Ipayipi ye-PTFE ethambileyo yokusetyenziswa ngamayeza | Iipayipi ezivunyiweyo yi-FDA

Ukusetyenziswa kwePTFE Smooth Bore Hose kwiShishini leMithi

Kwicandelo lamayeza, yonke indlela yolwelo kufuneka ihlangabezane nemfuno engenakuphikiswana ngayo: ucoceko olupheleleyo.

Xa iinjineli zikhangela "ipayipi ye-PTFE yokusetyenziswa kweyeza" isihluzo sokuqala abasisebenzisayo "sivunyiwe yi-FDA".Ipayipi ye-PTFE Smooth Bore".

Inkampani yethu ibisoloko ibonelela ngezisombululo ezithembekileyo kubathengi kangangeminyaka engamashumi amabini. Sisebenzisa izinto ze-PTFE ezi-100% ezingagugiyo, senza iipayipi ze-PTFE ezithambileyo ezinganeli nje i-FDA 21 CFR 177.1550 kodwa ezibonelela ngokusebenza okuphezulu ngexabiso elihlonipha uhlahlo-lwabiwo mali lwemali oluqinisiweyo lwanamhlanje.

Kutheni ishishini lamayeza likhethaI-PTFE?

I-Polytetrafluoroethylene ayisebenzi ngokweekhemikhali phantse kuzo zonke izinyibilikisi, i-asidi, isiseko, kunye nesithako esisebenzayo samayeza esifunyanwa xa kusenziwa amayeza.

Ngokungafaniyo nezinye iindlela ze-elastomeric okanye ze-silicone, i-PTFE ayizukudumba, iqhekeke, okanye ikhuphe iiplastiki xa ivezwe kwiikhemikhali ze-CIP/SIP ezinamandla ezifana ne-sodium hypochlorite okanye iisepha ezine-pH ephezulu. Umphezulu wayo wangaphakathi ogudileyo kakhulu (i-Ra ≤ 0.8 µm) unciphisa ngakumbi ukunamathela kwemveliso kunye nokwakheka kwe-biofilm, ukuqinisekisa ubunyulu bebhetshi ukuya kwibhetshi kwaye kunciphisa kakhulu ixesha lokuqinisekisa iinkqubo zokucoca.

Into yokuphonononga:

Umgca Wokugqiba Ukugonya WaseYurophu

I-biotech ephakathi eJamani yayilahlekelwa yi-2% yegonyo le-mRNA elixabiso liphezulu ngenxa yokufunxwa eludongeni olungaphakathi olurhabaxa lwemigca yayo yokudlulisa i-silicone ebhityiweyo. Emva kokutshintshela kwi-assemblies yethu ye-PTFE hose eqinisekisiweyo yi-FDA, ukulahleka kwemveliso kwehle ngaphantsi kwe-0.3% kwaye imijikelo yokuqinisekisa ukucoca yancitshiswa ukusuka kwiiyure ezisibhozo ukuya kwezine. Umthengi uxele ukuba wonge imali yonyaka ye-€450 000—eyaneleyo ukuthethelela ukulungiswa komgca opheleleyo kwikota enye.

Isifundo seTyala: Isityalo sokugquma iiHormone zase-US

I-CDMO eseFlorida yayifuna umgca wokudlulisa oguquguqukayo onokumelana nokuxhonywa kwe-acetone-based coating suspensions kunye nemijikelo ye-SIP ye-121 °C. Iipayipi zokhuphiswano ezinee-fluoroelastomer covers zasilela emva kweenyanga ezintathu zokujikeleza kobushushu. Iityhubhu zethu ze-PTFE ezithambileyo, ezigqunywe ngentsimbi engagqwali ye-316L yokumelana ne-kink, ngoku zisebenze iinyanga ezingama-24 ngaphandle kokulahlekelwa bubunyani. Esi sakhiwo siphumelele uhlolo olungalindelekanga lwe-FDA ngaphandle kokujonga okunxulumene nezinto ezihamba nolwelo.

Isiphelo

Xa iinjineli zamayeza zichaza “Ipayipi ye-PTFE egudileyoukusetyenziswa kwamayeza,” ngokwenene bacela izinto ezintathu: akukho mngcipheko wongcoliseko, ukwamkelwa kwemithetho engenamthungo, kunye noxanduva lwezemali. Idatha yentsimi yeminyaka engamashumi amabini ibonisa ukuba ipayipi yethu ye-PTFE ethambileyo eyi-100% inika zonke ezi zinto zintathu—ubungqina bokuba ubunyulu kunye noqoqosho zinokusebenza kunye kwizixhobo ezifanayo.