Granulator ihe ndina mmiri mmiri nke FL nwere ihe mkpuchi ikuku nke ATEX kwadoro nke ọma Zute FDA nke ọma

Granulator ihe ndina mmiri mmiri nke FL nwere ihe mkpuchi ikuku nke ATEX kwadoro nke ọma Zute FDA nke ọma

Ngwa granulator nke FL fluid bed bụ ngwa ọgwụ nke na-ejikọta ngwakọta, granulation na ọrụ ihicha n'ime imewe GMP nke na-enweghị oghere nwụrụ anwụ, nke nwere elu mara mma, na-arụ ọrụ n'okpuru nrụgide na-adịghị mma maka njide. Ọ na-eje ozi na ọgwụ (gụnyere TCM), nri na kemịkalụ.

Ihe na-eme ka ihe dị n'ime mmiri mmiri nwee otu isi ihe, modulu ịgba mmiri, ikuku dị n'imehapụModulu, modulu ikuku, na modulu njikwa. A na-etinye ihe ndị a n'ime akpa ngwaahịa ahụ. A na-eme ka ikuku dị nro, na-eme ka ọ dị ọcha, na-ewepụ mmiri mmiri.(Nhọrọ), ikpo ọkụ, na nzacha HEPA n'ikuku dị n'imehapụModulu tupu ịbanye na isi unit. Ikuku oyi kpọnwụrụ akpọnwụ na-agafe na efere nkesa ikuku iji nweta ọsọ otu maka mmiri mmiri. A na-ebuga mmiri binder site na mgbapụta peristaltic iji fesa nozzles, mee ka ọ gbaa atọm, ma kpuchie ya mgbe niile na ihe ndị a gbanyere mmiri mmiri iji kwalite njikọta. Ikpo nkụ n'otu oge na ikuku ọkụ na-emepụta granules.

N'oge a na-etinye ntụ ntụ n'ime ikuku, a na-eji akpa uzuzu enyocha ntụ ntụ dị nro nke dị n'ime modulu mwepụ uzuzu ma wepụta ya site na modulu ikuku. Mgbe a na-etinye ntụ ntụ, mwepụ ya site na iji aka rụọ ọrụ, granulator na-ebuli elu, ma ọ bụ mwepụ uzuzu site na njikọ mechiri emechi na granulator vacuum na-ebuli elu.

1)Site na iji njikwa PID na valvụ Siemens proportional, a na-agbanwe okpomọkụ ikuku site na gburugburu ruo 120°C. Site na ọkọnọ uzuoku kwụsiri ike na ọnyà uzuoku kwesịrị ekwesị, a na-ejigide nkwụsi ike okpomọkụ n'ime ±2°C nke ebe a na-ahazi iji gbochie mgbanwe ma melite nkwụsi ike mmepụta.

2)Sistemụ a na-enweta iru mmiri ruru 11 g/kg site na iwepu mmiri n'ime eriri igwe. Wheel desiccant nhọrọ na-ebelata iru mmiri ruo 5–8 g/kg, yana nhọrọ wiil buru ibu na-enweta 3–4 g/kg.na dSistemụ wiilụ nke ọ bụla na-eme ka iru mmiri dị elu karịa 1 g/kg

3)Sistemụ njikwa ikuku: Nzacha tupu G4 ọkọlọtọ + F8 nzacha ọkara + H13 HEPA (nwere ọdụ ụgbọ mmiri nnwale DOP maka nnwale iguzosi ike n'ezi ihe).

4)Ihe nlele nrụgide dị iche iche na ihe nlele nzacha mbụ/etiti; Ngosipụta mgbaàmà analog nke nrụgide HEPA dị iche na HMI.

5)Valvụ nha nhata na-achịkwa nrụgide na-adịghị mma iji gbochie ịda ada n'ihe ndina.

6)Ụlọ mgbasawanye a gbagọrọ agbagọ nwere ihe mkpuchi fesa dị elu nke nwere ọtụtụ elu.

7)Efere nkesa kachasị mma na-eme ka ikuku na-efegharị otu nha na nha granule kesaa.

8)PT emelitereD-Akpa nzacha 3D antistatic: Enweghị ike ịrapara, enwere ike ihicha ya nke ọma.

9)Oghere mgbawa nke e tinyere n'elu na-echebe ihe ndị nwere mmetụta nrụgide.

10)Nzacha uzuzu nke abụọ: F9 ( F9+H13: ,F9+H14:

11)Igwe ikuku centrifugal nke ATEX kwadoro na-eme ka ikuku na-aga nke ọma/nrụgide

12)Nhicha sistemụ CIP nhọrọỤlọ dị n'okpuru,akpa ngwaahịa, fluidizedụlọ, na ebe nzacha.

13)Akpaaka nke na-achịkwa ntụziaka maka usoro mmepụta/nhicha yana paramita enwere ike ịhazi.

14)Njikwa paswọọdụ nke ọkwa ise: Nyocha/Onye Ọrụ/Onye Nkà/Nlekọta/Onye Nchịkwa.

15)Izi ezi nke njikwa ikuku: ±5%; Na-akwado ụzọ nyocha, ndekọ data, na mbipụta.

16)Nchọpụta njedebe dabere na mmiri maka granulation. 

17)N'okpuru iwu CE (Ntuziaka Ngwaọrụ EU 2006/42/EC).