I-Smart Weigh izinikele ekusizeni amaklayenti akhulise umkhiqizo ngezindleko ezincishisiwe.
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I-Smart Weigh izinikele ekusizeni amaklayenti akhulise umkhiqizo ngezindleko ezincishisiwe.
Umbhali: Smartweigh–I-Multihead Weighter
Izinketho ezine zokupakishwa kwe-aseptic okufanele zicatshangelwe. Namuhla, ubuchwepheshe obuhlukahlukene obuqondiswe kubakhiqizi bezemithi kanye ne-biopharmaceutical buyi: (1) amagumbi okuhlanza ekilasi eligcwele ayi-100, (2) izihlukanisi, (3) amasistimu okuvimbela ukufinyelela okukhawulelwe (i-RABS), (4) amasistimu okusetshenziswa okukodwa. Iyiphi engcono kuwe? 1. I-Class 100 Cleanroom: Ubuchwepheshe be-Cleanroom ekuqaleni basungulwa ngawo-1960 ukuze busetshenziswe ezimbonini ze-aerospace neze-electronics ukugwema ukungcoliswa kwezingxenye ezincane.
Amagciwane ayizinhlayiya, futhi imboni yemithi yasheshe yaqaphela ukuthi leli khono lingaqinisekisa umoya oyinyumba. aleksandarlittlewolf - www.freepik.comPharma-gowning-young-technologist-putting-protective-rubber-gloves-production-factory-freepik-web.jpg Amakamelo okuhlanza Ekilasi Le-100 avame kakhulu ekukhiqizeni i-aseptic (ISO 5 kanye nokusebenza kweClass A/B kuyalingana), kusetshenziswa isihlungi se-particulate air (HEPA) esisebenza kahle kakhulu ukususa zonke izinhlayiya nama-bacteria. I-laminar yevolumu enkulu noma ukugeleza komoya okungaqondile kunciphisa ukudluliswa kwezinhlayiya ukusuka endaweni eyodwa kuya kwenye.
Ngawo-1970s, ukugcwaliswa kwe-aseptic kwenziwa emishinini ethile ngaphansi kwamaphaneli okuhlunga e-HEPA. Izingxenye zomshini ezingenhla kwesiqukathi zingaba umthombo wokungcola, futhi ngokuhamba kwesikhathi zihanjiswa kude kakhulu ngangokunokwenzeka ngaphansi kwezinga lokusebenza. Ukuze ugxilise kangcono umoya ohlungiwe emshinini, izimbozo zamafasitela epulasitiki nazo zengeziwe.
Indwangu yewindi iphinda ikhumbuze opharetha ukuthi agweme ukuthinta umshini noma umkhiqizo. Abakhiqizi baphendukela ophahleni lwe-HEPA oluyi-100% ukuze balawule amagumbi wonke ukuya ekilasini le-100. Lokhu kuthuthukisa ukulawula, kodwa kwandisa izindleko zemali nezindleko zokusebenza, ikakhulukazi uhlelo lokuphatha umoya.
2. Ama-Opto-Isolators: Ku-80s kanye nama-90s, izihlukanisi zathuthukiswa ukuze kuthuthukiswe umgoqo phakathi kwabantu nemikhiqizo ngenkathi kunciphisa izindleko. Isihlukanisi sichazwa njengegumbi elihlanzekile ebhokisini. Yonke le nqubo ivalwe ekhabetheni elivalekile, elicindezelwe ngomoya ohlungiwe izihlungi ze-HEPA.
Ngesikhathi sokusebenza, akekho u-opharetha ovunyelwe ukungena ngaphandle kwe-interface yegilavu. Isithombe sihlonipha i-chase-logeman anchaselogeman-isolator-web.jpg yesistimu yokuhlukanisa (iyunithi ephezulu yesihlungi se-HEPA asibonisiwe). Isithombe sihlonipha i-chase-logeman anchase-logman-isolator-inside-web.jpg iphakela indawo yangaphakathi ye-isolator ebonisa imbobo yamagilavu.
