PTFE Byoroheje-Bore Hose yo gukoresha imiti | Amazu yemewe na FDA

Porogaramu ya PTFE Yoroheje Bore Hose munganda zimiti

Mu rwego rwa farumasi, inzira zose zitemba zigomba kuba zujuje ibyifuzo bitavugwaho rumwe: isuku yuzuye.

Iyo injeniyeri zishakisha "PTFE hose yo gukoresha imiti" akayunguruzo ka mbere basaba ni "FDA yemewePTFE Byoroheje Bore hose”.

Isosiyete yacu imaze imyaka makumyabiri itanga ibisubizo byizewe kubakiriya. Dukoresheje ibikoresho 100% by'isugi PTFE, dukora ama shitingi ya PTFE yoroshye adahaza FDA 21 CFR 177.1550 gusa ahubwo anatanga imikorere isumba iyindi kubiciro byubahiriza ingengo yimari yimari yumunsi.

Kuki uruganda rwa farumasi ruhitamoPTFE?

Polytetrafluoroethylene yinjizwamo imiti hafi ya buri kintu cyose gishobora gukoreshwa, aside, ishingiro, nibikoresho bya farumasi bikora mugukora ibiyobyabwenge.

Bitandukanye nubundi buryo bwa elastomeric cyangwa silicone, PTFE ntizabyimba, kumeneka, cyangwa kumenagura plasitike mugihe ihuye nimiti ikaze ya CIP / SIP nka sodium hypochlorite cyangwa ibikoresho bya pH byinshi. Ubuso bwimbere bwimbere (Ra ≤ 0.8 µm) bugabanya cyane kugumya ibicuruzwa no gukora biofilm, bigatuma habaho isuku kandi bikagabanya cyane igihe cyo kwemeza protocole.

Inyigo:

Urukingo rwiburayi rwuzuza-Kurangiza

Ikinyabuzima giciriritse mu Budage cyatakaje kugeza 2% by'urukingo rwa mRNA rufite agaciro kanini kuri adsorption ku rukuta rw'imbere rw'imirongo yawo ya silicone. Nyuma yo guhindukira munteko yacu ya FDA yemewe-bore ya PTFE ya hose, igihombo cyibicuruzwa cyaragabanutse munsi ya 0.3% kandi isuku yo kwemeza yagabanijwe kuva mumasaha umunani kugeza saa yine. Umukiriya yatangaje ko yazigamye buri mwaka amayero 450 000-bihagije kugirango yemeze umurongo wuzuye mu gihembwe kimwe.

Inyigo: Uruganda rwa Hormone rwo muri Amerika

CDMO ikorera muri Floride yari ikeneye umurongo woherejwe byoroshye ushobora kwihanganira ihagarikwa rya asetone hamwe na 121 ° C SIP. Amarushanwa yo guhatana hamwe na fluoroelastomer yananiwe nyuma y'amezi atatu yo gusiganwa ku magare. Imiyoboro ya PTFE yoroshye-bore, yometse hejuru ya 316L ibyuma bitagira umuyonga kugirango irwanye kink, ubu imaze amezi 24 yumurimo uhoraho nta gutakaza ubunyangamugayo. Ikigo cyatsinze igenzura rya FDA ritunguranye hamwe na zeru zerekeranye nibice byamazi.

Umwanzuro

Iyo abahanga mu bya farumasi bagaragaje “PTFE yoroshye bore hoseyo gukoresha imiti, "barasaba rwose ibintu bitatu: ibyago byo kwanduza zeru, kwemererwa gukurikiza amategeko, hamwe ninshingano zamafaranga. Imyaka mirongo ibiri yamakuru yo mumurima yerekana ko isugi yacu 100% isugi PTFE yoroshye-bore hose itanga ibyo uko ari bitatu - byerekana ko ubuziranenge nubukungu bishobora kubana kubikoresho bimwe.