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Imithi, Amaphrojekthi Wokuhlanza Imboni Yezemithi

IMITHI, AMAPROJEKTHI OKUHLANZA AMAGUMBI EMITHI

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Ngokwezidingo zamakhasimende, amazinga okuklama nawokwakha amakhulu namakhulu ahlangabezana nezidingo zesitshalo sokuhlanza i-GMP, ilabhorethri yezilwane, ilabhorethri ye-physics kanye nekhemistri kanye nelebhu ye-microbiology, ngokuhambisana ngokuqinile "nezimiso zokulawulwa kokukhiqizwa kwezidakamizwa" kanye "nemininingwane yobuchwepheshe yokwakha amalabhorethri e-biosafety kanye namanye amazinga ochwepheshe, ukuhlangabezana nesimanje esihlanzekile sazo zonke izinhlobo zemithi yezokwelapha kanye nezidingo namazinga okukhiqizwa kwemishini yezokwelapha.

Izidingo zemboni ye-Biopharmaceutical umgomo we-GMP uwukuqinisekisa ukusungulwa kwesayensi, indawo eqinile yokukhiqiza izidakamizwa, inqubo, ukusebenza kanye nohlelo lokuphatha, ukwandisa ukuqedwa kwakho konke okungenzeka, okungaba khona kwezinto eziphilayo, uthuli, ukungcoliswa kwe-pyrogen, ukukhiqizwa kwekhwalithi ephezulu, impilo kanye ukuphepha kwemikhiqizo yezidakamizwa.

Ngocwaningo olujulile ngendawo yokukhiqiza yamakhasimende e-biopharmaceutical kanye nokuqongelela ulwazi lobunjiniyela, siwuqonda ngokucacile ukhiye wokulawulwa kwemvelo wenqubo yokukhiqiza ye-biopharmaceutical.Ukonga amandla kuyinto ehamba phambili yohlelo lwethu lwesistimu.Okungcono kakhulu esinakho ukuhlinzeka amakhasimende ngezidingo ze-GMP ne-Fed209D, ISO14644, IEST, EN1822 amazinga omhlaba.Ngasikhathi sinye, ukusetshenziswa kobuchwepheshe bakamuva bokonga amandla wezixazululo zemvelo, singahlinzeka ngokuhlela nokuklama kwezitshalo ze-GMP - uhlelo lokugeleza nokuhlanza izinto, uhlelo oluhlanzekile lwe-air conditioning, uhlelo lokuhlobisa oluhlanzekile, ukuguqulwa kokulondoloza amandla kwesitshalo sonke, amanzi. kanye nogesi, ipayipi legesi ehlanzekile, ukuqapha igumbi elihlanzekile, uhlelo lokulungisa kanye nezinye izinsiza ezibanzi ezisekela ukufakwa.

Biological Pharmaceutical industry GMP clean workshop umhlobiso wangaphakathi

1.Uphahlaenokufakwa okuhle kwangaphakathi, ayinalo uthuli futhi igqamile, umbala umpunga noma ukhethwe i-Party A, ugqinsi ongu-50mm, kanti ezinye izingxenye zenziwe ngepuleti le-aluminium elimpunga elikhanyayo nosilingi wethambo elimnyama lensimbi, ubukhulu obungu-0.6mm, 600X600, ngaphandle kwase indawo yokugcina amanzi, indawo ngaphambi kokungena efektri nendawo yokupakisha.

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2.IsikhawuNgokufakwa kwensimbi okunezinhlangothi ezimbiliiphaneli ye-sandwichindawo ebiyelwe nesikhawu, indawo ebiyelwe ukuya phezulu ophahleni, umhubhe ohlanzekile kanye nesikhawu seshabhu vula iwindi lengilazi le-aluminium ingxubevange, iwindi eliphakeme elingu-900mm, ukujiya kwengilazi okungu-8mm, ukuphakama okungu-1200mm, ukuphakama komnyango wengilazi (2100mm), impahla yewindi le-aluminium ingxubevange impahla yokuhlanza ekhethekile, i-bevel engu-45 degrees, kanye ne-Angle ye-yuan arc ye-yuan arc kanye ne-Yin Angle interface, Ukuthobelana nezimfuneko ezijwayelekile nezihlanzekile zokubulala amagciwane.

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3.umnyango ovaliwe:800X2100, iwindi lokubuka ingilazi, ukukhiya isiteshi sebhola.

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4. Isitezi:Isitezi sokuqala sikasimende sizophathwa nge-EPOXY resin EPOXY surface layer, 3mm EPOXY quartz mortar phakathi kwamagumbi okubumba umjovo, ukumelana nokuguga futhi ukumelana nokucindezela, kanye nongqimba lweresin engu-0.5mm EPOXY olunombala we-Apple oluhlaza noma njengoba kukhethwe i-Party A. Ihlanzekile futhi igqamile engenathuli, kulula ukuyihlanza, ayiqoqi amagciwane othuli.Noma izinto zaphansi nezindlela zokwelashwa zizokhethwa yi-Party A.

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ezinye izinhlelo zokusebenza

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