1. Lub Hom Phiaj: Cov txheej txheem no yog txhawm rau muab cov txheej txheem txheej txheem rau kev ua haujlwm aseptic thiab tiv thaiv chav tsis muaj menyuam.
2. Scope ntawm daim ntawv thov: kev sim tshuaj lom neeg
3. Tus Neeg Ua Haujlwm: QC Tus Thawj Saib Xyuas Kev Xeem
4.Definition: Tsis muaj
5. Kev ceev faj txog kev nyab xeeb
nruj me ntsis ua haujlwm aseptic los tiv thaiv kab mob microbial;Cov neeg ua haujlwm yuav tsum tua UV teeb ua ntej nkag mus rau hauv chav tsis muaj menyuam.
6. Cov txheej txheem
6.1.Chav tsev tsis muaj menyuam yuav tsum tau nruab nrog chav ua haujlwm tsis muaj menyuam thiab chav tsis muaj.Kev huv huv ntawm chav ua haujlwm tsis muaj menyuam yuav tsum ncav cuag chav kawm 10000. Qhov kub thiab txias hauv tsev yuav tsum khaws cia ntawm 20-24 ° C thiab cov av noo yuav tsum tau khaws cia ntawm 45-60%.Kev huv ntawm lub rooj zaum huv yuav tsum ncav cuag chav kawm 100.
6.2.Sterile chav tsev yuav tsum tau ceev kom huv si, thiab nws yog nruj me ntsis txwv tsis pub mus rhais cov khib nyiab kom tsis txhob muaj kab mob.
6.3.nruj me ntsis tiv thaiv kev kis kab mob ntawm txhua yam khoom siv kom tsis muaj menyuam thiab kab lis kev cai xov xwm.Cov uas muaj kab mob yuav tsum tsis txhob siv lawv.
6.4.Chav tsev tsis muaj menyuam yuav tsum tau nruab nrog cov tshuaj tua kab mob ua haujlwm, xws li 5% cresol tov, 70% cawv, 0.1% tshuaj chlormethionine, thiab lwm yam.
6.5.Chav tsev tsis muaj menyuam yuav tsum tau ua kom tsis muaj menyuam tsis tu ncua thiab ntxuav nrog cov tshuaj tua kab mob kom paub tseeb tias qhov huv ntawm chav tsis muaj menyuam ua tau raws li qhov xav tau.
6.6.Tag nrho cov twj paj nruag, cov twj paj nruag, tais diav thiab lwm yam khoom uas yuav tsum tau coj mus rau hauv chav tsis muaj menyuam yuav tsum tau muab kaw kom nruj thiab ua kom tsis muaj menyuam los ntawm txoj kev tsim nyog.
6.7.Ua ntej nkag mus rau hauv chav tsis muaj menyuam, cov neeg ua haujlwm yuav tsum ntxuav tes nrog xab npum lossis tshuaj tua kab mob, thiab tom qab ntawd hloov mus rau hauv cov khaub ncaws ua haujlwm tshwj xeeb, khau, kaus mom, lub qhov ncauj qhov ntswg thiab hnab looj tes hauv chav tsis muaj (lossis so lawv txhais tes dua nrog 70% ethanol) ua ntej nkag mus rau hauv chav tsis muaj menyuam.Ua haujlwm hauv cov kab mob hauv cov kab mob.
6.8.Ua ntej siv chav tsev tsis muaj menyuam, lub teeb ultraviolet hauv chav tsis muaj menyuam yuav tsum tau qhib rau irradiation thiab sterilization rau ntau tshaj 30 feeb, thiab lub rooj zaum huv si yuav tsum tau qhib rau cua tshuab tib lub sijhawm.Tom qab kev ua haujlwm tiav lawm, chav tsis muaj menyuam yuav tsum tau muab ntxuav hauv lub sijhawm thiab tom qab ntawd ua kom tsis muaj menyuam los ntawm lub teeb ultraviolet rau 20 feeb.
6.9.Ua ntej kev soj ntsuam, lub ntim sab nraud ntawm cov qauv kuaj yuav tsum khaws cia kom zoo thiab yuav tsum tsis txhob qhib kom tsis txhob muaj kab mob.Ua ntej kev soj ntsuam, siv 70% cawv paj rwb pob los tua kab mob rau sab nrauv.
6.10 ib.Thaum txhua qhov kev ua haujlwm, kev tswj tsis zoo yuav tsum tau ua los xyuas qhov kev ntseeg tau ntawm kev ua haujlwm aseptic.
