Kunemithombo emibili eyinhloko yokungcola egumbini lokuhlanza: Izinhlayiya kanye nama-microorganisms, ezingadalwa yizici zabantu nezemvelo, noma imisebenzi ehlobene nayo kwinqubo. Naphezu kwemizamo engcono kakhulu, ukungcoliswa kusazongena endaweni ehlanzekile. Izithwali ezingcolisweni ezijwayelekile zifaka imizimba yabantu (amaseli, izinwele), izici zezemvelo ezinjengothuli, intuthu, inkungu (imishini yokuhlanza, izindlela zokuhlanza), nezindlela zokuhlanza.
Isithwali esingcolisayo esivame kakhulu ngabantu. Ngisho nezingubo eziqinile kakhulu nezinqubo ezisetshenziswayo ezisebenza kakhulu, opharetha abaqeqeshiwe ngokungafanele basongelwa olukhulu ekungcoleni egumbini lokuhlanza. Abasebenzi abangalandeli imihlahlandlela yokuhlanza bayisici esisengozini enkulu. Uma nje isisebenzi esithile senza iphutha noma sikhohlwe isinyathelo, kuzoholela ekungcoleni kwayo yonke indawo ehlanzekile. Inkampani ingaqinisekisa ukuhlanzeka kwendawo ehlanzekile ngokuqapha okuqhubekayo nokuvuselelwa okuqhubekayo kokuqeqeshwa ngezinga lokungcola okungu-zero.
Eminye imithombo emikhulu yokungcola ngamathuluzi nemishini. Uma inqola noma umshini ubhujiswa kuphela ngaphambi kokungena e-Cleanroom, kungaletha ama-microorganisms. Imvamisa, abasebenzi abazi ukuthi imishini enamasondo igingqa phezu kwezindawo ezingcolile njengoba idonswa egumbini lokuhlanza. I-Surfaces (kufaka phakathi phansi, izindonga, imishini, njll.) Zihlolwe njalo ukubalwa okusebenzayo kusetshenziswa amapuleti okuxhumana aqukethe imidiya yokuxhumana equkethe imidiya yokukhula equkethe i-agar (TSA) neSaboraud Dextrose Agar (SDA). I-TSA iyi-medium ephakathi yenzelwe ama-bacterium, futhi i-SDA i-medium ekhula eyenzelwe isikhunta nezimvubelo. I-TSA ne-SDA ngokuvamile ifakwe emazingeni okushisa ahlukene, nge-TSA evezwa amazinga okushisa kububanzi obungu-30- 35˚C, okuwukushisa okuphezulu kokukhula kwamagciwane amaningi. Uhla lwe-20-25˚C lukulungele izinhlobo eziningi zokubumba nezinhlobo zezilwane.
I-Airflow yake yaba imbangela evamile yokungcola, kepha izinhlelo zanamuhla zokuhlanza i-HVAC ziqedile ukungcoliswa komoya. Umoya osendlini ehlanzekile ulawulwa futhi ubhekwe njalo (isib., Nsuku zonke, masonto onke) sokubalwa kwezinhlayiyana, ukubalwa okusebenzayo, izinga lokushisa, kanye nomswakama. Izihlungi zeHepa zisetshenziselwa ukulawula ukubalwa kwezinhlayiya zezinhlayiya emoyeni futhi kube nekhono lokuhlunga izinhlayiya phansi ku-0,2μm. Lezi zihlungi zivame ukugcinwa zisebenza ngokuqhubekayo ngesilinganiso sokugeleza esilinganiselwe ukuze silondoloze ikhwalithi yomoya egumbini. Umswakama uvame ukugcinwa ezingeni eliphansi ukuvikela ukwanda kwama-microorganisms anjengegciwane nokubumba okukhetha izindawo ezinomswakama.
Eqinisweni, izinga eliphakeme kakhulu futhi elivame kakhulu ukungcoliswa kokungcola ku-cleanroom ngu-opharetha.
Imithombo nemizila yokungena kokungcoliswa ayiyemeki kakhulu kusuka embonini kuya embonini, kepha kunomehluko phakathi kwezimboni ngokuya ngamazinga okungcoliswa okubekezelelekayo futhi angabekezeleleki. Isibonelo, abakhiqizi bamathebhulethi angenakuthezeka abadingi ukugcina izinga elifanayo lokuhlanzeka njengabakhiqizi bama-injectable agents angeniswa ngqo emzimbeni womuntu.
Abakhiqizi bezemithi banokubekezelela okuphansi kokungcoliswa kwe-microbial kunokwenziwa nge-tech-tech kagesi. Abakhiqizi be-semicondector abakhiqiza imikhiqizo emincane abakwazi ukwamukela noma yikuphi ukungcoliswa kwenhliziyo ukuqinisekisa ukusebenza komkhiqizo. Ngakho-ke, lezi zinkampani ziphathelene kuphela nokudla komkhiqizo okufakwe emzimbeni womuntu kanye nokusebenza kwe-chip noma ifoni ephathekayo. Zikhathazekile kancane ngokubumba, ukhunta noma ezinye izindlela zokungcoliswa kwe-microbial egumbini lokuhlanza. Ngakolunye uhlangothi, izinkampani ezenza imithi zikhathazekile ngayo yonke imithombo ephilayo nefile yokungcoliswa.