Ngemuva kokuqaliswa kokukhiqiza, isihlukanisi sizovulwa, sihlanzwe, futhi silungele ukusebenza okulandelayo. Uma sesivaliwe kabusha, isihlukanisi sigcwaliswa ngesibulala-magciwane, ngokuvamile i-vapor hydrogen peroxide (VHP), ukuvala amagciwane yonke into engaphakathi. Ngokungafani nesifutho esivamile noma isibulala-magciwane sokukhuhla, i-VHP ingena emifantwini emincane kakhulu.
Uma sekufakwe inzalo, noma yikuphi ukusetha kokugcina kwenziwa ngembobo yamagilavu. Ngokombono, kufanele kwenzeke ukusebenzisa i-isolator endaweni engalawulwa, njengendawo yokugcina impahla, ngu-opharetha ogqoke ijazi lelebhu. Ngokwethiyori kunjalo.
Eqinisweni, izinkampani eziningi zifake izihlukanisi emagumbini okuhlanza ekilasi le-100. Lokhu kunikeza isendlalelo esengeziwe sokuhlanza, kodwa inani wukuthuthukisa isihlukanisi okufanele sigwenywe. 3. I-Restricted Access Barrier System (RABS): I-RABS iwukuvumelana phakathi kwesistimu evulekile nesistimu ehlukile, i-RABS iqukethe inqubo ngaphakathi kwendawo ebiyelwe eqinile.
Ukungenelela kokusebenza kungena ngembobo yamagilavu. Syntegon Pharma technologies Syntegon-Pharma- products_filling and Closing_FXS_3100-web.jpg I-RABS evulekile inweba ophahleni, incike ohlelweni lokubamba komoya kanye nesistimu yokuhlunga. I-RABS evaliwe iqukethe isistimu yayo yokubamba komoya kanye nokuhlunga.
I-RABS inezinzuzo ezibalulekile zezindleko ngaphezu kwezihlukanisi ngenxa yobulula bayo. Lokhu kuyiqiniso ikakhulukazi uma zingatholakala ezindlini ezihlanzekile ezikhona bese zinciphisa izindleko zokwakha. Isidingo sokwakha igumbi elihlanzekile sinciphisa okunye ukonga kwezindleko uma kuqhathaniswa nezihlukanisi.
4. Amasistimu alahlwayo: Amasistimu okuphatha imikhiqizo alahlwayo aya ngokuya ethandwa kakhulu ezinhlelweni ze-aseptic. Lezi zinhlelo ziqukethe isikhwama sepulasitiki esithatha indawo yekani lensimbi lendabuko. Isikhwama siza sipakishwe kusengaphambili nazo zonke izihlungi, amashubhu, izimbobo, imibhobho yokugcwalisa, nezinye izisetshenziswa ezidingekayo.
Ivalwa esikhwameni sokuzivikela futhi ifakwe inzalo. Idivayisi yomkhiqizi iqedela uhlelo oluyinyumba futhi lulungele ukusebenza. Isithombe sihlonishwa yi-sartorioussaritus Img_OctoPlus-_4154-web.jpg Abanye abakhiqizi bahlinzeka ngezinhlelo ezisetshenziswa ngokwezifiso ezisetshenziswa kanye, okuhlanganisa i-Sartorius (i-PreVAS yayo - eqinisekisiwe ngaphambili, ehlanganiswe ngaphambili, eyanziwa inzalo - Project Syntegon), i-Pall Corporation (i-Biotech yayo kanye Ukusetshenziswa Kocansi System) njll.
Ngokuka-Marion Monstier, i-Sartorius Freeze-Thaw Products Manager, izinzuzo zamasistimu okusebenzisa kanye zihlanganisa: • Amasistimu avaliwe anciphisa ukudluliswa komkhiqizo nokuphatha, okunciphisa ingcuphe yokungcoliswa. • Ukushintsha amasistimu okusetshenziswa okukodwa phakathi kokusetshenziswa komkhiqizo kususa amathuba okungcola ngenxa yokuhlanza okungaphelele noma okungafanele. • Uma kuqhathaniswa namasistimu asebenziseka kabusha, lawa masistimu anciphisa ukushintsha nesikhathi sokusetha.
• Aqeda izidingo zokuqinisekisa ukuhlanza. • Adonsa amanzi kangcono, ngaleyo ndlela akhulise ukutholakala komkhiqizo.
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