Funteni hakɛ bɛ se ka kɛ mun ye?"Safety Threshold" latigɛ ka da baarakɛcogo wajibiyalenw kan.
Funteni hakɛ min bɛ bɛn hakɛ ma min bɛ se ka kɛ ka caya-Fɛɛrɛbɔ, sanfɛ{1}}filɛli nafamaw, o tɛ se ka sigi sen kan ni diyagoya ye; A bɛ dɔn ni tunɛri foro ka baarakɛ funteni ni funteni jiginni hakɛ yɛrɛ ye. Sariyabaju ye ka "baarakɛcogo dantɛmɛnenw datugu k'a sɔrɔ u bɛ lakana danfara dɔ to yen."
1. Funteni hakɛ basigilenw kunbɛncogo : 180℃.
Stérilisation température min ka dɔgɔn furakɛli tunɛri forow la, a ka c’a la, o bɛ kɛ degere 180 ye (misali la, da kɔnɔ furaji dɔw sterilize jalen na). O la, filɛri ka funteni hakɛ ka kan ka se degere 180 ma a dɔgɔyalenba la, k’a sɔrɔ a ma se. O funteni in na, filɛriw, nɛgɛw, ani karamɔgɔ ka kan ka sigicogo sabatili mara k’a sɔrɔ funteni ma wuli, ka kari, walima ka bɔ kɛnɛ kan.
2. Taabolow ka baarakɛcogo kɔrɔlen: 250-300℃.
Tunnel foro fanba minnu bɛ furajiw dilanyɔrɔw la, olu bɛ baara kɛ ni "250℃x 30 minutes" sterilisation (min bɛ GMP ka sariyaw labato aseptiki minɛnw minɛcogo la). Dɔw ka caya{3}}Farafɛnw (i n’a fɔ biologiki) yɛrɛ bɛ baara kɛ ni 300℃flash sterilization process ye. O la, o ko suguw la, filɛri min ka bon ni a ka ca ni hakɛ ye, n’a ka funteni hakɛ bɛ se degere 300 ma walima min ka ca ni o ye, o de ka kan walasa filɛri nafama kana dɔgɔya waati jan-waati caman-sumaya waati la (waati 8-12 tile kɔnɔ).
3. Baara dantɛmɛnen: 350 degɛrɛ .
Taabolo kɛrɛnkɛrɛnnen dɔw (i n’a fɔ pirojɛni jugumanba bɔli furakisɛw la minnu bɛ kɛ ni fɛnɲɛnamafagalanw ye) bɛ funteni hakɛ tɛmɛ degere 350 kan . O ko ninnu na, filɛri ka kan ka sariya gɛlɛnw dafa walasa ka funteni kunbɛn waati kuntaala surun na min bɛ se degere 350 ma ani ka funteni kunbɛn min bɛ se ka kɛ degere 320 ye . Ka fara o kan, sabatili ka kan ka sɛgɛsɛgɛ ni sɛgɛsɛgɛli caman ye minnu bɛ kɛ ka caya-sumaya waati sɛgɛsɛgɛli la ( min ka bon walima min bɛ bɛn 100 sɛgɛsɛgɛli ma).
Funteni kɔfɛ: filɛriw ka sanfɛ-Fɛnɲɛnɛma resistance .
O waati kelen na, funteni wajibiyalenw dafali tɛ bɔli kɛ. Filɛri minnu bɛ kɛ furakɛli-yɔrɔ jalen forow la, olu ka kan ka kɛ ni "sumaya, saniya, ani sabatili jogo sabatilenw ye":
1. Filtre matériel: fibre gilasi ye "baarakɛ-so" ye.
Glass fibre filter material: Ni funteni hakɛ bɛ se ka kɛ 350-400 degre ye , a bɛ kemikaliya sabatili barikama jira ani a tɛ volatiles bɔ funteni caman na, o b’a to a ka fisa ni sugandili ɲuman ye baarakɛcogo la ka tɛmɛ degere 300 kan
Composite High-Furakɛ- Misali la, gilasi fiyɛ ni seramiki fiyɛriw ka fɛnɲɛnamafagalanw bɛ se ka funteni muɲu ka tɛmɛ degere 400 kan , nka u ka kan k’a lajɛ ko farati tɛ fiɲɛ bɔli la (walasa ka minɛnw nɔgɔli bali).
