Dab tsi yog qhov yuav tsum tau ua kom huv qhov kev ntsuam xyuas kev tsim kho?
Kev ntxuav tes yog siv lub tshuab ntxuav huab cua los mus tswj cov neeg ua haujlwm thiab cov khoom siv los tswj cov plua tshauv, microbes, cov kab mob thiab lwm yam tshuaj phem hauv chav tu chav. Nyob rau tib lub sijhawm, nws zoo tiv thaiv qhov kis kab mob ntawm cov kab mob thiab ua kom huv huv thiab huv si. nyhuv. Kev tsim nyog rau qhov tsim nyog ntawm chav tu chav: Teeb raws li qib YY 0033-2000 "Guidelines for Production Management of Sterile Medical Devices" hauv Daim Ntawv Ntxiv B ntawm Cov Lus Qhia rau Kev Tsim Kho Qhov Khoos Huv Zov ntawm Chaw Tsim Tshuaj rau Aseptic Medical Devices.
1. Raws li qib ntawm cov huab cua huv, nws tuaj yeem sau nyob rau hauv cov kev coj ntawm cov neeg khiav, los ntawm qis rau siab; qhov kev cob qhia yog los ntawm sab hauv mus rau sab nraud, los ntawm siab mus qis.
2. Raws li kev tsim cov txheej txheem ntau lawm. Cov txheej txheem yog luv li sai tau, txo cov kev sib raug zoo, cov tswv yim zoo ntawm cov tib neeg thiab kev lag luam. Yuav tsum muaj cov neeg ua hauj lwm huv chav dej (chav vestibule room, washroom, hnav khaub ncaws ua hauj lwm hauv chav pw thiab chav tsis tuaj yeem), chav kho khoom (outsourcing, chav pw thiab hloov ob lub qhov rai), ntxiv rau kev siv cov khoom txheej txheem sab nraud, tab sis kuj tau nrog cov khoom khib nyiab, chav ntxhua khaub ncaws, chav cia ib ntus, chaw siv cov khoom siv chaw tu vaj tse, thiab lwm yam. Txhua chav tsis muaj kev sib cais. Cheeb tsam ntawm chav ntxuav chav yuav tsum nyob rau hauv kab nrog cov zauv ntau hauv qhov chaw uas tsim nyog tau txais cov kev txwv yooj yim.
3. Cov cua huv yuav tsum tau ua raws li cov cai ntawm Tshooj 9 ntawm GB 50457-2008 "Nruab Nrab rau Kev Tsim Kho Cov Chav Huv Si Pharmaceutical Industries". Cov pa ntawm huab cua hauv chav dej yuav tsum tau ua raws li qhov ntau tshaj li nram qab no: 1) cov huab cua ntshiab yuav tsum tau them rau qhov cua txias hauv lub cev thiab qhov chaw siab zoo hauv chav; 2) qhov cua hauv chav yuav tsum tsis pub tsawg tshaj 40 cubic meters / h.
4. Ib thaj chaw hauv chav dej yuav tsum tsis pub tsawg dua 4m2 (tshwj tsis yog txoj kev hauv tsev, khoom siv, thiab lwm yam) kom muaj kev nyab xeeb ntawm chaw khiav hauj lwm.
5. Nyob rau hauv rooj plaub ntawm vitro diagnostic reagents yuav tsum ua kom tau raws li "kev tshawb nrhiav hauv kev tshawb nrhiav tshuaj (vitamin diagnostic reagent production rules) (Kev Xaiv)" kev xav tau. Cov kev ua haujlwm tsis zoo, zoo ntshav qab zib, plasmid, lossis cov khoom siv ntshav yuav tsum tau ua kom tiav nyob rau hauv tsawg tshaj 10,000 npuas nrog cov kev ntsuas tsis zoo ntawm cov chaw nyob ib sab thiab ua raws li kev tiv thaiv kev tiv thaiv.
6. Yuav tsum ntaus cim rau kev xa rov qab cua, cua thiab dej kav dej.
7. Tsis muaj kev cuam tshuam kev kis kab mob hauv qhov chaw qub (thaj chaw) lossis chav nyob ze (thaj chaw). Cov txheej txheem ntau lawm thiab raw khoom tsis ua rau cov khoom tsis zoo; muaj cov xauv kauv lossis cov tshuaj tiv thaiv kev tiv thaiv ntawm cov chav ntxuav (zones) ntawm cov qib sib txawv, thiab cov khoom thauj tau los ntawm qhov muab hloov qhov rai.
Kev ntxuav tes ua haujlwm los ntawm kev yooj yim ntawm kev siv purification technology, uas tsis tuaj yeem tsuas tswj tau cov kabmob ntawm cov kabmob kabmob raws li qhov yuav tsum tau ua kom zoo rau ntau hom kev phais, tabsis tseem muaj cov cua sov thiab cov av txaus rau txhua tus neeg los tsim tsim thiab huv chaw phais chaw phais. Guangzhou Kedu Experimental Equipment Engineering Co., Ltd. tshwj xeeb hauv kev daws teeb meem laminar cov teeb meem hauv cov chav dej, cov chav dej, thiab lub chaw soj ntsuam, thiab tsim cov ntsiab lus raws li qhov tseeb ntawm lub tuam txhab.