1. Chinangwa: Iyi nzira ine chinangwa chekupa maitiro akaenzana ekushandiswa kweaseptic uye kudzivirira kwemakamuri asina hutachiona.
2. Chikamu chekushandiswa: biological test laboratory
3. Munhu ane mutoro: QC Supervisor Tester
4.Tsanangudzo: Hapana
5. Kuchengetedza kuchengetedza
Kunyatsoita maseptic mashandiro kudzivirira kusvibiswa kwehutachiona;vanoshanda vanofanira kudzima mwenje weUV vasati vapinda mukamuri isina utachiona.
6.Maitiro
6.1.Imba isina mbereko inofanirwa kunge ine imba yekuvhiya isina hutachiona uye bhafa.Kuchena kwekamuri yekushanda isina utachiona inofanira kusvika kukirasi 10000. Kupisa kwemukati kunofanira kuchengetedzwa pa 20-24 ° C uye hunyoro hunofanira kuchengetedzwa pa45-60%.Kuchena kwebhenji rakachena kunofanira kusvika mukirasi ye100.
6.2.Imba isina utachiona inofanira kugara yakachena, uye inorambidzwa zvachose kuunganidza marara kudzivirira kusvibiswa.
6.3.Kunyatsodzivirira kusvibiswa kwese sterillization zvishandiso uye tsika media.Avo vakasvibiswa vanofanira kurega kuashandisa.
6.4.Imba isina mbereko inofanirwa kuve nemishonga yekuuraya utachiona, senge 5% cresol solution, 70% doro, 0.1% chlormethionine solution, nezvimwe.
6.5.Imba isina utachiona inofanira kugara ichicheneswa uye kucheneswa nemishonga inouraya utachiona yakakodzera kuti ive nechokwadi chekuti hutsanana hwekamuri ine utachiona hunoenderana nezvinodiwa.
6.6.Zvese zviridzwa, zviridzwa, ndiro uye zvimwe zvinhu zvinoda kuunzwa mukamuri isina utachiona zvinofanirwa kuputirwa zvakasimba uye kuvharirwa nenzira dzakakodzera.
6.7.Vasati vapinda mukamuri isina utachiona, vashandi vanofanira kugeza maoko avo nesipo kana mushonga wekuuraya utachiona, vobva vachinja kuva mbatya dzebasa dzakakosha, shangu, ngowani, masiki uye magirovhosi mukamuri rebuffer (kana kupukuta maoko avo zvakare ne70% ethanol) vasati vapinda mukamuri isina utachiona.Ita maoparesheni mukamuri yebhakitiriya.
6.8.Usati washandisa kamuri isina hutachiona, mwenje weultraviolet mukamuri isina hutachiona unofanirwa kubatidzwa kuti uvheneke uye uvhare maminetsi anopfuura makumi matatu, uye bhenji rakachena rinofanira kubatidzwa kuti mweya uvhuvhute panguva imwe chete.Mushure mekuvhiyiwa kwapera, imba isina hutachiona inofanira kucheneswa nenguva uye yozoitwa sterilized ne ultraviolet mwenje kwemaminitsi makumi maviri.
6.9.Asati aongororwa, kurongedza kwekunze kweye sampuli kunofanirwa kuchengetedzwa uye hakufanirwe kuvhurwa kudzivirira kusvibiswa.Usati waongorora, shandisa 70% doro donje mabhora kuti ubvise hutachiona hwekunze.
6.10.Panguva yekushanda kwega kwega, kutonga kusina kunaka kunofanira kuitwa kutarisa kuvimbika kweaseptic operation.
6.11.Paunenge uchitora mvura yebhakitiriya, unofanirwa kushandisa bhora rekusveta kuti uibate.Usabata sadza nemuromo wako.
6.12.Iyo tsono inoculation inofanira kucheneswa nemoto pamberi uye mushure mekushandisa kwega kwega.Mushure mekutonhora, tsika inogona kuiswa inoculated.
6.13.Mashanga, machubhu ekuyedza, midziyo yepetri nemimwe midziyo ine mvura ine utachiona inofanira kunyikwa mubhaketi rekuuraya utachiona rine 5% mushonga weLysol wekuuraya utachiona, uye woburitswa wosukurudzwa mushure memaawa makumi maviri nemana.
6.14.Kana patafura kana pasi paine mvura yebhakitiriya, unofanira kubva wadira 5% carbolic acid solution kana 3% Lysol panzvimbo ine utachiona kwemaminitsi makumi matatu usati wairapa.Kana zvipfeko zvebasa neheti zvakasvibiswa nehutachiona hwehutachiona, zvinofanirwa kubviswa nekukurumidza uye kugezwa mushure mekudzvanywa kwemhepo.
6.15.Zvinhu zvese zvine mabhakitiriya mhenyu zvinofanirwa kuvharirwa utachiona zvisati zvasukwa pasi pepombi.Zvinorambidzwa zvachose kusvibisa seweji.
