Izinketho ze-Aseptic zokupakisha imithi

Umbhali: Smartweigh– Isisindo Sezinhloko Eziningi

Izinketho ezine zokupakisha ezingasebenzi kahle okufanele uzicabangele. Namuhla, ubuchwepheshe obuhlukahlukene obuqondiswe kubakhiqizi bemithi kanye ne-biopharmaceutical yilokhu: (1) amakamelo okuhlanza ekilasini eliphelele ayi-100, (2) ama-isolators, (3) izinhlelo zokuvimbela ukufinyelela okunqunyelwe (i-RABS), (4) izinhlelo zokusetshenziswa kanye. Yikuphi okungcono kakhulu kuwe?​1. Igumbi Lokuhlanza Lekilasi 100: Ubuchwepheshe begumbi lokuhlanza basungulwa ekuqaleni ngawo-1960 ukuze busetshenziswe embonini yezindiza kanye ne-elekthronikhi ukugwema ukungcoliswa kwezinhlayiya zezingxenye ezincane.

Amabhaktheriya ayizinhlayiya, futhi imboni yezemithi yasheshe yaqaphela ukuthi leli khono lingaqinisekisa umoya ongcolile. aleksandarlittlewolf - www.freepik.comPharma-gowning-young-technologist-putting-protective-rubber-gloves-production-factory-freepik-web.jpg Amakamelo okuhlanza ekilasi 100 avame kakhulu ekukhiqizeni i-aseptic (ukusebenza kwekilasi le-ISO 5 kanye ne-A/B kuyafana), kusetshenziswa isihlungi se-high-efficiency particulate air (HEPA) ukususa zonke izinhlayiya namagciwane. Ukugeleza komoya okukhulu kwe-laminar noma kwe-unidirectional kunciphisa ukudluliselwa kwezinhlayiya kusuka endaweni eyodwa kuya kwenye.

Ngawo-1970, ukugcwaliswa kwe-aseptic kwenziwa emishinini ekhethekile ngaphansi kwamaphaneli okuhlunga e-HEPA. Izingxenye zomshini ezingaphezu kwesitsha zingumthombo ongaba khona wokungcola, futhi ngokuhamba kwesikhathi zisuswa kude ngangokunokwenzeka ngaphansi kwezinga lokusebenza. Ukuze kugxilwe kangcono umoya ohlungiwe emshinini, kuye kwanezelwa nezimbozo zamafasitela epulasitiki.

Indwangu yefasitela iphinde ikhumbuze umqhubi ukuthi agweme ukuthinta umshini noma umkhiqizo. Abakhiqizi baphendukele ophahleni lwe-HEPA oluyi-100% ukulawula amakamelo aphelele abe yikilasi le-100. Lokhu kuthuthukisa ukulawula, kodwa kwandisa izindleko zemali kanye nokusebenza, ikakhulukazi uhlelo lokuphatha umoya.

2. Ama-Opto-Isolators: Ngawo-80s kanye nawo-90s, ama-isolators athuthukiswa ukuze kuthuthukiswe isithiyo phakathi kwabantu nemikhiqizo ngenkathi kunciphisa izindleko. I-isolator ichazwa njengegumbi elihlanzekile ebhokisini. Yonke inqubo ivaliwe ekhabetheni elivaliwe, elicindezelwe ngomoya ohlungiwe yizihlungi ze-HEPA.

Ngesikhathi sokusebenza, akekho umqhubi ovunyelwe ukungena ngaphandle kokusebenzisa isikhombikubona segilavu. Isithombe ngenxa ye-chase-logeman anchaselogeman-isolator-web.jpg sohlelo lokuzihlukanisa (isihlungi se-HEPA seyunithi ephezulu asiboniswanga). Isithombe ngenxa ye-chase-logeman anchase-logman-isolator-inside-web.jpg siphakela ingaphakathi le-isolator elibonisa imbobo yegilavu.

Ngemva kokuqaliswa kokukhiqiza, i-isolator izovulwa, ihlanzwe, futhi ilungele ukuqaliswa okulandelayo. Uma isivalwe kabusha, i-isolator igcwaliswa nge-sterilant, ngokuvamile i-vapor hydrogen peroxide (VHP), ukuze ihlanze konke okungaphakathi. Ngokungafani nokuhlanza okuvamile noma ukuhlanza nge-scrub, i-VHP ingena emifantwini emincane kakhulu.