6.11.Thaum nqus cov kab mob ua kua, koj yuav tsum siv lub tshuab nqus dej kom nqus nws.Tsis txhob kov cov quav cab ncaj qha nrog koj lub qhov ncauj.
6.12.Lub koob inoculation yuav tsum tau ua kom tsis muaj hluav taws xob ua ntej thiab tom qab siv txhua.Tom qab txias, kab lis kev cai tuaj yeem raug inoculated.
6.13.Cov straws, cov raj xa dej, cov tais diav thiab lwm yam khoom siv uas muaj cov kab mob ua kua yuav tsum tau muab tso rau hauv lub thoob kom tsis muaj menyuam uas muaj 5% Lysol tov tshuaj tua kab mob, thiab tshem tawm thiab yaug tom qab 24 teev.
6.14 ib.Yog tias muaj cov kab mob ua kua dej nchuav rau ntawm lub rooj lossis hauv pem teb, koj yuav tsum tam sim ntawd ncuav 5% carbolic acid tov los yog 3% Lysol rau ntawm qhov chaw muaj kab mob tsawg kawg 30 feeb ua ntej kho nws.Thaum cov khaub ncaws ua haujlwm thiab cov kaus mom muaj cov kab mob sib kis, lawv yuav tsum tau muab tshem tawm tam sim ntawd thiab ntxuav tom qab lub tshuab ua kom tsis muaj zog.
6.15.Txhua yam khoom uas muaj cov kab mob nyob yuav tsum tau muab tshuaj tua kab mob ua ntej yuav muab yaug hauv qab tus kais dej.Nws yog txwv tsis pub ua kom muaj kuab paug rau cov kav dej.
6.16.Tus naj npawb ntawm cov neeg nyob hauv chav tsis muaj menyuam yuav tsum tau kuaj xyuas txhua hli.Nrog rau lub rooj ntev zaum huv si qhib, noj ntau cov tais diav uas tsis muaj menyuam yaus nrog ib txoj kab uas hla ntawm 90 mm, thiab aseptically txhaj li 15 ml ntawm cov as-ham agar culture nruab nrab uas tau yaj thiab txias txog li 45 ° C.Tom qab solidification, muab nws upside down ntawm 30 mus rau 35 Incubate rau 48 teev nyob rau hauv ib tug ℃ incubator.Tom qab ua pov thawj tsis muaj menyuam, muab 3 mus rau 5 daim phiaj thiab muab tso rau ntawm sab laug, nruab nrab thiab sab xis ntawm txoj haujlwm ua haujlwm.Tom qab qhib lub hau thiab nthuav tawm rau 30 feeb, muab lawv tso rau hauv qhov cub ntawm 30 txog 35 ° C rau 48 teev thiab tshem tawm.tshuaj xyuas.Qhov nruab nrab ntawm cov kab mob sib txawv ntawm cov phaj hauv chav kawm 100 qhov chaw huv yuav tsum tsis pub tshaj 1 colony, thiab cov naj npawb nruab nrab hauv chav kawm 10000 huv yuav tsum tsis pub tshaj 3 pawg.Yog tias qhov kev txwv ntau dhau lawm, chav tsis muaj menyuam yuav tsum tau muab tshuaj tua kab mob kom huv si kom txog thaum rov kuaj xyuas raws li qhov yuav tsum tau ua.
7. Xa mus rau tshooj (Sterility Inspection Method) nyob rau hauv "Txoj Kev Tshuaj Ntsuam Xyuas Tshuaj Hygienic" thiab "China Standard Operating Practices for Drug Inspection".
8. Distribution Department: Lub Chaw Tswj Xyuas Zoo
Kev qhia txog chav huv huv:
Tom qab tau txais ib puag ncig tsis muaj menyuam thiab cov ntaub ntawv tsis muaj menyuam, peb yuav tsum tuav lub xeev tsis muaj menyuam txhawm rau kawm txog cov kab mob tshwj xeeb uas paub txog lossis siv lawv txoj haujlwm.Txwv tsis pub, ntau yam kab mob los ntawm sab nraud tuaj yeem sib xyaw tau yooj yim. Qhov tshwm sim ntawm kev sib xyaw ntawm cov kab mob tsis sib xws los ntawm sab nraud yog hu ua cov kab mob sib kis hauv microbiology.Kev tiv thaiv kev kis kab mob yog cov txheej txheem tseem ceeb hauv kev ua haujlwm microbiological.Ua kom tsis muaj menyuam ntawm ib sab tes thiab kev tiv thaiv kev sib kis ntawm lwm qhov yog ob yam ntawm cov txheej txheem aseptic.Tsis tas li ntawd, peb yuav tsum tiv thaiv cov kab mob hauv qab no, tshwj xeeb tshaj yog cov kab mob pathogenic microorganisms lossis cov kab mob uas tsis muaj nyob hauv cov xwm txheej, los ntawm kev khiav tawm ntawm peb cov thawv sim mus rau hauv ib puag ncig sab nraud.Rau cov hom phiaj no, hauv microbiology, muaj ntau yam kev ntsuas.
