Tanthauzirani Malangizo atsopano a ASME/BPE-1997 a High Purity Ball Valves for Pharmaceutical Applications.

Vavu ya mpira woyera kwambiri ndi chiyani? Valve ya Mpira Wapamwamba Wapamwamba ndi chipangizo chowongolera kuyenda chomwe chimakwaniritsa miyezo yamakampani pazinthu zakuthupi ndi kapangidwe ka pure.
Izi zimagwiritsidwa ntchito mu "machitidwe othandizira" monga kukonza nthunzi yotsuka pofuna kuyeretsa ndi kuwongolera kutentha.M'makampani opanga mankhwala, ma valve a mpira sagwiritsidwa ntchito muzogwiritsira ntchito kapena njira zomwe zingagwirizane mwachindunji ndi mapeto.
Kodi mavavu oyeretsedwa kwambiri m'mafakitale ndi otani? Makampani opanga mankhwala amapeza njira zosankhira ma valve kuchokera kuzinthu ziwiri:
ASME/BPE-1997 ndi chikalata chokhazikika chokhudza mapangidwe ndi kugwiritsa ntchito zida m'makampani opanga mankhwala. Mulingo uwu umapangidwira kupanga, zida, zomanga, kuyang'anira ndi kuyesa zombo, mapaipi ndi zina zowonjezera monga mapampu, ma valve ndi zozolowera zomwe zimagwiritsidwa ntchito pamakampani azopharmaceutical. Kwenikweni, chikalatacho chimanena kuti, "... ndipo ndi gawo lofunikira kwambiri pakupanga zinthu, monga madzi a jakisoni (WFI), nthunzi yoyera, ultrafiltration, kusungirako zinthu zapakatikati ndi ma centrifuges. ”
Masiku ano, makampaniwa amadalira ASME/BPE-1997 kuti adziwe mapangidwe a valve ogwiritsira ntchito osagwirizana ndi mankhwala.
Mavavu omwe amagwiritsidwa ntchito kwambiri mu machitidwe a biopharmaceutical process amaphatikizapo ma valve a mpira, ma valve a diaphragm, ndi ma check valves.
Kutsimikiziridwa ndi ndondomeko yoyendetsera ntchito yowonetsetsa kuti kuberekanso kwa chinthu chopangidwa kapena kupangidwa.Pulogalamuyi imasonyeza kuyeza ndi kuyang'anira zigawo zamakina, nthawi yopangira, kutentha, kupanikizika ndi zina.Kamodzi kachitidwe ndi zinthu za dongosolo limenelo zimatsimikiziridwa kuti zikhoza kubwerezedwa, zigawo zonse ndi zikhalidwe zimaganiziridwa kuti ndizovomerezeka.Palibe kusintha komwe kungapangidwe ku "package systems" yomaliza popanda ndondomeko ndi ndondomeko yomaliza.
Palinso nkhani zokhudzana ndi kutsimikizira zakuthupi.An MTR (Material Test Report) ndi mawu ochokera kwa wopanga zoponya zomwe zimalemba zomwe zimapangidwira ndikutsimikizira kuti zidachokera kumayendedwe apadera poponya.
Opanga mipando amapereka malipoti opangidwa kuti awonetsetse kuti mipando ikutsatira malangizo a FDA. (FDA/USP Class VI) Zida zovomerezeka zokhalamo zikuphatikizapo PTFE, RTFE, Kel-F ndi TFM.
Ultra High Purity (UHP) ndi mawu omwe cholinga chake ndi kutsindika kufunika koyera kwambiri.Izi ndi mawu omwe amagwiritsidwa ntchito kwambiri pamsika wa semiconductor kumene chiwerengero chochepa cha tinthu tating'onoting'ono tomwe timadutsa mumtsinje timafunika.Mavavu, mapaipi, zosefera, ndi zipangizo zambiri zomwe zimagwiritsidwa ntchito pomanga zimakumana ndi mlingo uwu wa UHP pamene zakonzedwa, zopakidwa, ndi kuchitidwa pansi pazikhalidwe zina.
