{"id":966,"date":"2026-05-21T08:24:26","date_gmt":"2026-05-21T08:24:26","guid":{"rendered":"https:\/\/isbm-blow-molding.com\/?p=966"},"modified":"2026-05-21T08:24:26","modified_gmt":"2026-05-21T08:24:26","slug":"isbm-medical-device-bottle-production-korean-guide","status":"publish","type":"post","link":"https:\/\/isbm-blow-molding.com\/tr\/isbm-medical-device-bottle-production-korean-guide\/","title":{"rendered":"ISBM T\u0131bbi Cihaz \u015ei\u015fe \u00dcretimi: Kore D\u00fczenleme K\u0131lavuzu 2026"},"content":{"rendered":"<div style=\"margin: 0; padding: 20px; font-family: 'Helvetica Neue',Helvetica,Arial,sans-serif; color: #1f2937; line-height: 1.78; background: #fff;\">\n<p><!-- HERO: clean medical blue --><\/p>\n<header style=\"position: relative; min-height: min(580px,86vh); display: flex; align-items: center; padding: clamp(40px,6vw,80px) clamp(18px,5vw,56px); background: #020c1a; background-image: linear-gradient(150deg,rgba(2,8,22,0.98) 0%,rgba(4,22,54,0.94) 58%,rgba(3,105,161,0.34) 100%),url('https:\/\/isbm-blow-molding.com\/wp-content\/uploads\/2026\/02\/ISBM-2.webp'); background-size: cover; background-position: center;\">\n<div style=\"max-width: 680px;\"><span style=\"display: inline-block; font-size: 10px; font-weight: bold; letter-spacing: 2.5px; text-transform: uppercase; color: #7dd3fc; border: 1px solid rgba(125,211,252,0.35); padding: 4px 12px; border-radius: 3px; margin-bottom: 18px;\">ISBM Uygulamalar\u0131 \u00b7 T\u0131bbi Cihaz Ambalaj\u0131 \u00b7 Kore ISBM 2026<\/span><\/p>\n<h1 style=\"font-size: clamp(24px,4.2vw,40px); font-weight: 900; color: #fff; line-height: 1.18; margin: 0 0 20px; letter-spacing: -0.5px;\">ISBM T\u0131bbi Cihaz \u015ei\u015fesi<br \/>\n\u00dcretim: Kore D\u00fczenleme K\u0131lavuzu<\/h1>\n<p style=\"font-size: clamp(14px,1.9vw,17px); color: #e0f2fe; line-height: 1.7; margin: 0 0 28px; max-width: 560px;\">Kore t\u0131bbi cihaz ambalaj\u0131, en y\u00fcksek uyumluluk gerektiren ISBM uygulamas\u0131d\u0131r; burada her \u015fi\u015fenin biyolojik uyumluluk testinden ge\u00e7mesi, sterilizasyon onay\u0131 almas\u0131, GMP IQ\/OQ\/PQ standartlar\u0131na g\u00f6re boyutsal olarak nitelendirilmesi ve belgelenmi\u015f temiz bir ortamda \u00fcretilmesi gerekmektedir. Bu pazara do\u011fru \u015fekilde giren Koreli ISBM \u00fcreticileri, Kore t\u0131bbi cihaz \u015firketlerinin 10-15 y\u0131l boyunca yeniledi\u011fi bir tedarik\u00e7i yeterlili\u011fi olu\u015ftururlar. D\u00fczenleyici \u00e7er\u00e7eveyi anlamadan girenler ise ilk KFDA tedarik\u00e7i denetiminden ge\u00e7emeyen \u015fi\u015feler \u00fcretirler.<\/p>\n<div style=\"display: flex; flex-wrap: wrap; gap: 8px;\"><span style=\"background: rgba(255,255,255,0.08); border: 1px solid rgba(255,255,255,0.18); color: #e0f2fe; font-size: 11.5px; font-weight: 600; padding: 5px 14px; border-radius: 20px;\">KFDA S\u0131n\u0131f I\u2013IV D\u00fczenleyici \u00c7er\u00e7evesi<\/span><br \/>\n<span style=\"background: rgba(255,255,255,0.08); border: 1px solid rgba(255,255,255,0.18); color: #e0f2fe; font-size: 11.5px; font-weight: 600; padding: 5px 14px; border-radius: 20px;\">ISO 10993 Biyouyumluluk<\/span><br \/>\n<span style=\"background: rgba(255,255,255,0.08); border: 1px solid rgba(255,255,255,0.18); color: #e0f2fe; font-size: 11.5px; font-weight: 600; padding: 5px 14px; border-radius: 20px;\">GMP IQ \/ OQ \/ PQ Do\u011frulama<\/span><\/div>\n<p style=\"font-size: 11px; color: #38bdf8; margin: 22px 0 0;\">Kore Ever-Power M\u00fchendislik Masas\u0131 \u00b7 Ansan-si \u00b7 May\u0131s 2026<\/p>\n<\/div>\n<\/header>\n<p>&nbsp;<\/p>\n<p><!