Intangiriro
Mu buryo bw'imiti, icyumba gisukuye bivuga icyumba cyujuje ibisabwa na GMP. Bitewe n'ibisabwa bikomeye byo kuvugurura ikoranabuhanga mu nganda ku bijyanye n'umusaruro, icyumba gisukuye cya laboratwari kizwi kandi nk'"umurinzi w'inganda zigezweho."
1. Icyumba gisukuye ni iki?
Icyumba gisukuye, kizwi kandi nk'icyumba kitagira ivumbi, gikoreshwa mu bikorwa by'umwuga mu nganda cyangwa mu bushakashatsi bwa siyansi, harimo gukora imiti, imiyoboro ihuriweho, CRT, LCD, OLED na micro LED ecran, nibindi.
Icyumba gisukuye cyagenewe kubungabunga urugero ruto cyane rw'uduce duto, nk'umukungugu, ibinyabuzima byo mu kirere, cyangwa uduce twahumekewe. By'umwihariko, icyumba gisukuye gifite urugero rw'ubwandu bugenzurwa, rugenwa n'umubare w'uduce kuri metero kibe ku ngano yagenwe y'uduce duto.
Icyumba gisukuye gishobora kandi gusobanura ahantu hose ho kubika ibintu hashyirwaho ingamba zo kugabanya ubwandu bw'udukoko no kugenzura ibindi bipimo by'ibidukikije nk'ubushyuhe, ubushuhe n'umuvuduko. Mu rwego rw'imiti, icyumba gisukuye ni icyumba cyujuje ibisabwa n'ibipimo bya GMP bisobanurwa mu bipimo bya GMP aseptic. Ni uruvange rw'igishushanyo mbonera cy'ubuhanga, inganda, kurangiza no kugenzura imikorere (ingamba zo kugenzura) zisabwa kugira ngo icyumba gisanzwe gihindurwe icyumba gisukuye. Ibyumba bisukuye bikoreshwa mu nganda nyinshi, aho uduce duto dushobora kugira ingaruka mbi ku gikorwa cyo gukora.
Ibyumba bifite isuku biratandukanye mu bunini no mu buryo bugoye kandi bikoreshwa cyane mu nganda nko mu nganda zikora ibikoresho bya semiconductor, imiti, ikoranabuhanga rya bio, ibikoresho by'ubuvuzi n'ubumenyi bw'ubuzima, ndetse no mu nganda zikora ibintu by'ingenzi bikunze gukoreshwa mu by'indege, mu by'ikoranabuhanga ry'urumuri, mu bya gisirikare no mu ishami rishinzwe ingufu.
2. Guteza imbere icyumba gisukuye
Icyumba cyo gusukura cya none cyavumbuwe n'umuhanga mu bya fiziki w'Umunyamerika Willis Whitfield. Whitfield, nk'umukozi wa Sandia National Laboratories, yashushanyije igishushanyo mbonera cy'icyumba cyo gusukura mu 1966. Mbere y'uko Whitfield avumbura, icyumba cyo gusukura cya mbere cyakundaga guhura n'ibibazo by'uduce duto n'umwuka utamenyekanye.
Whitfield yashushanyije icyumba gisukuye gifite umwuka uhoraho kandi uyunguruye neza kugira ngo gikomeze gusukura. Inyubako nyinshi zikora ibikoresho byo mu bwoko bwa "compatible circuit" muri Silicon Valley zubatswe n'ibigo bitatu: MicroAire, PureAire, na Key Plastics. Bakoze ibikoresho byo mu bwoko bwa "laminar flow units", udusanduku tw'uturindantoki, ibyumba bisukuye n'aho kwiyuhagirira, ndetse n'ibigega bya "chemical tanks" n'intebe zo gukoreramo mu kubaka "insinga zihujwe". Ibi bigo bitatu kandi ni byo byabanje gukoresha Teflon mu imbunda zihujwe n'umwuka, ipompo za "chemical", imashini zo gusukura, imbunda zo mu mazi, n'ibindi bikoresho bikenewe mu gukora ibikoresho byo mu bwoko bwa "compatible circuit". William (Bill) C. McElroy Jr. yabaye umuyobozi w'ubuhanga, umuyobozi w'icyumba cyo gushushanya, QA/QC, n'umuhanga mu gushushanya ibyo bigo bitatu, kandi imiterere ye yongereyeho patenti 45 z'umwimerere mu ikoranabuhanga ry'icyo gihe.
