FL Fluid Bed Granulator ifite icyuma gishyushya amashanyarazi cyemewe na ATEX. Menya neza FDA

FL Fluid Bed Granulator ifite icyuma gishyushya amashanyarazi cyemewe na ATEX. Menya neza FDA

Igikoresho cyo gukurura amazi cya FL ni igikoresho cyo mu rwego rw'imiti gihuza imikorere yo kuvanga, gukurura no kumisha mu buryo bukurikije GMP, nta mwanya upfuye gifite ubuso busesuye, gikorera munsi y'igitutu kibi cyo gukingira. Gitanga serivisi mu by'imiti (harimo na TCM), ibiribwa n'imiti.

Igikoresho cyo gukurura amazi kigizwe n'igice cy'ingenzi, module yo gutera, umwuka murirekamodule, module y'imyotsi isohora umwuka, na module yo kugenzura. Ibikoresho bishyirwa mu gikoresho cy'ibicuruzwa. Umwuka ukorwa unyuzwa mu buryo bw'ibanze, uyungururwa mu buryo buciriritse, kandi ugakurwamo ubushuhe(Amahitamo), gushyushya, no kuyungurura HEPA mu kirere murirekamodule mbere yo kwinjira mu gice cy’ingenzi. Umwotsi urimo umwuka unyura mu gice gikwirakwiza umwuka kugira ngo ugere ku muvuduko umwe wo guhinduranya ibintu. Amazi yo gufatanya atangwa binyuze mu ipompo ikoresha peristaltique kugira ngo atere imiyoboro, ashyiremo atome, kandi akomeze gusigwa ku duce twangiritse kugira ngo arusheho guterana. Kumisha icyarimwe hakoreshejwe umwuka ushyushye birema uduce duto.

Mu gihe cyo gukuramo ifu, ifu nziza ishyirwa mu mwuka iyungururwa n'imifuka y'umukungugu iri muri module yo gukuramo ivumbi hanyuma igasohoka binyuze muri module yo gusohora ivumbi. Nyuma yo gukuramo ifu, gusohora ivumbi bishobora gukorwa hakoreshejwe intoki, gusohora ivumbi riterura rigahinduka, cyangwa gusohora ivumbi binyuze mu guhuza ifunze na module yo gukuramo ivumbi.

1)Hakoreshejwe uburyo bwa PID bwo kugenzura hakoreshejwe vali za Siemens, ubushyuhe bw'umwuka bushobora guhindurwa kuva kuri dogere selisiyusi 120. Hamwe n'umwuka uhoraho n'imitego ikwiye y'umwuka, ubushyuhe bugumana ubuziranenge buri hagati ya dogere selisiyusi ± 2 uvuye aho buherereye kugira ngo hirindwe ihindagurika ry'ikirere no kongera ubuziranenge bw'umusaruro.

2)Iyi sisitemu igera kuri 11 g/kg y'ubushuhe bw'amazi binyuze mu gukuraho ubushuhe mu miyoboro. Ipine y'amazi yo gusukura igabanya ubushuhe kuri 5–8 g/kg, hamwe n'ipine nini cyane igera kuri 3–4 g/kg.na dsisitemu z'amapine ya ual zigumana ubushuhe ≤1 g/kg

3）Sisitemu yo gufata umwuka: Agasanduku gasanzwe ka G4 mbere yo gupima + akayunguruzo k’ubugari ka F8 + HEPA H13 (karimo umuyoboro wo gupima DOP kugira ngo hakorwe isuzuma ry’ubuziranenge).

4)Ibipimo by'umuvuduko bitandukanye ku byuma by'ibanze/by'imbere bigenzura uko biziba; ikimenyetso cy'umuvuduko w'impinduka cya HEPA kigaragaza kuri HMI.

5)Valve ipima umuvuduko mubi kugira ngo hirindwe ko igitanda cyagwa.

6)Icyumba cyo kwagura gifite imiyoboro miremire yo gusukura.

7)Ibyuma byo gukwirakwiza bikozwe neza bitanga umusaruro ukwirakwira hamwe n'ingano y'utubuto.

8）PT yavuguruyeD-Amasakoshi ya 3D arwanya static: Ntiyafata, anyura cyane, ashobora gusukurwa.

9)Umwobo wo guturika ushyizwe hejuru urinda ibice bishobora kwangirika n'umuvuduko.

10)Uburyo bwo kuyungurura ivumbi bwa kabiri: F9 ( F9+H13: ,F9+H14:

11)Imashini ikoresha centrifugal yemejwe na ATEX ikomeza urujya n'uruza rw'umwuka/umuvuduko uhamye

12)Gusukura sisitemu ya CIP nta yandi mahitamoIcyumba cyo hasi,igikoresho gicuruzwa, fluidizedicyumba, n'aho icyuma gifungurira.

13）Uburyo bwo gukora/gusukura bukoresha uburyo bwa “automation” bukoreshwa mu gutunganya no gukaraba ibintu hakoreshejwe uburyo bushobora guhindurwa.

14)Igenzura ry'ijambo ry'ibanga ry'icyiciro cya gatanu: Monitor/Operator/Technician/Maintenance/Admin.

15)Uburyo bwo kugenzura ikirere: ± 5%; Ishyigikira inzira yo kugenzura, kwandika amakuru, no kuyacapa.

16）Gupima ubushyuhe bushingiye ku bushyuhe mu gihe habayeho ubwinshi bw'ibinure. 

17)Gukurikiza amategeko agenga imashini (CE) (Amabwiriza y’imashini ya EU 2006/42/EC).