-- KFDA CLASSIFICATION REFERENCE --><\/p>\n<div style=\"background: #f0f9ff; border: 1px solid #bae6fd; border-radius: 8px; padding: 20px 24px; margin: 44px 0 0;\">\n<p style=\"font-size: 10.5px; font-weight: 800; letter-spacing: 2px; text-transform: uppercase; color: #075985; margin: 0 0 14px;\">Kore G\u0131da ve \u0130la\u00e7 \u0130daresi (KFDA) T\u0131bbi Cihaz S\u0131n\u0131fland\u0131rmas\u0131 \u2014 Ambalaj\u0131n Etkisi \u00d6zeti<\/p>\n<div style=\"overflow-x: auto;\">\n<table style=\"width: 100%; border-collapse: collapse; font-size: 13px; min-width: 520px;\">\n<thead>\n<tr style=\"background: #075985;\">\n<th style=\"color: #fff; padding: 9px 12px; text-align: left; font-weight: bold;\">KFDA S\u0131n\u0131f\u0131<\/th>\n<th style=\"color: #fff; padding: 9px 12px; text-align: left; font-weight: bold;\">Kore Onay Yolu<\/th>\n<th style=\"color: #fff; padding: 9px 12px; text-align: left; font-weight: bold;\">Ambalaj Gereksinimi<\/th>\n<th style=\"color: #fff; padding: 9px 12px; text-align: left; font-weight: bold;\">Kore ISBM Uygulamas\u0131<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td style=\"padding: 8px 12px; border-bottom: 1px solid #bae6fd; font-weight: 600;\">S\u0131n\u0131f I<\/td>\n<td style=\"padding: 8px 12px; border-bottom: 1px solid #bae6fd;\">\uc2e0\uace0 (Bildirim)<\/td>\n<td style=\"padding: 8px 12px; border-bottom: 1px solid #bae6fd;\">Temel malzeme izlenebilirli\u011fi + boyutlar<\/td>\n<td style=\"padding: 8px 12px; border-bottom: 1px solid #bae6fd;\">Numune kaplar\u0131, d\u00fc\u015f\u00fck riskli numune kaplar\u0131<\/td>\n<\/tr>\n<tr style=\"background: #f0f9ff;\">\n<td style=\"padding: 8px 12px; border-bottom: 1px solid #bae6fd; font-weight: 600;\">II. S\u0131n\u0131f<\/td>\n<td style=\"padding: 8px 12px; border-bottom: 1px solid #bae6fd;\">Sertifikasyon (Sertifika)<\/td>\n<td style=\"padding: 8px 12px; border-bottom: 1px solid #bae6fd;\">ISO 10993 biyolojik uyumluluk + GMP dok\u00fcmantasyonu<\/td>\n<td style=\"padding: 8px 12px; border-bottom: 1px solid #bae6fd;\">IVD reaktif \u015fi\u015feleri, tan\u0131 kitleri, y\u0131kama \u015fi\u015feleri<\/td>\n<\/tr>\n<tr>\n<td style=\"padding: 8px 12px; border-bottom: 1px solid #bae6fd; font-weight: 600; color: #0369a1;\">S\u0131n\u0131f III<\/td>\n<td style=\"padding: 8px 12px; border-bottom: 1px solid #bae6fd;\">\ud5c8\uac00 (KFDA Onay\u0131)<\/td>\n<td style=\"padding: 8px 12px; border-bottom: 1px solid #bae6fd; font-weight: 600; color: #0369a1;\">Tam GMP onay\u0131 + ekstrakte edilebilir\/s\u0131zabilir maddeler<\/td>\n<td style=\"padding: 8px 12px; border-bottom: 1px solid #bae6fd;\">\u0130la\u00e7 da\u011f\u0131t\u0131m sistemi kaplar\u0131, steril cihaz ambalajlar\u0131<\/td>\n<\/tr>\n<tr style=\"background: #f0f9ff;\">\n<td style=\"padding: 8px 12px; font-weight: 600; color: #0369a1;\">S\u0131n\u0131f IV<\/td>\n<td style=\"padding: 8px 12px;\">\ud5c8\uac00 (KFDA Onay\u0131)<\/td>\n<td style=\"padding: 8px 12px; font-weight: 600; color: #0369a1;\">Tam GMP + klinik veriler + sterilizasyon validasyonu<\/td>\n<td style=\"padding: 8px 12px;\">\u0130mplant bile\u015fen kaplar\u0131, ya\u015fam destekleyici cihaz ambalajlar\u0131<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n<\/div>\n<p><!