3. Amahame yo gusukura umwuka wo mu cyumba
Ibyumba bisukuye bigenzura uduce tw’umwuka hakoreshejwe filter za HEPA cyangwa ULPA, hakoreshejwe uburyo bwa laminar (inzira imwe) cyangwa inzira ihindagurika (inzira ihindagurika kandi idahindagurika).
Sisitemu z'umwuka zikoresha icyerekezo kimwe cyangwa ziyobora umwuka wayunguruwe mu buryo buhoraho umanuka cyangwa utambitse ku byuma biyungurura biri ku rukuta hafi y'icyumba gisukuye, cyangwa zigasubiramo zinyuze mu mpande zo hasi zifite imyenge.
Uburyo bwo guhumeka umwuka bukoreshwa mu buryo bwa laminar bukoreshwa hejuru ya 80% by'igisenge cy'icyumba gisukuye kugira ngo umwuka uhore uhoraho. Ibyuma bitavubura cyangwa ibindi bikoresho bidapfuka bikoreshwa mu kubaka ibyuma biyungurura umwuka n'udupfuka kugira ngo birinde uduce twinshi kwinjira mu mwuka. Uburyo bwo guhumeka umwuka bukoresha ibyuma biyungurura umwuka n'udupfuka umwuka bitagira icyerekezo kimwe bikoresha udupfuka umwuka duto n'udupfuka umwuka tudafite icyerekezo runaka kugira ngo umwuka ugume mu cyumba gisukuye kandi gihoraho, nubwo byose bitaba mu cyerekezo kimwe.
Umwotsi mubi ugerageza gufata uduce dushobora kuba turi mu kirere ukadutwara hasi, aho twinjira muri filter hanyuma tugasohoka mu cyumba gisukuye. Hari ahantu hamwe hongeramo ibyumba bisukuye: umwuka utangwa mu mfuruka zo hejuru z'icyumba, hakoreshwa filter za hepa zimeze nk'umufana, kandi filter zisanzwe za hepa nazo zishobora gukoreshwa hamwe n'aho umwuka usohoka mu buryo bumeze nk'umufana. Aho umwuka ugaruka hashyirwa hasi ku rundi ruhande. Igipimo cy'uburebure n'uburebure bw'icyumba muri rusange kiri hagati ya 0.5 na 1. Ubu bwoko bw'icyumba gisukuye bushobora kandi kugera ku isuku yo mu cyiciro cya 5 (Icyiciro cya 100).
Ibyumba bifite isuku bisaba umwuka mwinshi kandi akenshi biba biri ku bushyuhe n'ubushuhe bugenzurwa. Kugira ngo bigabanye ikiguzi cyo guhindura ubushyuhe cyangwa ubushuhe bw'ikirere, hafi 80% by'umwuka usubirwamo (niba imiterere y'ibicuruzwa ibyemerera), kandi umwuka usubirwamo ubanza kuyungururwa kugira ngo ukureho uduce duto tw'umwuka mu gihe hagumana ubushyuhe n'ubushuhe bikwiye mbere yo kunyura mu cyumba gisukuye.
Uduce duto two mu kirere (ibintu bihumanya) tuba tureremba hirya no hino. Uduce twinshi two mu kirere duto duto buhoro buhoro, kandi umuvuduko wo gutuza uterwa n'ingano yatwo. Sisitemu yo gufata umwuka yakozwe neza igomba gutanga umwuka mwiza kandi usukuye wasubiwemo mu cyumba gisukuye hamwe, kandi ikajyana utwo duce kure y'icyumba gisukuye hamwe. Bitewe n'imikorere, umwuka uva mu cyumba ukunze kuzunguruka unyuze muri sisitemu yo gufata umwuka, aho ibyuma bikuraho utuntu.
