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KUBALULEKILE KOKUKHONZA AMANQAKU EGUMBI LOKUHLANZA

igumbi elihlanzekile
uhlelo lwegumbi lokuhlanza

Kunemithombo emibili eyinhloko yokungcola ekamelweni elihlanzekile: izinhlayiya nama-microorganisms, okungabangelwa izici zomuntu nezemvelo, noma imisebenzi ehlobene kule nqubo. Naphezu kwemizamo emihle kakhulu, ukungcola kusazongena endlini ehlanzekile. Izithwali zokungcola ezivamile zifaka imizimba yabantu (amaseli, izinwele), izici zemvelo ezifana nothuli, intuthu, inkungu noma amathuluzi (impahla yaselabhorethri, okokuhlanza), nezindlela zokusula ezingafanele nezindlela zokuhlanza.

Umthwali wokungcola ovame kakhulu ngabantu. Ngisho nezingubo eziqinile kakhulu nezinqubo zokusebenza eziqinile, abaqhubi abangaqeqeshwanga kahle bawusongo olukhulu lokungcola endlini ehlanzekile. Izisebenzi ezingalandeli iziqondiso zegumbi lokuhlanza ziyisici esiyingozi kakhulu. Uma nje isisebenzi esisodwa senza iphutha noma sikhohlwe isinyathelo, lokho kuzoholela ekungcolisweni kwalo lonke igumbi elihlanzekile. Inkampani ingaqinisekisa kuphela ukuhlanzeka kwegumbi elihlanzekile ngokuqapha okuqhubekayo kanye nokubuyekezwa okuqhubekayo kokuqeqeshwa ngenani lokungcoliswa elinguziro.

Eminye imithombo emikhulu yokungcola ngamathuluzi nemishini. Uma inqola noma umshini wesulwa kuphela ngaphambi kokungena egumbini elihlanzekile, ungase ulethe amagciwane. Imvamisa, abasebenzi abazi ukuthi okokusebenza okunamasondo kugingqika ezindaweni ezingcolile njengoba kuphushelwa endlini ehlanzekile. Indawo engaphezulu (okuhlanganisa iphansi, izindonga, okokusebenza, njll.) ihlolwa njalo ukuze ikwazi ukubala kusetshenziswa amapuleti okuxhumana aklanywe ngokukhethekile aqukethe imidiya yokukhula efana ne-Trypticase Soy Agar (TSA) ne-Sabouraud Dextrose Agar (SDA). I-TSA iyindawo yokukhula eyenzelwe amagciwane, futhi i-SDA iyindawo yokukhula eklanyelwe isikhunta nama-yeast. I-TSA ne-SDA ngokuvamile zifukanyelwa emazingeni okushisa ahlukene, i-TSA ichayeke emazingeni okushisa ebangeni elingu-30-35˚C, okuyizinga lokushisa elilungile lokukhula kwamagciwane amaningi. Ububanzi obungu-20-25˚C bulungele izinhlobo eziningi zesikhunta nemvubelo.

Ukugeleza komoya kwaba yimbangela evamile yokunukubezeka, kodwa amasistimu anamuhla e-HVAC ahlanzekile acishe aqeda ukungcoliswa komoya. Umoya osegumbini elihlanzekile ulawulwa futhi ugadwe njalo (isb., nsuku zonke, maviki onke, ngekota) ngezibalo zezinhlayiya, ukubala okusebenzayo, izinga lokushisa, kanye nomswakama. Izihlungi ze-HEPA zisetshenziselwa ukulawula isibalo sezinhlayiyana ezisemoyeni futhi zibe nekhono lokuhlunga izinhlayiya zehle ziye ku-0.2µm. Lezi zihlungi ngokuvamile zigcinwa zisebenza ngokuqhubekayo ngezinga lokugeleza elilinganiselwe ukuze kugcinwe ikhwalithi yomoya egumbini. Umswakamo uvamise ukugcinwa usezingeni eliphansi ukuze kuvinjwe ukwanda kwama-microorganisms afana namagciwane kanye nesikhunta esikhetha indawo enomswakama.

Eqinisweni, izinga eliphezulu kakhulu kanye nomthombo ovame kakhulu wokungcola endaweni yokuhlanza u-opharetha.

Imithombo kanye nezindlela zokungena zokunukubezeka azihlukani kakhulu nezimboni, kodwa kunomehluko phakathi kwezimboni ngokwamazinga okungcola angabekezeleleka futhi angabekezeleleki. Isibonelo, abakhiqizi bamaphilisi angenakudliwa akudingeki bagcine izinga lokuhlanzeka elifanayo njengabakhiqizi bama-ejenti angenayo afakwa ngokuqondile emzimbeni womuntu.

Abakhiqizi bemithi banokubekezelelana okuphansi kokungcoliswa kwamagciwane kunabakhiqizi be-elekthronikhi abasezingeni eliphezulu. Abakhiqizi be-semiconductor abakhiqiza imikhiqizo encane kakhulu abakwazi ukwamukela noma yikuphi ukungcoliswa kwe-particle ukuze baqinisekise ukusebenza komkhiqizo. Ngakho-ke, lezi zinkampani zikhathazeke kuphela ngobunyumba bomkhiqizo ozofakwa emzimbeni womuntu kanye nokusebenza kwe-chip noma umakhalekhukhwini. Abanandaba kangako nesikhunta, ukhunta noma ezinye izinhlobo zokungcoliswa kwamagciwane endaweni ehlanzekile. Ngakolunye uhlangothi, izinkampani ezenza imithi zikhathazeke ngayo yonke imithombo ephilayo nefile yokungcola.