Fɛn minnu dagalen don: poliporopilini gansan ni poliyesitɛri filɛtiri fɛn minnu bɛ se ka funteni hakɛ 80-120 dɔrɔn sɔrɔ, wa u bɛna wuli ka u tiɲɛ funteni caman na. U dagalen don kosɛbɛ ka baara kɛ ni u ye tunnel jalen forow la.
2. Jɛkuluw ka fɛnw : "High-Fɔcogo faratiw" bɔ yen.
Kalansen: Aw bɛ 304/316 inox kɛ ka nɔgɔ ni nɛgɛ ion bɔli bali funteni caman na.
Sealant: Aw bɛ baara kɛ ni High-Temperature- silikoni lastikuw ye minnu bɛ se ka bana sɔrɔ (funteni kunbɛncogo min ka bon walima min bɛ bɛn degere 300 ma ) sanni nitirili lastikuw (funteni kunbɛncogo) nɔ na min ka dɔgɔn walima min bɛ bɛn degere 120 ma ) walasa ka kari ni ji bɔn funteni caman na.
Dɛmɛn mesh: nɛgɛfɛn ka kan ka kɛ ni passivation furakɛli ye walasa ka oksidan caman walima fɛnɲɛnamafagalanw bɔli bali.
3. Laadalata: "Seriya fila" tɛmɛ walasa ka lakana sabati .
Filɛri nafa: A ka kan ka tɛmɛ EN 1822 sɛgɛsɛgɛli kɛcogo la, ni H13 nafa ye walima ka tɛmɛ o kan ( a ka bon walima a bɛ bɛn 99,97% @ 0,3μm ma) walasa ka fɛnɲɛnama misɛnniw ni fɛnɲɛnamafagalanw bɛɛ minɛ.
Integrity: After high-Semperature sterilization, pass PAO/DEHS Integrity testing ni bɔgɔbɔli hakɛ min ka dɔgɔ walima min bɛ bɛn 0,01% ma. Kɔrɔbɔli jaabiw ka kan ka GMP kunnafoniw nɔfɛtaama wajibiyalenw dafa.
"farati dogolenw" min ye funteni jugu sugandili ye .
Ni filɛri ka funteni hakɛ ma bɛn, a kɔlɔlɔw bɛ se ka fura ɲumanya bila farati la k’a ɲɛsin a ma:
Funteni hakɛ min bɛ se ka funteni kunbɛn: filɛri fɛn bɛ dɔgɔya ani ka karɔbɔni kɛ funteni caman na, o bɛ na ni filɛri nafama dɔgɔyali ye. Kɛnɛyaji misɛnniw walima fɛnɲɛnamafagalanw bɛ se ka don foro kɔnɔ ani ka minɛnw nɔgɔ.
Funteni hakɛ dantɛmɛnen : ka ultra{0}}High-Temperature Filter (misali la, ka baara kɛ ni 400 degere filɛri ye ni baara kɛcogo funteni yɛrɛ ye 250 ye ) sugandi ka dɔ fara minɛnw musakaw kan (ultraature models are 2-3 compense than conventional models) ani fana a bɛ se ka kɛ fana ko a bɛ se ka kɛ ko a bɛ se ka fiɲɛ kunbɛn ka tɛmɛ a dan kan.
Sariyabaju min bɛ "funteni bɛnnen" latigɛ ka ɲɛsin sanfɛ-Fɛɛrɛba ma, min ka bon-filɛli nafamaw furakɛli tunɛriw kɔnɔ, o ye ka baara kɛ ni funteni hakɛ danma yɛrɛ ye i n’a fɔ jateminɛ kɛcogo, ka 10%-20% lakana hakɛ dɔ fara a kan. I n'a fo:
250 degɛrɛ sterilisation processus → Filter sugandi ni 300℃temperature resistance ye;
300 degɛrɛ sterilisation processus → Filter sugandi ni 350℃temperature resistance ye.
O waati kelen na, jateminɛ bɛɛ ka kan ka kɛ ka da filɛriw sabatili kan, u jɔcogo labatoli, ani u musaka hakɛ kan. O cogo la dɔrɔn, furakɛli pakew kɔnɔ minɛnw bɛ se k’u ka saniya lafasali sira laban mara sigida gɛlɛn kɔnɔ min ka bon-Semperature sterilization, tiɲɛ na, ka GMP ka wajibi gɛlɛnw dafa furakɛli sigida sterili la.