I. Khoom siv system
Hauv kev tsim cov tshuaj aseptic, cov yam ntxwv zoo ntawm txhua yam khoom siv (Cov khoom siv raw, dej rau kev txhaj tshuaj, ntim cov ntaub ntawv uas ncaj qha hu rau cov tshuaj) muaj feem xyuam rau cov yam ntxwv zoo ntawm cov khoom kawg. Cov txheej txheem rau daim ntawv txais nyiaj, kev tshuaj xyuas tsis tu ncua, kuaj, kuaj xyuas, tso tawm, khaws cia, faib thiab siv cov khoom tsim tawm ntawm lub tuam txhab yuav tsum tau kuaj xyuas kom paub meej tias lawv siv tau. Rau qhov yuav tsum tau ua piv txwv, thov xa mus rau qhov piv txwv ntxiv ntawm GMP (Hloov kho hauv 2010). Kev tshuaj xyuas cov khoom siv yuav tsum tsom rau cov khoom tsis muaj menyuam thiab / lossis cov khoom yuav tsis muaj pyrogen.
Cov cheeb tsam ntawm kev txhawj xeeb tshwj xeeb rau kev tswj cov khoom aseptic cov khoom muaj xws li:
1. Dej system
Dej rau kev txhaj tshuaj yog ib feem ntawm ntau yam khoom tsis muaj menyuam. Dej rau kev txhaj tshuaj kuj yog siv rau depyrogenation (los yog endotoxin) thiab ntxuav cov khoom siv thiab cov roj hmab ntsaws.
(1) Saib xyuas thiab nkag siab txog cov ntsiab lus ntawm cov dej tsim tawm thiab kev faib khoom.
(2) Ntsuas cov duab kos raws li kev tsim ntawm cov dej hauv lub cev, tshawb xyuas cov dej xau, txoj kab nqes hauv cov kav dej (los ntawm kev txheeb xyuas cov duab kos axonometric thiab cov kab nqes hav), qhov kawg tuag, cov khoom tsis huv hauv cov kab ke, thiab lwm yam.
(3) Ntsuam xyuas yuav ua li cas los tsim kom muaj microbial ceeb toom txwv thiab kev kho cov txwv.
(4) Ntsuas cov ntsiab lus piv txwv, cov txheej txheem, zaus, thiab kev xeem.
(5) Tshawb xyuas cov cuab yeej tseem ceeb tiv thaiv kev saib xyuas thiab ntsuas cov txheej txheem, suav nrog cov txheej txheem kev npaj thiab rov ua dua cov khoom siv.
(6) Tshawb xyuas cov ntaub ntawv qub kom paub meej tias cov haujlwm saum toj no tau ua tiav raws li tus txheej txheem.
(7) Tshawb xyuas thiab saib xyuas kev saib xyuas cov dej tsis tu ncua (on-line TOC thiab conductivity).
(8) Tshawb xyuas cov ntaub ntawv sib txawv rau tshuaj, microbiological, thiab kab mob endotoxin kuaj.
(9) Tshawb xyuas cov txiaj ntsig ntawm lossis siab dua qhov kev ceeb toom thiab kho cov kev txwv.
2. Ntshiab huv
Ntshiab huv yog siv los ua kom tsis muaj cua sov thiab lwm yam txheej txheem, xws li kev ua kom tsis muaj menyuam ntawm cov khoom siv thiab cov kav dej, nrog rau kev sib cuag ncaj qha nrog cov khoom siv lossis cov khoom nto, lossis kev sib cuag nrog lwm yam khoom uas yuav cuam tshuam rau cov khoom zoo. Thaum cov pa ntshiab yog condensed, nws yuav tsum ua kom tau raws li qhov yuav tsum tau ua ntawm cov dej rau kev txhaj tshuaj, thiab tib lub sijhawm, nws yuav tsum tau saib xyuas cov roj uas tsis yog condensable, tus nqi superheat, ziab tus nqi thiab lwm yam khoom.
3. txheej txheem roj
Kev tswj cov txheej txheem roj thiab cov cuab yeej muaj feem xyuam tuaj yeem tshawb xyuas nrog cov chaw thiab cov khoom siv. Kev saib xyuas tshwj xeeb yuav tsum tau them rau kev tswj hwm cov txheej txheem roj av pom cov kauj ruam thiab kev ntsuas kev ntseeg siab, suav nrog cov roj inert siv los tiv thaiv cov khoom.
4. Cov ntaub ntawv
Qib ntawm microbial paug ntawm cov ntaub ntawv yuav tsum raug txo kom tsawg. Thaum tsim nyog, cov qauv zoo ntawm cov ntaub ntawv yuav tsum suav nrog microbial txwv, kab mob endotoxin lossis pyrogen tshuaj xyuas cov khoom.
(1) Cov roj hmab pov tseg
Cov neeg tsim khoom ntawm kev npaj siv cov khoom siv roj hmab pov tseg yuav tsum ua cov kev tshuaj xyuas nruj ntawm cov khoom siv roj hmab ntsaws thiab ntxiv cov tshuaj endotoxin thiab pom cov khoom txawv txawv tshuaj xyuas rau cov qauv kev tswj xyuas sab hauv.
