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Ipai mitsetse yemichina yekurongedza inorema otomatiki kubva muna 2012

Sarudzo dzeAseptic dzekurongedza mishonga

Munyori: Smartweigh– Huremu hwemisoro yakawanda

Sarudzo ina dzekuisa mapurasitiki asina utachiona dzekufunga nezvadzo. Nhasi uno, matekinoroji akasiyana-siyana anotarisana nevagadziri vemishonga ne biopharmaceutical ndeaya: (1) dzimba dzekuchenesa dzekirasi yakazara zana, (2) zvinoparadzanisa, (3) masisitimu ekudzivirira kupinda (RABS), (4) masisitimu ekushandisa kamwe chete. Ndeipi yakakunakira?​1. Kirasi 100 Nzvimbo Yekuchenesa: Tekinoroji yekuchenesa yakatanga kugadzirwa muma1960 kuti ishandiswe mumaindasitiri endege nemagetsi kudzivirira kusvibiswa kwezvikamu zvidiki.

Mabhakitiriya zvimedu, uye indasitiri yemishonga yakakurumidza kuona kuti hunyanzvi uhwu hwaigona kuvimbisa mhepo isina utachiona. aleksandarlittlewolf - www.freepik.comPharma-gowning-young-technologist-putting-protective-rubber-gloves-production-factory-freepik-web.jpg Makamuri ekuchenesa eClass 100 ndiwo anonyanya kushandiswa mukugadzira zvinhu zvisina utachiona (ISO 5 neA/B Class performance yakaenzana), uchishandisa firita yemhepo ine simba guru (HEPA) kubvisa zvimedu zvese nemabhakitiriya. Kuyerera kwemhepo yakakura kana kuti imwe nzira kunoderedza kutamiswa kwezvimedu kubva panzvimbo imwe kuenda kune imwe.

Mumakore ekuma1970, kuzadza kweaseptic kwaiitwa pamashini espec pasi peHEPA filter panels. Zvikamu zvemuchina zviri pamusoro pemudziyo zvinogona kukonzera kusvibiswa, uye nekufamba kwenguva zvinofambiswa kure sezvinobvira pasi pedanho rekushanda. Kuti mhepo yakaseferwa inyatsoiswa pamuchina, mapurasitiki ekufukidza mahwindo akawedzerwawo.

Jira repahwindo rinoyeuchidzawo mushandi kuti asabata muchina kana chigadzirwa. Vagadziri vakashandisa 100% HEPA ceiling kudzora makamuri ese kusvika kukirasi 100. Izvi zvinovandudza kutonga, asi zvinowedzera mari yekushandisa uye mari yekushandisa, kunyanya sisitimu yekubata mhepo.

2. MaOpto-Isolators: Mumakore ekuma80 nema90, maOpto-Isolators akagadzirwa kuti agadzirise muganho uripo pakati pevanhu nezvinhu ukuwo achideredza mitengo. MaOpto-Isolator anotsanangurwa sekamuri rakachena mubhokisi. Maitiro ese anovharwa mukabati rakavharwa, rakamanikidzwa nemhepo yakaseferwa nemaHEPA filters.

Panguva yekushanda, hapana mushandisi anotenderwa kupinda kunze kwekunge achishandisa girovhosi. Mufananidzo kubva kuna chase-logeman anchaselogeman-isolator-web.jpg we isolation system (top unit HEPA filter haisi kuratidzwa). Mufananidzo kubva kuna chase-logeman anchase-logman-isolator-inside-web.jpg unoisa mukati me isolator inoratidza girovhosi.

Mushure mekushanda kwekugadzira, chinovhara chinovhurwa, chocheneswa, uye chogadzirira kumhanya kunotevera. Kana chavharwazve, chinovhara chinozadzwa nemushonga unouraya utachiona, unowanzova vapor hydrogen peroxide (VHP), kuti ubvise utachiona hwese huri mukati. Kusiyana nekupfapfaidza kana kuscrub, VHP inopinda mumipata midiki.

Kana zvangoiswa mushonga wekuuraya utachiona, chero kugadziriswa kwekupedzisira kunoitwa kuburikidza negurovhosi. Padzidziso, zvinofanirwa kunge zvichikwanisika kushandisa chinobvisa utachiona munzvimbo isina kudzorwa, senge mudura, nemushandi akapfeka jasi remurabhoritari. Mupfungwa ndizvo zvazviri.

Kutaura zvazviri, makambani mazhinji akaisa ma isolators mumakamuri ekuchenesa ekirasi 100. Izvi zvinopa imwe nhanho yekuchenesa, asi kukosha ndekugadzira isolator yekudzivirira. 3. Restricted Access Barrier System (RABS): RABS isungano pakati pesystem yakavhurika nesystem yakaparadzana, RABS ine maitiro mukati menzvimbo yakaoma.

Kupindira kwekushanda kunopinda nepachiteshi chegirovhosi. Matekinoroji eSyntegon Pharma Syntegon-Pharma- products_filling and Closing_FXS_3100-web.jpg RABS yakavhurika inosvika padenga, zvichienderana nehurongwa hwemukamuri hwekubata nekuchenesa mweya. RABS yakavharwa ine hurongwa hwayo hwekubata nekuchenesa mweya.

RABS ine zvakanakira zvikuru pamutengo wayo kupfuura zvinoparadzanisa dzimba nekuda kwekureruka kwayo. Izvi zvinonyanya kuitika kana dzichigona kuwanikwa mudzimba dzekuchenesa dziripo uye dzoderedza mari yekuvaka. Kudiwa kwekuvaka imba yakachena kunoderedza zvimwe zvezvishoma zvinoderedza mari kana tichienzanisa nezviparadzanisa dzimba.

4. Masisitimu Anoraswa: Masisitimu ekubata zvinhu zvinoraswa ari kuwedzera kufarirwa mukushandiswa kweasina utachiona. Masisitimu aya ane bhegi repurasitiki rekutsiva gaba resimbi rechinyakare. Bhegi iri rinouya rakaiswa mafirita ese, machubhu, maports, ma nozzles ekuzadza, nezvimwe zvinodiwa.

Yakavharirwa mubhegi rinodzivirira uye inocheneswa. Mudziyo wemugadziri unopedzisa sisitimu isina utachiona uye yakagadzirira kushanda. Mufananidzo kubva kuna sartorioussaritus Img_OctoPlus-_4154-web.jpg Vamwe vagadziri vanopa masisitimu akagadzirwa ekushandisa kamwe chete, anosanganisira Sartorius (PreVAS yayo - yakavimbiswa kare, yakaunganidzwa kare, yakacheneswa kare - Project Syntegon), Pall Corporation (Sisitimu yayo yeBiotech yaimbova Sexual Use) nezvimwewo.

Sekureva kwaMarion Monstier, Sartorius Freeze-Thaw Products Manager, zvakanakira masisitimu anoshandiswa kamwe chete zvinosanganisira: • Masisitimu akavharwa anoderedza kutamiswa uye kubatwa kwechigadzirwa, zvichideredza njodzi yekusvibiswa. • Kutsiva masisitimu anoshandiswa kamwe chete pakati pekushandiswa kwechigadzirwa kunobvisa mukana wekusvibiswa kwese nekuda kwekucheneswa kusina kukwana kana kusina kukodzera. • Zvichienzaniswa nemasisitimu anogona kushandiswazve, masisitimu aya anoderedza kuchinja uye nguva yekugadzika.

• Zvinobvisa zvinodiwa zvekuongorora kucheneswa. • Zvinoderedza mvura zviri nani, zvichiita kuti chigadzirwa chidzoke zvakare.

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