High Containment Wet Type Granulation Line
Nta
1.Adopt airbag seal, kev ruaj ntseg interlock tswj;
2.Adopt PE hnab los yog ab valve rau thauj thiab unloading;
3.Adopt BIBO system rau cua tso pa, nrog F9 / H13 lim;
4.WIP tu / CIP tu / phau ntawv disassembly tu.
OEB Containment definition
APIs nrog cytotoxicity thiab kev ua haujlwm siab yog ib chav kawm ntawm cov khoom xyaw tshuaj uas muaj cov tshuaj pharmacological siab, nrog cov tshuaj kho mob qis dua thiab cov kev mob tshwm sim tsawg dua, thiab tau nyiam ntau ntawm kev ua lag luam hauv xyoo tas los no.Txawm hais tias kev ua lag luam rau cov tshuaj siv tau dav dav, lawv kuj ntsib cov teeb meem loj dua.Ntxiv nrog rau kev tua cov qog nqaij hlav cancer, cov tshuaj tiv thaiv qog kuj tseem tuaj yeem tua cov hlwb qub.Lawv qhov rhiab heev tuaj yeem ua rau muaj kev tsis haum rau tib neeg, thiab lawv muaj kev phom sij heev rau cov neeg noj qab haus huv.Yog li ntawd, qhov kev pheej hmoo tseem ceeb suav nrog hauv cov txheej txheem tsim khoom ntawm cytotoxic thiab nquag nquag APIs yog plua plav.Qhov kev daws teeb meem zoo tshaj plaws yog siv cov cuab yeej sib cais airtight los tswj cov plua plav tawm hauv cov txheej txheem tsim khoom.Nyob rau hauv qhov kev pom ntawm tus yam ntxwv no, qhov project no tsuas yog kawm txog OEL (Occupational Exposure Limit) qhov tseem ceeb nyob rau hauv cov khoom siv sib txawv toxicity txaus ntshai, nrog rau cov khoom siv OEB airtight qib thiab airtight zoo.Raws li cov yam ntxwv ntawm cytotoxic thiab cov ntaub ntawv muaj zog heev, raws li lub labyrinth sealing tshuab uas twb muaj lawm, tsis zoo siab sealing tshuab thiab airtight cais tshuab, muaj ntau yam kev sib khi ua ke tsim nyog rau cov ntaub ntawv no tau kawm.Micro-leakage sealing tshuab tuaj yeem thaiv lossis thaiv nrog cytotoxicity siab.Leakage channels ntawm active APIs los tswj tus nqi to
OEB cov khoom yuav tsum tau
1.OEB 1 ~ 2 nws yuav tsum tau teeb tsa cov chaw tsim khoom hauv zos, xws li kev ua pa hauv zos ntawm cov ntsiab lus raug.
2.OEB 3 Thaum muaj kev sib cuag nrog kev ua haujlwm, cov khoom siv airtight thiab cov chaw yuav tsum tau txais ntau li ntau tau, thiab tswj kev ntsuas xws li qhov cua, laminar flow hood, kev ua haujlwm ywj pheej nrog cov khoom siv cua hauv zos, fume hood, thiab lwm yam. qhov chaw raug tshuaj lom neeg plua plav.
3. OEB 4-5 qib Kev Ua Haujlwm Tseem Ceeb yuav tsum tau muab rau kev siv cov txheej txheem ntim khoom thiab cov chaw ua haujlwm puv ntoob, thiab tsim cov txheej txheem tsim khoom siv hauv tsev.Cov khoom lag luam yuav tsum tau txais tag nrho cov khoom siv thiab cov chaw nyob.Kev koom tes nrog kev ua haujlwm, kev tswj kev ntsuas xws li kev cais tawm, lub thawv ntim hnab looj tes kaw, α-β valve, lub hnab hauv thiab lub hnab tawm, thiab lwm yam yuav tsum tau siv.Cov cuab yeej tsim khoom yuav tsum siv nws tus kheej siab airtightness, xws li lub tshuab ziab khaub ncaws peb-hauv-ib.
Kev tsim khoom - cov cuab yeej ua haujlwm siab heev
Kev tsim khoom - cov cuab yeej ua haujlwm siab heev
Production - Lean Management (Kev sib sau ntawm qhov chaw)
Kev tsim khoom-Kev tswj hwm zoo
Txoj cai zoo:
cov neeg siv khoom ua ntej, zoo ua ntej, kev txhim kho txuas ntxiv thiab kev ua tau zoo.
Cov cuab yeej ua haujlwm siab tshaj + cov cuab yeej ntsuas qhov tseeb + cov txheej txheem nruj + kev tshuaj xyuas cov khoom tiav + cov neeg siv khoom FAT
= Zero defect ntawm lub Hoobkas khoom
Kev Tswjhwm Zoo (precision testing instruments)
packing & shipping
