PTFE Smooth-Bore Hose don Amfani da Magunguna | Hoses da FDA ta Amince

Aikace-aikace na PTFE Smooth Bore Hose a cikin Masana'antar Pharmaceutical

A cikin sashin harhada magunguna, kowane hanyar ruwa dole ne ta cika buƙatun da ba za a iya sasantawa ba: cikakkiyar tsafta.

Lokacin da injiniyoyi ke neman "PTFE hose don amfani da magunguna" tace ta farko da suke nema shine "FDA-amincePTFE Smooth Bore tiyo".

Kamfaninmu yana samar da ingantaccen mafita ga abokan ciniki har tsawon shekaru ashirin. Yin amfani da 100% budurwa PTFE abu, muna ƙera santsi-bare PTFE hoses waɗanda ba kawai gamsar da FDA 21 CFR 177.1550 ba amma kuma suna ba da kyakkyawan aiki a farashin da ke mutunta kasafin kuɗi na yau.

Me yasa masana'antar harhada magunguna ke zaɓaPTFE?

Polytetrafluoroethylene ba shi da ƙarancin sinadarai ga kusan kowane sauran ƙarfi, acid, tushe, da kayan aikin magunguna waɗanda aka ci karo da su a masana'antar magunguna.

Ba kamar elastomeric ko silicone madadin ba, PTFE ba za ta kumbura, fasa, ko leach plasticizers ba lokacin da aka fallasa su zuwa sinadarai na CIP/SIP kamar su sodium hypochlorite ko babban-pH detergents. Fuskar cikinta mai laushi mai laushi (Ra ≤ 0.8 µm) yana ƙara rage girman mannewar samfur da samuwar biofilm, yana tabbatar da tsaftar tsari-zuwa-tsalle da rage girman lokacin tabbatarwa don tsaftace ladabi.

Nazarin Harka:

Layin Cika-Game da Alurar rigakafin Turai

Wani tsakiyar sikelin fasahar kere-kere a Jamus yana asarar kusan kashi 2% na maganin mRNA mai kima zuwa adsorption akan bangon ciki na layukan canja wurin silicone ɗin sa. Bayan canjawa zuwa FDA-certified santsi-bore PTFE tiyo majalisai, samfur asarar kika aika a kasa 0.3 % da tsaftacewa ingancin hawan keke da aka taqaitaccen daga takwas hours zuwa hudu. Abokin ciniki ya ba da rahoton tanadi na shekara-shekara na € 450 000 - ya isa ya tabbatar da sake fasalin cikakken layi a cikin kwata guda.

Nazarin Harka: Tushen Rufin Hormone na Amurka

CDMO na tushen Florida yana buƙatar layin canja wuri mai sassauƙa wanda zai iya jure duka dakatarwar shafi na tushen acetone da 121°C SIP hawan keke. Masu fafatawa a gasa tare da murfin fluoroelastomer sun gaza bayan watanni uku na hawan keke. Mu PTFE santsi-bare bututu, over-braided tare da 316L bakin karfe juriya, yanzu shiga 24 watanni na ci gaba da sabis ba tare da mutunci asara. Wurin ya wuce binciken binciken FDA mai ban mamaki tare da abubuwan lura da sifili masu alaƙa da abubuwan haɗin-ruwa.

Kammalawa

Lokacin da injiniyoyin magunguna suka ƙayyade "PTFE santsi mara busa tiyoga Pharmaceutical amfani,” da gaske suna tambayar abubuwa uku: sifili gurbatawa hadarin, sifili yarda yarda, da kuma kasafin kudi alhakin. Shekaru ashirin da suka gabata na filin data nuna cewa mu 100 % budurwa PTFE santsi-raho tiyo isar da dukan uku-tabbatar da cewa tsarki da tattalin arziki na iya zama tare a kan wannan kayan aiki.