-- TOC --><\/p>\n<nav style=\"margin: 32px 0 0; background: #f9fafb; border: 1px solid #e5e7eb; border-radius: 8px; padding: 20px 22px;\">\n<p style=\"font-size: 10.5px; font-weight: bold; text-transform: uppercase; letter-spacing: 1.5px; color: #374151; margin: 0 0 12px;\">\u0130\u00e7indekiler<\/p>\n<div style=\"display: grid; grid-template-columns: repeat(auto-fit,minmax(min(100%,260px),1fr)); gap: 4px 20px;\"><a style=\"color: #0369a1; text-decoration: none; font-size: 14px; padding: 3px 0; display: block;\" href=\"#s1\">1. Kore T\u0131bbi Cihaz Ambalaj Pazar\u0131 ve ISBM'nin Rol\u00fc<\/a><br \/>\n<a style=\"color: #0369a1; text-decoration: none; font-size: 14px; padding: 3px 0; display: block;\" href=\"#s2\">2. KFDA T\u0131bbi Cihaz Kay\u0131t \u00c7er\u00e7evesi<\/a><br \/>\n<a style=\"color: #0369a1; text-decoration: none; font-size: 14px; padding: 3px 0; display: block;\" href=\"#s3\">3. Malzeme Se\u00e7imi: T\u0131bbi Kaplar i\u00e7in PET, PETG ve PP<\/a><br \/>\n<a style=\"color: #0369a1; text-decoration: none; font-size: 14px; padding: 3px 0; display: block;\" href=\"#s4\">4. ISO 10993 Biyouyumluluk De\u011ferlendirme Protokol\u00fc<\/a><br \/>\n<a style=\"color: #0369a1; text-decoration: none; font-size: 14px; padding: 3px 0; display: block;\" href=\"#s5\">5. Sterilizasyon Y\u00f6ntemi Uyumlulu\u011fu<\/a><br \/>\n<a style=\"color: #0369a1; text-decoration: none; font-size: 14px; padding: 3px 0; display: block;\" href=\"#s6\">6. Ekstraksiyon ve S\u0131z\u0131nt\u0131 Maddeleri: KFDA Beklentileri<\/a><br \/>\n<a style=\"color: #0369a1; text-decoration: none; font-size: 14px; padding: 3px 0; display: block;\" href=\"#s7\">7. Kore ISBM i\u00e7in Temiz Oda \u00dcretim Standartlar\u0131<\/a><br \/>\n<a style=\"color: #0369a1; text-decoration: none; font-size: 14px; padding: 3px 0; display: block;\" href=\"#s8\">8. GMP Do\u011frulama: Kore ISBM Hatlar\u0131 i\u00e7in IQ, OQ ve PQ<\/a><br \/>\n<a style=\"color: #0369a1; text-decoration: none; font-size: 14px; padding: 3px 0; display: block;\" href=\"#faq\">SSS<\/a><\/div>\n<\/nav>\n<p><!-- S1 --><\/p>\n<section id=\"s1\" style=\"margin: 56px 0 0; padding: 36px 0 0; border-top: 2px solid #0369a1;\">\n<h2 style=\"font-size: clamp(18px,2.6vw,24px); font-weight: 800; color: #075985; margin: 0 0 18px;\">1. Kore T\u0131bbi Cihaz Ambalaj Pazar\u0131 ve ISBM'nin Rol\u00fc<\/h2>\n<figure style=\"margin: 0 0 22px;\"><img decoding=\"async\" style=\"width: 100%; height: auto; border-radius: 8px; display: block;\" src=\"https:\/\/isbm-blow-molding.com\/wp-content\/uploads\/2026\/02\/Injection-Stretch-Blow-Molding-HGY150-V4-EV.webp\" alt=\"Kore t\u0131bbi cihaz \u015fi\u015fe \u00fcretimi i\u00e7in Kore yap\u0131m\u0131 Ever-Power ISBM HGY150-V4-EV tamamen elektrikli servo makine \u2014 EV servo, \u00b10,05 saniye \u00fcfleme bekleme hassasiyeti, \u00b10,3\u00b0C \u015fartland\u0131rma s\u0131cakl\u0131\u011f\u0131 homojenli\u011fi ve KFDA S\u0131n\u0131f II ve III t\u0131bbi cihaz ambalaj do\u011frulama dok\u00fcmantasyonu i\u00e7in d\u00f6ng\u00fcden d\u00f6ng\u00fcye GMP proses veri kayd\u0131 \u00f6zelliklerine sahiptir.\" \/><figcaption style=\"font-size: 12px; color: #6b7280; margin-top: 8px; text-align: center;\">Kore t\u0131bbi cihaz ambalajlamas\u0131 i\u00e7in Kore yap\u0131m\u0131 Ever-Power HGY150-V4-EV tamamen elektrikli ISBM platformu; EV servonun \u00b10,3\u00b0C ko\u015fulland\u0131rma s\u0131cakl\u0131\u011f\u0131 hassasiyeti, \u00b10,05s \u00fcfleme bekleme s\u00fcresi ve d\u00f6ng\u00fcden d\u00f6ng\u00fcye proses kayd\u0131, t\u0131bbi cihaz ISBM'sini farmas\u00f6tik ISBM'den ay\u0131ran \u00fc\u00e7 KFDA GMP gereksinimini kar\u015f\u0131lamaktad\u0131r: onaylanm\u0131\u015f proses parametre aral\u0131klar\u0131, denetim izleri i\u00e7eren elektronik proses kay\u0131tlar\u0131 ve cihaz\u0131n tescil s\u00fcresinin tamam\u0131 boyunca \u00fcretim verilerinin saklanmas\u0131 (Kore KFDA \uc758\ub8cc\uae30\uae30\uc758 \uc81c\uc870 \ubc0f \ud488\uc9c8\uad00\ub9ac \uae30\uc900 kapsam\u0131nda \u00fcretim tarihinden itibaren en az 3 y\u0131l).