Iyo inzira, ibikoresho fatizo cyangwa ibicuruzwa birimo ubushuhe bwinshi, umwuka mubi cyangwa imyuka, uyu mwuka ntushobora kugaruka mu cyumba. Uyu mwuka ukunze kurangira mu kirere, hanyuma umwuka mwiza 100% ushyirwa mu cyumba gisukuye hanyuma ugatunganywa mbere yo kwinjira mu cyumba gisukuye.
Ingano y'umwuka winjira mu cyumba gisukuye igenzurwa neza, kandi ingano y'umwuka usohoka nayo igenzurwa cyane. Ibyumba byinshi bisukuye bifite umuvuduko, ibyo bikaba bigerwaho no kwinjira mu cyumba gisukuye gifite umwuka mwinshi ugereranije n'umwuka usohoka mu cyumba gisukuye. Umuvuduko mwinshi ushobora gutuma umwuka usohoka uturutse munsi y'inzugi cyangwa unyuze mu tuyobo duto cyangwa icyuho kiri mu cyumba gisukuye icyo ari cyo cyose. Ibanga ryo gushushanya neza icyumba gisukuye ni ahantu hakwiye ho kwinjiza umwuka (imyotsi) n'imyotsi (imyotsi isohoka).
Mu gushyira icyumba gisukuye, aho ibyuma bitanga umwuka n'ibisohora umwuka biherereye bigomba kuba ingenzi. Ibyuma bitanga umwuka n'ibigarura umwuka (biri ku rwego rwo hasi) bigomba kuba biri ku mpande z'icyumba gisukuye. Niba umukoresha akeneye kurindwa ibicuruzwa, umwuka utembera ugomba kuba kure y'umukoresha. Ishami rishinzwe ubuvuzi bw'ibanze rya Amerika (FDA) n'Umuryango w'Ubumwe bw'u Burayi bifite amabwiriza akaze n'imipaka ku kwanduza kwa mikorobe, kandi plenums hagati y'icyuma gifata umwuka n'icyuma gishyushya umuyaga n'amatafari afatisha nabyo birashobora gukoreshwa. Ku byumba bidafite umwuka bisaba umwuka wo mu cyiciro cya A, umwuka utembera uhereye hejuru ugana hasi kandi uba umwe cyangwa ugororotse, ugenzura ko umwuka utanduye mbere yuko ugera ku gicuruzwa.
4. Kwanduza icyumba gisukuye
Ikibazo gikomeye ku kwanduza icyumba gisukuye gituruka ku bakoresha ubwabo. Mu nganda z’ubuvuzi n’imiti, kugenzura udukoko ni ingenzi cyane, cyane cyane udukoko dushobora kuva mu ruhu tugashyirwa mu mwuka. Kwiga ku bimera bya mikorobe byo mu byumba bisukuye ni ingenzi cyane ku bahanga mu by’imikorobe n’abakozi bashinzwe kugenzura ubuziranenge kugira ngo basuzume impinduka zigenda zibaho, cyane cyane mu gusuzuma ubwoko bw’imiti idashobora kwangirika no gukora ubushakashatsi ku buryo bwo gusukura no kwica udukoko. Ibimera bisanzwe byo mu byumba bisukuye bifitanye isano ahanini n’uruhu rw’umuntu, kandi hazabaho udukoko duturuka ahandi hantu, nko mu bidukikije no mu mazi, ariko mu rugero ruto. Udukoko dusanzwe twa mikorobe tugizwe na Micrococcus, Staphylococcus, Corynebacterium na Bacillus, naho udukoko twa mikorobe tugizwe na Aspergillus na Penicillium.
Hari ibintu bitatu by'ingenzi kugira ngo icyumba gisukure gikomeze gusukurwa.