Imboni yezemithi ilawulwa yi-FDA futhi kufanele ilandele ngokuqinile imithethonqubo yeGood Manufacturing Practices (GMP) ngoba imiphumela yokungcola embonini yezemithi iyingozi kakhulu. Akukhona nje kuphela ukuthi abakhiqizi bezidakamizwa kufanele baqinisekise ukuthi imikhiqizo yabo ayinamagciwane, kudingeka futhi babe nemibhalo kanye nokulandelelwa kwayo yonke into. Inkampani yemishini yobuchwepheshe obuphezulu ingathumela ikhompuyutha ephathekayo noma i-TV inqobo nje uma idlulisa ucwaningo lwayo lwangaphakathi. Kodwa akulula kangako embonini yezemithi, yingakho kubalulekile ukuthi inkampani ibe nayo, isebenzise futhi ibhale phansi izinqubo zokusebenza zegumbi lokuhlanza. Ngenxa yokucatshangelwa kwezindleko, izinkampani eziningi ziqasha izinsizakalo zokuhlanza ezichwepheshile zangaphandle ukuze zenze izinsiza zokuhlanza.

Uhlelo olubanzi lokuhlola imvelo yegumbi elihlanzekile kufanele lufake izinhlayiya ezibonakalayo nezingabonakali zomoya. Nakuba kungekho sidingo sokuthi zonke izinto ezingcolisayo kulezi zindawo ezilawulwayo zihlonzwe ama-microorganisms. Uhlelo lokulawula imvelo kufanele lubandakanye izinga elifanele lokuhlonza ibhaktheriya lesampula elikhishwe. Ziningi izindlela zokuhlonza amagciwane ezitholakalayo njengamanje.

Isinyathelo sokuqala ekuhlonzweni kwebhaktheriya, ikakhulukazi uma kuziwa ekuhlukaniseni i-cleanroom, indlela ye-Gram stain, njengoba inganikeza izinkomba ezichaza umthombo wokungcola kwamagciwane. Uma ukuhlukaniswa kwe-microbial kanye nokuhlonza kubonisa i-Gram-positive cocci, ukungcola kungenzeka ukuthi kuvela kubantu. Uma ukuhlukaniswa kwe-microbial kanye nokuhlonza kubonisa izinduku ezine-Gram-positive, ukungcola kungase kuvele othulini noma ezinhlobonhlobo ezimelana nezibulala-magciwane. Uma ukuhlukaniswa kwe-microbial kanye nokuhlonza kubonisa ama-Gram-negative rod, umthombo wokungcola kungenzeka ukuthi uvela emanzini noma kunoma iyiphi indawo emanzi.

Ukuhlonza amagciwane endaweni ehlanzekile yezemithi kuyadingeka kakhulu ngoba kuhlobene nezici eziningi zokuqinisekiswa kwekhwalithi, njengama-bioassays ezindaweni zokukhiqiza; ukuhlolwa kokuhlonza amagciwane emikhiqizweni yokugcina; izinto eziphilayo ezingashiwongo emikhiqizweni eyinyumba nasemanzini; ukulawulwa kwekhwalithi yobuchwepheshe bokugcina ukuvutshelwa embonini ye-biotechnology; kanye nokuqinisekiswa kokuhlolwa kwe-microbial ngesikhathi sokuqinisekisa. Indlela ye-FDA yokuqinisekisa ukuthi amagciwane angaphila endaweni ethile izovame ukwanda. Lapho amazinga okungcoliswa kwe-microbial edlula izinga elishiwo noma imiphumela yokuhlolwa kwe-sterility ikhombisa ukungcola, kuyadingeka ukuthi kuqinisekiswe ukusebenza kahle kokuhlanza nokubulala amagciwane futhi kuqedwe ukukhonjwa kwemithombo yokungcola.

Kunezindlela ezimbili zokuqapha izindawo zemvelo ezihlanzekile:

1. Amapuleti okuxhumana

Lezi zitsha ezikhethekile zesiko ziqukethe isikhungo sokukhula esiyinyumba, esilungiselelwe ukuba sibe phezulu kunomkhawulo wesitsha. Isembozo sepuleti lokuxhumana simboza indawo okumele ithathwe isampula, futhi noma yimaphi ama-microorganisms abonakala phezulu azonamathela endaweni ye-agar futhi afukamele. Le nqubo ingabonisa inani lama-microorganisms abonakalayo endaweni.

2. Indlela ye-Swab

Lokhu kuyinyumba futhi kugcinwa oketshezini olufanelekile oluyinyumba. I-swab isetshenziswa endaweni yokuhlola futhi i-microorganism ibonakala ngokubuyisela i-swab phakathi nendawo. Ama-swabs avame ukusetshenziswa ezindaweni ezingalingani noma ezindaweni okunzima ukuzisampula ngepuleti lokuxhumana. Ukusampula kwe-swab kuwukuhlolwa kwekhwalithi.


Isikhathi sokuthumela: Oct-21-2024
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