<\/figcaption><\/figure>\n<p style=\"font-size: 16px; margin-bottom: 14px;\">K\u00fcresel de\u011fer s\u0131ralamas\u0131nda ilk 10 aras\u0131nda yer alan ve y\u0131ll\u0131k 8,51 trilyon KRW b\u00fcy\u00fcme g\u00f6stererek 2025 y\u0131l\u0131nda 12,4 trilyon KRW'ye ula\u015facak olan Kore t\u0131bbi cihaz end\u00fcstrisi, in vitro tan\u0131 (IVD), reaktif depolama, numune toplama ve ila\u00e7 da\u011f\u0131t\u0131m cihaz\u0131 ambalaj\u0131 i\u00e7in \u00f6nemli miktarda hassas plastik kaplara ihtiya\u00e7 duymaktad\u0131r. Koreli ISBM \u015fi\u015feleri bu pazara hizmet vermektedir \u00e7\u00fcnk\u00fc ISBM'nin tek a\u015famal\u0131 i\u015flemi, Koreli t\u0131bbi cihaz \u015firketlerinin reaktifler, y\u0131kama sol\u00fcsyonlar\u0131, kalibrasyon s\u0131v\u0131lar\u0131 ve tan\u0131 kiti bile\u015fenleri i\u00e7in birincil kap olarak ihtiya\u00e7 duydu\u011fu boyutsal hassasiyete (\u00b10,04 mm boyun d\u0131\u015f \u00e7ap\u0131), optik \u015feffafl\u0131\u011fa (g\u00f6rsel dolum seviyesi onay\u0131 i\u00e7in bulan\u0131kl\u0131k \u22642,51 trilyon KRW) ve yap\u0131sal b\u00fct\u00fcnl\u00fc\u011fe (duvar kal\u0131nl\u0131\u011f\u0131 CV1 ...<\/p>\n<p style=\"font-size: 16px; margin-bottom: 14px;\">Kore men\u015feli ISBM, Kore t\u0131bbi cihaz kaplar\u0131 pazar\u0131nda \u00fc\u00e7 \u00f6zel boyut ve geometri kategorisinde cam ve IBM (enjeksiyonlu \u015fi\u015firme kal\u0131plama) ile rekabet etmektedir. Birincisi, ISBM'nin \u00fcst\u00fcn duvar homojenli\u011fi ve optik \u015feffafl\u0131\u011f\u0131n\u0131n, cam\u0131n a\u011f\u0131rl\u0131\u011f\u0131 ve k\u0131r\u0131lma riski olmadan IBM'in yeteneklerini a\u015ft\u0131\u011f\u0131, dar ila orta boyunlu (13-38 mm) 30 ml-500 ml \u015fi\u015felerdir. \u0130kincisi, kit bile\u015fenleri i\u00e7in \u00f6zde\u015f \u015fi\u015felerin \u00e7oklu bo\u015fluklu hassas \u00fcretimi (2-4 bo\u015fluk), bo\u015fluklar aras\u0131 boyut varyasyonunun \u2264\u00b10,04 mm boyun d\u0131\u015f \u00e7ap\u0131n\u0131 kar\u015f\u0131lamas\u0131 gereken bir spesifikasyondur; ISBM bu spesifikasyonu tek ad\u0131ml\u0131 \u00f6n kal\u0131ptan \u015fi\u015feye kontrol\u00fcyle kar\u015f\u0131lamaktad\u0131r. \u00dc\u00e7\u00fcnc\u00fcs\u00fc, dolum seviyesi g\u00f6r\u00fcn\u00fcrl\u00fc\u011f\u00fcn\u00fcn estetik bir tercihten ziyade bir g\u00fcvenlik fonksiyonu oldu\u011fu \u015feffaf reaktif \u015fi\u015feleridir; bu gereklilik, opak se\u00e7enekleri tamamen ortadan kald\u0131r\u0131r ve Kore men\u015feli ISBM'nin 0,5 metre mesafeden reaktif seviyesini do\u011frulayan bulan\u0131kl\u0131k performans\u0131n\u0131 (\u22642,5%) gerektirir.<\/p>\n<p style=\"font-size: 16px; margin-bottom: 0;\">Kore t\u0131bbi cihaz uygulamalar\u0131 i\u00e7in ISBM'nin en \u00f6nemli avantaj\u0131, Kore ila\u00e7 sekt\u00f6r\u00fcndekiyle ayn\u0131d\u0131r: d\u00f6ng\u00fcden d\u00f6ng\u00fcye s\u00fcre\u00e7 izlenebilirli\u011fi. Kore KFDA t\u0131bbi cihaz GMP'si (\uc758\ub8cc\uae30\uae30\uc758 \uc81c\uc870 \ubc0f \ud488\uc9c8\uad00\ub9ac \uae30\uc900, ISO 13485'e e\u015fde\u011fer), her \u00fcretim partisi i\u00e7in birincil kap \u00fcretim s\u00fcreci ko\u015fullar\u0131n\u0131n belgelenmesini gerektirir. Kore EV servo ISBM platformlar\u0131nda <a style=\"color: #0369a1; font-weight: 600; text-decoration: none;\" href=\"https:\/\/isbm-blow-molding.com\/tr\/product-category\/4-station-isbm-machine\/\">Kore yap\u0131m\u0131 Ever-Power 4 \u0130stasyonlu ISBM Makine Serisi<\/a> Bu veriler otomatik olarak olu\u015fturulur; b\u00f6ylece Kore t\u0131bbi cihaz ambalajlar\u0131 i\u00e7in GMP dok\u00fcmantasyon y\u00fck\u00fc, manuel inceleme g\u00f6revinden ziyade bir veri y\u00f6netimi g\u00f6revine d\u00f6n\u00fc\u015f\u00fcr.