I-FL Fluid Bed Granulator ene-Centrifugal Blower eqinisekiswe yi-ATEX ihlangabezana ngokugcwele ne-FDA

I-FL Fluid Bed Granulator ene-Centrifugal Blower eqinisekiswe yi-ATEX ihlangabezana ngokugcwele ne-FDA

I-FL fluid bed granulator iyithuluzi elisezingeni lemithi elihlanganisa imisebenzi yokuxuba, ukuhlanganisa kanye nokomisa ngendlela ehambisana ne-GMP, engenasikhala esifile enezindawo ezicwebezelisiwe, esebenza ngaphansi kwengcindezi engemihle yokuvimba. Isebenza ngemithi (kufaka phakathi i-TCM), ukudla kanye nezicelo zamakhemikhali.

I-granulator yombhede omanzi iqukethe iyunithi eyinhloko, imodyuli yokufafaza, umoya ngaphakathivumelaimodyuli, imodyuli yokukhipha umoya, kanye nemodyuli yokulawula. Izinto zilayishwa esitsheni somkhiqizo. Umoya wenqubo udlula ekuhlungweni okuyinhloko, ekuhluzweni okuphakathi, nasekususeni umswakama(Inketho), ukushisa, kanye nokuhlunga kwe-HEPA emoyenivumelaimodyuli ngaphambi kokungena eyunithini eyinhloko. Umoya opholile udlula epuletini lokusabalalisa umoya ukuze kufezwe isivinini esifanayo sokushintshashintsha kwezinto. Uketshezi lwe-binder luhanjiswa ngephampu ye-peristaltic ukuze kufakwe ama-nozzles, kufakwe i-atom, bese kufakwa njalo ezinhlayiyeni ezishintshashintshayo ukuze kukhuthazwe ukuhlangana. Ukomisa ngasikhathi sinye ngomoya oshisayo kwakha ama-granules.

Ngesikhathi sokuxuba, impuphu ecolekile efakwe ekugelezeni komoya ihlungwa ngezikhwama zothuli kumojuli wokususa uthuli bese ikhishwa ngemojuli yokukhipha umoya. Ngemuva kokuxuba, ukukhishwa kungenziwa ngokusebenza ngesandla, i-lifting-tilting granulator, noma i-vacuum discharge ngokuxhumeka okuvaliwe ne-lifting vacuum granulator.

1）Kusetshenziswa ukulawulwa kwe-PID ngama-valve alinganayo e-Siemens, izinga lokushisa lomoya lingalungiswa kusuka endaweni ezungezile liye ku-120°C. Ngokunikezwa komusi okuzinzile kanye nezithiyo ezifanele zomusi, ukuzinza kokushisa kugcinwa ngaphakathi kuka-±2°C wesikhathi esibekiwe ukuvimbela ukuguquguquka nokuthuthukisa ukuzinza kokukhiqiza.

2）Uhlelo lufinyelela umswakama wokungena ongu-11 g/kg ngokukhipha umswakama nge-coil. Isondo le-desiccant elingakhethwa linciphisa umswakama ube ngu-5–8 g/kg, kanti inketho yesondo elikhulu kakhulu lifinyelela ku-3–4 g/kg.kanye no-dizinhlelo zamasondo omabili zigcina umswakama ≤1 g/kg

3）Uhlelo lokuphatha umoya: Isihlungi esijwayelekile se-G4 pre-filter + isihlungi esiphakathi se-F8 + i-H13 HEPA (ene-DOP test port yokuhlola ubuqotho).

4）Amageyiji okucindezela ahlukene ezihlungini eziyinhloko/eziphakathi aqapha ukuvaleka; isignali ye-analog yokucindezela okuhlukile ye-HEPA iboniswa ku-HMI.

5）I-valve elinganayo ilawula ingcindezi engemihle ukuvimbela ukubhidlika kombhede.

6）Igumbi lokunweba elithambile elinama-nozzles okufutha anobude obuningi.

7）Ipuleti lokusabalalisa elenziwe kahle liqinisekisa ukugeleza komoya okufanayo kanye nokusatshalaliswa kosayizi we-granule.

8）I-PT ethuthukisiweDIzikhwama zokuhlunga ze-3D ezingashukumi: Azinamatheli, zivuleka kalula, ziyahlanzeka.

9）Umoya wokuqhuma oqonde phezulu ofakwe phezulu uvikela izingxenye ezizwela ukucindezeleka.

10）Ukuhlunga uthuli lwesibili: F9 ( F9+H13: ,F9+H14:

11）Isifutho se-centrifugal esiqinisekiswe yi-ATEX sigcina ukuhamba komoya/ingcindezi kuzinzile

12）Ukuhlanza uhlelo lwe-CIP ongakhetha kukhoIgumbi elingezansi,isitsha somkhiqizo, i-fluidizedigumbi, kanye nendlu yokuhlunga.

13）Ukuzenzakalela okuqhutshwa yiresiphi kwemijikelezo yokukhiqiza/yokuhlanza enemingcele engenziwa ngokwezifiso.

14）Ukulawula iphasiwedi okunezigaba ezinhlanu: Umqaphi/Umqhubi/Uchwepheshe/Ukugcinwa/Umphathi.

15）Ukunemba kokulawula ukuhamba komoya: ± 5%; Isekela umkhondo wokuhlola, ukurekhoda idatha, kanye nokuphrinta.

16）Ukutholwa kwe-endpoint esekelwe kumswakama ukuze kutholakale i-granulation. 

17）Ukuthobela i-CE (i-EU Machinery Directive 2006/42/EC).