Cov kev coj ua zoo tshaj plaws rau cov cuab yeej siv thiab kev ua kom tsis muaj menyuam hauv Sterile Manufacturing
Ua kom tiav GMP Daim Ntawv Qhia Ua Raws Li Kev Ua Haujlwm Kev Ua Haujlwm Tom Qab Kev Ua Kom Zoo
1. Khoom siv tsim & Kev Kho Cov Qauv
1.1 Cov ntaub ntawv tsim qauv
Cov lus piav qhia ntxaws ntxaws (PFDs, P&IDs) yuav tsum tau muab rau hauv pob ntawv tsim nyog thawj zaug thiab khaws cia tam sim no. Kev saib xyuas cov cai yuav tsum tau txhais nyob rau hauv URS (User Requirements Specification). Tswb yuav tsum tau lees paub thiab trended; ceeb toom tseem ceeb yuav tsum tau tshuaj xyuas tam sim.
1.2 Kev Pab Cuam Hauv Tsev
Cov khoom siv yuav tsum tau tsim rau kev saib xyuas sab nraud. Yog tias tsim nyog kev saib xyuas sab hauv, txwv tsis pub nkag mus, cov phiaj xwm ua haujlwm tau hais tseg, thiab tom qab tu tshuaj tua kab mob / EM yog qhov yuav tsum tau ua. Tag nrho cov tshuab tseem ceeb (Autoclaves, HVAC, Dej) yuav tsum raug pom zoo kom rov qab mus rau kev pabcuam tom qab kev npaj kho. Kev kho tsis tau npaj rau ntawm cov cuab yeej tseem ceeb yuav tsum ua rau muaj kev ntsuam xyuas cuam tshuam.
1.3 Particle Saib Xyuas & Qauv
Particle counters thiab sampling tubes yuav tsum tsim nyog. Tube ntev yuav tsum yog < 1 meter nrog qhov khoov me me. Hauv unidirectional flow systems, isokinetic sampling taub hau yuav tsum tau siv, nyob ze rau qhov chaw tseem ceeb los xyuas kom meej tus neeg sawv cev sampling.
2. Sterilization validation & Txheej txheem kev ncaj ncees
2.1 Preference rau Terminal Sterilization
Terminal sterilization nyob rau hauv cov thawv zaum kawg yog nyiam rau nws cov qib siab ntawm kev lees paub. Kev lees paub yuav tsum suav nrog cov khoom muaj pes tsawg leeg, khaws cia, thiab tuav sijhawm. Cov qauv thauj khoom (max / min) yuav tsum rov siv dua tsawg kawg ib xyoos ib zaug rau cua sov sterilization.
2.2 Tiv tauj Management & Ntxuav
Ob leeg ncaj qha (tswj, koob) thiab tsis ncaj (stopper bowls, guide rails) tiv tauj qhov chaw yuav tsum tau sterilized, nyiam dua tom qab reassembly. Conveyor siv yuav tsum tsis txhob hla Qib A / B partitions tshwj tsis yog tsis tu ncua kom tsis muaj menyuam (piv txwv li, sterilization qhov).
2.3 Biological Indicators (BI)
BIs txhawb lub cev tsis tab sis tsis hloov lawv. Cov neeg muab khoom yuav tsum tsim nyog, thiab txhua batch txheeb xyuas rau pej xeem, purity, thiab tus kheej. Parameters xws li D-tus nqi thiab Z-tus nqi yuav tsum tau lees paub los ntawm cov ntawv pov thawj batch tsim nyog.
3. Tom qab Sterilization tuav & Khoom Segregation
3.1 Kev sib cais thiab kev txheeb xyuas
Ib txoj hauv kev meej yuav tsum tau tsim kom muaj kev sib txawv ntawm cov khoom tsis muaj tshuaj lom thiab tsis muaj tshuaj lom / cov khoom siv. Cov khoom siv thauj khoom (cov pob tawb / cov tais) yuav tsum tau sau kom meej meej lossis ntsuas hauv tshuab hluav taws xob nrog cov npe khoom, tus lej batch, thiab kev ua kom tsis muaj menyuam. Qhov taw qhia zoo li autoclave daim kab xev tej zaum yuav siv tau tab sis tsuas yog qhia tau hais tias ib tug txheej txheem tau tshwm sim, tsis yog guaranteed sterility theem.