Umkhakha wezemithi ulawulwa yi-FDA futhi kufanele ulandele ngokuqinile imithethonqubo yokukhiqiza (GMP) yokungcola ngoba imiphumela yokungcola embonini yezemithi ayilimazi kakhulu. Hhayi nje kuphela ukuthi abakhiqizi bezidakamizwa kufanele baqinisekise ukuthi imikhiqizo yabo ingenamagciwane, iyadingeka futhi ukuthi ibe nemibhalo nokulandela kwakho konke. Inkampani yemishini ephezulu yezobuchwepheshe ingathumela ilaptop noma i-TV inqobo nje uma idlula ukucwaningwa kwayo kwangaphakathi. Kepha akukhona lokho okulula embonini yezemithi, yingakho kubalulekile ukuthi inkampani ibe nayo, isebenzise kanye nezinqubo zokuhlanza izinqubo zokuhlanza impahla. Ngenxa yokucatshangelwa kwezindleko, izinkampani eziningi ziqasha izinsizakalo zokuhlanza ezakhi zangaphandle ukwenza izinsizakalo zokuhlanza.
Uhlelo oluphelele lokuhlola imvelo kufanele lufake izinhlayiya ezibonakalayo nezingabonakali zomoya. Yize kungekho mqondo wokuthi bonke abangcolisiwe kulezi zindawo ezilawulwayo zikhonjwe ngama-microorganisms. Uhlelo lokulawula imvelo kufanele lubandakanye izinga elifanelekile lokukhonjwa kwamagciwane kokukhishwa kwesampula. Kunezindlela eziningi zokuhlonza ama-bacterial okwamanje ezitholakalayo.
Isinyathelo sokuqala ekukhonjweni kwamagciwane, ikakhulukazi uma kukhulunywa ngokuhlanza indawo yokuhlanza indawo yokuhlala, kuyindlela yebala legramu, ngoba inganikeza imikhondo yokuhumusha emthonjeni wokungcoliswa kwe-microbial. Uma ukuhlukaniswa kwe-microbial nokukhonjwa kukhombisa i-COCCI enhle, ukungcola kungenzeka ukuthi kuvela kubantu. Uma ukuhlala kwe-microbial nokukhonjwa kukhombisa izinduku ze-gram-positive, ukungcoliswa kungenzeka ukuthi zivela othulini noma ezinkingeni ezingavikeli phansi. Uma ukuhlukaniswa kwe-microbial nokukhonjwa kukhombisa izinduku ezingezinhle, umthombo wokungcola kungenzeka uvele emanzini noma kunoma yimuphi umkhawulo wamanzi.
Ukukhonjwa kwe-Microbial egumbini lokuhlanza lezemithi kuyadingeka kakhulu ngoba kuhlobene nezici eziningi zokuqinisekiswa kwekhwalithi, njengezilwane ze-bioassations ezindaweni zokukhiqiza; Ukuhlolwa kokuhlonza amagciwane kwemikhiqizo yokuphela; izidalwa ezingenakuvinjwa emikhiqizweni yama-oyinyumba namanzi; Ukulawulwa kwekhwalithi yobuchwepheshe bokugcina bokuvutshelwa embonini ye-biotechnology; kanye nokuqinisekiswa kokuhlolwa kwe-microbial ngesikhathi sokuqinisekiswa. Indlela kaFDA yokuqinisekisa ukuthi amagciwane angaphila endaweni ethile azovame ukuvame kakhulu. Lapho amazinga okungcola ama-microbial edlula izinga elithile noma imiphumela yokuhlolwa kwezindawo ezishukumisayo akhombisa ukungcoliswa, kuyadingeka ukuqinisekisa ukusebenza kwama-ejenti wokuhlanza kanye namagciwane futhi kuqede ukukhonjwa kwemithombo yokungcolisa.
Kunezindlela ezimbili zokuqapha indawo yokuhlanza indawo yokuhlanza:
1. Amapuleti okuxhumana
Lezi zidlo zesiko ezikhethekile ziqukethe i-medile yokukhula medial, elungiselelwe ukuba ngaphezulu kunomkhawulo wendishi. Isembozo sepuleti yokuxhumana nemboza ingaphezulu ukuze ifakwe isampula, futhi noma yimaphi ama-microorganisms abonakale ebusweni azonamathela ebusweni be-agar futhi afunga. Le ndlela ingakhombisa inani lama-microorganisms abonakalayo ngaphezulu.
2. Indlela ye-SWAB
Lokhu kuyinyumba futhi kugcinwe ngoketshezi oluyinyumba olufanele. I-swab isetshenziswa endaweni yokuhlola futhi i-microorganism ikhonjwa ngokuthola kabusha i-swab in the medium. Ama-Swabs ajwayele ukusetshenziswa ezindaweni ezingalingani noma ezindaweni ezinzima ukusampula ngepuleti yokuxhumana. ISampling yeSwaB ingaphezulu kokuhlolwa okufanelekile.
Isikhathi sePosi: Oct-21-2024