda z’amazi, n’ibindi bikoresho nkenerwa mu kubyaza umusaruro amashanyarazi. William.
3. Amahame yicyumba gisukuye cyo mu kirere
Ibyumba bisukuye bigenzura ibice byo mu kirere ukoresheje filtri ya HEPA cyangwa ULPA, ukoresheje laminari (inzira imwe) cyangwa imivurungano (imivurungano, inzira imwe).
Sisitemu yo mu kirere ya Laminar cyangwa inzira imwe iyobora akayunguruzo kayunguruzo mu guhora kumanuka kumanuka cyangwa gutambitse kuri filtri iri kurukuta hafi yicyumba gisukuye, cyangwa ikazenguruka ikoresheje imbaho zo hejuru zisobekeranye.
Sisitemu yo mu kirere ya Laminar ikoreshwa mubisanzwe hejuru ya 80% yicyumba gisukuye kugirango igumane umwuka uhoraho. Ibyuma bitagira umwanda cyangwa ibindi bikoresho bitamenetse bikoreshwa mukubaka akayunguruzo ka laminari yo mu kirere hamwe na hoods kugirango birinde uduce twinshi twinjira mu kirere. Imyuka ihindagurika, cyangwa idafite icyerekezo cyogukoresha ikirere gikoresha laminar yo mu kirere hamwe n’umuvuduko udasanzwe wo kuyungurura kugira ngo umwuka mu cyumba gisukuye uhore ugenda, nubwo atari byose mu cyerekezo kimwe.
Umwuka mubi ugerageza gufata uduce dushobora kuba mu kirere tukayijugunya hasi, aho binjira muyungurura hanyuma bakava mucyumba gisukuye. Ahantu hamwe hazongerwamo ibyumba bisukuye bya vector: umwuka utangwa mugice cyo hejuru cyicyumba, hifashishijwe akayunguruzo ka hepa kameze nkabafana, kandi akayunguruzo ka hepa gasanzwe karashobora kandi gukoreshwa hamwe n’ibicuruzwa bitanga umuyaga umeze nk’abafana. Garuka ibyuka byashyizwe kumurongo wo hepfo kurundi ruhande. Ikigereranyo cy'uburebure n'uburebure bw'icyumba muri rusange kiri hagati ya 0.5 na 1. Ubu bwoko bw'icyumba gisukuye bushobora no kugera ku isuku yo mu cyiciro cya 5 (Icyiciro 100).
Ibyumba bisukuye bisaba umwuka mwinshi kandi mubisanzwe biri mubushuhe bugenzurwa nubushuhe. Kugabanya ikiguzi cyo guhindura ubushyuhe bwibidukikije cyangwa ubuhehere, hafi 80% yumuyaga urasubirwamo (niba ibicuruzwa biranga ibicuruzwa bibyemerera), kandi umwuka wazengurutswe ubanza kuyungurura kugirango ukureho umwanda mugihe ukomeza ubushyuhe nubushuhe bukwiye mbere yo kunyura mubyumba bisukuye.
Ibice byo mu kirere (umwanda) bireremba hirya no hino. Ibice byinshi byo mu kirere bigenda buhoro buhoro, kandi igipimo cyo gutura giterwa nubunini bwacyo. Sisitemu yatunganijwe neza igomba gutanga umwuka mwiza kandi uzungurutswe muyungurura umwuka mwiza kugirango usukure icyumba hamwe, kandi utware ibice kure yicyumba gisukuye hamwe. Ukurikije imikorere, umwuka wakuwe mucyumba usanzwe uzunguruka binyuze muri sisitemu yo gukoresha ikirere, aho muyungurura ikuraho uduce.
Niba inzira, ibikoresho fatizo cyangwa ibicuruzwa birimo ubuhehere bwinshi, imyuka cyangwa imyuka yangiza, uyu mwuka ntushobora kuzenguruka mucyumba. Uyu mwuka usanzwe unaniwe mukirere, hanyuma 100% umwuka mwiza winjizwa muri sisitemu yicyumba gisukuye hanyuma ukavurwa mbere yo kwinjira mucyumba gisukuye.
Umubare wumwuka winjira mucyumba gisukuye uragenzurwa cyane, kandi ingano yumwuka unaniwe nayo iragenzurwa cyane. Ibyumba byinshi bisukuye birashyirwaho igitutu, ibyo bigerwaho no kwinjira mucyumba gisukuye gifite umwuka mwinshi kuruta umwuka uva mucyumba gisukuye. Umuvuduko mwinshi urashobora gutuma umwuka usohoka munsi yinzugi cyangwa unyuze mubice bito byanze bikunze cyangwa icyuho mubyumba byose bisukuye. Urufunguzo rwicyumba cyiza gisukuye ni ahantu heza ho gufata umwuka (gutanga) no gusohora (umunaniro).