Makampani opanga ma semiconductor amapeza mafotokozedwe a ma valve opangidwa kuchokera pakuphatikiza zambiri zomwe zimayendetsedwa ndi gulu la SemaSpec.Kupanga ma microchip wafers kumafuna kutsata mwamphamvu kwambiri miyezo kuti athetse kapena kuchepetsa kuipitsidwa kuchokera ku tinthu tating'ono, kutulutsa mpweya ndi chinyezi.
Muyezo wa SemaSpec umafotokoza za gwero la tinthu tating'ono, kukula kwa tinthu, gwero la mpweya (kudzera pa msonkhano wofewa wa valve), kuyezetsa kutayikira kwa helium, ndi chinyezi mkati ndi kunja kwa malire a valve.
Ma valve a mpira amatsimikiziridwa bwino muzogwiritsira ntchito zovuta kwambiri. Zina mwazabwino zopangira izi ndi izi:
Mechanical polishing - Malo opukutidwa, ma welds ndi mawonekedwe omwe amagwiritsidwa ntchito amakhala ndi mawonekedwe osiyanasiyana apansi akamayang'ana pansi pa galasi lokulitsa.Kupukuta kwamakina kumachepetsa mikwingwirima yonse yapamtunda, maenje ndi zosiyana kuti zikhale zolimba yunifolomu.
Kupukuta kwamakina kumachitika pazida zozungulira pogwiritsa ntchito aluminiyamu abrasives.Kupukuta kwa makina kumatha kutheka ndi zida zamanja zamalo akuluakulu padziko lapansi, monga ma reactors ndi zombo zomwe zili m'malo, kapena zodziwikiratu zodziwikiratu za mipope kapena ma tubular parts.Mndandanda wa grit polishes umagwiritsidwa ntchito motsatizana motsatizana mpaka kumapeto komwe kufunidwa kapena kuuma kwapang'onopang'ono kukwaniritsidwa.
Electropolishing ndi kuchotsa zinthu zosawoneka bwino kwambiri pazitsulo pogwiritsa ntchito njira za electrochemical. Kumapangitsa kuti pamwamba pakhale kusalala kapena kusalala bwino komwe, kumawoneka pansi pa galasi lokulitsa, kumawoneka ngati kopanda mawonekedwe.
Chitsulo chosapanga dzimbiri chimagonjetsedwa ndi dzimbiri mwachibadwa chifukwa chokhala ndi chromium yambiri (kawirikawiri 16% kapena kuposerapo muzitsulo zosapanga dzimbiri) . Electropolishing imapangitsa kukana kwachilengedwe kumeneku chifukwa ndondomekoyi imasungunula chitsulo chochuluka (Fe) kuposa chromium (Cr) .
Chotsatira cha njira iliyonse yopukutira ndi kulengedwa kwa "yosalala" pamwamba yomwe imatanthauzidwa ngati roughness (Ra) .Malinga ndi ASME/BPE; "Mapuleti onse adzawonetsedwa mu Ra, microinches (m-in), kapena micrometers (mm)."
Kusalala kwa pamwamba kumayezedwa ndi profilometer, chida chodziwikiratu chokhala ndi mkono wofanana ndi cholembera. Cholembera chimadutsa pamwamba pachitsulo kuti ayeze kutalika kwa nsonga ndi kuzama kwa zigwa.
Ubale pakati pa malo opukutidwa ndi opukutidwa, kuchuluka kwa njere zonyezimira ndi kuuma kwapamtunda (pambuyo ndi pambuyo pa electropolishing) zikuwonetsedwa mu tebulo ili m'munsimu.
