I-PTFE Smooth-Bore Hose Yokusetshenziswa Kwemithi | Amapayipi Avunywe yi-FDA

Izicelo ze-PTFE Smooth Bore Hose embonini Yezemithi

Emkhakheni wemithi, yonke indlela yoketshezi kufanele ihlangabezane nesidingo esingaxoxiswana: ukuhlanzeka okuphelele.

Lapho onjiniyela besesha i-“PTFE hose yokusetshenziswa kwezemithi” isihlungi sokuqala abasisebenzisayo sithi “sigunyazwe yi-FDAIpayipi le-PTFE Smooth Bore”.

Inkampani yethu ibilokhu ihlinzeka ngezixazululo ezinokwethenjelwa kumakhasimende iminyaka engamashumi amabili. Sisebenzisa u-100 % wezinto ezimsulwa ze-PTFE, sakha amapayipi e-PTFE abushelelezi anganeli nje kuphela ukwanelisa i-FDA 21 CFR 177.1550 kodwa futhi alethe ukusebenza okuphakeme ngentengo ehlonipha ukuqinisa isabelomali sekhephithali yanamuhla.

Kungani imboni yezemithi ikhethaI-PTFE?

I-Polytetrafluoroethylene ifaka amakhemikhali kuwo wonke ama-solvent, i-asidi, isisekelo, kanye nesithako esisebenzayo somuthi esitholakala lapho kwakhiwa izidakamizwa.

Ngokungafani nezinye izindlela ze-elastomeric noma i-silicone, i-PTFE ngeke ikhukhumale, iqhekeke, noma ivule amapulasitiki uma evezwe kumakhemikhali anolaka e-CIP/SIP afana ne-sodium hypochlorite noma okokuhlanza okune-pH ephezulu. Indawo yayo engaphakathi ebushelelezi kakhulu (Ra ≤ 0.8 µm) iphinde inciphise ukunamathela komkhiqizo kanye nokwakheka kwe-biofilm, iqinisekise ubumsulwa be-batch-to-batch futhi yehlise ngokumangazayo isikhathi sokuqinisekisa sokuhlanza izivumelwano.

Ucwaningo lwesigameko:

I-European Vaccine Fill-Finish Line

I-biotech yesilinganiso esimaphakathi e-Germany ibilahlekelwa kufika ku-2 % womuthi wokugoma wenani eliphezulu we-mRNA ukuze ifakwe odongeni olungaphakathi oluqinile lwemigqa yokudlulisa ye-silicone ephothiwe. Ngemva kokushintshela emibuthanweni yethu yepayipi le-PTFE eqinisekiswe yi-FDA eqinisekiswe yi-FDA, ukulahlekelwa komkhiqizo kwehle ngaphansi kuka-0.3 % futhi imijikelezo yokuqinisekisa yokuhlanza yafushaniswa kusukela emahoreni ayisishiyagalombili kuya kwamane. Ikhasimende libike ukonga konyaka okungu-€450 000—okwanele ukuze kuthethelelwe ukufakwa kabusha kwemigqa egcwele phakathi nekota eyodwa.

I-Case Study: I-US Hormone Tablet Coating Plant

I-CDMO esekelwe eFlorida idinga ulayini wokudlulisa oguquguqukayo ongamelana nakho kokubili ukumiswa kokunamathela okusekelwe ku-acetone kanye nemijikelezo ye-SIP engu-121 °C. Amapayipi esiqhudelana nawo anamakhava e-fluoroelastomer ahlulekile ngemva kwezinyanga ezintathu zokuhamba ngebhayisikili elishisayo. Amashubhu ethu e-PTFE abushelelezi, aboshwe ngokweqile ngensimbi engagqwali engu-316L yokumelana ne-kink, manje asengene izinyanga ezingu-24 zesevisi eqhubekayo ngaphandle kokulahlekelwa ubuqotho. Isikhungo siphumelele ukuhlolwa okumangazayo kwe-FDA ngokunganaki lutho okuhlobene nezingxenye zendlela yoketshezi.

Isiphetho

Lapho onjiniyela bemithi becacisa “Ipayipi le-PTFE elibusheleleziukuze kusetshenziswe imithi,” empeleni bacela izinto ezintathu: ingozi yokungcoliswa ingekho, ukwamukelwa okulawulwayo okungenazihibe, kanye nesibopho sezimali Iminyaka engamashumi amabili yedatha yasensimini ibonisa ukuthi ipayipi lethu le-PTFE elimsulwa elingu-100 % liletha konke okuthathu—okufakazela ukuthi ubumsulwa nomnotho kungahlalisana emishinini efanayo.