Mugihe utegura icyumba gisukuye, ahabigenewe gutangwa no gusohora (garuka) grilles igomba kuba iyambere. Kwinjira (igisenge) no gusubiza grilles (kurwego rwo hasi) bigomba kuba kumpande zinyuranye zicyumba gisukuye. Niba umukoresha akeneye kurindwa ibicuruzwa, umuvuduko wumwuka ugomba kuba kure yuwukora. Amerika FDA hamwe n’ubumwe bw’ibihugu by’Uburayi bifite umurongo ngenderwaho ukomeye kandi ntarengwa byo kwanduza mikorobe, kandi hashobora no gukoreshwa plenum hagati y’umuyaga uhumeka hamwe n’iyungurura umuyaga hamwe na matelas zifatika. Kubyumba bitagira ingano bisaba umwuka wo mu cyiciro cya A, umwuka uva hejuru ukageza hasi kandi ntuyobora cyangwa laminari, byemeza ko umwuka utanduye mbere yuko uhura nibicuruzwa.
4. Kwanduza icyumba gisukuye
Iterabwoba rikomeye ryogusukura ibyumba bituruka kubakoresha ubwabo. Mu nganda zubuvuzi n’imiti, kugenzura mikorobe ni ingenzi cyane, cyane cyane mikorobe zishobora kuva mu ruhu zigashyirwa mu kirere. Kwiga ibimera bya mikorobe byibyumba bisukuye bifite akamaro kanini kubashinzwe ubuzima bwa mikorobi hamwe nabakozi bashinzwe kugenzura ubuziranenge kugirango basuzume impinduka zigenda zihinduka, cyane cyane mugupima imiti irwanya ibiyobyabwenge ndetse nubushakashatsi bwuburyo bwo gukora isuku no kwanduza. Ibimera bisanzwe bisukuye bifitanye isano nuruhu rwabantu, kandi hazabaho na mikorobe ituruka ahandi, nko mubidukikije n'amazi, ariko muke. Ubwoko bwa bagiteri busanzwe burimo Micrococcus, Staphylococcus, Corynebacterium na Bacillus, na genera ya fungal harimo Aspergillus na Penicillium.
Hariho ibintu bitatu byingenzi kugirango isuku yicyumba isukure.
(1). Ubuso bwimbere bwicyumba gisukuye nibikoresho byimbere
Ihame nuko guhitamo ibikoresho ari ngombwa, kandi isuku ya buri munsi no kuyanduza ni ngombwa. Kugirango twubahirize GMP kandi tugere ku bisobanuro by’isuku, ubuso bwose bwicyumba gisukuye bugomba kuba bworoshye kandi bwumuyaga, kandi ntibutange umwanda wabo bwite, ni ukuvuga ko nta mukungugu, cyangwa imyanda, birwanya ruswa, byoroshye koza, bitabaye ibyo bizatanga ahantu ho kubyara mikorobe, kandi ubuso bugomba kuba bukomeye kandi buramba, kandi ntibushobora gucika, kumeneka cyangwa kumeneka. Hano haribikoresho bitandukanye byo guhitamo, harimo na dagad ihenze cyane, ibirahure, nibindi. Ibyiza kandi byiza cyane ni ikirahure. Isuku buri gihe no kuyanduza bigomba gukorwa hubahirijwe ibisabwa byibyumba bisukuye murwego rwose. Inshuro irashobora kuba nyuma ya buri gikorwa, inshuro nyinshi kumunsi, burimunsi, iminsi mike, rimwe mucyumweru, nibindi. Birasabwa ko ameza yabakozi agomba gusukurwa no kwanduzwa nyuma ya buri gikorwa, hasi igomba kwanduzwa buri munsi, urukuta rugomba kwanduzwa buri cyumweru, kandi umwanya ugomba guhanagurwa no kwanduzwa buri kwezi ukurikije urwego rwicyumba gisukuye kandi hagashyirwaho ibipimo byashyizweho.