Ma micrometers ndi muyezo wamba wa ku Ulaya, ndipo metric system ndi yofanana ndi microinches.Imodzi ya microinch ikufanana ndi pafupifupi ma micrometer 40. Chitsanzo: Mapeto otchulidwa ngati 0,4 microns Ra ndi ofanana ndi 16 mainchesi Ra.
Chifukwa cha kusinthasintha kwachilengedwe kwa mapangidwe a valve a mpira, amapezeka mosavuta pampando, chisindikizo ndi zipangizo za thupi.
Makampani opanga mankhwala a biopharmaceutical amakonda kukhazikitsa "makina osindikizidwa" ngati n'kotheka. Zowonjezera za Tube Kunja kwa Diameter (ETO) zolumikizira zili mumzere welded kuti athetse kuipitsidwa kunja kwa malire a valve / chitoliro ndikuwonjezera kuuma kwa makina opangira mapaipi. mosavuta disasssembled ndi reconfigured.
Zopangira za Cherry-Burrell pansi pa mayina amtundu "I-Line", "S-Line" kapena "Q-Line" zimapezekanso pamakina oyeretsa kwambiri monga mafakitale a chakudya / chakumwa.
Extended chubu Kunja Diameter (ETO) malekezero amalola mu mzere kuwotcherera valavu mu mapaipi system.ETO malekezero ndi kakulidwe kuti agwirizane chitoliro (chitoliro) dongosolo m'mimba mwake ndi khoma makulidwe.The yaitali chubu kutalika accommodates orbital weld mitu ndipo amapereka kutalika kokwanira kupewa kuwonongeka kwa valavu chisindikizo thupi chifukwa kuwotcherera kutentha.
Ma valve a mpira amagwiritsidwa ntchito kwambiri popanga ma valve chifukwa cha kusinthasintha kwawo.
Kuonjezera apo, gawo lapakati la valve la mpira limachotsedwa kuti lilole kulowa mkati mwa weld bead, yomwe imatha kutsukidwa ndi / kapena kupukutidwa.
Kukhetsa kwamadzi ndikofunikira kuti ma bioprocessing asungidwe muukhondo komanso wosabala. Madzi otsala akatha kukhetsa amakhala malo opangira mabakiteriya kapena tizilombo tating'onoting'ono tomwe timapanga tizilombo tomwe timapanga tizilombo toyambitsa matenda, zomwe zimapangitsa kuti pakhale zolemetsa zosavomerezeka pa system.Sites pomwe madzi amaundana amathanso kukhala malo oyambitsa dzimbiri, ndikuwonjezera kuipitsidwa kowonjezera ku system. kukhetsa kwatha.
Malo akufa mu makina opangira mapaipi amatanthauzidwa ngati groove, tee, kapena kutambasula kuchokera ku chitoliro chachikulu chomwe chimadutsa kuchuluka kwa chitoliro (L) chomwe chimatanthauzidwa mu ID ya chitoliro chachikulu (D). Malo akufa ndi osafunika chifukwa amapereka malo otsekera omwe sangapezeke mwa kuyeretsa kapena kuyeretsa, zomwe zimachititsa kuti mankhwala awonongeke. masinthidwe.
Zowonongeka zamoto zimapangidwira kuti ziteteze kufalikira kwa zakumwa zoyaka moto pakachitika mzere wa ndondomeko moto.Mapangidwewa amagwiritsa ntchito mpando wakumbuyo wachitsulo ndi anti-static kuti ateteze kutentha.Mafakitale a biopharmaceutical ndi zodzoladzola nthawi zambiri amakonda zozimitsa moto m'machitidwe operekera mowa.
FDA-USP23, Class VI yovomerezeka ya mipando ya valavu ya mpira ikuphatikizapo: PTFE, RTFE, Kel-F, PEEK ndi TFM.
