Jun 15, 2007
Wan ɔspitul inschrumɛnt jɔyn kin jɔs nid plus ɔ mayns 0.02mm, we bɔku industrial shɔp dɛn kin ol. Wetin dɛn nɔ kin ebul fɔ du ɔltɛm na fɔ mek dɛn prodyuz di pruf dɛn we de biɛn ɛni yunit. Na dis na wetin da pruf de, ɛn aw fɔ rayt am insay wan rikwest fɔ kot so di ansa dɛn go kɔmparabl.
Bɔku tɛm dɛn kin kot di pat dɛn we dɛn kin yuz fɔ mɛn pipul dɛn lɛk se na jɔs pat dɛn we gɛt ay prɛsishɔn, ɛn dis kin mis di pɔynt. wan stenlɛs jɔyn na ɔspitul inschrumɛnt kin ol plus ɔ mayns 0.02mm, we di industrial shɔp dɛn kin ol fayv maykron ɔltɛm. Di rial get nɔto di tolɛreshɔn bɔt na wetin dɛn kin prodyuz as pruf biɛn ɛvri yunit: matirial sɛtifiket, klin rɛkɛd, sterilayz kɔmpatibiliti validɛshɔn ɛn chenj kɔntrol rɛkɔd.
Dat de ɛksplen wetin mek di sem drɔin kin kot pas dɛbul fɔ wan mɛdikal kɔstɔma. Wan kɔstɔma we de na di industri kin tek di pat; wan mɛdikal kɔstɔma kin aksept di pat plus di rɛkɔd fɔ aw i travul. Di fɔs wan kin abop pan di fil we pɔsin we gɛt ɛkspiriɛns de fil. Di sɛkɔn wan nid fɔ du di wok, ɛn di wan we mek am fɔ ebul fɔ mek da rɛkɔd de bak sɔm ia afta dat. So we dɛn de kwalifay wan saplay fɔ wok fɔ mɛn pipul dɛn, di yusful kwɛstyɔn nɔto us mashin dɛn gɛt bɔt if dɛn inspekshɔn rɛkɔd dɛn kin fɛn bay batch.
Di 316L stenlɛs, taytaniɔm ɛn PEEK we dɛn yuz na mɛdikal pat dɛn ɔl nid matirial sɛtifiket, bɔt wan mil sɛtifiket nɔmɔ nɔ kin du. Wetin wan mɛdikal kɔstɔma nid na di linkej we de pruv se dis ɔt bin go insay dis batch ɔf pat — wan map frɔm mɛlt nɔmba to dɔn lɔt. Wan miks bɔndɛl we de na di midul de brok di chen.
Saund praktis na fɔ tag pan risit, skan pan isyu, ɛn isolate remnants sɛpret. I tan lɛk se na westɛm ditel, bɔt i de disayd if dɛn kin lɔk wan lɔt we dɛn afɛkt insay 4 awa we sɔntin nɔ apin. Dis na di pɔynt we dɛn kin skip mɔ pan bɔlk ɔda: di mɔ di lɔt big, na di ay chans fɔ miks ɛn di ay traceability kɔst — we na pat pan wetin mek smɔl mɛdikal batch nɔ chip.
Dɛn kin sho klin as rεsidyual patikyula pan wan yunit εria ɔ tכtal rεsidyual mas, yet bɔku drɔin dεm jכs se di sεf fɔ klin ɛn nɔ gɛt ɔyl. Dat nɔto akshɔnable we dɛn aksept am, so i degenerate insay wan kɔstɔma we de was di pat wit wayt klos fɔ luk fɔ wan dak mak — we nɔto sayɛns, ɛn garanti fɔ dɔn wit agyumɛnt.
Di we aw dɛn kin wok na fɔ split klin to tri tin dɛn we dɛn rayt: di we aw dɛn kin klin (ultrasonic, spray ɔ vapor phase), di we aw dɛn kin tɛst (particle count ɔ gravimetric), ɛn di pak (dabul bag ɔnda vaykum ɔ klin rum bɔks). fכ pat dεm we leta dεn go stεrilayz, kכnfכm se di klin-ejεnt rεsidεnt nכ go kכnflik wit di stεrilayz mεtכd: εtilin oksayd de sεnsitiv to rεsidεns, we irεdyushכn de kia mכr bכt di mεtirial in כwn rεdyushכn tכlerεns.
Di step we dɛn kin skip pas ɔl fɔ pik di mɛrɛsin matirial na fɔ aks if di matirial kin liv di sterilayzeshɔn we di kɔstɔma dɔn pik. di sem PEEK de chenj dimenshכnal stεbiliti afta ripit כtoklev saykl dεm; sɔm polycarbonate gred yɔlɔ ɛn embrittle afta iradyeshɔn; mɛtal pat dɛn kin pit afta dɛn dɔn ripit saykl dɛn.