(1). Igice cy'imbere cy'icyumba gisukuye n'ibikoresho byacyo by'imbere
Ihame ni uko guhitamo ibikoresho ari ingenzi, kandi gusukura no kwica udukoko buri munsi ni ingenzi cyane. Kugira ngo hubahirizwe amabwiriza ya GMP kandi hagerwe ku isuku, ubuso bwose bw'icyumba gisukuye bugomba kuba bwiza kandi butagira umwuka, kandi ntibutange umwanda wabwo bwite, ni ukuvuga ko nta mukungugu, cyangwa imyanda, burwanya ingese, bworoshye gusukura, bitabaye ibyo butanga ahantu ho kororoka kwa mikorobe, kandi ubuso bugomba kuba bukomeye kandi burambye, kandi ntibushobora kwangirika, kuvunika cyangwa gucika. Hari ibikoresho bitandukanye byo guhitamo, harimo n'amabati ahenze, ibirahure, nibindi. Amahitamo meza kandi meza ni ibirahure. Gusukura no kwica udukoko buri gihe bigomba gukorwa hakurikijwe ibisabwa n'ibyumba bisukuye ku nzego zose. Inshuro zishobora kuba nyuma ya buri gikorwa, inshuro nyinshi ku munsi, buri munsi, buri minsi mike, rimwe mu cyumweru, nibindi. Ni byiza ko ameza yo gukoreramo agomba gusukurwa no gusukurwa nyuma ya buri gikorwa, hasi hagasukurwa udukoko buri munsi, urukuta rugasukurwa buri cyumweru, kandi ahantu hagasukurwa no gusukurwa udukoko buri kwezi hakurikijwe urwego rw'icyumba gisukuye n'amahame n'ibipimo byashyizweho, kandi inyandiko zigomba kubikwa.
(2). Kugenzura umwuka mu cyumba gisukuye
Muri rusange, ni ngombwa guhitamo igishushanyo mbonera cy’icyumba gikwiye gisukuye, gukora isuku ihoraho, no gukurikirana buri munsi. Hakwiye kwitabwaho cyane gukurikirana bagiteri zireremba mu byumba bisukuye bya farumasi. Bagiteri zireremba mu mwanya zikurwamo n’icyuma gipima bagiteri zireremba kugira ngo gikuremo umwuka runaka mu mwanya. Umuyaga unyura mu isahani yuzuyemo uburyo bwo gukurura. Isahani yo gupima izafata mikorobe, hanyuma isahani igashyirwa mu cyuma gikonjesha kugira ngo ibarwe umubare w’amakoloni no kubara umubare w’udukoko turi mu mwanya. Udukoko turi mu gice cya laminar natwo tugomba kumenyekana, hakoreshejwe icyuma gipima bagiteri zireremba mu gice cya laminar. Ihame ry’imikorere risa n’iryo gupima ahantu, uretse ko aho icyitegererezo kigomba gushyirwa mu gice cya laminar. Niba umwuka uremereye ukenewe mu cyumba kidafunze, ni ngombwa kandi gukora isuzuma rya mikorobe ku mwuka uremereye. Hakoreshejwe icyuma gipima umwuka uremereye gihuye, umuvuduko w’umwuka uremereye ugomba guhindurwa ku rugero rukwiye kugira ngo hirindwe konona udukoko n’ibidukikije.
(3). Ibisabwa ku bakozi bakora mu cyumba gisukuye
Abakozi bakora mu byumba bisukuye bagomba guhabwa amahugurwa ahoraho mu bijyanye no kurwanya umwanda. Binjira kandi basohoka mu cyumba gisukuye banyuze mu byuma bifunga umwuka, mu bwogero cyangwa mu byumba byo kwambariramo imyenda, kandi bagomba kwambara imyenda yihariye yo gupfuka uruhu n'ibintu bihumanya umubiri. Bitewe n'uburyo icyumba gisukuye gishyirwa mu byiciro cyangwa imikorere yacyo, imyenda y'abakozi ishobora gukenera uburinzi bworoshye nko mu makoti yo muri laboratwari n'ingofero, cyangwa ishobora kuba ipfutse neza kandi nta ruhu igaragara. Imyenda isukuye yo mu cyumba ikoreshwa mu gukumira uduce duto cyangwa mikorobe gusohoka mu mubiri w'uwambaye no kwanduza ibidukikije.
