1. Inhloso: Le nqubo ihlose ukuhlinzeka ngenqubo ejwayelekile yokusebenza kwe-aseptic kanye nokuvikela amakamelo angcolile.
2. Ububanzi bokusetshenziswa: ilabhorethri yokuhlola izinto eziphilayo
3. Umuntu Onomthwalo Wemfanelo: Umhloli Womphathi we-QC
4. Incazelo: Akukho
5. Izinyathelo zokuphepha
Yenza imisebenzi engasasebenzi kahle ukuvimbela ukungcoliswa kwamagciwane; abaqhubi kufanele bacime isibani se-UV ngaphambi kokungena egumbini elihlanzekile.
6. Izinqubo
6.1. Igumbi elihlanzekile kufanele libe negumbi lokusebenzela elihlanzekile kanye negumbi lokuphumula. Ukuhlanzeka kwegumbi lokusebenzela elihlanzekile kufanele kufinyelele ku-class 10000. Izinga lokushisa langaphakathi kufanele ligcinwe ku-20-24°C kanye nomswakama kufanele kugcinwe ku-45-60%. Ukuhlanzeka kwebhentshi elihlanzekile kufanele kufinyelele ku-class 100.
6.2. Igumbi elihlanzekile kufanele ligcinwe lihlanzekile, futhi akuvunyelwe ngokuphelele ukuqoqa imfucuza ukuze kuvinjelwe ukungcola.
6.3. Vimbela ngokuqinile ukungcoliswa kwayo yonke imishini yokubulala amagciwane kanye nemithombo yokukhulisa. Labo abangcolisiwe kufanele bayeke ukuyisebenzisa.
6.4. Igumbi elihlanzekile kufanele lifakwe izibulali-magciwane ezisebenza ngokugcwele, njengesixazululo se-cresol esingu-5%, i-alcohol engu-70%, isixazululo se-chlormethionine esingu-0.1%, njll.
6.5. Igumbi elihlanzekile kufanele lihlanzwe njalo ngesibulali-magciwane esifanele ukuqinisekisa ukuthi ukuhlanzeka kwegumbi elihlanzekile kuhlangabezana nezidingo.
6.6. Zonke izinto zokusetshenziswa, izinto zokusetshenziswa, izitsha nezinye izinto okudingeka zilethwe ekamelweni elingcolile kufanele ziboshwe kahle futhi zihlanzwe ngezindlela ezifanele.
6.7. Ngaphambi kokungena egumbini elihlanzekile, abasebenzi kumele bahlanze izandla zabo ngensipho noma ngesibulala-magciwane, bese beshintsha izingubo zomsebenzi ezikhethekile, izicathulo, izigqoko, imaski namagilavu egumbini elinomoya opholile (noma basule izandla zabo futhi nge-ethanol engu-70%) ngaphambi kokungena egumbini elihlanzekile. Yenza imisebenzi ekamelweni elihlanzekile.
6.8. Ngaphambi kokusebenzisa igumbi elihlanzekile, isibani se-ultraviolet ekamelweni elihlanzekile kumele sivulwe ukuze sikhanyiselwe futhi sihlanzwe amagciwane isikhathi esingaphezu kwemizuzu engama-30, futhi ibhentshi elihlanzekile kumele livulwe ukuze kuphefumulelwe umoya ngesikhathi esifanayo. Ngemva kokuba umsebenzi usuqediwe, igumbi elihlanzekile kufanele lihlanzwe ngesikhathi bese lihlanzwa ngokukhanya kwe-ultraviolet imizuzu engama-20.
6.9. Ngaphambi kokuhlolwa, iphakheji yangaphandle yesampula yokuhlola kufanele igcinwe ingashintshi futhi akumele ivulwe ukuze kuvinjelwe ukungcola. Ngaphambi kokuhlolwa, sebenzisa amabhola kakotini angu-70% otshwala ukuze uhlanze ubuso bangaphandle.
6.10. Ngesikhathi sokusebenza ngakunye, kufanele kwenziwe ukulawulwa okungekuhle ukuze kuhlolwe ukuthembeka kokusebenza kwe-aseptic.
