High Containment Wet Type Granulation Line

Tsanangudzo Pfupi:

Yakakodzera kugadzirwa kwemishonga ine muchetura yakanyanya, inoshanda zvakanyanya, uye yakanyanya allergenic yakasimba, uye inofanirwa kusvika mumudziyo OEB4 & OEB5 kudzikisa njodzi dzevashandisi panguva yekugadzira uye kukanganisa kwezvakatipoteredza.

Midziyo iyi inoenderana neChina's 2010 vhezheni yeGMP, European GMP, uye FDA mirau, uye inosangana neOEB's airtight zvinodiwa, kuitira kuti kuderedze kukuvadzwa kwechigadzirwa kune vanosangana nemidziyo;

Reference Standard EHS Mirayiridzo yeChinese Pharmaceutical Indasitiri (2020);Occupational Exposure Limits yeHazardous Factors Munzvimbo Yebasa

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Features

1.Adopt air bag chisimbiso, chengetedzo interlock control;
2.Adopt PE bhegi kana ab valve yekutakura uye kuburitsa;
3.Adopt BIBO system yemhepo inopera, neF9 / H13 filters;
4.WIP kuchenesa / CIP kuchenesa / Manual disassembly kuchenesa.

Tsanangudzo yeOEB yemukati

APIs ine cytotoxicity uye yakakwirira chiitiko ikirasi yemishonga yemishonga ine yakakwirira pharmacological chiitiko, ine yakaderera kiriniki dosi uye mashoma mhedzisiro, uye yakakwezva kutarisisa kwakawanda kubva kumusika mumakore achangopfuura.Kunyange zvazvo misika yemishonga inoshandiswa zvakanyanya yakafara, ivo vanotarisana nematambudziko makuru.Pamusoro pekuuraya maseru egomarara, anti-tumor mishonga inogona kuurayawo masero akajairwa.Kukurudzira kwavo kunogona kukonzera kusawirirana muvanhu, uye zvinokuvadza zvakanyanya kuhutano hwevanhu vane hutano.Naizvozvo, njodzi huru inotariswa mukugadzirwa kwecytotoxic uye yakanyanya kushanda API ndeyekuratidzwa kweguruva.Mhinduro yakanakisa ndeye kushandisa airtight yekuzviparadzanisa tekinoroji kudzora huwandu hwekudonha kweguruva mukugadzira maitiro.Tichifunga nezve hunhu uhu, chirongwa ichi chinonyanya kudzidza iyo inoshanda OEL (Occupational Exposure Limit) kukosha pasi peakasiyana anoshanda ehupfu hwengozi mazinga, pamwe chete nemidziyo inoenderana OEB isina mhepo nhanho uye isina mhepo zano.Zvinoenderana nehunhu hwecytotoxic uye inoshanda zvakanyanya mbishi zvinhu, zvichibva pane iripo labyrinth yekuisa chisimbiso tekinoroji, isina kusimba yekuisa chisimbiso tekinoroji uye isina airtight yekuzviparadzanisa tekinoroji, akasiyana ekuisa chisimbiso musanganiswa akakodzera zvinhu zvakadaro akadzidziswa.Micro-leakage sealing tekinoroji inogona kuvharira kana kuvharira nepamusoro cytotoxicity.Leakage chiteshi cheanoshanda APIs kudzora chiyero chekudonha

OEB midziyo zvinodiwa

1.OEB 1~2 inodiwa kumisikidza zvivakwa zvemuno zvinokonzeresa, sekufemesa kwemukati kunoshanda panzvimbo dzakashama.

2.OEB 3 Kana kubata basa kuchibatanidzwa, midziyo isingadzivirirwe nemhepo uye zvivakwa zvinofanirwa kutorwa zvakanyanya sezvinobvira, uye matanho ekudzora akadai semhepo inofefetera, laminar flow hood, kamuri yekuvhiya yakazvimirira ine mudziyo wekufemesa mhepo, fume hood, zvichingodaro. zvikamu zviri pachena zveguruva rezvinodhaka.

3. OEB 4-5 level Kunyanya kukoshesa kunofanira kupiwa kushandiswa kwe-full-process yakavharwa midziyo uye zvivakwa, uye dhizaini yakavharirwa nzira dzekugadzira tekinoroji.Mutsara wechigadzirwa unofanirwa kutora iyo yese yakavharirwa michina uye zvivakwa.Kusanganisira kusangana kwebasa, matanho ekudzora akadai seaisolator, girafu bhokisi rakavharwa kushanda, α-β valve, bhegi mukati uye bhegi kunze, nezvimwe zvinofanira kushandiswa.Midziyo yekugadzira inofanirwa kushandisa yayo yakakwira mhepo, senge matatu-mu-imwe yakaoma.

Kugadzira - advanced processing equipment

Kugadzira - advanced processing equipment

Kugadzira - Lean manejimendi (Assembly saiti)

Kugadzira- Hunhu manejimendi

Hunhu mutemo:
mutengi kutanga, mhando yekutanga, inoenderera mberi nekuvandudza uye kugona.

Yepamberi yekugadziridza michina + chaiyo yekuyedza zviridzwa + yakasimba maitiro kuyerera + yapera chigadzirwa chekuongorora + mutengi FAT
=Zero defect yezvigadzirwa zvefekitari