Ipayipi Le-PTFE Elibushelelezi Lokusetshenziswa Kwemithi | Amapayipi Avunyiwe yi-FDA

Ukusetshenziswa kwe-PTFE Smooth Bore Hose embonini yezemithi

Emkhakheni wezokwelapha, yonke indlela yoketshezi kumele ihlangabezane nesidingo esingaxoxiswana ngaso: ukuhlanzeka okuphelele.

Lapho onjiniyela befuna “ipayipi le-PTFE lokusetshenziswa kwemithi” isihlungi sokuqala abasisebenzisayo “sivunyiwe yi-FDAIpayipi le-PTFE Smooth Bore".

Inkampani yethu ibilokhu inikeza izixazululo ezithembekile kumakhasimende iminyaka engamashumi amabili. Sisebenzisa izinto ze-PTFE ezi-100% ezingagugi, sakha amapayipi e-PTFE abushelelezi angagcini nje ngokwanelisa i-FDA 21 CFR 177.1550 kodwa futhi ahlinzeka ngokusebenza okuphezulu ngentengo ehlonipha isabelomali sezimali sanamuhla esiqinile.

Kungani imboni yezemithi ikhethaI-PTFE?

I-Polytetrafluoroethylene ayisebenzi ngamakhemikhali cishe kuzo zonke izithako ezincibilikisayo, i-asidi, isisekelo, kanye nezithako ezisebenzayo zemithi ezitholakala ekukhiqizweni kwemithi.

Ngokungafani nezinye izindlela ze-elastomeric noma ze-silicone, i-PTFE ngeke ivuvuke, iqhekeze, noma ikhiphe ama-plasticizer lapho ivezwa kumakhemikhali anamandla e-CIP/SIP njenge-sodium hypochlorite noma izihlanzi ezine-pH ephezulu. Ubuso bayo bangaphakathi obubushelelezi kakhulu (Ra ≤ 0.8 µm) bunciphisa kakhulu ukunamathela komkhiqizo kanye nokwakheka kwe-biofilm, buqinisekisa ubumsulwa be-batch-to-batch futhi bunciphisa kakhulu isikhathi sokuqinisekiswa kwezinqubo zokuhlanza.

Ucwaningo lwesigameko:

Umugqa Wokugcwalisa Umgomo WaseYurophu

I-biotech ephakathi eJalimane yayilahlekelwa kufikela ku-2% womuthi wokugomela i-mRNA onenani eliphezulu ngenxa yokumuncwa odongeni lwangaphakathi oluqinile lwemigqa yayo yokudlulisa i-silicone elukiwe. Ngemva kokushintshela kuma-hose assemblies ethu e-smooth-bore PTFE aqinisekiswe yi-FDA, ukulahlekelwa komkhiqizo kwehle ngaphansi kuka-0.3% kanti imijikelezo yokuqinisekisa ukuhlanza yancishiswa kusukela emahoreni ayisishiyagalombili kuya kwamane. Ikhasimende libike ukonga konyaka okungu-€450 000—okwanele ukuthethelela ukulungiswa kabusha komugqa ogcwele ngaphakathi kwekota eyodwa.

Ucwaningo Lwecala: Isitshalo Sokumboza Amaphilisi E-US Hormone

I-CDMO eseFlorida yayidinga umugqa wokudlulisa oguquguqukayo ongamelana nokumiswa kwe-acetone okusekelwe ku-coating kanye nemijikelezo ye-SIP engu-121 °C. Amapayipi okuncintisana anezimbozo ze-fluoroelastomer ahlulekile ngemuva kwezinyanga ezintathu zokujikeleza kokushisa. Amashubhu ethu e-PTFE abushelelezi, aboshwe kakhulu ngensimbi engagqwali engu-316L yokumelana ne-kink, manje asesebenze izinyanga ezingu-24 ngaphandle kokulahlekelwa ubuqotho. Lesi sikhungo siphumelele ukuhlolwa kwe-FDA okumangazayo ngaphandle kokubhekwa okuhlobene nezingxenye zendlela yoketshezi.

Isiphetho

Uma onjiniyela bemithi bechaza “Ipayipi le-PTFE elibushelelezi"Ukusetshenziswa kwemithi," empeleni bacela izinto ezintathu: akukho ngozi yokungcola, ukwamukelwa kwemithetho okungenamthungo, kanye nomthwalo wemfanelo wezezimali. Iminyaka engamashumi amabili yedatha yasensimini ikhombisa ukuthi ipayipi lethu le-PTFE elibushelelezi elingu-100% linikeza konke lokhu okuthathu - okufakazela ukuthi ubumsulwa kanye nomnotho kungahlala ndawonye emishinini efanayo.