<\/p>\n<\/section>\n<p><!-- S2 --><\/p>\n<section id=\"s2\" style=\"margin: 56px 0 0; padding: 36px 0 0; border-top: 2px solid #e5e7eb;\">\n<h2 style=\"font-size: clamp(18px,2.6vw,24px); font-weight: 800; color: #075985; margin: 0 0 18px;\">2. KFDA T\u0131bbi Cihaz Kay\u0131t \u00c7er\u00e7evesi: Koreli ISBM Ambalaj \u00dcreticilerinin Bilmesi Gerekenler<\/h2>\n<p style=\"font-size: 16px; margin-bottom: 14px;\">Kore G\u0131da ve \u0130la\u00e7 \u0130daresi (KFDA), T\u0131bbi Cihazlar Yasas\u0131 (\uc758\ub8cc\uae30\uae30\ubc95) kapsam\u0131nda t\u0131bbi cihazlar\u0131 risk seviyesine g\u00f6re d\u00f6rt s\u0131n\u0131fa ay\u0131r\u0131r. Bu s\u0131n\u0131fland\u0131rma, onay s\u00fcrecini ve ambalaj \u00fcreticileri i\u00e7in kritik \u00f6nem ta\u015f\u0131yan \u00fcretim dok\u00fcmantasyonu ve do\u011frulama derinli\u011fini belirler. Kore ISBM ambalaj \u00fcreticileri, m\u00fc\u015fterilerinin cihaz\u0131n\u0131n hangi s\u0131n\u0131fa girdi\u011fini anlamal\u0131d\u0131r; \u00e7\u00fcnk\u00fc ambalaj \u00fcreticisinin GMP y\u00fck\u00fcml\u00fcl\u00fckleri, ambalaj \u00fcreticisinin kendi s\u0131n\u0131fland\u0131rmas\u0131na de\u011fil, cihaz s\u0131n\u0131f\u0131na ba\u011fl\u0131d\u0131r.<\/p>\n<p style=\"font-size: 16px; margin-bottom: 14px;\">Kore S\u0131n\u0131f I t\u0131bbi cihazlar\u0131 (\uc2e0\uace0\ud488\ubaa9), genel numune toplama kaplar\u0131, S\u0131n\u0131f I numune kaplar\u0131 ve steril olmayan temass\u0131z aksesuarlar i\u00e7in ambalajlar da dahil olmak \u00fczere d\u00fc\u015f\u00fck riskli cihazlar\u0131 ve aksesuarlar\u0131 kapsar. S\u0131n\u0131f I uygulamalar\u0131 i\u00e7in Kore ISBM kaplar\u0131 yaln\u0131zca temel malzeme tan\u0131mlamas\u0131 (re\u00e7ine s\u0131n\u0131f\u0131, renk ana kar\u0131\u015f\u0131m lotu), boyut kay\u0131tlar\u0131 (boyun d\u0131\u015f \u00e7ap\u0131, \u015fi\u015fe y\u00fcksekli\u011fi, a\u011f\u0131rl\u0131k) ve g\u0131da temas\u0131 pozitif liste onay\u0131 gerektirir. Kore g\u0131da temas\u0131 ambalaj standartlar\u0131n\u0131 zaten kar\u015f\u0131layan Kore ISBM \u00fcreticileri, minimum ek dok\u00fcmantasyon yat\u0131r\u0131m\u0131yla S\u0131n\u0131f I t\u0131bbi cihaz kaplar\u0131 sa\u011flayabilir.<\/p>\n<p style=\"font-size: 16px; margin-bottom: 14px;\">Kore S\u0131n\u0131f II t\u0131bbi cihazlar\u0131 (\uc778\uc99d\ud488\ubaa9), orta riskli IVD reaktif kaplar\u0131n\u0131, tan\u0131 kiti bile\u015fenlerini, y\u0131kama sol\u00fcsyonu \u015fi\u015felerini ve klinik numune saklama kaplar\u0131n\u0131 kapsar. S\u0131n\u0131f II i\u00e7in Kore ISBM ambalajlama standartlar\u0131, ISO 10993 biyolojik uyumluluk de\u011ferlendirmesi (minimum sitotoksisite), belirli parti ve kaliteye kadar malzeme izlenebilirli\u011fi, her bir bo\u015fluktan boyut yeterlilik sertifikas\u0131 ve GMP parti kay\u0131tlar\u0131n\u0131n saklanmas\u0131n\u0131 gerektirir. Cihaz \u00fcreticisini sertifikaland\u0131ran Kore yetkili kurulu\u015fu (\uc778\uc99d\uae30\uad00), cihaz sertifikasyon denetiminin bir par\u00e7as\u0131 olarak ambalaj \u00fcreticisinin kalite dok\u00fcmantasyonunu inceler; bu da ambalaj GMP dok\u00fcmantasyonunu t\u0131bbi cihaz m\u00fc\u015fterisinin KFDA sertifikasyonu i\u00e7in do\u011frudan bir \u00f6n ko\u015ful haline getirir.