PTFE Smooth-Bore Hose Yogwiritsa Ntchito Mankhwala | Mapaipi Ovomerezedwa ndi FDA

Kugwiritsa ntchito PTFE Smooth Bore Hose mu Pharmaceutical Viwanda

M'gawo lazamankhwala, njira iliyonse yamadzimadzi iyenera kukwaniritsa zofunikira zosakambidwa: ukhondo weniweni.

Akatswiri akafufuza "PTFE hose kuti agwiritse ntchito mankhwala" fyuluta yoyamba yomwe amagwiritsa ntchito ndi "FDA-approved.PTFE Smooth Bore hose”.

Kampani yathu yakhala ikupereka mayankho odalirika kwa makasitomala kwazaka makumi awiri. Pogwiritsa ntchito 100 % zida za PTFE za namwali, timapanga mapaipi osalala a PTFE omwe samangokhutiritsa FDA 21 CFR 177.1550 komanso amapereka magwiridwe antchito apamwamba pamtengo womwe umalemekeza kukhwimitsa ndalama zamasiku ano.

Chifukwa chiyani makampani opanga mankhwala amasankhaPTFE?

Polytetrafluoroethylene imalowa m'thupi ku zosungunulira zilizonse, asidi, maziko, ndi mankhwala omwe amakumana nawo popanga mankhwala.

Mosiyana ndi njira zina za elastomeric kapena silikoni, PTFE sidzatupa, kusweka, kapena kutulutsa mapulasitiki akakumana ndi mankhwala ankhanza a CIP/SIP monga sodium hypochlorite kapena zotsukira pH. Malo ake amkati osalala kwambiri (Ra ≤ 0.8 µm) amachepetsanso kumamatira kwazinthu ndi mapangidwe a biofilm, kuwonetsetsa chiyero cha batch-to-batch ndikuchepetsa kwambiri nthawi yotsimikizira yoyeretsa.

Nkhani Yophunzira:

European Vaccine Fill-Finish Line

Katemera wina wapakatikati wa Germany anali kutaya mpaka 2% ya katemera wa mRNA wamtengo wapatali kwambiri atalowa pakhoma lamkati la mizere yake yoluka ya silikoni. Titasinthira kumisonkhano yathu yapaipi ya PTFE yotsimikizika ya FDA, kutayika kwazinthu kudatsikira pansi pa 0.3% ndipo maulendo otsimikizira kuyeretsa adafupikitsidwa kuchoka pa maola asanu ndi atatu mpaka anayi. Makasitomala adanenanso kuti apulumutsidwa pachaka ndi €450 000-zokwanira kutsimikizira kubweza kwa mzere wonse mkati mwa kotala imodzi.

Nkhani Yophunzira: Chomera Chopaka Pamapiritsi cha Hormone cha US

CDMO yochokera ku Florida inkafunika chingwe chosinthira chomwe chimatha kupirira kuyimitsidwa kokhala ndi acetone ndi ma 121 ° C SIP. Mapaipi opikisana nawo okhala ndi zovundikira za fluoroelastomer adalephera patatha miyezi itatu yakukwera njinga yotentha. Machubu athu a PTFE osalala, opangidwa mopitilira muyeso ndi 316L zitsulo zosapanga dzimbiri kuti azitha kukana, tsopano alowa miyezi 24 yogwira ntchito mosalekeza popanda kutaya umphumphu. Malowa adachita kafukufuku wodabwitsa wa FDA ndikuwonera ziro zokhudzana ndi zigawo zamadzimadzi.

Mapeto

Pamene akatswiri opanga mankhwala amatchula "PTFE payipi yosalalakuti agwiritse ntchito mankhwala, "akufunadi zinthu zitatu: chiwopsezo cha kuipitsidwa kwa ziro, kuvomereza kosagwirizana ndi malamulo, ndi udindo wandalama." Zaka makumi awiri za data zakumunda zikuwonetsa kuti payipi yathu ya 100 % PTFE yosalala yosalala imapereka zonse zitatu - kutsimikizira kuti chiyero ndi chuma zitha kukhala pazida zomwezo.