Imyenda isukuye yo mu cyumba ubwayo ntigomba kurekura uduce duto cyangwa imigozi kugira ngo hirindwe kwanduzwa ibidukikije. Ubu bwoko bw'umwanda ku bakozi bushobora kugabanya imikorere y'ibicuruzwa mu nganda zikora imiti n'izikora imiti, kandi bushobora gutera kwandura hagati y'abakozi bo kwa muganga n'abarwayi bo mu rwego rw'ubuzima, urugero. Ibikoresho byo kwirinda mu cyumba gisukuye birimo imyenda yo kwirinda, inkweto, inkweto, amatapi, udupfuka ubwanwa, ingofero zizengurutse, udupfuka, imyenda y'akazi/amakoti yo muri laboratwari, amakanzu, uturindantoki n'udutanda tw'intoki, amaboko n'udupfukantoki tw'inkweto n'inkweto. Ubwoko bw'imyenda isukuye yo mu cyumba ikoreshwa bugomba kugaragaza icyumba gisukuye n'icyiciro cy'ibicuruzwa. Ibyumba bisukuye byo hasi bishobora gusaba inkweto zidasanzwe zifite udupfukanto tworoshye rwose tutazahagarara ku mukungugu cyangwa ku mwanda. Ariko, kubera impamvu z'umutekano, udupfukantoki tw'inkweto ntidushobora guteza akaga. Imyenda isukuye yo mu cyumba isanzwe irakenewe kugira ngo winjire mu cyumba gisukuye. Amakoti yoroshye yo muri laboratwari, udupfukantoki two mu mutwe n'udupfukantoki tw'inkweto birashobora gukoreshwa mu cyumba gisukuye cyo mu cyiciro cya 10.000. Ku cyumba gisukuye cyo mu cyiciro cya 100, hakenewe udupfukantoki tw'umubiri wose, imyenda yo kurinda ifite zipu, amadarubindi, udupfukantoki, uturindantoki n'udupfukantoki tw'inkweto. Byongeye kandi, umubare w'abantu bari mu cyumba gisukuye ugomba kugenzurwa, hagati ya metero kare 4 na 6 ku muntu, kandi igikorwa kigomba kuba gito, hirindwa ingendo nini kandi zihuse.
5. Uburyo bukunze gukoreshwa mu gusukura icyumba
(1). Gukuraho imiyoboro y'imirasire y'urumuri rwa UV
(2). Gukuraho imiyoboro ya ozone
(3). Gukuraho gazi. Imiti igabanya ubukana irimo formaldehyde, epoxyothane, aside peroxyacetic, aside carbolic na aside lactic, nibindi.
(4) Imiti yica udukoko
Imiti isanzwe yo kwica udukoko irimo inzoga ya isopropyl (75%), ethanol (75%), glutaraldehyde, Chlorhexidine, nibindi. Uburyo gakondo bwo kwica udukoko mu byumba bisukuye mu nganda z’imiti zo mu Bushinwa ni ugukoresha formaldehyde fumigation. Inganda z’imiti zo mu mahanga zizera ko formaldehyde ifite ingaruka mbi ku mubiri w’umuntu. Ubu muri rusange zikoresha glutaraldehyde spraying. Umuti wica udukoko ukoreshwa mu byumba bisukuye ugomba gusukurwa no kuyungururwa unyuze mu kayunguruzo ka 0.22μm mu kabati k’umutekano w’ibinyabuzima.
6. Gushyira mu byiciro icyumba gisukuye
Icyumba gisukuye gishyirwa mu byiciro hakurikijwe umubare n'ingano y'uduce twemewe kuri buri ngano y'umwuka. Imibare minini nka "Class 100" cyangwa "Class 1000" yerekeza kuri FED-STD-209E, igaragaza umubare wa 0.5μm cyangwa uduce tunini twemewe kuri buri metero kibe y'umwuka. Ibipimo ngenderwaho kandi byemerera guhindurwamo; urugero, SNOLAB ikorerwa mu cyumba gisukuye cya Class 2000. Ibipimo by'uduce tw'umwuka dukwirakwira mu kirere bikoreshwa mu kumenya ingano y'uduce tw'umwuka turi mu kirere kingana cyangwa kinini kurusha ingano runaka ahantu hagenwe ho gufatira ingero.