<\/p>\n<p style=\"font-size: 16px; margin-bottom: 0;\">\u0130la\u00e7 da\u011f\u0131t\u0131m sistemlerini, steril cihaz temas y\u00fczeylerini ve ya\u015fam destekleyici cihaz ambalajlar\u0131n\u0131 kapsayan Kore S\u0131n\u0131f III ve IV t\u0131bbi cihazlar\u0131 (\ud5c8\uac00\ud488\ubaa9), en kapsaml\u0131 Kore ISBM \u00fcretim validasyonunu gerektirir: tam ISO 10993 biyolojik uyumluluk serisi (tipik olarak ISO 10993-5 sitotoksisite, ISO 10993-10 duyarl\u0131l\u0131k, ISO 10993-12 numune haz\u0131rlama), ekstraksiyon ve s\u0131z\u0131nt\u0131 (E&amp;L) \u00e7al\u0131\u015fmas\u0131, GMP IQ\/OQ\/PQ validasyonu, sterilizasyon validasyonu (kap doldurulduktan sonra sterilize ediliyorsa) ve cihaz\u0131n \ud5c8\uac00 (onay) dosyas\u0131 alt\u0131nda KFDA birincil kap kayd\u0131. S\u0131n\u0131f III\/IV tedarikine giren Kore ISBM \u00fcreticileri, ilk ticari teslimattan \u00f6nce 6-12 ayl\u0131k bir yeterlilik zaman \u00e7izelgesi ve 25-55 milyon KRW'lik bir validasyon yat\u0131r\u0131m\u0131 planlamal\u0131d\u0131r.<\/p>\n<\/section>\n<p><!-- S3 --><\/p>\n<section id=\"s3\" style=\"margin: 56px 0 0; padding: 36px 0 0; border-top: 2px solid #e5e7eb;\">\n<h2 style=\"font-size: clamp(18px,2.6vw,24px); font-weight: 800; color: #075985; margin: 0 0 18px;\">3. Malzeme Se\u00e7imi: Kore T\u0131bbi Cihaz Kaplar\u0131 i\u00e7in PET, PETG ve PP<\/h2>\n<figure style=\"margin: 0 0 22px;\"><img decoding=\"async\" style=\"width: 100%; height: auto; border-radius: 8px; display: block;\" src=\"https:\/\/isbm-blow-molding.com\/wp-content\/uploads\/2026\/02\/bottle-7.webp\" alt=\"Kore ISBM t\u0131bbi cihaz PET \u015fi\u015feleri \u2014 Kore tan\u0131 kiti ikincil ambalaj\u0131 i\u00e7in \u00b10,04 mm boyun d\u0131\u015f \u00e7ap\u0131 tolerans\u0131na sahip, kristal berrakl\u0131\u011f\u0131nda, dolum seviyesinin g\u00f6rsel olarak do\u011frulanmas\u0131n\u0131 sa\u011flayan ve kapatma torku uyumlulu\u011fu i\u00e7in tutarl\u0131 boyun di\u015f profiline sahip \u015feffaf PET S\u0131n\u0131f II IVD reaktif \u015fi\u015feleri.\" \/><figcaption style=\"font-size: 12px; color: #6b7280; margin-top: 8px; text-align: center;\">Kore ISBM onayl\u0131 t\u0131bbi cihaz PET \u015fi\u015feleri \u2014 \u00b10,04 mm boyun d\u0131\u015f \u00e7ap\u0131 yeterlili\u011fine sahip kristal PET (bulan\u0131kl\u0131k \u22642,0%) i\u00e7inde S\u0131n\u0131f II IVD reaktif depolama. Kore tan\u0131 end\u00fcstrisinin standart boyun biti\u015fi, 15\u2013100 ml reaktif \u015fi\u015feleri i\u00e7in GPI 24\/415 ve 100\u2013500 ml i\u00e7in GPI 28\/415'tir; bu da tek bir onayl\u0131 Kore ISBM tedarik\u00e7isinden birden fazla Kore IVD \u00fcreticisinin kit bile\u015fen \u015fi\u015felerinde standartla\u015ft\u0131r\u0131lm\u0131\u015f Kore ge\u00e7meli kapak ve vidal\u0131 kapak yeterlili\u011fini sa\u011flar.<\/figcaption><\/figure>\n<p style=\"font-size: 16px; margin-bottom: 14px;\">Kore ISBM t\u0131bbi cihaz kaplar\u0131 i\u00e7in malzeme se\u00e7imi \u00fc\u00e7 fakt\u00f6re ba\u011fl\u0131d\u0131r: belirli reaktif veya cihaz i\u00e7eri\u011fiyle kimyasal uyumluluk, sterilizasyon y\u00f6ntemi uyumlulu\u011fu ve mevzuata uygunluk. PETG'nin estetik ama\u00e7l\u0131 tercih edilen malzeme oldu\u011fu Kore K-Beauty uygulamalar\u0131n\u0131n aksine, Kore t\u0131bbi cihaz uygulamalar\u0131, se\u00e7imden \u00f6nce dikkatli bir malzeme analizi gerektirir; PETG, PET ve PP'nin her birinin farkl\u0131 cihaz kategorileri i\u00e7in uygunlu\u011funu belirleyen belirli g\u00fc\u00e7l\u00fc ve zay\u0131f y\u00f6nleri vard\u0131r.