3.2 Cov ntaub ntawv & Traceability
Txhua lub voj voog ua kom tsis muaj menyuam yuav tsum muaj cov ntaub ntawv nrog a tus cim tshwj xeeb. Kev ua raws cai yuav tsum tau tshuaj xyuas thiab pom zoo raws li ib feem ntawm batch ntawv pov thawj thiab cov txheej txheem tso tawm.
4. Ntim Kev Ncaj Ncees & Hloov khoom siv
4.1 Kev tiv thaiv tom qab Sterilization
Cov khoom uas tsis siv tam sim ntawd tom qab ua kom tsis muaj menyuam yuav tsum muab cia rau hauv tsim nyog ntim ntim nrog lub sijhawm tuav lub sijhawm ntev tshaj plaws. Cheebtsam hauv ntau txheej ntim tsis muaj menyuam tuaj yeem muab khaws cia sab nraum chav huv yog tias cov khaubncaws sab nraud povtseg yooj yim rau kev tua kab mob / tshem tawm tam sim ntawd thaum hloov los ntawm airlocks rau hauv Qib A.
4.2 Hloov mus rau Qib A/B Zones
Cov ntaub ntawv xa mus rau Qib A yuav tsum siv txoj kev siv tau (piv txwv li, Airlocks los yog Rapid Transfer Ports (RTP)) thaum disinfecting lub ntim txheej. Cov txheej txheem yuav tsum ua tau zoo txo qhov muaj peev xwm kis tau mus rau qib uas tau txais rau thaj chaw lub hom phiaj.
4.3 Kev lees paub ntawm kev ntim khoom
Kev ntim khoom yuav tsum txo qhov kev pheej hmoo ntawm cov kab mob sib kis, kab mob microbial, lossis tshuaj lom neeg thiab ua tau raws li txoj kev ua kom tsis muaj menyuam. Seal kev ncaj ncees thiab cov hnub tas sij hawm tshaj plaws ntawm cov khoom sterilized yuav tsum tau validated. Cov teeb meem yuav tsum raug tshuaj xyuas kom muaj kev ncaj ncees ua ntej siv.
4.4 Kev tua kab mob ntawm cov khoom uas tsis yog Sterilizable
Rau cov khoom tsim nyog uas tsis tuaj yeem ua kom tsis muaj menyuam (tsis muaj kev sib cuag), yuav tsum tau tsim kom muaj kev siv tshuaj tua kab mob thiab kev hloov pauv. Thaum disinfected, lawv yuav tsum tau tiv thaiv los ntawm re-contamination thiab muab tso rau hauv Environmental Monitoring (EM) npaj.
5. Ethylene Oxide (EO) Sterilization
5.1 Txheej txheem Parameter
EO tsuas yog siv thaum lwm txoj hauv kev tsis tuaj yeem siv tau. Kev lees paub yuav tsum ua pov thawj tsis muaj khoom puas tsuaj thiab paub meej tias aeration / degassing txo cov seem EO roj kom muaj kev nyab xeeb.
5.2 Cov Ntsiab Lus Tseem Ceeb
| Critical Parameter | GMP Requirement |
|---|---|
| Gas concentration | Kev soj ntsuam ncaj qha ntawm EO ceev thaum raug. |
| Cov av noo & Equilibrium | Cov ntaub ntawv yuav tsum ncav cuag qhov kub thiab av noo sib npaug ua ntej raug. |
| Tiv tauj Microbial | Kev sib cuag ncaj qha ntawm cov roj thiab cov hlwb yog qhov tseem ceeb (tsis muaj kev tiv thaiv). |
| Nphav & Aeration | Validated ntev rau tua-lub sij hawm thiab tom qab desorption. |
Tham nrog peb cov kws tshaj lij GMP Engineering
Los ntawm kev tsim cov cuab yeej siv rau kev siv cov kev hloov pauv tsis muaj menyuam, xyuas kom koj lub chaw muaj ntau tshaj qhov kev xav tau ntawm Annex 1.
Kev cob qhia kws tshaj lij muab rau ZJBOCON Engineering Excellence.