PTFE Smooth-Bore Hose rau Kev Siv Tshuaj | FDA pom zoo Hoses

Kev siv ntawm PTFE Smooth Bore Hose hauv Kev Lag Luam Pharmaceutical

Hauv kev lag luam tshuaj, txhua txoj hauv kev ua kua yuav tsum ua kom tau raws li qhov xav tau tsis sib tham: kev huv huv.

Thaum cov kws tsim khoom tshawb nrhiav "PTFE hose rau kev siv tshuaj" thawj lim lawv thov yog "FDA-pom zooPTFE Smooth Bore hose”.

Peb lub tuam txhab tau muab cov kev daws teeb meem txhim khu kev qha rau cov neeg siv khoom tau nees nkaum xyoo. Siv 100% nkauj xwb PTFE cov ntaub ntawv, peb tsim du-bore PTFE hoses uas tsis tsuas yog txaus siab rau FDA 21 CFR 177.1550 tab sis kuj xa superior kev ua tau zoo ntawm tus nqi uas hwm hnub no cov nyiaj txiag nruj.

Vim li cas kev lag luam kws tshuaj xaivPTFE?

Polytetrafluoroethylene yog chemically inert rau txhua qhov hnyav, acid, puag, thiab cov khoom siv tshuaj nquag ntsib hauv kev tsim tshuaj.

Tsis zoo li elastomeric lossis silicone lwm txoj kev, PTFE yuav tsis o, tawg, los yog leach plasticizers thaum raug CIP / SIP chemicals xws li sodium hypochlorite los yog high-pH detergents. Nws ultra-smooth sab hauv nto (Ra ≤ 0.8 µm) ntxiv txo cov khoom adhesion thiab biofilm tsim, kom ntseeg tau batch-rau-batch purity thiab txo cov sij hawm siv tau rau kev tu cov txheej txheem.

Case Study:

European Vaccine Fill-Finish Line

Ib nrab-scale biotech hauv lub teb chaws Yelemees tau poob txog li 2% ntawm cov tshuaj tiv thaiv mRNA uas muaj txiaj ntsig zoo rau adsorption ntawm cov phab ntsa sab hauv ntawm nws cov braided silicone hloov kab. Tom qab hloov mus rau peb FDA-certified smooth-bore PTFE hose sib dhos, cov khoom poob poob qis dua 0.3% thiab tu validation voj voog tau luv los ntawm yim teev mus rau plaub. Cov neeg siv khoom tau tshaj tawm cov nyiaj khaws cia txhua xyoo ntawm € 450 000 - txaus los ua pov thawj tag nrho cov kab rov ua haujlwm hauv ib lub hlis twg.

Case Study: US Hormone Tablet Coating Plant

Florida-based CDMO xav tau ib txoj kab hloov pauv hloov tau yooj yim uas tuaj yeem tiv taus ob qho tib si acetone-raws li txheej txheej thiab 121 ° C SIP cycles. Cov neeg sib tw hoses nrog fluoroelastomer npog ua tsis tiav tom qab peb lub hlis ntawm thermal cycling. Peb cov PTFE du-bore leeg, dhau-braided nrog 316L stainless hlau rau kink tsis kam, tam sim no tau nkag 24 lub hlis ntawm kev pabcuam txuas ntxiv yam tsis muaj kev ntseeg siab. Lub chaw tau dhau los ua qhov tsis txaus ntseeg FDA tshawb xyuas nrog xoom kev soj ntsuam ntsig txog cov kua dej-txoj kev.

Xaus

Thaum kws tshuaj engineers hais tias "PTFE du bore hoserau kev siv tshuaj, "lawv tab tom thov rau peb yam: tsis muaj kev pheej hmoo kis kab mob, tsis muaj kev tswj hwm kev lees paub, thiab kev lav phib xaub. Ob xyoo caum ntawm cov ntaub ntawv qhia tau hais tias peb 100% nkauj xwb PTFE du-bore hose muab tag nrho peb-ua pov thawj tias purity thiab kev lag luam tuaj yeem ua ke ntawm tib yam khoom.