Nooca Qoyan ee Qoyan ee Sare ee Xariiqda granulation Sawirka

Qoyan Nooca Qoyan ee Sare Line Granulation

Sharaxaad Gaaban:

Waxay ku habboon tahay soo saarista dawooyinka adag ee sunta ah, aadka u firfircoon, iyo xasaasiyadda aadka u sarreeya, waana inay gaadhaan xakamaynta OEB4 & OEB5 si loo yareeyo khatarta hawl-wadeennada inta lagu jiro habka wax-soo-saarka iyo saameynta deegaanka

Qalabku wuxuu u hoggaansamaa nooca Shiinaha ee 2010 ee GMP, Yurub GMP, iyo xeerarka FDA, wuxuuna la kulmaa shuruudaha hawo-mareenka ee OEB, si loo yareeyo waxyeellada badeecada ee xiriirka qalabka;

Tixraaca Heerka Tilmaamaha EHS ee Warshadaha Dawooyinka ee Shiinaha (2020);Xadka Soo-gaadhista Shaqada ee Arrimaha Khatarta ah ee Goobta Shaqada

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Faahfaahinta Alaabta

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Astaamaha

1.Adopt shaabadda bacda hawada, xakamaynta is-dhexgalka badbaadada;
2.Adopt PE bac ama ab valve ee rarista iyo dejinta;
3.Adopt nidaamka BIBO ee qiiqa hawada, oo leh filtarrada F9 / H13;
4.WIP nadiifinta / nadiifinta CIP / nadiifinta gacanta

OEB qeexida xakamaynta

API-yada leh cytotoxicity iyo firfircoonida sare waa nooc ka mid ah maaddooyinka dawooyinka oo leh firfircooni farmaajo sare leh, oo leh qiyaas caafimaad oo hooseeya iyo waxyeelooyin yar yar, waxayna soo jiidatay dareenka suuqa sannadihii la soo dhaafay.Inkasta oo suuqa dawooyinka aadka u firfircooni uu ballaadhan yahay, haddana waxa ay sidoo kale la kulmaan caqabado waaweyn.Ka sokow dilka unugyada kansarka, daawooyinka ka hortagga burooyinka waxay sidoo kale dili karaan unugyada caadiga ah.Dareenkoodu wuxuu dadka ku keeni karaa dareen-celin xasaasiyadeed, waxayna aad khatar ugu yihiin caafimaadka dadka caafimaadka qaba.Sidaa darteed, khatarta ugu weyn ee loo tixgeliyo habka wax soo saarka ee cytotoxic iyo API-yada aadka u firfircoon waa soo-gaadhista boodhka.Xalka ugu fiican waa in la isticmaalo tignoolajiyada go'doominta hawo-mareenka si loo xakameeyo qadarka boodhka ka daadanaya habka wax soo saarka.Marka la eego sifadan, mashruucani wuxuu inta badan daraaseeyaa qiyamka OEL ee lagu dabaqi karo (Xdidaada Soo-gaadhista Shaqada) ee hoos yimaada heerarka khatarta sunta sunta ee walxaha kala duwan, iyo sidoo kale qalabka u dhigma heerka hawo-mareenka ee OEB iyo istiraatiijiyadda hawo-mareenka.Marka loo eego sifooyinka cytotoxic iyo alaabta ceeriin ee aadka u firfircoon, oo ku saleysan tikniyoolajiyadda xiritaanka shaybaarka ee jira, tignoolajiyada xiritaanka cadaadiska xun iyo tignoolajiyada go'doominta hawada, isku-dhafka xirmooyinka kala duwan ee ku habboon alaabtan oo kale ayaa la bartay.Tignoolajiyada xidhitaanka dheecaanka-yar-yar waxay xannibi kartaa ama ku xannibi kartaa cytotoxicity sare.Kanaalada daadinta ee API-yada firfircoon si loo xakameeyo heerka daadinta

Shuruudaha qalabka OEB

1.OEB 1 ~ 2 waxaa looga baahan yahay in la sameeyo tas-hiilaad qabyo ah oo maxalli ah, sida hawo-qaadasho maxalli ah oo wax ku ool ah oo meelaha bannaan ah.

2.OEB 3 Marka xidhiidhka shaqadu ku lug leedahay, waa in la qaataa qalabka iyo tas-hiilaadka hawo-mareenka sida ugu badan ee suurtogalka ah, iyo in la isticmaalo tallaabooyinka xakamaynta sida hawo-qaadista, daboolka qulqulka laminarka, qol hawleed madax-bannaan oo leh qalabka hawo-mareenka, daboolka qiiqa, iwm. qaybaha qaawan ee boodhka daroogada.

3. Heerka OEB 4-5 Mudnaanta waa in la siiyaa isticmaalka hab-socodka buuxa ee qalabka iyo tas-hiilaadka, iyo naqshadeynta waddooyinka wax-soo-saarka tignoolajiyada ee xiran.Khadka badeecada waa inuu qaataa dhammaan qalabka iyo tas-hiilaadka kuxiran.Ku lug lahaanshaha xiriirka shaqada, tillaabooyinka xakamaynta sida go'doominta, sanduuqa galoofka ee shaqada xiran, α-β valve, bacda gudaha iyo bacda dibadda, iwm. waa in la isticmaalo.Qalabka wax-soo-saarku waa inuu isticmaalo hawo-mareenkiisa sare, sida qalajiyaha saddex-in-hal.

Wax-soo-saarka - qalabka wax-soo-saarka ee horumarsan

Wax-soo-saarka - qalabka wax-soo-saarka ee horumarsan

Wax-soo-saarka - Maaraynta caatada ah (goobta shirarka)

Wax-soo-saarka- Maamulka tayada

Siyaasadda tayada
marka hore macmiilka, tayada ugu horeysa, horumar joogto ah iyo heer sare.

Qalab horumarsan + qalabka tijaabada saxda ah + socodka adag ee nidaamka + hubinta badeecada + baruurta macaamiisha
=Ciladaha eber ee alaabta warshadda