Filifiliga aseptic mo le afifiina o vailaau

2022/08/15

Tusitala: Smartweigh–Fa'amamafa'aulu tele

E fa filifiliga afifi aseptic e mafaufau i ai. I aso nei, o tekinolosi eseese o loʻo faʻatatau i le gaosiga o vailaʻau ma biopharmaceutical e: (1) potu mama 100 vasega atoa, (2) faʻaesea, (3) faʻatapulaʻaina auala pa puipui (RABS), (4) faiga faʻaoga tasi. O le fea e sili mo oe?1. Vasega 100 Potu Mama: O tekonolosi potu mama na amata fausia i le 1960s mo le fa'aogaina i le va'alele ma mea tau eletise e aloese ai mai le afaina o vaega laiti.

O siama o ni mea ninii, ma e leʻi umi ae iloa e le falemaʻi o vailaʻau e mafai e lenei tomai ona faʻamaonia le ea mama. aleksandarlittlewolf - www.freepik.comPharma-gowning-young-technologist-putting-protective-rubber-gloves-production-factory-freepik-web.jpg Vasega 100 potu mama e sili ona taatele i le gaosiga o le aseptic (ISO 5 ma le A/B Class performance e tutusa), e fa'aogaina ai le fa'amama o le ea (HEPA) maualuga e aveese uma ai vaega ma siama. Latuma voluma laminar po'o le tasi fa'asolo ea tafe fa'aitiitia le fesiitaiga o vaega mai le tasi nofoaga i le isi.

I le vaitau o le 1970, sa fa'atumuina aseptic i masini fa'apitoa i lalo ole fa'amama a le HEPA. O vaega o le masini i luga a'e o le atigipusa e mafai ona mafua ai le fa'aleagaina, ma i le aluga o taimi o lo'o fa'agasolo mamao i lalo ole tulaga faigaluega. Ina ia sili atu le faʻaogaina o le ea faʻamama i luga o le masini, ua faʻapipiʻi foʻi ufiufi faʻamalama palasitika.

O le ie faamalama e faamanatu atu ai foi i le tagata faafoe e aloese mai le paʻi i le masini poʻo le oloa. O tagata gaosi oloa na liliu i le 100% HEPA faʻalo e pulea potu atoa i le vasega 100. O lenei mea e faʻaleleia ai le pulea, ae faʻateleina tupe faavae ma tau faʻagaioiga, aemaise lava le faʻaogaina o le ea.

2. Opto-Isolators: I le 80s ma le 90s, na atiaʻe ai ni faʻaesea e faʻaleleia ai le pa i le va o tagata ma oloa aʻo faʻaititia le tau. O le isolator o loʻo faʻamatalaina o se potu mama i totonu o se pusa. O le faagasologa atoa o loʻo tapunia i totonu o se kapoti faʻamaufaʻailoga, faʻapipiʻiina i le ea e faʻamamaina e HEPA filiga.

I le taimi o le taotoga, e leai se tagata e fa'atagaina e ulufale i totonu vagana ai le fa'aoga totigilima. Ata fa'aaloaloga a chase-logeman anchaselogeman-isolator-web.jpg mo faiga fa'amama (e le o fa'aalia le filiga HEPA pito i luga). Ata mai le fa'aaloaloga a chase-logeman anchase-logman-isolator-inside-web.jpg fafaga le fa'aesea totonu o lo'o fa'aalia ai le uafu totigilima.

A maeʻa le gaosiga o le taʻavale, o le a tatalaina le faʻamama, faʻamamā, ma sauni mo le isi taʻavale. O le taimi lava e toe fa'amaufa'ailogaina ai, e fa'atumuina le mea fa'a'ese'ese i se fa'ama'i, e masani lava ona fa'amama le vai (VHP), e fa'amama mea uma i totonu. E le pei o le fa'amama fa'aleaganu'u po'o le fa'amama fa'ama'i fa'ama'i, e o'o le VHP i ni va'a laiti.

A mae'a ona fa'amama, so'o se seti fa'ai'u e faia i le uafu totigilima. I le talitonuga, e tatau ona mafai ona faʻaogaina le faʻaesea i se avanoa e le pulea, e pei o se faleteuoloa, e se tagata faʻatautaia o loʻo ofuina se ofu talaloa. O le manatu e faapea.

O le mea moni, o le tele o kamupani ua faʻapipiʻiina ni mea faʻapitoa i le vasega 100 potu mama. E maua ai se vaega fa'aopoopo o le fa'amamāina, ae o le tau o le fa'atupuina o se mea fa'aesea e 'alo'ese ai. 3. Fa'atapula'a Avanoa Pa'a Fa'atonu (RABS): RABS ose fa'a'i'uga i le va o se faiga fa'alatalata ma se faiga tu'ufua, o le RABS o lo'o iai le fa'agasologa i totonu o se pa puipui.

O fa'agaioiga fa'agaioiga e ui atu i le uafu totigilima. Syntegon Pharma technologies Syntegon-Pharma-products_filling and Closing_FXS_3100-web.jpg O le RABS tatala e faʻalautele atu i le taualuga, faʻalagolago i le faʻaogaina o le ea ma le faʻaogaina o le masini. O le RABS tapuni o lo'o i ai lana lava fa'aogaina o le ea ma le fa'amamaina.

O le RABS e sili atu le tau nai lo mea faʻapitoa ona o lona faigofie. E moni lava lenei mea pe afai e mafai ona maua i totonu o potu mama o loʻo iai ona faʻaititia lea o tau faufale. O le mana'oga e fau se potu mama e fa'amalieina ai nisi o tupe fa'aalu pe a fa'atusatusa i mea fa'apitoa.

4. Fa'aogaina faiga: Fa'agata fa'atau oloa ua fa'ateleina ma sili atu ona lauiloa i fa'aoga aseptic. O nei faiga e iai se taga palasitika e sui ai le apa u'amea masani. O le ato e sau muamua faʻapipiʻi ma mea uma e faamama, paipa, ports, faʻatumu faʻamau, ma isi mea manaʻomia.

E fa'amaufa'ailogaina i totonu o se ato puipui ma fa'amama. O le masini gaosi mea e fa'auma le fa'aogaina o le tino ma sauni mo le fa'agaioiga. Ata fa'aaloaloga a sartorioussaritus Img_OctoPlus-_4154-web.jpg O nisi tagata gaosi oloa latou te ofoina atu faiga fa'apitoa e tasi, e aofia ai Sartorius (ona PreVAS - mua'i fa'amaonia, mua'i fa'apipi'iina, mua'i fa'amama - Project Syntegon), Pall Corporation (ana Biotech i le taimi e fa'aoga ai feusuaiga. System) ma isi.

E tusa ai ma Marion Monstier, Sartorius Freeze-Thaw Products Manager, o le lelei o faiga faʻaoga tasi e aofia ai: • O faiga tapuni e faʻaitiitia ai le fesiitaiga ma le taulimaina o oloa, faʻaitiitia le lamatiaga o le faʻaleagaina. • O le suiina o faiga fa'aoga tasi i le va o fa'amomoli o oloa e fa'ate'aina ai le ono fa'ama'i fa'asaga ona o le le atoatoa po'o le fa'amama le talafeagai. • Fa'atusatusa i faiga toe fa'aaogaina, o nei faiga fa'aopoopo e fa'aitiitia ai suiga ma taimi fa'atulagaina.

• Latou te fa'aumatia mana'oga fa'amaonia fa'amama. • E sili atu le tafe, ma faʻateleina ai le toe faʻaleleia o oloa.

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