(2). Kugenzura umwuka mubyumba bisukuye
Muri rusange, birakenewe guhitamo igishushanyo mbonera cyicyumba gisukuye, gukora buri gihe, no gukora buri munsi. Hagomba kwitabwaho cyane cyane kugenzura za bagiteri zireremba mu byumba bisukura imiti. Bagiteri zireremba mu kirere zikururwa na bacteri zireremba hejuru kugirango zikuremo umwuka runaka mu kirere. Umwuka wo mu kirere unyura mu isahani yo guhuza yuzuyemo umuco wihariye. Isahani yo guhuza izafata mikorobe, hanyuma isahani ishyirwe muri incubator kugirango ibare umubare wabakoloni kandi ubare umubare wa mikorobe mu mwanya. Microorganismes murwego rwa laminar nayo igomba gutahurwa, ukoresheje laminar igereranije na bacteri sampler. Ihame ryakazi risa niy'umwanya wo gutoranya umwanya, usibye ko aho icyitegererezo kigomba gushyirwa murwego rwa laminari. Niba umwuka wugarijwe usabwa mucyumba cya sterile, birakenewe kandi gukora mikorobe ku mwuka wafunzwe. Ukoresheje icyuma gikwirakwiza ikirere gikwiranye, umuvuduko wumwuka wumwuka uhumeka ugomba guhindurwa mukurwego rukwiye kugirango wirinde kwangiza mikorobe n’ibitangazamakuru by’umuco.
(3). Ibisabwa kubakozi mucyumba gisukuye
Abakozi bakorera mu byumba bisukuye bagomba guhabwa amahugurwa ahoraho mubitekerezo byo kurwanya umwanda. Binjira kandi basohoka mucyumba gisukuye binyuze mu ndege, kwiyuhagira mu kirere no / cyangwa guhindura ibyumba, kandi bagomba kwambara imyenda yabugenewe kugira ngo bapfuke uruhu kandi bisanzwe byanduza umubiri. Ukurikije ibyiciro cyangwa imikorere yicyumba gisukuye, imyambaro y abakozi irashobora gusaba gusa uburinzi bworoshye nkamakoti ya laboratoire hamwe na hoods, cyangwa irashobora gupfukiranwa rwose kandi ntigaragaze uruhu urwo arirwo rwose. Imyenda yo mucyumba isukuye ikoreshwa kugirango irinde ibice na / cyangwa mikorobe idasohoka mu mubiri wambaye kandi byanduza ibidukikije.
Imyenda yo mucyumba isukuye ubwayo ntigomba kurekura ibice cyangwa fibre kugirango birinde kwanduza ibidukikije. Ubu bwoko bwanduye bwanduye burashobora kugabanya imikorere yibicuruzwa munganda zikoreshwa na semiconductor ninganda zimiti, kandi birashobora gutera kwanduzanya hagati yubuvuzi n’abarwayi bo mu nganda zita ku buzima, urugero. Ibikoresho byo gukingira ibyumba bisukuye birimo imyenda ikingira, inkweto, inkweto, udufunzo, ubwanwa bwogosha, ingofero zizengurutse, masike, imyenda y'akazi / amakoti ya laboratoire, amakanzu, uturindantoki n'udutoki, amaboko n'inkweto hamwe na boot. Ubwoko bw'imyenda isukuye ikoreshwa igomba kwerekana icyumba gisukuye hamwe nicyiciro cyibicuruzwa. Ibyumba byo hasi bisukuye birashobora gusaba inkweto zidasanzwe zifite ibirenge byoroshye rwose bitazahagarara kumukungugu cyangwa umwanda. Ariko, kubwimpamvu z'umutekano, inkweto zinkweto ntizishobora guteza akaga. Imyenda yo mucyumba isukuye isanzwe isabwa kwinjira mucyumba gisukuye. Ikoti ryoroshye rya laboratoire, igipfukisho cyumutwe hamwe ninkweto zinkweto zirashobora gukoreshwa mubyumba 10,000 bisukuye. Icyumba cya 100 cyicyumba gisukuye, gupfunyika umubiri wose, imyenda irinda zipper, amadarubindi, masike, gants na bipfundikizo bya boot. Byongeye kandi, umubare wabantu bari mucyumba gisukuye ugomba kugenzurwa, ugereranije impuzandengo ya 4 kugeza kuri 6 m2 / umuntu, kandi ibikorwa bigomba kwitonda, birinda kugenda nini kandi byihuse.
5. Uburyo bukoreshwa muburyo bwo kwanduza ibyumba bisukuye
(1). Kwanduza UV
(2). Ozone
(3). Kwangiza gazi Disinfectants zirimo formaldehyde, epoxyethane, aside peroxyacetic aside, aside kariboli hamwe nuruvange rwa acide lactique, nibindi.