Dɛn prɔblɛm ya nɔ de si na di protɔtayp stej ɛn dɛn kin kɔmɔt na do we di kɔstɔma dɔn dɔn sterilayz validɛshɔn ɛn de pripia fɔ volyum. Fɔ di mɛdikal pat dɛn we dɛn mek bay injɛkshɔn mold ɔ invɛstmɛnt kastin, tri kwɛstyɔn dɛn de insay di kot stej: us sterilayzeshɔn we, wetin na di maksimal nɔmba fɔ di saykl dɛn, ɛn na dimɛnshɔnal data bifo ɛn afta sterilayzeshɔn we dɛn nid. Fɔ ansa dɛn tri wɛl dɛn de impɔtant pas sɔm sɛnt pan di prayz.
Fɔ chenj chamfer pan wan industrial pat kin gri insay wan mɛsej. Na wan mɛdikal pat i nɔ go ebul: ɛni chenj we afɛkt fɔm, matirial, prɔses ɔ saplay de go tru chenj kɔntrol, dɛn de asɛs am agens validɛshɔn we dɛn dɔn kɔmplit, ɛn dɛn de ri-validet am usay nid de. Dat nɔto birokrasi; i de bikɔs fɔ validet wan tɛm de kɔst fa fawe pas fɔ chenj wan tɛm.
Di prɛktikal kɔnsɛkshɔn na dat wan mɛdikal kot fɔ inklud chenj mɛnejɛmɛnt as rial kɔst: kɔntrol prɔses dɔkyumɛnt, chenj rivyu rɛkɔd, ɛn sial stɔrɔj fɔ superseded tul. Na dat mek bak di bespɔk mɛdikal pat dɛn kin tek tu tɛm pas di tɛm fɔ divɛlɔp pas di industrial pat dɛn we gɛt di sem kɔmplisiti. Dɛn nɔ kin spɛn di tɛm fɔ mek mashin; i de spɛn fɔ kɔnfɔm if chenj de mek di validɛshɔn we bin dɔn de bifo nɔ valid.
di mεdikal program dεm na tipikli lכw vכlyum εn hכy miks: wan pletfכm kin rכn fכ כndrεd yunit dεm insay wan ia split akraos wan duzin vεryכnt, εvri wan gεt in כwn stεrilayzεshכn mεtכd, pak εn lεbul. Ɔda lɛk dis nɔ kin kot as yunit prays tɛm kwantiti, bikɔs di kɔst sidɔm na chenj ɔva — nyu klin program, difrɛn sterilayz pauch, fresh batch rɛkɔd, ripit fɔs-atikul inspekshɔn.
Wan spɔlayt we de kot mɛdikal pat dɛn pan volyum prayz go ɔlmost shɔ se i go gɛt prɔblɛm we dɛn de ɛksɛkushɔn: ɔ prayz inkris mid-program, ɔ rɛkɛd dɛn kwayɛt wan drɔp. Di we we pɔsin kin wok na fɔ tɔk bɔt ɛni ia volyum, di vayriɔnt kɔnt ɛn di minim batch saiz na di RFQ, ɛn aks fɔ tu-pat kot — batch kɔst plus yunit kɔst — so dat di prokyumɛnt go si us pat dɛn swɛt.
Na scheduling kɔnsikuns de bak. Bɔku tɛm, di mɛdikal pat dɛn nɔ kin ebul fɔ sheb wan layn wit di wok we dɛn de du na di industri; klin, asembli ɛn pak nid dediket winda dɛn, we min se dɛn gɛt rizɔv kapasiti pas fɔ ful-ɔp di gap dɛn. Wan yusful ɔdit kwɛshɔn na ɔmɔs shift da layn de bin kip fɔ mɛdikal wok las mɔnt. Wan patikyula nɔmba kin min rial ɛkspiriɛns pan mɛrɛsin; wi kin fit yu olwes in usually min none.
Kɔmprɛs insay 4 layn dɛn we pɔsin we bay kin rili yuz: matirial sɛtifiket dɛn fɔ map to lɔt nɔmba dɛn we dɔn dɔn; klin fɔ tɔk bɔt di we aw dɛn de klin, di we aw dɛn de du di tɛst ɛn di we aw dɛn pak am; stεrilayzεshכn kכmpatibiliti mכs kכnfכm na kot stej inklud saykl kכnt; ɛn chenj kɔntrol fɔ fiks wan rivyu dedlayn ɛn nem udat gɛt ri-validɛshɔn. We dɛn rayt am na di RFQ, dɛn 4 layn dɛn de kin separet di saplay dɛn wantɛm wantɛm.
Wan ɔda tin we wi fɔ tek tɛm wit: fɔ fɛn di mɛrɛsin pat dɛn pan prayz nɔmɔ na trap. Na di sem batch, di kot we smɔl pas ɔl kin kɔmɔt frɔm wan shɔp we nɔ ɛva du mɛdikal wok, ɛn wetin i lɛf na jɔs dɛn 4 tin dɛn de. Di kɔst de kam bak we dɛn de validet, ɛn di tɔtal de dɔn ɔp. Split di saplay kot insay mashin kɔst ɛn kɔmplians kɔst, ɛn i kin bi klia udat dɔn rili du dis bifo. Luk di ditel dɛn bɔt di prɔdak we di wan we mek am
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