Umuyoboro mwinshi Wet Ubwoko bwa Granulation Umurongo
Ibiranga
1.Kwemeza kashe yikibuga cyindege, kugenzura umutekano uhuza umutekano;
2.Kwemeza igikapu cya PE cyangwa ab valve yo gupakira no gupakurura;
3.Kwemeza sisitemu ya BIBO yumuyaga mwinshi, hamwe na F9 / H13 muyunguruzi;
4.Isuku rya WIP / Isuku ya CIP / Gukuraho intoki.
Ibisobanuro bya OEB
APIs zifite cytotoxicity hamwe nibikorwa byinshi nicyiciro cyibikoresho bya farumasi bifite ibikorwa byinshi bya farumasi, hamwe na dosiye yo mumavuriro yo hasi hamwe ningaruka nkeya, kandi byashimishije cyane isoko mumyaka yashize.Nubwo isoko ryibiyobyabwenge bikora cyane ni binini, nabyo bihura nibibazo bikomeye.Usibye kwica selile, imiti irwanya ibibyimba irashobora no kwica selile zisanzwe.Gukangurira kwabo birashobora gutera allergie reaction kubantu, kandi byangiza cyane ubuzima bwabantu bafite ubuzima bwiza.Kubwibyo, ingaruka nyamukuru zasuzumwe mubikorwa byo gukora cytotoxic kandi ikora cyane APIs ni uguhungabanya umukungugu.Igisubizo cyiza nugukoresha tekinoroji yo kwigunga yumuyaga kugirango ugenzure ingano yimivu iva mubikorwa.Urebye ibi biranga, uyu mushinga wiga cyane cyane indangagaciro za OEL (Occupational Exposure Limit) zikoreshwa muburyo butandukanye bwibintu byangiza uburozi, hamwe nibikoresho bijyanye na OEB urwego rwumuyaga hamwe ningamba zo guhumeka ikirere.Ukurikije ibiranga cytotoxique kandi ikora cyane yibikoresho fatizo, hashingiwe ku buhanga buriho bwo gufunga labyrint, tekinoloji mbi yo gufunga igitutu hamwe n’ikoranabuhanga ryo kwigunga mu kirere, hakozwe ubushakashatsi butandukanye bwo gufunga ibimenyetso bifatika nk'ibyo.Tekinoroji ya Micro-leakage irashobora guhagarika cyangwa guhagarika hamwe na cytotoxicity nyinshi.Imiyoboro yamenetse ya API ikora kugirango igenzure igipimo cyo kumeneka
Ibikoresho bya OEB
1.OEB 1 ~ 2 birasabwa gushyiraho ibikoresho byateguwe byimbere, nkibihumeka neza byaho ahantu hagaragara.
2.OB ibice byagaragaye byumukungugu wibiyobyabwenge.
3. Urwego rwa OEB 4-5 Icyambere kigomba guhabwa umwanya mugukoresha ibikoresho byose byuzuye hamwe nibikoresho, hamwe no gushushanya inzira zikorana buhanga.Umurongo wibicuruzwa ugomba gufata ibikoresho nibikoresho byose bifunze.Uruhare rwabakozi, ingamba zo kugenzura nka isolator, agasanduku ka globisiyo ifunze, α-β valve, igikapu mumifuka hanze, nibindi bigomba gukoreshwa.Ibikoresho byo kubyaza umusaruro bigomba gukoresha imbaraga zabyo zo hejuru cyane, nka bitatu-byumye.
Umusaruro - ibikoresho byo gutunganya neza
Umusaruro - ibikoresho byo gutunganya neza
Umusaruro - Gucunga neza (Urubuga rwinteko)
Umusaruro- Gucunga ubuziranenge
Politiki nziza:
umukiriya ubanza, ubuziranenge ubanza, gukomeza gutera imbere no kuba indashyikirwa.
Ibikoresho bigezweho byo gutunganya + ibikoresho byo gupima neza + gutembera neza + kugenzura ibicuruzwa byarangiye + umukiriya FAT
= Inenge ya zeru yibicuruzwa byuruganda
Kugenzura ubuziranenge bw'umusaruro (ibikoresho byo gupima neza)
gupakira & kohereza