Chav tsev tsis muaj menyuam feem ntau yog chav me me tshwj xeeb hauv chav kuaj microbiology.Yuav ua tau nrog cov ntawv thiab iav.Thaj chaw yuav tsum tsis txhob loj heev, txog 4-5 square meters, thiab qhov siab yuav tsum yog li 2.5 meters.Ib chav tsis yuav tsum tau teeb tsa sab nraum chav tsis muaj menyuam.Lub qhov rooj ntawm chav tsis muaj thiab lub qhov rooj ntawm chav tsis muaj menyuam yuav tsum tsis txhob ntsib tib qho kev taw qhia kom tsis txhob muaj cua nkag los ntawm kev coj mus rau lwm yam kab mob.Ob chav sterile thiab buffer room yuav tsum yog airtight.Cov khoom siv cua hauv tsev yuav tsum muaj cov khoom siv cua lim.Hauv pem teb thiab phab ntsa ntawm chav sterile yuav tsum du, nyuaj rau harbor av thiab yooj yim los ntxuav.Qhov chaw ua haujlwm yuav tsum yog theem.Ob chav sterile thiab tsis chav tsev yog nruab nrog ultraviolet teeb.Lub teeb ultraviolet hauv chav tsis muaj menyuam yog 1 meter deb ntawm qhov chaw ua haujlwm.Cov neeg ua haujlwm nkag mus rau hauv chav tsis muaj menyuam yuav tsum hnav khaub ncaws tsis muaj menyuam thiab cov kaus mom.
Tam sim no, cov chav tsis muaj menyuam feem ntau muaj nyob rau hauv microbiology factories, thaum lub chaw soj nstuam dav siv lub rooj zaum huv.Lub luag haujlwm tseem ceeb ntawm lub rooj zaum huv si yog siv cov khoom siv laminar cua ntws los tshem tawm ntau cov plua plav me me nrog rau cov kab mob ntawm qhov chaw ua haujlwm.Cov cuab yeej hluav taws xob tso cai rau huab cua dhau los ntawm hepa lim thiab tom qab ntawd nkag mus rau qhov chaw ua haujlwm, kom lub chaw ua haujlwm ib txwm khaws cia nyob rau hauv kev tswj ntawm cov cua tsis huv.Tsis tas li ntawd, muaj cov ntaub thaiv huab cua ceev ntawm sab ze rau sab nraud kom tiv thaiv cov kab mob sab nraud ntawm huab cua nkag.
Hauv cov chaw uas muaj kev nyuaj, cov thawv ntoo tsis muaj menyuam kuj tuaj yeem siv tsis siv lub rooj zaum huv.Lub thawv tsis muaj menyuam muaj cov qauv yooj yim thiab txav tau yooj yim.Muaj ob lub qhov nyob rau pem hauv ntej ntawm lub thawv, uas yog thaiv los ntawm kev thawb-rub qhov rooj thaum tsis ua haujlwm.Koj tuaj yeem nthuav koj txhais tes rau hauv lub sijhawm ua haujlwm.Sab saum toj ntawm pem hauv ntej yog nruab nrog iav los pab txhawb kev ua haujlwm sab hauv.Muaj lub teeb ci ultraviolet hauv lub thawv, thiab cov tais diav thiab cov kab mob tuaj yeem muab tso rau hauv qhov rooj me me ntawm sab.
Aseptic kev khiav hauj lwm cov tswv yim tam sim no tsis tsuas yog ua lub luag haujlwm tseem ceeb hauv kev tshawb fawb microbiological thiab kev siv, tab sis kuj tau siv dav hauv ntau yam biotechnologies.Piv txwv li, transgenic technology, monoclonal antibody technology, thiab lwm yam.
Post lub sij hawm: Mar-06-2024