(4) Imiti yica udukoko
Indwara zanduza zisanzwe zirimo inzoga ya isopropyl (75%), Ethanol (75%), glutaraldehyde, Chlorhexidine, nibindi. Inganda zimiti zamahanga zemeza ko formaldehyde ifite ingaruka mbi kumubiri wumuntu. Ubu muri rusange bakoresha spray ya glutaraldehyde. Imiti yica udukoko ikoreshwa mu byumba bya sterile igomba guhindurwa kandi ikayungururwa hifashishijwe akayunguruzo ka 0.22 mm mu biro by’umutekano w’ibinyabuzima.
6. Gutondekanya icyumba gisukuye
Icyumba gisukuye cyashyizwe mubikorwa ukurikije umubare nubunini bwibice byemewe kuri buri kirere cyumwuka. Umubare munini nka "Icyiciro 100" cyangwa "Icyiciro 1000" bivuga FED-STD-209E, byerekana umubare wa 0.5μm cyangwa ibice binini byemewe kuri metero kibe yumuyaga. Igipimo nacyo cyemerera interpolation; kurugero, SNOLAB ibungabungwa mubyumba 2000 bisukuye. Umucyo utandukanya urumuri rwimyuka ikoreshwa mukumenya ubunini bwibice byo mu kirere bingana cyangwa binini kuruta ubunini bwagenwe ahantu hatoranijwe.
Agaciro icumi kerekana ISO 14644-1 isanzwe, igaragaza logarithm ya cumi yumubare wibice 0.1μm cyangwa binini byemewe kuri metero kibe yumuyaga. Kurugero, icyumba cya ISO Icyiciro cya 5 gifite isuku gifite ntarengwa 105 / m3. FS 209E na ISO 14644-1 zombi zitekereza ko hariho isano ya logarithmic hagati yubunini bwibice hamwe nubunini bwibice. Kubwibyo, zero ibice byibandaho ntibibaho. Ibyiciro bimwe ntibisaba kwipimisha kubunini buke kuko kwibanda ni bike cyane cyangwa hejuru cyane kuburyo bidashoboka, ariko ibisa nkibi ntibigomba gufatwa nka zeru. Kubera ko 1m3 igera kuri metero kibe 35, ibipimo byombi bingana hafi iyo bipimye 0.5μm. Umwuka usanzwe murugo ni hafi 1.000.000 cyangwa ISO 9.
ISO 14644-1 na ISO 14698 ni amahame ya leta yashyizweho n’umuryango mpuzamahanga ushinzwe ubuziranenge (ISO). Iyambere ireba icyumba gisukuye muri rusange; icya nyuma cyo gusukura icyumba aho biocontamination ishobora kuba ikibazo.
Inzego zishinzwe kugenzura ubu zirimo: ISO, USP 800, Leta zunze ubumwe z’Amerika 209E (igipimo cyabanje, n'ubu kiracyakoreshwa) Itegeko ry’ubuziranenge n’umutekano ry’ibiyobyabwenge (DQSA) ryashinzwe mu Gushyingo 2013 kugira ngo rikemure impfu ziterwa n’ibiyobyabwenge n’ibibazo bikomeye. Itegeko ry’ibiribwa, ibiyobyabwenge, n’amavuta yo kwisiga (FD&C Act) rishyiraho umurongo ngenderwaho na politiki byihariye byo gushyiraho abantu. 503A igenzurwa nabakozi babiherewe uburenganzira (farumasi / abaganga) ninzego zemewe na leta cyangwa federasiyo 503B ifitanye isano n’ibigo byohereza hanze kandi bisaba kugenzurwa bitaziguye n’umufarumasiye wabiherewe uruhushya kandi ntabwo akeneye kuba farumasi yemewe. Ibikoresho bibona impushya binyuze mubuyobozi bushinzwe ibiryo n'ibiyobyabwenge (FDA).
Amabwiriza y’ubumwe bw’ibihugu by’Uburayi arakomeye kuruta ayandi mabwiriza kandi arasaba icyumba gisukuye kugira ngo agere ku mubare w’ibice iyo ukora (mugihe cyo kubyara) no kuruhuka (mugihe nta musaruro ubaho ariko icyumba AHU kirimo).
8. Ibibazo byabajijwe muri laboratoire
(1). Nigute ushobora kwinjira no gusohoka mucyumba gisukuye? Abantu nibicuruzwa byinjira kandi bisohoka binyuze mumiryango itandukanye no gusohoka. Abantu binjira kandi basohoka banyuze mu ndege (bamwe bafite ubwogero bwo mu kirere) cyangwa badafite indege kandi bambara ibikoresho byo kubarinda nka kode, masike, gants, inkweto n'imyenda ikingira. Ibi ni ukugabanya no guhagarika ibice byazanywe nabantu binjira mucyumba gisukuye. Ibicuruzwa byinjira kandi bisohoka mucyumba gisukuye unyuze mu muyoboro.
