Aseptic sarudzo dzekurongedza kwemishonga

2022/08/15

Munyori: Smartweigh–Multihead Weighter

Ina aseptic yekurongedza sarudzo yekufunga nezvayo. Nhasi, matekinoroji akasiyana anonangana nevagadziri vemishonga uye biopharmaceutical ndeaya: (1) yakazara kirasi zana dzimba dzekuchenesa, (2) isolators, (3) inorambidzwa kupinda zvipingamupinyi masisitimu (RABS), (4) masisitimu ekushandisa kamwe chete. Ndeipi yakakunakira? 1. Kirasi 100 Yekuchenesa Kamuri: Tekinoroji yekamuri yekuchenesa yakatanga kugadzirwa muma1960 kuti ishandiswe mumaindasitiri ezvemhepo nemagetsi kudzivirira kusvibiswa kwezvikamu zvidiki.

Utachiona zvidimbu, uye indasitiri yemishonga yakakurumidza kuona kuti hunyanzvi uhu hwaigona kuvimbisa mweya usina hutachiona. aleksandarlittlewolf - www.freepik.comPharma-gowning-young-technologist-putting-protective-rubber-gloves-production-factory-freepik-web.jpg Dzimba dzekuchenesa dzeClass 100 ndidzo dzinonyanya kuwanikwa mukugadzirwa kweaseptic (ISO 5 uye A/B Class performance yakaenzana), uchishandisa sefa yepamusoro-soro yemhepo (HEPA) kubvisa zvimedu zvese nemabhakitiriya. Huru vhoriyamu laminar kana unidirectional kuyerera kwemhepo kunoderedza kutamiswa kwezvimedu kubva kune imwe nzvimbo kuenda kune imwe.

Mumakore ekuma1970, kuseptic kuzadzwa kwakaitwa pamichina yakatarwa pasi peHEPA sefa mapaneru. Zvikamu zvemuchina pamusoro pemudziyo zvinogona kukonzera kusvibiswa, uye nekufamba kwenguva zvinofambiswa kusvika pazasi pezinga rekushanda. Kuti unyatso kutarisisa mweya wakasefa pamushini, mapurasitiki ekuvhara mahwindo akawedzerwa zvakare.

Iro jira rehwindo rinoyeuchidzawo mushandisi kuti arege kubata muchina kana chigadzirwa. Manufacturers akatendeukira 100% HEPA ceilings kudzora yose makamuri kuti kirasi 100. Izvi anovandudza kuzvidzora, asi anowedzera guru uye kushandisa mari, kunyanya mhepo kubata hurongwa.

2. Opto-Isolators: Mune 80s uye 90s, isolators yakagadzirwa kuti ivandudze chipingamupinyi pakati pevanhu uye zvigadzirwa uku ichideredza mutengo. Iyo isolator inotsanangurwa sekamuri yakachena mubhokisi. Maitiro ese akavharwa mukabati yakavharwa, yakamanikidzwa nemhepo yakasefa neHEPA mafirita.

Panguva yekushanda, hapana mushandisi anotenderwa kupinda kunze kweiyo girovhosi interface. Mufananidzo unoremekedza chase-logeman anchaselogeman-isolator-web.jpg ye isolation system (yepamusoro unit HEPA sefa haina kuratidzwa). Mufananidzo unofadza chase-logeman anchase-logman-isolator-inside-web.jpg inodyisa iyo isolator yemukati inoratidza girovhosi port.

Mushure mekumhanya kwekugadzira, iyo isolator inovhurwa, kucheneswa, uye kugadzirira kumhanya kunotevera. Kana yangovharwa patsva, iyo isolator inozadzwa neyakaorera, kazhinji mhute hydrogen peroxide (VHP), kuomesa zvese zviri mukati. Kusiyana nechinyakare pfapfaidzo kana kukwesha disinfection, VHP inopinda mudiki diki remakorokoza.

Kana yangoitwa sterilized, chero kuseta kwekupedzisira kunoitwa kuburikidza negirovhosi port. Muchirevo, zvinofanirwa kunge zvichikwanisika kushandisa iyo isolator munzvimbo isingadzoreki, senge dura, nemushandisi akapfeka jasi rebhu. Zvichitaurwa ndizvo.

Muchokwadi, makambani mazhinji akaisa ma isolator mukirasi 100 dzimba dzekuchenesa. Izvi zvinopa imwe yekuwedzera dhizaini yekuchenesa, asi kukosha kusimudzira yekuzviparadzanisa nevamwe kudzivirira. 3. Restricted Access Barrier System (RABS): RABS inopindirana pakati pehurongwa hwakazaruka uye imwe yega yega, RABS ine maitiro mukati mekuvhara kwakaoma.

Kupindira kwekushanda kunopinda kuburikidza negorofu port. Syntegon Pharma technologies Syntegon-Pharma- products_filling and Closing_FXS_3100-web.jpg Iyo RABS yakazaruka inotambanukira kusvika kusirin'i, ichitsamira pamabatiro emhepo yekamuri uye nefiltration system. Yakavharwa RABS ine yayo yemhepo inobata uye kusefa system.

RABS ine zvakakosha mutengo wakanakira pamusoro pezvitsaura nekuda kwekureruka kwayo. Izvi ndezvechokwadi kunyanya kana achigona kuwanikwa mudzimba dzakachena dziripo uyezve kuderedza mari yekuvaka. Iko kudikanwa kwekuvaka kamuri yakachena kunobvisa kumwe kuchengetwa kwemutengo uchienzaniswa nevanozviparadzanisa nevamwe.

4. Disposable systems: Disposable chigadzirwa chekubata masisitimu ari kuramba achizivikanwa mune eseptic application. Masisitimu aya ane bhegi repurasitiki rekutsiva gaba resimbi rechinyakare. Bhegi rinouya rakafanorongedzerwa neese mafirita, tubing, madoko, kuzadza nozzles, uye zvimwe zvinodiwa zvinodiwa.

Yakavharwa muhomwe yekudzivirira uye yakavharwa. Iyo yekugadzira mudziyo inopedzisa iyo system isina kuchena uye yakagadzirira kushanda. Mufananidzo nerubatsiro rwe sartorioussaritus Img_OctoPlus-_4154-web.jpg Vamwe vagadziri vanopa masisitimu ekushandisa akasarudzika, anosanganisira Sartorius (yayo PreVAS - yakavharwa, yakavharwa, yakavharwa, isati yaitwa sterilized - Project Syntegon), Pall Corporation (yayo Biotech kamwe chete Kushandiswa Kwepabonde System) nezvimwewo.

Sekureva kwaMarion Monstier, Sartorius Freeze-Thaw Products Manager, zvakanakira zvekushandisa kamwe chete masisitimu zvinosanganisira: • Yakavharwa masisitimu anoderedza kufambiswa kwechigadzirwa uye kubata, kuderedza njodzi yekusvibiswa. • Kutsiva maitiro ekushandisa kamwe chete pakati pechigadzirwa chinomhanya kunobvisa mukana wekusvibiswa-kusvibiswa nekuda kwekuchenesa kusina kukwana kana kusina kukodzera. • Kuenzaniswa nemasisitimu anogona kushandiswazve, aya mamwe masisitimu anoderedza shanduko uye nguva yekumisikidza.

• Vanobvisa kucheneswa kwekusimbisa zvinodiwa. • Vanodonhedza zviri nani, nokudaro vachiwedzera kupora kwechigadzirwa.

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