1. Injongo: Le nkqubo ijolise ekuboneleleni ngenkqubo esemgangathweni yokusebenza kwe-aseptic kunye nokukhuselwa kwamagumbi angenazintsholongwane.
2. Umda wesicelo: ilabhoratri yovavanyo lwebhayoloji
3. Umntu onoxanduva: QC Supervisor Tester
4.Ingcaciso: Akukho
5. Amanyathelo okhuseleko
Yenza ngokungqongqo imisebenzi ye-aseptic ukuthintela ukungcoliseka kwe-microbial;abasebenzi kufuneka bacime isibane se-UV phambi kokuba bangene kwigumbi elingenazintsholongwane.
6.Iinkqubo
6.1.Igumbi elingenazintsholongwane kufuneka lixhotyiswe ngegumbi lokusebenza elingenazintsholongwane kunye negumbi le-buffer.Ukucoceka kwegumbi lokusebenza oyinyumba kufuneka kufikelele kwiklasi ye-10000. Ukushisa kwangaphakathi kufuneka kugcinwe kwi-20-24 ° C kwaye umswakama kufuneka ugcinwe kwi-45-60%.Ukucoceka kwebhentshi ecocekileyo kufuneka kufikelele kwiklasi ye-100.
6.2.Igumbi elingenazintsholongwane kufuneka ligcinwe licocekile, kwaye akuvumelekanga ngokungqongqo ukufumba inkunkuma ukuze kuthintelwe ukosuleleka.
6.3.Ukuthintela ngokungqongqo ukosuleleka kwazo zonke izixhobo zokuvala inzala kunye nemidiya yenkcubeko.Abo bangcolisekileyo kufuneka bayeke ukuzisebenzisa.
6.4.Igumbi elingenazintsholongwane kufuneka lixhotyiswe ngee-disinfectants ezisebenzayo, ezifana ne-5% yesisombululo se-cresol, i-70% yotywala, i-0.1% isisombululo se-chlormethionine, njl.
6.5.Igumbi elingenazintsholongwane kufuneka licocwe rhoqo kwaye licocwe ngesibulali ntsholongwane esifanelekileyo ukuqinisekisa ukuba ucoceko lwegumbi elingenazintsholongwane luyahlangabezana neemfuno.
6.6.Zonke izixhobo, izixhobo, izitya kunye nezinye izinto ezifuna ukungeniswa kwigumbi elingenazintsholongwane kufuneka zisongelwe ngokuqinileyo kwaye zicolwe ngeendlela ezifanelekileyo.
6.7.Phambi kokuba bangene kwigumbi elingenazintsholongwane, abasebenzi kufuneka bahlambe izandla zabo ngesepha okanye ngesibulali-ntsholongwane, emva koko batshintshe banxibe iimpahla ezikhethekileyo zomsebenzi, izihlangu, iminqwazi, iimaski kunye neeglavu kwigumbi elingenazintsholongwane (okanye bosule izandla zabo nge-ethanol engama-70%) phambi kokuba bangene kwigumbi elingenazintsholongwane.Yenza imisebenzi kwigumbi lebhaktheriya.
6.8.Ngaphambi kokusebenzisa igumbi elingenazintsholongwane, isibane se-ultraviolet kwigumbi elingenazintsholongwane kufuneka sivulwe ukuze kufakwe iradiation kunye nokuvala inzala ngaphezu kwemizuzu engama-30, kwaye ibhentshi ecocekileyo kufuneka ivulwe ukuvuthela komoya ngaxeshanye.Emva kokuba utyando lugqityiwe, igumbi eliyinyumba kufuneka licocwe kwangethuba kwaye emva koko licocwe ngokukhanya kwe-ultraviolet imizuzu engama-20.
6.9.Phambi kokuhlolwa, ukupakishwa kwangaphandle kwesampulu yovavanyo kufuneka kugcinwe kucocekile kwaye akufuneki kuvulwe ukunqanda ungcoliseko.Ngaphambi kokuhlolwa, sebenzisa i-70% yeebhola zomqhaphu zotywala ukuze ubulale iintsholongwane kumphezulu ongaphandle.
6.10.Ngexesha lomsebenzi ngamnye, ulawulo olubi kufuneka lwenziwe ukujonga ukuthembeka kokusebenza kwe-aseptic.