6.16.Huwandu hwemakoloni mukamuri isina utachiona hunofanirwa kuongororwa mwedzi wega wega.Nebhenji rakachena rakavhurika, tora madhishi akati wandei ane dhayamita ye90 mm, wobaya jekiseni zvine mutsindo 15 ml yezvinovaka muviri agar culture medium yakanyungudutswa nekutonhodzwa kusvika 45°C.Mushure mekuoma, isai yakatsikitsira pasi pa 30 kusvika 35 Incubate kwemaawa makumi mana nemasere mu ℃ incubator.Mushure mekuratidza sterility, tora 3 kusvika ku5 mahwendefa uye uise kuruboshwe, pakati nekurudyi kwenzvimbo yekushanda.Mushure mekuvhura chivharo nekuvafumura kwemaminetsi makumi matatu, zviise zvakatsikitsira pasi muincubator ye30 kusvika 35 ° C kwemaawa makumi mana nemasere uye uzvibudise.kuongorora.Avhareji yenhamba yemabhakitiriya akasiyana-siyana pandiro mukirasi ye100 nzvimbo yakachena haifaniri kudarika 1 koloni, uye nhamba yevhareji mukirasi 10000 yakachena imba haifaniri kudarika 3 makoloni.Kana muganho ukapfuudzwa, imba isina utachiona inofanira kunyatso shandiswa disinfected kudzamara kuongororwa kwakadzokororwa kwazadzisa zvinodiwa.
7. Tarisa kuchitsauko (Sterility Inspection Method) mu "Drug Hygienic Inspection Methods" uye "China Standard Operating Practices for Drug Inspection".
8. Dhipatimendi Rokugovera: Dhipatimendi reKubata Kwehutano
Yakachena kamuri yehunyanzvi kutungamira:
Mushure mekuwana nharaunda isina hutachiona uye zvinhu zvisina hutachiona, isu tinofanirwa kuchengetedza nyika isina hutachiona kuitira kuti tidzidze chaiyo inozivikanwa microorganism kana kushandisa mabasa ayo.Zvikasadaro, tupukanana twakasiyana-siyana kubva kunze hunogona kusanganiswa zviri nyore. Chiitiko chekusanganiswa kwezvipembenene zvisina basa kubva kunze kunonzi kusvibisa mabhakitiriya mune microbiology.Kudzivirira kusvibiswa inzira yakakosha mubasa remicrobiological.Kuzadza sterilization kune rimwe ruoko uye kudzivirira kusvibiswa kune rimwe mativi maviri emaitiro aseptic.Pamusoro pezvo, tinofanira kudzivirira utachiona huri pasi pekudzidza, kunyanya pathogenic microorganisms kana genetically engineered microorganisms izvo zvisipo mumasikirwo, kutiza kubva mumidziyo yedu yekuyedza kuenda kunze kwezvakatipoteredza.Nezvinangwa izvi, mune microbiology, kune akawanda matanho.
Kamuri isina mbereko kazhinji kakamuri kadiki kakamisikidzwa murabhoritari yemicrobiology.Inogona kugadzirwa nemashizha negirazi.Nzvimbo yacho haifanire kunge yakakura, inenge 4-5 square metres, uye kureba kunofanira kunge kuri 2.5 metres.Imba yebhafa inofanirwa kugadzikwa kunze kwekamuri isina hutachiona.Gonhi rekamuri yebhafa nemusuwo wekamuri isina utachiona hazvifanirwe kutarisana negwara rimwe chete kudzivirira kuyerera kwemhepo kubva pakuunza mabhakitiriya akasiyana.Imba yese ine sterile room nebuffer room inofanirwa kunge isina mhepo.Indoor ventilation equipment inofanirwa kunge iine air filtration devices.Pasi uye madziro ekamuri isina utachiona inofanira kunge yakatsetseka, yakaoma kuchengeta tsvina uye nyore kuchenesa.Nzvimbo yebasa inofanira kunge yakaenzana.Ese ari maviri sterile room uye buffer room ane ultraviolet mwenje.Mwenje ye ultraviolet mukamuri isina hutachiona ndeye 1 mita kubva panzvimbo yebasa.Vashandi vanopinda mukamuri isina utachiona vanofanira kupfeka hanzu dzine utachiona neheti.
Parizvino, makamuri asina kuchena anowanikwa mumafekitori emicrobiology, nepo marabhoritari akajairwa anoshandisa bhenji rakachena.Basa guru rebhenji rakachena kushandisa laminar kuyerera kwemhepo mudziyo kubvisa akasiyana madiki madiki anosanganisira ma microorganisms ari pabasa.Chigadzirwa chemagetsi chinobvumira mweya kupfuura nehepa sefa uye wobva wapinda panzvimbo yebasa, kuitira kuti nzvimbo yebasa igare yakachengetwa pasi pekutonga kwemhepo inoyerera isina kuchena.Uyezve, kune chidzitiro chemhepo chepamusoro-soro padivi padyo nekunze kudzivirira mhepo yekunze yebhakitiriya kupinda.
Munzvimbo dzine mamiriro ezvinhu akaoma, mabhokisi emapuranga asingabereki anogona kushandiswawo panzvimbo pebhenji rakachena.Bhokisi risingabereki rine chimiro chakareruka uye chiri nyore kufamba.Kune maburi maviri kumberi kwebhokisi, ayo anovharika nekusundidzira-kudhonza magonhi kana isiri kushanda.Iwe unogona kutambanudza maoko ako mukati panguva yekushanda.Chikamu chepamusoro chepamberi chakashongedzerwa negirazi kuti chifambise kushanda kwemukati.Kune mwenje we ultraviolet mukati mebhokisi, uye midziyo nemabhakitiriya zvinogona kuiswa mukati nemusuwo diki padivi.
Aseptic maitiro ekushandisa parizvino haangoite basa rakakosha mukutsvagisa microbiological uye mashandisirwo, asi zvakare anoshandiswa zvakanyanya mumazhinji biotechnologies.Semuenzaniso, transgenic tekinoroji, monoclonal antibody tekinoroji, nezvimwe.
Nguva yekutumira: Mar-06-2024