<\/p>\n<p style=\"font-size: 16px; margin-bottom: 14px;\"><strong>Kore t\u0131bbi cihazlar\u0131 i\u00e7in PET:<\/strong> PET (polietilen tereftalat), Kore'de S\u0131n\u0131f I ve II t\u0131bbi cihaz kaplar\u0131 i\u00e7in en yayg\u0131n kullan\u0131lan ISBM malzemesidir. Avantajlar\u0131 aras\u0131nda, ortam depolama s\u0131cakl\u0131klar\u0131nda d\u00fc\u015f\u00fck s\u0131zma oran\u0131 (risk de\u011ferlendirmesi i\u00e7in ISO 10993-17 ile iyi karakterize edilmi\u015ftir), Kore IVD reaktif matrislerinin \u00e7o\u011funlu\u011funu olu\u015fturan sulu \u00e7\u00f6zeltiler, asidik tamponlar (pH 3-9) ve tuzlu \u00e7\u00f6zeltileri kapsayan geni\u015f kimyasal uyumluluk ve Kore KFDA ba\u015fvurular\u0131nda g\u00fc\u00e7l\u00fc bir uyumluluk ge\u00e7mi\u015fi bulunmaktad\u0131r. S\u0131n\u0131rlamalar\u0131 ise \u015funlard\u0131r: PET, 65-70\u00b0C'nin \u00fczerinde deforme olur (gama sterilizasyon \u0131s\u0131 y\u00fckleri i\u00e7in \u00f6nemlidir - genellikle endi\u015fe kayna\u011f\u0131 de\u011fildir \u00e7\u00fcnk\u00fc PET, gama veya EO ile oda s\u0131cakl\u0131\u011f\u0131nda sterilize edilir), PET, 340 nm'nin alt\u0131ndaki UV radyasyonunu emer (UV'ye duyarl\u0131 reaktifler i\u00e7in \u00f6nemlidir - fotosensitif tan\u0131 form\u00fclasyonlar\u0131 i\u00e7in UV stabilize edilmi\u015f PET kaliteleri belirtilmelidir) ve PET, 10%'nin \u00fczerinde organik \u00e7\u00f6z\u00fcc\u00fc i\u00e7eri\u011fine sahip reaktifler i\u00e7in kullan\u0131lmamal\u0131d\u0131r (gerilme \u00e7atlamas\u0131 riski).<\/p>\n<p style=\"font-size: 16px; margin-bottom: 14px;\"><strong>Kore t\u0131bbi cihazlar\u0131nda PETG:<\/strong> PETG (polietilen tereftalat glikol), kolorimetrik testlerin g\u00f6rsel yorumlanmas\u0131 i\u00e7in kristal berrakl\u0131\u011f\u0131n\u0131n (bulan\u0131kl\u0131k \u22641,5%) gerekli oldu\u011fu Kore S\u0131n\u0131f II tan\u0131 kiti bile\u015fenleri ve PET'in daha y\u00fcksek sertli\u011fi nedeniyle elde edilmesi daha zor olan, k\u0131r\u0131labilir veya \u00e7izgi \u015feklinde kesilebilir \u00f6zellikler gerektiren Kore IVD kaplar\u0131 i\u00e7in tercih edilir. PETG'nin baz\u0131 organik \u00e7\u00f6z\u00fcc\u00fclere (40%'nin \u00fczerindeki etanol, aseton, MEK) kar\u015f\u0131 daha d\u00fc\u015f\u00fck kimyasal direnci, Kore laboratuvar y\u0131kama \u00e7\u00f6zeltileri ve \u00e7\u00f6z\u00fcc\u00fc i\u00e7eren reaktifler i\u00e7in kullan\u0131m\u0131n\u0131 s\u0131n\u0131rland\u0131r\u0131r; 30%'nin \u00fczerindeki organik \u00e7\u00f6z\u00fcc\u00fc konsantrasyonuna sahip herhangi bir Kore t\u0131bbi cihaz reaktifi i\u00e7in PETG belirtmeden \u00f6nce uyumlulu\u011fu do\u011frulay\u0131n.<\/p>\n<p style=\"font-size: 16px; margin-bottom: 0;\"><strong>Kore t\u0131bbi cihazlar\u0131 i\u00e7in PP:<\/strong> Kore'de buhar otoklav\u0131na (20 dakika boyunca 121\u00b0C) dayanmas\u0131 gereken t\u0131bbi cihaz kaplar\u0131 i\u00e7in do\u011fru malzeme se\u00e7imi polipropilendir; PET ve PETG otoklav s\u0131cakl\u0131klar\u0131na dayanamaz. Kore'de otoklav uyumlu t\u0131bbi cihaz kaplar\u0131 i\u00e7in PP ISBM, PP s\u0131cak dolum ISBM \u00f6zelli\u011fini (120\u2013145\u00b0C ko\u015fulland\u0131rma, \u0131s\u0131t\u0131lm\u0131\u015f kal\u0131p taban\u0131 ek par\u00e7alar\u0131) gerektirir; bu, PET ISBM'ye g\u00f6re teknik olarak daha zorlu ve daha az yayg\u0131n bir i\u015flemdir. PP t\u0131bbi cihaz kaplar\u0131 i\u00e7in teklif veren Koreli ISBM \u00fcreticileri, s\u00f6zle\u015fmeyi kabul etmeden \u00f6nce makinelerinin ko\u015fulland\u0131rma istasyonunun maksimum s\u0131cakl\u0131\u011f\u0131n\u0131 do\u011frulamal\u0131d\u0131r. PETG'nin kolorimetrik uygulamalar i\u00e7in sa\u011flad\u0131\u011f\u0131 optik \u015feffafl\u0131k gereksinimleri, kapsaml\u0131 k\u0131lavuzda ele al\u0131nm\u0131\u015ft\u0131r. <a style=\"color: #0369a1; font-weight: 600; text-decoration: none;\" href=\"https:\/\/isbm-blow-molding.com\/tr\/how-to-improve-transparency-isbm-injection-stretch-blow-molding\/\">Kore ISBM \u015feffafl\u0131\u011f\u0131n\u0131n iyile\u015ftirilmesi<\/a>.