Yog hais tias precision machining confers "lub zog nyuaj" rau kev soj ntsuam kev xa tawm, kev tshawb fawb nruj me ntsis ntim muab lub "mos zog" tiv thaiv kev siv lub davhlau ya nyob twg. Cov kws tshaj lij kev lag luam tau lees tias: "Kev ntim khoom tsis muaj menyuam ua rau ob qho kev tsim khoom zaum kawg thiab thawj qhov thaiv kev nyab xeeb." Rau Chav Kawm III liTau koobnkag mus rau cov ntaub so ntswg tsis muaj menyuam, ntim kev ncaj ncees dais ncaj qha rau tus neeg mob ciaj sia. Microscopic defects pheej hmoo microbial ingress thiab iatrogenic kev puas tsuaj. Yog li, nkag siab txog Sterile Barrier System (SBS) cov hauv paus ntsiab lus yog qhov tseem ceeb rau kev nce qib zoo.

Tuohy koob feem ntau undergoEthylene Oxide (ETO) kom tsis muaj menyuam. Qhov no - qhov kub thiab txias modality haum rau ya raws- / tshav kub- cov khoom siv rhiab heev (piv txwv li, yas hubs). ETO roj tshem tawm cov kab mob, spores, fungi, thiab kab mob. Txawm li cas los xij, ETO kev ua kom tsis muaj menyuam nthuav tawm qhov nyuaj thiab muaj kev phom sij. Cov kev txhawj xeeb tseem ceeb suav nrogtoxic residuals. ETO yog carcinogenic; post- cov khoom ua kom tsis muaj menyuam yuav tsum muaj kev ua kom tsis muaj zog- yuam cua los yog cua sov degassing- kom ntseeg tau tias cov khoom seem poob qis dua qhov kev tswj hwm (feem ntau tsawg dua lossis sib npaug li 10 ug / g). Peb cov neeg koom tes ua kom tsis muaj menyuam tuav cov voj voog thiab cov txheej txheem kuaj cov seem, muab cov khoom ua kom tsis muaj menyuam- cov ntawv pov thawj tshwj xeeb ua kom tsis muaj menyuam kom lav kev nyab xeeb hauv chaw kho mob.

Kev xaiv cov khoom ntim khoom thauj mus rau SBS. Tam sim no Tuohy koob ntim khoom feem ntau ua haujlwmhlwv systems. Thermoformed pob tshab tais-feem ntau yog PET lossis APET- muab qhov pom tseeb thiab nruj, ua kom pom cov khoom thaum tiv thaiv qhov muag muag. Lidstock universally suav nrogTyvek® (DuPont), high - ntom polyethylene fiber nruab nrab. Tyvek® xa cov khoom tshwj xeeb microbial barrier thaum tso cai ETO gas permeation rau kom tsis muaj menyuam thiab aeration. Critically, nws muaj superior tsim kua muag kuj thiab tshav kub- foob lub zog, tswj kev ruaj ntseg thaum lub sij hawm shipping vibrations los yog climatic fluctuations.

Cov qauv tsim kev sib npaugkev siv hluav taws xob thiab kev ruaj ntseg. Blister kab noj hniav suav nrog cov yam ntxwv khaws cia- lub cev snaps lossis kev sib txhuam zoo sib xws- tuav rab koob thiab hub. Qhov immobilization no tiv thaiv kev thauj mus los -induced oscillation uas tuaj yeem ua rau lub taub hau puas. Qhib mechanisms mandatepeel- qhib kev ua haujlwm. Cov kws kho mob pib tsim kua muag raws li ua ntej- tau qhab nia perforations; Tyvek® ply sib cais ua kom zoo, nthuav tawm cov cuab yeej yam tsis muaj qhov cuam tshuam rau hauv thaj chaw tsis muaj menyuam. Kev simulated qhib kev sim ua kom muaj txiaj ntsig zoo sib xws (feem ntau 3N-10N) thiab hnab looj tes- ua haujlwm zoo.

Kev huv huv thaum ntim khoom yog ISO 13485 qhov tseem ceeb. Kev thauj khoom thiab sealing kis tau nyob rau hauv cov chaw tswj huv huv. Cov neeg ua haujlwm ua raws li kev cai hnav khaub ncaws nruj. Thaum tshav kub kub- cov khoom siv sealing tau dhau lub sijhawm ntsuas kub, siab, thiab lub sijhawm nyob. Cov khoom ua tiav tiav lub ntsej muag kev puas tsuaj: dye penetration tests detect micro-channel leaks; Kev ntsuam xyuas npuas emission txheeb xyuas holistic foob kev ncaj ncees; Cov teeb meem microbial validate sterility assurance qib.

Tsis tas li ntawd,labeling thiab traceabilityyog integral. Txoj cai tswjfwm hais kom meej meej: cov khoom siv npe, cov lus qhia tshwj xeeb, ntau tus lej, hnub tsim khoom / hnub tas sijhawm, ntsuas ntsuas kom tsis muaj menyuam, cov ntsiab lus ntawm cov chaw tsim khoom, thiab cov lus ceeb toom ("Ib leeg-siv," "Sterile," "Tsis Txhob Siv Yog Pob puas"). Kev luam ntawv siv laser etching lossis kev kho mob - qib inks resistant rau fading los yog smearing. Tseem ceeb heev,sterilization ntsuas​ (piv txwv li, Class I chemical indicators) undergo irreversible color change (eg, red to blue) post-ETO exposure, muab tam sim ntawd pom kev pom zoo ntawm sterilization tiav.

Thaum kawg, ntim khoom yuav tsum muaj sia nyobsimulated faib stressors. Cov khoom lag luam hla thoob ntiaj teb cov saw hlau- ua rau lub sijhawm thauj khoom, tuav, chaw khaws khoom, thiab kev hloov pauv huab cua. Kev ntsuam xyuas lub rooj vibration, kev sim poob, thiab compression stacking simulate phem tshaj - rooj plaub, xyuas SBS robustness. Tsuas yog thaum tshem tawm lub roj teeb ntawm qhov kev siv tau ua haujlwm ua peb cov koob Tuohy tawm ntawm lub Hoobkas, yog lub hom phiaj rau cov chaw kho mob thoob ntiaj teb. Qhov kev ua tau zoo ntawm qhov kev cuam tshuam zaum kawg no ua rau peb txoj kev ncaj ncees rau kev cog lus zoo- cog lus muab txhais ua kev tiv thaiv tus neeg mob.