PTFE Ithumbu eliMfidi-Mbhobho lokuSetyenzisa aMachiza | Imibhobho evunyiweyo yi-FDA

Usetyenziso lwe-PTFE Smooth Bore Hose kuShishino loShishino

Kwicandelo lamachiza, yonke indlela yolwelo kufuneka ihlangabezane nemfuno engaxoxisiyo: ukucoceka ngokupheleleyo.

Xa iinjineli zikhangela i-“PTFE hose kusetyenziso lwamayeza” isihluzo sokuqala abasisebenzisayo “sivunywe yi-FDA.Ithumbu le-PTFE eligudileyo”.

Inkampani yethu ibibonelela ngezisombululo ezithembekileyo kubathengi iminyaka engamashumi amabini. Sisebenzisa i-100 % imathiriyeli enyulu ye-PTFE, senza imibhobho ye-PTFE egudileyo enganelisiyo kuphela i-FDA 21 CFR 177.1550 kodwa ihambisa ukusebenza okuphezulu ngexabiso elihlonipha uqingqo-mali lwanamhlanje oluqiniswayo.

Kutheni imboni yamayeza ikhethaPTFE?

I-Polytetrafluoroethylene ingena ngokwekhemikhali phantse kuyo yonke into enyibilikayo, iasidi, isiseko, kunye nesithako esisebenzayo soxubo-mayeza esifunyenwe kwimveliso yamachiza.

Ngokungafaniyo nezinye iindlela ze-elastomeric okanye ze-silicone, i-PTFE ayiyi kudumba, iqhekeke, okanye ifake iiplasticizers xa ivezwe kwiikhemikhali ezinobundlobongela ze-CIP/SIP ezifana ne-sodium hypochlorite okanye izicoci eziphezulu ze-pH. Umphezulu wayo wangaphakathi ogudileyo (Ra ≤ 0.8 µm) uphinda unciphise ukunamathela kwemveliso kunye nokwakheka kwe-biofilm, iqinisekisa ukucoceka kwe-batch-to-batch kunye nokunciphisa ngokumangalisayo ixesha lokuqinisekisa lokucoca iiprothokholi.

Into yokuphonononga:

I-European Vaccine Finish Line

I-bitech-scale ephakathi eJamani yayilahlekelwe ukuya kuthi ga kwi-2 % yesitofu sokugonya sexabiso eliphezulu le-mRNA ukuya kwi-adsorption kudonga lwangaphakathi olurhabaxa lwemigca yokudlulisela ephothiweyo ye-silicone. Emva kokutshintshela kwiindibano zethu zepayipi ze-PTFE eziqinisekisiweyo ze-FDA-eqinisekisiweyo, ilahleko yemveliso yehla ngaphantsi kwe-0.3 % kunye nemijikelo yokuqinisekisa yokucoca yancitshiswa ukusuka kwiiyure ezisibhozo ukuya kwezine. Umthengi uxele ugcino lonyaka lwe-€450 000-eyanele ukuthethelela ukubuyisela kwakhona nge-layini epheleleyo kwikota enye.

Uphononongo olungumzekelo: I-US Hormone Tablet Coating Plant

I-CDMO esekelwe eFlorida yayidinga umgca wokudlulisa oguquguqukayo onokunyamezela zombini i-acetone-based based suspensions kunye ne-121 ° C SIP cycles. Imibhobho ekhuphisanayo enezigqubuthelo ze-fluoroelastomer ayiphumelelanga emva kweenyanga ezintathu zebhayisekile eshushu. Iityhubhu zethu ze-PTFE ezigudileyo, eziboshwe ngokugqithiseleyo nge-316L yensimbi engenasici kwi-kink resistance, ngoku sele ingene kwiinyanga ze-24 zenkonzo eqhubekayo ngaphandle kokulahlekelwa yingqibelelo. Eli ziko liphumelele uphicotho olumangalisayo lwe-FDA ngokuqatshelwa kweqanda okunxulumene nezinto zendlela yolwelo.

Ukuqukumbela

Xa iinjineli zamayeza zichaza “PTFE ithumbu eligudileyo lokubhobhozaukuze kusetyenziswe amayeza,” ngokwenene bacela izinto ezintathu: umngcipheko wokungcoliseka, ukwamkelwa ngokungenamthungo kokulawulwa, kunye noxanduva lwemali.Iminyaka engamashumi amabini yedatha yasendle ibonisa ukuba i-100 % yethu ye-PTFE ye-hose ye-virgin e-smooth-bore ihambisa zontathu-ebonisa ukuba ukucoceka kunye noqoqosho kunokuhlalisana kwisixhobo esifanayo.