6.11.Xa ufunxa ulwelo lwebhaktiriya, kufuneka usebenzise ibhola yokufunxa ukuyifunxa.Musa ukubamba umququ ngqo ngomlomo wakho.
6.12.Inaliti yokutofa kufuneka icocwe ngedangatye phambi nasemva kokusetyenziswa ngakunye.Emva kokupholisa, inkcubeko inokugonywa.
6.13.Iindiza, iityhubhu zokuvavanya, izitya zepetri kunye nezinye izitya eziqulethe ulwelo lwebhaktiriya kufuneka zifakwe kwibhakethi yokuvala inzala ene-5% yesisombululo se-Lysol sokubulala iintsholongwane, kwaye ikhutshwe kwaye ihlanjululwe emva kweeyure ezingama-24.
6.14.Ukuba kukho ulwelo lwebhaktheriya echithwe kwitafile okanye emgangathweni, kufuneka ugalele ngokukhawuleza isisombululo se-5% ye-carbolic acid okanye i-3% ye-Lysol kwindawo engcolileyo ubuncinane imizuzu engama-30 ngaphambi kokuyinyanga.Xa iimpahla zokusebenza kunye neminqwazi yosulelwe yi-bacterial fluid, kufuneka ikhutshwe ngokukhawuleza kwaye ihlanjwe emva koxinzelelo oluphezulu lwe-sterilization.
6.15.Zonke izinto ezinebhaktheriya ephilayo kufuneka zibulawe iintsholongwane phambi kokuba zihlanjwe phantsi kwempompo.Akuvumelekanga ngokungqongqo ukungcolisa umjelo ophantsi komhlaba ohambisa amanzi amdaka.
6.16.Inani leekoloni kwigumbi elingenazintsholongwane kufuneka lijongwe ngenyanga.Ngebhentshi ecocekileyo evuliweyo, thatha inani lezitya zepetri ezinobukhulu obuphakathi obuyi-90 mm, kwaye utofe nge-aseptically malunga ne-15 ml yezondlo ze-agar medium medium enyibilikisiweyo kwaye yapholiswa malunga ne-45°C.Emva kokuqina, yibeke ijongise ezantsi kuma-30 ukuya kuma-35 Fudumeza iiyure ezingama-48 kwi-incubator engu-℃.Emva kokubonisa ubunyumba, thatha iipleyiti ezi-3 ukuya kwezi-5 kwaye uzibeke ekhohlo, phakathi nasekunene kwendawo yokusebenza.Emva kokuvula isigqubuthelo kunye nokutyhila imizuzu engama-30, zibeke phezulu kwi-incubator ye-30 ukuya kwi-35 ° C iiyure ezingama-48 kwaye uzikhuphe.hlola.Inani eliqhelekileyo leebhaktheriya ezixubileyo kwi-plate kwiklasi ye-100 indawo ecocekileyo ayiyi kudlula i-coloni ye-1, kwaye inani eliqhelekileyo kwiklasi ye-10000 igumbi elicocekileyo aliyi kudlula iikholoni ezi-3.Ukuba umda ugqithisiwe, igumbi elingenazintsholongwane kufuneka lihlanjululwe ngokucokisekileyo i-disinfected de ukuhlolwa okuphindaphindiweyo kuhlangabezane neemfuno.
7. Bhekisela kwisahluko (iNdlela yoHlolo lweSterility) kwi "Iindlela zokuHlola iDrug Hygienic Inspection" kunye ne "China Standard Operating Practices for Inspection of Drug".
8. ISebe loSasazo: iSebe loLawulo loMgangatho
Igumbi elicocekileyo lesikhokelo sobugcisa:
Emva kokufumana indawo engcolileyo kunye nezixhobo ezingcolileyo, kufuneka sigcine imeko engcolileyo ukuze sifunde i-microorganism ethile eyaziwayo okanye ukusebenzisa imisebenzi yabo.Ngaphandle koko, ii-microorganisms ezahlukeneyo ezivela ngaphandle zinokuxubana ngokulula. Isenzeko sokuxutywa kwee-microorganisms ezingabalulekanga ezivela ngaphandle kuthiwa yi-bacteria engcolisayo kwi-microbiology.Ukuthintela ungcoliseko yindlela ebalulekileyo kumsebenzi we-microbiological.Ukuvala inzala ngokupheleleyo kwelinye icala kunye nokuthintela ukosuleleka kwelinye yimiba emibini yobuchule be-aseptic.Ukongeza, kufuneka sithintele ii-microorganisms eziphantsi kophononongo, ngakumbi ii-microorganisms ze-pathogenic okanye ii-microorganisms ezenziwe ngofuzo ezingekho kwindalo, ekubalekeni kwizikhongozelo zethu zokulinga ukuya kwindawo yangaphandle.Ngezi njongo, kwi-microbiology, kukho imilinganiselo emininzi.