(2). Hari ikintu kidasanzwe kijyanye no gushushanya ibyumba bisukuye? Guhitamo ibikoresho byubaka ibyumba bisukuye ntibigomba kubyara ibice byose, kubwibyo muri rusange epoxy cyangwa polyurethane igorofa irahitamo. Ibyuma bisize ibyuma cyangwa ifu yometseho ibyuma byoroheje bya sandwich ibice hamwe nibisenge. Inguni-Iburyo irinda impande zigoramye. Ihuriro ryose kuva ku mfuruka kugeza hasi no mu mfuruka kugeza ku gisenge bigomba gufungwa na kashe ya epoxy kugirango wirinde ikintu icyo ari cyo cyose cyaduka cyangwa ibisekuruza ku ngingo. Ibikoresho biri mucyumba gisukuye byateguwe kugirango habeho kwanduza ikirere gito. Koresha gusa mope nindobo. Ibikoresho byo mucyumba bisukuye nabyo bigomba kuba byateguwe kugirango bitange uduce duto kandi byoroshye kubisukura.
(3). Nigute ushobora guhitamo imiti yica udukoko? Icya mbere, isesengura ryibidukikije rigomba gukorwa kugirango hemezwe ubwoko bw’ibinyabuzima byanduye binyuze mu gukurikirana ibidukikije. Intambwe ikurikiraho ni ukumenya imiti yica udukoko ishobora kwica umubare uzwi wa mikorobe. Mbere yo gukora ikizamini cyo guhura nigihe cyo kwica (test tube dilution method or method material material) cyangwa ikizamini cya AOAC, imiti yica udukoko iriho igomba gusuzumwa kandi ikemezwa ko ikwiye. Kwica mikorobe mucyumba gisukuye, muri rusange hari ubwoko bubiri bwuburyo bwo guhinduranya: Sisitemu yo kwanduza indwara imaze kugenwa, hashobora gukorwa ikizamini cya bactericidal efficacy kugirango gitange umusingi wo guhitamo imiti yica udukoko. Nyuma yo kurangiza ikizamini cya bactericidal efficacy, hakenewe ikizamini cyo kwiga. Ubu ni uburyo bw'ingenzi bwo kwerekana niba isuku no kwanduza SOP hamwe n'ikizamini cya bactericidal efficacy ya disinfectant ari ingirakamaro. Igihe kirenze, ibinyabuzima bitaramenyekana mbere birashobora kugaragara, kandi uburyo bwo kubyaza umusaruro, abakozi, nibindi nabyo birashobora guhinduka, bityo SOPs yo gukora isuku no kuyanduza bigomba gusubirwamo buri gihe kugirango hemezwe niba bigikoreshwa mubidukikije.
(4). Isuku ya koridoro cyangwa koridoro yanduye? Ifu nka tableti cyangwa capsules ni koridoro isukuye, mugihe ibiyobyabwenge bidafite ubuzima, ibiyobyabwenge byamazi, nibindi ni koridoro yanduye. Mubisanzwe, imiti ya farumasi yubushyuhe buke nkibinini cyangwa capsules byumye kandi byuzuye ivumbi, kubwibyo rero birashoboka cyane ko hashobora kubaho ingaruka zikomeye zo kwanduzanya. Niba itandukaniro ryumuvuduko uri ahantu hasukuye na koridoro ari ryiza, ifu izava mucyumba ijya muri koridoro hanyuma birashoboka cyane ko yimurirwa mucyumba gikurikiraho gisukuye. Kubwamahirwe, imyiteguro yumye ntishobora gushyigikira byoroshye gukura kwa mikorobe, nkuko bisanzwe rero, ibinini na poro bikozwe mubikoresho bya koridoro isukuye kuko mikorobe zireremba muri koridoro zidashobora kubona aho zishobora gutera imbere. Ibi bivuze ko icyumba gifite umuvuduko mubi kuri koridor. Kuri sterile (itunganijwe), aseptic cyangwa nkeya ya bioburden hamwe n’ibicuruzwa bikoreshwa mu bya farumasi, mikorobe ikunze kubona imico ifasha gutera imbere, cyangwa kubijyanye n’ibicuruzwa bitunganijwe neza, mikorobe imwe irashobora kuba ibiza. Kubwibyo, ibi bikoresho akenshi bikozwe hamwe na koridoro yanduye kuko ikigamijwe ari ukurinda mikorobe zishobora kuba mucyumba gisukuye.
Igihe cyo kohereza: Gashyantare-20-2025