Mzere Wonyowa Wapamwamba Wonyowa wa Granulation Line Chithunzi

High Containment Wet Type Granulation Line

Kufotokozera Kwachidule:

Ndi oyenera kupanga mankhwala oopsa kwambiri, okangalika kwambiri, komanso allergenic olimba kwambiri, ndipo amayenera kufika kumudzi OEB4 & OEB5 kuti achepetse kuopsa kwa ogwira ntchito panthawi yopanga ndi kukhudza chilengedwe.

Zipangizozi zimagwirizana ndi malamulo a 2010 a GMP, European GMP, ndi FDA ku China, ndipo zimakwaniritsa zofunikira za OEB, pofuna kuchepetsa kuwonongeka kwa mankhwala pazida;

Maupangiri a Reference Standard EHS ku China Pharmaceutical Industry (2020);Malire Owonekera Pantchito Pazinthu Zowopsa Pantchito

Titumizireni imelo

Tsatanetsatane wa Zamalonda

Zogulitsa Tags

Mawonekedwe

1.Adopt air bag chisindikizo, chitetezo interlock control;
2.Adopt PE thumba kapena ab valve kuti mutenge ndi kutsitsa;
3.Adopt dongosolo la BIBO la kutulutsa mpweya, ndi F9 / H13 zosefera;
4.WIP kuyeretsa / CIP kuyeretsa / Manual disassembly kuyeretsa.

Tanthauzo lachitetezo cha OEB

Ma API okhala ndi cytotoxicity ndi zochitika zapamwamba ndi gulu lazinthu zamankhwala zomwe zimakhala ndi mankhwala apamwamba kwambiri, okhala ndi mlingo wocheperako wachipatala komanso zotsatirapo zochepa, ndipo akopa chidwi kwambiri pamsika m'zaka zaposachedwa.Ngakhale kuti msika wa mankhwala omwe akugwira ntchito kwambiri ndi waukulu, amakumananso ndi zovuta zambiri.Kuphatikiza pa kupha maselo a khansa, mankhwala oletsa chotupa amathanso kupha maselo abwinobwino.Kudziwitsidwa kwawo kungayambitse kusamvana mwa anthu, ndipo kumavulaza kwambiri thanzi la anthu athanzi.Choncho, chiopsezo chachikulu chomwe chimaganiziridwa popanga cytotoxic ndi API yogwira ntchito kwambiri ndikuwonetsa fumbi.Njira yabwino kwambiri ndiyo kugwiritsa ntchito ukadaulo wodzipatula wopanda mpweya kuti muchepetse kuchuluka kwa fumbi lomwe limatuluka popanga.Potengera izi, pulojekitiyi imayang'ana kwambiri za OEL (Occupational Exposure Limit) zomwe zikuyenera kugwiritsidwa ntchito pansi paziwopsezo zowopsa za zinthu zomwe zimagwira ntchito, komanso zida zofananira mulingo wa OEB komanso njira yopumira mpweya.Malinga ndi mawonekedwe a cytotoxic komanso zopangira zogwira ntchito kwambiri, kutengera ukadaulo wosindikizira wa labyrinth, ukadaulo wotseketsa kupanikizika koyipa komanso ukadaulo wodzipatula wopanda mpweya, mitundu yosiyanasiyana yosindikiza yoyenera zida zotere yaphunziridwa.Tekinoloje yosindikiza ya Micro-leakage imatha kuletsa kapena kutsekereza ndi cytotoxicity yayikulu.Njira zotayikira za ma API ogwira ntchito kuti muwongolere kuchuluka kwa kutayikira

Zofunikira za zida za OEB

1.OEB 1~2 ikufunika kukhazikitsa zida zokokera m'deralo, monga mpweya wabwino wamalo omwe ali pamalo owonekera.

2.OEB 3 Pamene kukhudzana kwa ogwira ntchito kumakhudzidwa, zida ndi malo osungira mpweya ayenera kutengedwa momwe angathere, ndipo njira zowongolera monga mpweya wabwino, laminar flow hood, chipinda chodziyimira pawokha chokhala ndi chipangizo cholowera mpweya, fume hood, ndi zina zotero. mbali zowonekera za fumbi la mankhwala.

3. OEB 4-5 mlingo Chofunika kwambiri chiyenera kuperekedwa kwa kugwiritsa ntchito zipangizo zonse zotsekedwa ndi zipangizo, ndi mapangidwe a njira zopangira zamakono zotsekedwa.Mzere wazogulitsa uyenera kutengera zida zonse zotsekedwa ndi zida.Kuphatikizira kukhudzana ndi ntchito, njira zowongolera monga isolator, glove box yotsekedwa ntchito, α-β valve, thumba mkati ndi thumba kunja, ndi zina zotero.Zipangizo zopangira zimayenera kugwiritsa ntchito mphamvu zake zokhala ndi mpweya wambiri, monga chowumitsira atatu mu chimodzi.

Kupanga - zida zapamwamba zopangira

Kupanga - zida zapamwamba zopangira

Kupanga - Kasamalidwe kotsamira (malo a msonkhano)

Production- Quality Management

Ndondomeko Yabwino:
kasitomala choyamba, khalidwe choyamba, mosalekeza kuwongolera ndi kuchita bwino.

Zida zogwirira ntchito zapamwamba + zida zoyezera mwatsatanetsatane + njira zoyendetsera bwino + zomaliza zoyendera + kasitomala FAT
=Ziro zolakwika pazantchito zamafakitale