Agaciro ka desimali kavuga ku gipimo cya ISO 14644-1, kigaragaza umubare w’uduce twa 0.1μm cyangwa tunini twemewe kuri metero kibe y’umwuka. Urugero, icyumba gisukuye cya ISO Class 5 gifite utuce twa 105/m3. FS 209E na ISO 14644-1 byombi bifata ko hari isano iri hagati y’ingano y’uduce twa 1 n’ubwinshi bw’uduce twa 1. Kubwibyo, ubunini bw’uduce twa zeru ntibubaho. Amwe mu matsinda ntasaba gupimwa ingano zimwe na zimwe z’uduce kuko ubunini buba buri hasi cyane cyangwa burebure cyane ku buryo bushoboka, ariko ubugari nk’ubwo ntibugomba gufatwa nka zeru. Kubera ko 1m3 ari metero kibe zigera kuri 35, ibipimo byombi birangana iyo bipima uduce twa 0.5μm. Umwuka usanzwe wo mu nzu ni hafi 1,000,000 cyangwa ISO 9.
ISO 14644-1 na ISO 14698 ni amahame atari aya leta yashyizweho n'Umuryango Mpuzamahanga Ushinzwe Ubuziranenge (ISO). Aya mbere areba icyumba gisukuye muri rusange, aya kabiri areba icyumba gisukuye aho kwanduzanya kw'ibinyabuzima bishobora kuba ikibazo.
Inzego zishinzwe kugenzura ubu zirimo: ISO, USP 800, US Federal Standard 209E (ihame ryabanje, riracyakoreshwa) Itegeko ry’Ubuziranenge n’Umutekano w’Imiti (DQSA) ryashyizweho mu Gushyingo 2013 kugira ngo rikemure impfu ziyongera ku biyobyabwenge n’ingaruka mbi zikomeye. Itegeko ry’Ibiribwa, Imiti, n’Ibyuma bya Leta (Ihame rya FD&C) rishyiraho amabwiriza na politiki byihariye ku miti ikoreshwa n’abantu. 503A igenzurwa n’abakozi bemewe (abafarumasiye/abaganga) n’ibigo byemewe na leta cyangwa leta. 503B ifitanye isano no gutanga serivisi z’abakozi kandi isaba ko umufarumasiye wemewe agenzurwa mu buryo butaziguye kandi ntabwo ikeneye kuba farumasi yemewe. Ibigo bibona uruhushya binyuze mu Kigo gishinzwe Ibiribwa n’Imiti (FDA).
Amabwiriza ya EU GMP arakomeye kurusha andi mabwiriza kandi asaba umwanya usukuye kugira ngo haboneke umubare w'uduce tw'ibinyabutabire mu gihe cy'ikorwa (mu gihe cyo gukora) no mu gihe cyo kuruhuka (igihe nta musaruro urimo gukorwa ariko icyumba cya AHU kirimo).
8. Ibibazo by'abashya mu bushakashatsi
(1). Ni gute winjira kandi usohoka mu cyumba gisukuye? Abantu n'ibicuruzwa binjira kandi bisohoka binyuze mu nzira zitandukanye zo kwinjira no gusohoka. Abantu binjira kandi basohoka binyuze mu byuma bifunga (bamwe bafite douche) cyangwa badafite ibyuma bifunga kandi bambara ibikoresho byo kwirinda nk'udupfukamunwa, udupfukamunwa, uturindantoki, inkweto n'imyenda yo kwirinda. Ibi ni ukugira ngo ugabanye kandi uhagarike uduce twinjizwa n'abantu binjira mu cyumba gisukuye. Ibicuruzwa byinjira kandi bisohoka mu cyumba gisukuye binyuze mu muyoboro w'imizigo.
(2). Hari ikintu kidasanzwe kijyanye n'imiterere y'icyumba gisukuye? Guhitamo ibikoresho by'ubwubatsi by'icyumba gisukuye ntibigomba gutanga uduce duto, bityo rero irangi ryo hasi rya epoxy cyangwa polyurethane ni ryo ryiza. Hakoreshwa ibyuma bisukuye cyangwa ifu yoroshye ya sandwich partition hamwe n'ibisenge. Inguni z'iburyo zirinda ubuso bugoramye. Impande zose kuva ku mfuruka kugeza hasi no ku mfuruka kugeza ku gisenge zigomba gufungwa n'umusemburo wa epoxy kugira ngo hirindwe ko uduce duto dushyirwa cyangwa ngo dukore ku mfuruka. Ibikoresho byo mu cyumba gisukuye byagenewe gutanga umwuka muke. Koresha gusa mops n'indobo byakozwe byihariye. Ibikoresho byo mu cyumba gisukuye bigomba kandi gukorerwa kugira ngo bitange uduce duto kandi byoroshye gusukura.