Igumbi elingenazintsholongwane lidla ngokuba ligumbi elincinci elimiswe ngokukodwa kwilebhu ye-microbiology.Inokwakhiwa ngamashiti kunye neglasi.Ummandla akufanele ube mkhulu kakhulu, malunga ne-4-5 square metres, kwaye ukuphakama kufuneka kube malunga neemitha ezi-2.5.Igumbi le-buffer kufuneka limiswe ngaphandle kwegumbi elingenazintsholongwane.Ucango lwegumbi lesithinteli kunye nocango lwegumbi elingenazintsholongwane akufuneki lujonge kwicala elinye ukuthintela ukuphuma komoya ekungeniseni iibhaktheriya ezahlukeneyo.Zombini igumbi elingenazintsholongwane kunye negumbi le-buffer kufuneka lingangeni moya.Izixhobo zokungenisa umoya zangaphakathi kufuneka zibe nezixhobo zokucoca umoya.Umgangatho kunye neendonga zegumbi elingenazintsholongwane kufuneka zibe mpuluswa, kube nzima ukugcina ukungcola kwaye kulula ukucoceka.Umphezulu womsebenzi kufuneka ube kwinqanaba.Zombini igumbi elingenazintsholongwane kunye negumbi le-buffer lixhotyiswe ngezibane ze-ultraviolet.Izibane ze-ultraviolet kwigumbi elingenazintsholongwane ziyimitha eyi-1 ukusuka kumphezulu womsebenzi.Abasebenzi abangena kwigumbi elingenazintsholongwane kufuneka banxibe iimpahla ezizintsholongwane kunye neminqwazi.
Okwangoku, amagumbi angenazintsholongwane ahlala kwiifektri ze-microbiology, ngelixa iilabhoratri eziqhelekileyo zisebenzisa ibhentshi ecocekileyo.Umsebenzi ophambili webhentshi ecocekileyo kukusebenzisa isixhobo sokuhamba komoya se-laminar ukususa uthuli oluncinci oluhlukeneyo kubandakanya ii-microorganisms kumphezulu womsebenzi.Isixhobo sombane sivumela umoya ukuba udlule kwisihluzo se-hepa uze ungene kumphezulu womsebenzi, ukuze umphezulu womsebenzi uhlale ugcinwe phantsi kolawulo lokuqukuqela komoya oyinyumba.Ngaphezu koko, kukho umkhusane womoya onesantya esiphezulu kwicala elikufutshane nangaphandle ukuthintela ukungena komoya webhaktiriya wangaphandle.
Kwiindawo ezineemeko ezinzima, iibhokisi zamaplanga ezingenazintsholongwane zinokusetyenziswa endaweni yebhentshi ecocekileyo.Ibhokisi eyinyumba inesakhiwo esilula kwaye kulula ukuyihambisa.Kukho imingxunya emibini phambi kwebhokisi, evalwe ziingcango zokutyhala xa ingasebenzi.Unokwandisa iingalo zakho ngexesha lokusebenza.Inxalenye ephezulu yangaphambili ixhotyiswe ngeglasi ukuququzelela ukusebenza kwangaphakathi.Kukho isibane se-ultraviolet ngaphakathi kwebhokisi, kwaye izitya kunye neebhaktheriya zinokufakwa ngomnyango omncinci kwicala.
Ubuchule bokusebenza be-Aseptic okwangoku abudlali kuphela indima ebalulekileyo kuphando lwe-microbiological kunye nokusetyenziswa, kodwa zikwasetyenziswa ngokubanzi kwi-biotechnologies ezininzi.Ngokomzekelo, iteknoloji ye-transgenic, iteknoloji ye-antibody ye-monoclonal, njl.
Ixesha lokuposa: Mar-06-2024