Uma sekuhlanjululwe, noma yikuphi ukusethwa kokugcina kwenziwa nge-glove port. Ngokwethiyori, kufanele kube nokwenzeka ukusebenzisa i-isolator endaweni engalawulwa, njenge-warehouse, ngumsebenzisi ogqoke ijazi lelebhu. Ngokwethiyori kunjalo.

Eqinisweni, izinkampani eziningi zifake ama-isolator ezindaweni zokuhlanza zekilasi le-100. Lokhu kunikeza ungqimba olwengeziwe lokuhlanza, kodwa inani ukuthuthukisa i-isolator ukuze ugweme. 3. Uhlelo Lokuvimbela Ukufinyelela Olukhawulelwe (i-RABS): I-RABS iyisivumelwano phakathi kohlelo oluvulekile nohlelo oluhlukanisiwe, i-RABS iqukethe inqubo ngaphakathi kwendawo evalekile eqinile.

Ukungenelela kokusebenza kungena ngembobo yegilavu. Ubuchwepheshe be-Syntegon Pharma I-Syntegon-Pharma- products_filling kanye ne-Closing_FXS_3100-web.jpg I-RABS evulekile ifinyelela ophahleni, incike ohlelweni lokuphatha umoya kanye nokuhlunga lwegumbi. I-RABS evaliwe iqukethe uhlelo lwayo lokuphatha umoya kanye nokuhlunga.

I-RABS inezinzuzo ezinkulu zezindleko kunezihlukanisi ngenxa yobulula bayo. Lokhu kuyiqiniso ikakhulukazi uma zingatholakala emakamelweni okuhlanza akhona bese zinciphisa izindleko zokwakha. Isidingo sokwakha igumbi elihlanzekile sinciphisa ezinye zezindleko zokonga uma kuqhathaniswa nezihlukanisi.

4. Izinhlelo ezilahlwayo: Izinhlelo zokuphatha imikhiqizo elahlwayo ziya ngokuya zithandwa kakhulu ekusetshenzisweni kwe-aseptic. Lezi zinhlelo ziqukethe isikhwama sepulasitiki ukuze sithathe indawo yethini lensimbi lendabuko. Isikhwama siza sipakishwe kusengaphambili ngezihlungi zonke, amapayipi, ama-port, ama-nozzle okugcwalisa, nezinye izesekeli ezidingekayo.

Ivalwe esikhwameni esivikelayo futhi ihlanzwe nge-sterilize. Idivayisi yomenzi iqeda uhlelo luhlanzekile futhi lulungele ukusebenza. Isithombe ngomusa we-sartorioussaritus Img_OctoPlus-_4154-web.jpg Abanye abakhiqizi banikeza izinhlelo ezisetshenziswa kanye, okuhlanganisa i-Sartorius (i-PreVAS yayo - eqinisekisiwe kusengaphambili, ehlanganisiwe kusengaphambili, ehlanzwe kusengaphambili - i-Project Syntegon), i-Pall Corporation (i-Biotech yayo kanye ne-Sexual Use System) njll.

Ngokusho kukaMarion Monstier, uMphathi Wemikhiqizo kaSartorius Freeze-Thaw, izinzuzo zezinhlelo ezisetshenziswa kanye zifaka: • Izinhlelo ezivaliwe zinciphisa ukudluliselwa nokuphathwa komkhiqizo, kunciphisa ingozi yokungcola. • Ukushintsha izinhlelo ezisetshenziswa kanye phakathi kokusetshenziswa komkhiqizo kuqeda amathuba okungcoliswa okuhlobene ngenxa yokuhlanzwa okungaphelele noma okungafanele. • Uma kuqhathaniswa nezinhlelo ezingasetshenziswa kabusha, lezi zinhlelo ezihlukile zinciphisa isikhathi sokushintsha kanye nokusetha.

• Ziqeda izidingo zokuqinisekiswa kokuhlanza. • Zikhipha amanzi kangcono, ngaleyo ndlela zandise ukubuyiswa komkhiqizo.

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