TFM ndi PTFE yosinthidwa ndi mankhwala yomwe imatseka kusiyana pakati pa PTFE yachikhalidwe ndi PFA.TFM yosungunuka imayikidwa ngati PTFE malinga ndi ASTM D 4894 ndi ISO Draft WDT 539-1.5. Poyerekeza ndi PTFE yachikhalidwe, TFM ili ndi zotsatirazi zowonjezera:
Mipando yodzaza ndi ma cavity imapangidwa kuti iteteze kupanga zinthu zomwe, zikatsekeredwa pakati pa mpira ndi thupi, zimatha kulimbitsa kapena kulepheretsa kugwira ntchito bwino kwa membala wotseka wa valve. Ma valve apamwamba oyeretsedwa omwe amagwiritsidwa ntchito muutumiki wa nthunzi sayenera kugwiritsa ntchito makonzedwe a mipando iyi, chifukwa nthunzi imatha kupeza njira pansi pa mpando ndikukhala malo oti mabakiteriya akukula. kupasula.
Ma valve a mpira ali m'gulu la "ma valve ozungulira". Kuti agwiritse ntchito, pali mitundu iwiri ya ma actuators: pneumatic ndi electro. pamutuwu, onani "Mmene Mungasankhire Choyimitsa Vavu Mpira" pambuyo pake m'bukuli.
Ma Valves Apamwamba Oyera a Mpira amatha kutsukidwa ndikuyikidwa ku BPE kapena Semiconductor (SemaSpec) zofunika.
Kuyeretsa koyambira kumachitika pogwiritsa ntchito njira yoyeretsera ya akupanga yomwe imagwiritsa ntchito mankhwala ovomerezeka a alkaline poyeretsa ndi kuchotsera mafuta, ndi njira yopanda zotsalira.
Zigawo zokhala ndi kupanikizika zimayikidwa ndi nambala ya kutentha ndipo zimatsagana ndi chiphaso choyenera cha kusanthula.A Mill Test Report (MTR) amalembedwa pa kukula ndi nambala iliyonse ya kutentha.Zolembazi zikuphatikiza:
Nthawi zina akatswiri opanga ndondomeko amafunika kusankha pakati pa ma valve a pneumatic kapena magetsi kuti apange machitidwe oyendetsa ndondomeko. Mitundu yonse iwiri ya actuators ili ndi ubwino ndipo ndizofunika kukhala ndi deta kuti apange chisankho chabwino.
Ntchito yoyamba posankha mtundu wa actuator (pneumatic kapena magetsi) ndikuzindikira gwero lamphamvu kwambiri lamagetsi la actuator.Mfundo zazikuluzikulu zomwe muyenera kuziganizira ndi:
Othandizira kwambiri pneumatic actuators amagwiritsa ntchito mpweya wothamanga wa 40 ku 120 psi (3 mpaka 8 bar) . Kawirikawiri, amapangidwa kuti azitha kupanikizika ndi 60 mpaka 80 psi (4 mpaka 6 bar) .Kuthamanga kwapamwamba kwa mpweya nthawi zambiri kumakhala kovuta kutsimikizira, pamene kutsika kwa mpweya kumafuna ma pistoni akuluakulu a diaphragms kapena diaphragms kuti apange torque yofunikira.
Magetsi amagetsi amagwiritsidwa ntchito ndi mphamvu ya 110 VAC, koma amatha kugwiritsidwa ntchito ndi ma motors osiyanasiyana a AC ndi DC, onse amodzi ndi atatu.
Kutentha kwamitundu yosiyanasiyana ya ma pneumatic actuators ndi -4 mpaka 1740F (-20 mpaka 800C), koma imatha kupitilira mpaka -40 mpaka 2500F (-40 mpaka 1210C) yokhala ndi zisindikizo zosankha, ma valavu owongolera, ma valve otsekera, ma valve otsekera. etc.) amagwiritsidwa ntchito, amatha kutentha mosiyanasiyana kusiyana ndi actuator, ndipo izi ziyenera kuganiziridwa muzogwiritsira ntchito zonse.Muzogwiritsira ntchito kutentha pang'ono, khalidwe la mpweya wokhudzana ndi mame liyenera kuganiziridwa.Dew point ndi kutentha kumene condensation imapezeka mu air.Condensation ikhoza kuzizira ndi kutsekereza mzere woperekera mpweya, kulepheretsa actuator kuti asagwire ntchito.