(3). Ni gute wahitamo umuti uvura indwara ukwiye? Ubwa mbere, hagomba gukorwa isesengura ry’ibidukikije kugira ngo hemezwe ubwoko bw’udukoko twanduye binyuze mu kugenzura ibidukikije. Intambwe ikurikiraho ni ukumenya umuti wica udukoko ushobora kwica umubare uzwi wa mikorobe. Mbere yo gukora ikizamini cyo kwangirika kw’igihe cyo gukora ikizamini (uburyo bwo gupima umuyoboro w’igerageza cyangwa uburyo bwo gukoresha ibintu byo hejuru) cyangwa ikizamini cya AOAC, imiti ivura indwara ihari igomba gusuzumwa no kwemezwa ko ikwiriye. Kugira ngo wice udukoko mu cyumba gisukuye, muri rusange hari ubwoko bubiri bw’uburyo bwo gusimburanya imiti: ① Guzunguruka umuti umwe wica udukoko n’undi wica udukoko, ② Guzunguruka imiti ibiri yica udukoko n’undi wica udukoko. Nyuma yo kumenyekana ko sisitemu yo kwica udukoko, hashobora gukorwa ikizamini cyo kwica udukoko kugira ngo habeho ishingiro ryo guhitamo imiti yica udukoko. Nyuma yo kurangiza ikizamini cyo kwica udukoko, hakenewe ikizamini cyo mu murima. Ubu ni uburyo bw'ingenzi bwo kwemeza niba SOP yo gusukura no kwica udukoko n’ikizamini cyo kwica udukoko cy’imiti ivura indwara ari ingirakamaro. Uko igihe kigenda gihita, udukoko tutaraboneka dushobora kugaragara, kandi inzira zo gukora, abakozi, n'ibindi nabyo bishobora guhinduka, bityo SOP zo gusukura no kwica udukoko zigomba gusuzumwa buri gihe kugira ngo hemezwe niba zigikoreshwa mu bidukikije ubu.
(4). Imihanda isukuye cyangwa imihanda yanduye? Ifu nk'ibinini cyangwa ibinini ni imihanda isukuye, mu gihe imiti idasesagura, imiti y'amazi, nibindi ari imihanda yanduye. Muri rusange, imiti ikoreshwa mu buvuzi nke nka ibinini cyangwa ibinini byumye kandi byuzuye ivumbi, bityo hari amahirwe menshi yo kwanduzwa n'ibindi. Niba itandukaniro ry'umuvuduko hagati y'ahantu hasukuye n'imihanda ari ryiza, ifu izava mu cyumba ijya mu muhanda hanyuma ikazamurwa mu cyumba gishya gisukuye. Ku bw'amahirwe, imyinshi mu myiteguro yumye ntiyorohereza mikorobe gukura, bityo nk'uko bisanzwe, ibinini n'ifu bikorerwa mu mihanda isukuye kuko mikorobe zireremba mu muhanda zidashobora kubona ahantu zishobora gukurira. Ibi bivuze ko icyumba gifite umuvuduko mubi kuri uwo muhanda. Ku miti idasesagura (yatunganyijwe), idasesagura cyangwa ifite umutwaro muto w'ibinyabuzima n'imiti y'amazi, mikorobe akenshi zibona imiterere ishyigikira aho zishobora gukurira, cyangwa mu gihe hari imiti idasesagura, mikorobe imwe ishobora guteza akaga. Kubwibyo, iyi mikorobe akenshi iba ifite imihanda yanduye kuko intego ari ukurinda mikorobe zishobora gukwirakwira mu cyumba gisukuye.
Igihe cyo kohereza: Gashyantare-20-2025