(2) Microbial thiab kab mob endotoxin tshawb pom cov khoom
Ntsuam xyuas lub tuam txhab kev tswj cov khoom siv los txiav txim siab seb puas tsim los yog tsis tsim nyog rau cov qauv kev kuaj microbial lossis kab mob endotoxin. Tshawb xyuas cov ntaub ntawv xeem kom paub meej tias cov khoom ua tau raws li cov qauv. Yog tias tsis tau raws li tus qauv, xyuas seb puas muaj kev tshawb nrhiav los txiav txim qhov ua rau thiab siv qhov kev kho kom raug.
(3) Kev lees paub tus qauv ntawm cov khoom ntim hauv kev sib cuag ncaj qha nrog tshuaj
Lub cev thiab tshuaj lom neeg cov khoom ntawm cov khoom ntim uas tuaj rau hauv kev sib cuag ncaj qha nrog cov khoom siv tshuaj yog qhov tseem ceeb rau kev ua kom tsis muaj menyuam thiab ruaj khov ntawm cov khoom kawg. Qee cov khoom ntim uas tuaj rau hauv kev sib cuag ncaj qha nrog cov khoom siv tshuaj zoo sib xws (xim thiab qhov loj), tab sis yog ua los ntawm cov khoom sib txawv lossis muaj cov kev kho deg sib txawv, xws li siliconized rubber plugs thiab Hom I iav ammonium sulfide kho. Yog li ntawd, cov txheej txheem kev soj ntsuam cuam tshuam ntawm lub tsev lag luam yuav tsum raug kuaj xyuas kom ntseeg tau tias cov ntaub ntawv ntim khoom uas tuaj yeem cuam tshuam ncaj qha nrog cov khoom siv tshuaj ib txwm ua tau raws li cov qauv tsim nyog.
Kev ua tiav ntawm cov ntaub ntawv ntim khoom uas ncaj qha mus rau cov tshuaj yog qhov tseem ceeb heev rau cov khoom tsis muaj menyuam, yog li nws tseem yuav tsum tau xyuas seb lub tuam txhab puas tau txheeb xyuas qhov tseeb ntawm cov khoom thiab qhov loj ntawm cov khoom ntim uas ncaj qha mus rau cov tshuaj los ntawm kev sim.
(4) Kev ncaj ncees ntawm cov khoom ntim hauv kev sib cuag ncaj qha nrog tshuaj
Kev sib khi tsis txaus ntawm cov thawv ntim khoom yuav ua rau cov khoom sib kis. Yog li ntawd, kev ncaj ncees ntawm cov khoom ntim uas tuaj rau hauv kev sib cuag ncaj qha nrog cov khoom siv tshuaj yog qhov tseem ceeb los xyuas kom meej tias cov khoom nyob twj ywm tsis muaj menyuam thaum caij tsheb thauj mus los, khaws cia, thiab siv. Kev ntsuam xyuas thiab kev tshawb fawb los ntsuas qhov ncaj ncees ntawm tag nrho cov khoom ntim cov khoom tsis muaj menyuam uas tuaj rau hauv kev sib cuag ncaj qha nrog cov khoom siv tshuaj yuav tsum suav nrog yam tsawg kawg nkaus:
① Txheeb xyuas tias tag nrho cov khoom ntim khoom ntim khoom tuaj yeem ua tau raws li cov qauv, suav nrog cov lus qhia tshwj xeeb thiab qhov ntev.
② Paub meej tias cov kev tshawb fawb sib thooj ua haujlwm siab simulates cov txheej txheem kom tsis muaj menyuam, suav nrog cov xwm txheej phem tshaj plaws hauv kev ua haujlwm thiab khaws cia.
③Qhia kom meej tias tus qauv tsim nyog yog siv rau kev kuaj xyuas. Piv txwv li, rau cov khoom lag luam uas tsis muaj tshuaj tua kab mob, cov qauv kuaj uas tau xaiv yuav tsum tau ua raws li qhov ntau tshaj plaws ntawm kev ua kom tsis muaj menyuam.
④ Lub rhiab heev ntawm qhov kev xeem tau piav qhia meej.
⑤ Lub thawv ntim-lub foob kev ncaj ncees yuav tsum tau ua kom pom los ntawm kev pov thawj raws li ib feem ntawm qhov kev kawm ruaj ntseg (uas tuaj yeem hloov tau los ntawm kev kuaj tsis muaj menyuam) thiab yuav tsum them rau hnub tas sij hawm ntawm cov khoom.
(5) Kev hloov khoom siv
Ntim cov ntaub ntawv uas tuaj rau hauv kev sib cuag ncaj qha nrog cov khoom yuav tsum ua raws li txoj kev yooj yim tshaj plaws thaum lub sij hawm xa khoom ntawm kev tu, kom tsis muaj menyuam, thiab siv. Ntim cov ntaub ntawv uas ncaj qha hu rau cov khoom thaum lub sij hawm xa khoom yuav tsum tau muab kaw thiab khaws cia kom tsis txhob muaj kuab paug thib ob. Cov txheej txheem hloov khoom siv yuav tsum tau them sai sai rau txoj kev hloov pauv kom tsis txhob muaj kev ua qias tuaj, xws li: hloov mus raws li cov txheej txheem kev ua haujlwm tau teev tseg, cov txheej txheem ntim khoom thiab cov kev ntsuas sib xws, lub sijhawm khaws cia, thiab lwm yam.