Magetsi oyendetsa magetsi amakhala ndi kutentha kwa -40 mpaka 1500F (-40 mpaka 650C) .Akagwiritsidwa ntchito panja, magetsi a magetsi ayenera kukhala olekanitsidwa ndi chilengedwe kuti ateteze chinyezi kulowa mkati mwa ntchito zamkati. ndi kuziziziritsa pamene sizikuyenda, kusinthasintha kwa kutentha kungayambitse chilengedwe "kupuma" ndi condense.Choncho, magetsi onse ogwiritsira ntchito panja ayenera kukhala ndi chowotcha.
Nthawi zina zimakhala zovuta kulungamitsa kugwiritsa ntchito ma actuators amagetsi m'malo owopsa, koma ngati mpweya woponderezedwa kapena ma pneumatic actuators sangapereke mawonekedwe ofunikira, ma actuators amagetsi okhala ndi nyumba zosankhidwa moyenera angagwiritsidwe ntchito.
Bungwe la National Electrical Manufacturers Association (NEMA) lakhazikitsa malangizo omanga ndi kuika makina oyendetsa magetsi (ndi zipangizo zina zamagetsi) kuti agwiritse ntchito m’madera oopsa.
VII Kalasi Yowopsa Yamalo Oyamba (Gasi Wophulika kapena Nthunzi) Amakumana ndi Khodi Yamagetsi Yadziko Lonse pazofunsira; imakwaniritsa zofunikira za Underwriters' Laboratories, Inc. kuti zigwiritsidwe ntchito ndi petulo, hexane, naphtha, benzene, butane, propane, acetone, Atmospheres of benzene, lacquer solvent vapors ndi gasi.
Pafupifupi onse opanga ma actuator amagetsi ali ndi mwayi wosankha mtundu wotsatira wa NEMA VII wa mzere wawo wazogulitsa.
Kumbali ina, makina oyendetsa pneumatic ali mwachibadwa kuphulika.Pamene magetsi oyendetsa magetsi amagwiritsidwa ntchito ndi ma pneumatic actuators m'madera owopsa, nthawi zambiri amakhala otsika mtengo kusiyana ndi magetsi oyendetsa magetsi.Valve yoyendetsa ndege yoyendetsa magetsi imatha kuikidwa m'dera lopanda ngozi ndi kuponyedwa pazitsulo. Kutetezedwa kwachilengedwe kwa ma pneumatic actuators m'malo owopsa kumawapangitsa kukhala chisankho chothandiza pakugwiritsa ntchito izi.
Spring returns.Chizindikiro china cha chitetezo chomwe chimagwiritsidwa ntchito kwambiri mu makina opangira ma valve mumsika wamakono ndi njira yobwerera ku kasupe (kulephera kotetezeka).Ngati mphamvu yamagetsi kapena chizindikiro chalephera, makina oyendetsa masika amayendetsa valavu kumalo otetezeka omwe adakonzedweratu.Iyi ndi njira yothandiza komanso yotsika mtengo kwa makina oyendetsa pneumatic, ndipo chifukwa chachikulu chomwe ma pneumatic actuators amagwiritsidwa ntchito kwambiri m'makampani onse.
Ngati kasupe sangathe kugwiritsidwa ntchito chifukwa cha kukula kwa actuator kapena kulemera kwake, kapena ngati gawo lochitapo kawiri layikidwa, thanki ya accumulator ikhoza kuikidwa kuti isungire kuthamanga kwa mpweya.


Nthawi yotumiza: Jul-25-2022