6.11. Uma umunca uketshezi olubangelwa amagciwane, kufanele usebenzise ibhola lokumunca ukuze umunce. Ungathinti utshani ngqo ngomlomo wakho.
6.12. Inaliti yokugoma kumele ihlanzwe ngelangabi ngaphambi nangemva kokusetshenziswa ngakunye. Ngemva kokupholisa, isiko lingagonywa.
6.13. Izitsha zotshani, amashubhu okuhlola, izitsha ze-petri nezinye izitsha eziqukethe uketshezi lwebhaktheriya kufanele zicwiliswe ebhakedeni lokubulala amagciwane eliqukethe isisombululo se-5% se-Lysol sokubulala amagciwane, bese zikhishwa bese zihlanzwa ngemva kwamahora angama-24.
6.14. Uma kukhona uketshezi olunegciwane oluchithekile etafuleni noma phansi, kufanele uthele ngokushesha isisombululo se-5% carbolic acid noma i-3% Lysol endaweni engcolile okungenani imizuzu engama-30 ngaphambi kokuyelapha. Uma izingubo zomsebenzi nezigqoko zingcoliswe uketshezi olunegciwane, kufanele zikhunyulwe ngokushesha bese zigezwa ngemva kokuhlanza nge-high pressure steam.
6.15. Zonke izinto eziqukethe amabhaktheriya aphilayo kumele zihlanzwe ngamagciwane ngaphambi kokuba zihlanzwe ngaphansi kompompi. Akuvunyelwe ngokuphelele ukungcolisa indle.
6.16. Inani lamakholoni egumbini elihlanzekile kufanele lihlolwe njalo ngenyanga. Uma ibhentshi livulekile, thatha izitsha eziningana ze-petri ezihlanzekile ezinobubanzi obungaphakathi obungu-90 mm, bese ufaka ngokungenamagciwane cishe u-15 ml we-nutrient agar medium encibilikisiwe futhi epholile cishe ku-45°C. Ngemva kokuqina, yibeke phansi ku-30 kuya ku-35. Faka amahora angu-48 ku-℃ incubator. Ngemva kokuqinisekisa ukuthi ayizinyumba, thatha amapuleti angu-3 kuya ku-5 bese uwabeka ngakwesobunxele, maphakathi nakwesokudla sendawo yokusebenza. Ngemva kokuvula isembozo nokuwaveza imizuzu engu-30, wabeke phansi ku-30 kuya ku-35°C incubator amahora angu-48 bese uwakhipha. Hlola. Inani elimaphakathi lamagciwane ahlukahlukene epuletini endaweni ehlanzekile yeklasi 100 akumele lidlule ikholoni eli-1, kanti inani elimaphakathi ekamelweni elihlanzekile leklasi 10000 akumele lidlule amakholoni angu-3. Uma umkhawulo udluliwe, igumbi elihlanzekile kufanele lihlanzwe kahle kuze kube yilapho ukuhlolwa okuphindaphindiwe kuhlangabezana nezidingo.
7. Bheka isahluko (Indlela Yokuhlola Inzalo) ku-"Drug Hygienic Inspection Methods" kanye ne-"China Standard Operating Practices for Drug Inspection".
8. UMnyango Wokusabalalisa: UMnyango Wokuphatha Ikhwalithi
Isiqondiso sobuchwepheshe segumbi elihlanzekile:
Ngemva kokuthola indawo engcolile nezinto ezihlanzekile, kumelwe sigcine isimo esihlanzekile ukuze sifunde i-microorganism ethile eyaziwayo noma sisebenzise imisebenzi yayo. Ngaphandle kwalokho, ama-microorganism ahlukahlukene avela ngaphandle angaxubana kalula. Isenzakalo sokuxuba ama-microorganism angabalulekile avela ngaphandle sibizwa ngokuthi ama-bacteria angcolisayo ku-microbiology. Ukuvimbela ukungcola kuyindlela ebalulekile emsebenzini we-microbiology. Ukuhlanza ngokuphelele ngakolunye uhlangothi kanye nokuvimbela ukungcola kolunye kuyizinto ezimbili zobuchwepheshe be-aseptic. Ngaphezu kwalokho, kumelwe sivimbele ama-microorganism acwaningwayo, ikakhulukazi ama-microorganism abangela izifo noma ama-microorganism athuthukiswe ngofuzo angekho emvelweni, ukuthi angaphumi ezitsheni zethu zokuhlola aye endaweni yangaphandle. Ngalezi zinhloso, ku-microbiology, kunezindlela eziningi zokulinganisa.
Igumbi elihlanzekile livame ukuba yigumbi elincane elibekwe ngokukhethekile elabhorethri ye-microbiology. Lingakhiwa ngamashidi nengilazi. Indawo akufanele ibe nkulu kakhulu, cishe amamitha-skwele angu-4-5, futhi ukuphakama kufanele kube cishe amamitha angu-2.5. Igumbi elihlanzekile kufanele libekwe ngaphandle kwegumbi elihlanzekile. Umnyango wegumbi elihlanzekile kanye nomnyango wegumbi elihlanzekile akufanele kubheke ohlangothini olufanayo ukuvimbela ukugeleza komoya ekuletheni amabhaktheriya ahlukahlukene. Kokubili igumbi elihlanzekile kanye negumbi elihlanzekile kumele kungabi nomoya. Imishini yokungenisa umoya yangaphakathi kumele ibe namadivayisi okuhlunga umoya. Iphansi kanye nezindonga zegumbi elihlanzekile kumele kube bushelelezi, kube nzima ukugcina ukungcola futhi kube lula ukukuhlanza. Indawo yokusebenza kufanele ibe yizinga. Kokubili igumbi elihlanzekile kanye negumbi elihlanzekile kufakwe izibani ze-ultraviolet. Izibani ze-ultraviolet ekamelweni elihlanzekile ziqhele ngemitha elilodwa ukusuka endaweni yokusebenza. Abasebenzi abangena ekamelweni elihlanzekile kufanele bagqoke izingubo nezigqoko ezihlanzekile.
Njengamanje, amakamelo ahlanzekile akhona kakhulu emafektri e-microbiology, kuyilapho ama-laboratory ajwayelekile esebenzisa ibhentshi elihlanzekile. Umsebenzi oyinhloko webhentshi elihlanzekile ukusebenzisa idivayisi yokugeleza komoya e-laminar ukususa uthuli oluncane oluhlukahlukene okuhlanganisa nama-microorganisms endaweni yokusebenza. Idivayisi kagesi ivumela umoya ukuthi udlule esihlungini se-hepa bese ungena endaweni yokusebenza, ukuze indawo yokusebenza ihlale ilawulwa umoya ohlanzekile ogelezayo. Ngaphezu kwalokho, kunekhethini lomoya elisheshayo ohlangothini oluseduze nangaphandle ukuvimbela umoya wangaphandle wamagciwane ukuthi ungangeni.
Ezindaweni ezinezimo ezinzima, amabhokisi ahlanzekile ngokhuni angasetshenziswa esikhundleni sebhentshi elihlanzekile. Ibhokisi elihlanzekile linesakhiwo esilula futhi kulula ukulihambisa. Kunezimbobo ezimbili ngaphambili kwebhokisi, ezivinjwe yiminyango yokusunduza uma ingasebenzi. Ungelula izingalo zakho phakathi nokusebenza. Ingxenye engenhla yangaphambili ifakwe ingilazi ukuze kube lula ukusebenza ngaphakathi. Kukhona isibani se-ultraviolet ngaphakathi kwebhokisi, futhi izitsha namagciwane kungafakwa ngomnyango omncane ohlangothini.
Amasu okusebenza kwe-Aseptic okwamanje awagcini nje ngokudlala indima ebalulekile ocwaningweni lwe-microbiological kanye nezicelo, kodwa futhi asetshenziswa kabanzi kwezobuchwepheshe be-bio. Isibonelo, ubuchwepheshe be-transgenic, ubuchwepheshe be-monoclonal antibody, njll.
Isikhathi sokuthunyelwe: Mashi-06-2024