<\/p>\n<\/section>\n<p><!-- S4 --><\/p>\n<section id=\"s4\" style=\"margin: 56px 0 0; padding: 36px 0 0; border-top: 2px solid #e5e7eb;\">\n<h2 style=\"font-size: clamp(18px,2.6vw,24px); font-weight: 800; color: #075985; margin: 0 0 18px;\">4. ISO 10993 Biyouyumluluk De\u011ferlendirmesi: Koreli ISBM \u00dcreticilerinin Sa\u011flamas\u0131 Gerekenler<\/h2>\n<p style=\"font-size: 16px; margin-bottom: 14px;\">ISO 10993-1:2018 (T\u0131bbi cihazlar\u0131n biyolojik de\u011ferlendirilmesi - B\u00f6l\u00fcm 1: Risk y\u00f6netimi s\u00fcreci kapsam\u0131nda de\u011ferlendirme ve test), Kore G\u0131da ve \u0130la\u00e7 \u0130daresi'nin (KFDA) t\u00fcm Kore t\u0131bbi cihaz birincil ambalajlar\u0131 i\u00e7in referans ald\u0131\u011f\u0131 biyolojik uyumluluk de\u011ferlendirmesi i\u00e7in uluslararas\u0131 standartt\u0131r. ISO 10993, sabit bir test bataryas\u0131 \u00f6ng\u00f6rmez; cihaz\u0131n insan v\u00fccuduyla temas \u015fekline (y\u00fczey temas\u0131, delinmi\u015f y\u00fczey, kan temas\u0131) ve s\u00fcresine (s\u0131n\u0131rl\u0131, uzun s\u00fcreli, kal\u0131c\u0131) g\u00f6re testleri se\u00e7en risk tabanl\u0131 bir de\u011ferlendirme yakla\u015f\u0131m\u0131 belirtir.<\/p>\n<p style=\"font-size: 16px; margin-bottom: 14px;\">Kore ISBM reaktif \u015fi\u015feleri (S\u0131n\u0131f II IVD, hasta ile dolayl\u0131 temas \u2014 reaktif, hasta ile de\u011fil, cihazla temas eder): Biyouyumluluk de\u011ferlendirmesi genellikle ISO 10993-5 (sitotoksisite) ve ISO 10993-12 (biyolojik de\u011ferlendirme i\u00e7in numune haz\u0131rlama) ile s\u0131n\u0131rl\u0131d\u0131r. Bu iki test, PET veya PETG malzemenin dolayl\u0131 hasta maruziyetiyle ilgili miktarlarda sitotoksik madde salmad\u0131\u011f\u0131n\u0131 ve sonraki testler i\u00e7in kullan\u0131lan numune haz\u0131rlama protokol\u00fcn\u00fcn ge\u00e7erli oldu\u011funu do\u011frular. Kore ISBM S\u0131n\u0131f II IVD reaktif \u015fi\u015fesi i\u00e7in toplam test maliyeti: Kore test laboratuvar\u0131nda (Kore Test ve Ara\u015ft\u0131rma Enstit\u00fcs\u00fc \u2014 KTR veya Kore Uygunluk Laboratuvarlar\u0131 \u2014 KCL) 4-8 milyon KRW.<\/p>\n<p style=\"font-size: 16px; margin-bottom: 14px;\">Kore'de S\u0131n\u0131f III t\u0131bbi cihaz kaplar\u0131 (hastan\u0131n cildi veya mukoza zar\u0131 ile do\u011frudan temas eden) i\u00e7in: tam ISO 10993 de\u011ferlendirmesi, sitotoksisite (ISO 10993-5), duyarl\u0131l\u0131k (ISO 10993-10), tahri\u015f (ISO 10993-23), akut sistemik toksisite (ISO 10993-11) ve subkronik toksisiteyi (ISO 10993-11 - 90 g\u00fcnl\u00fck \u00e7al\u0131\u015fma) i\u00e7erebilir. Toplam test maliyeti: 25-65 milyon KRW ve 6-9 ay takvim s\u00fcresi. S\u0131n\u0131f III cihaz \u00fcreticilerine tedarik sa\u011flayan Koreli ISBM ambalaj \u00fcreticileri, bu de\u011ferlendirmeyi kal\u0131p kalifikasyonu a\u015famas\u0131nda planlamal\u0131d\u0131r; m\u00fc\u015fteri ambalaj spesifikasyonuna zaten karar vermi\u015fken, s\u00f6zle\u015fme imzaland\u0131\u011f\u0131nda de\u011fil.<\/p>\n<p style=\"font-size: 16px; margin-bottom: 0;\">Kore ISBM biyouyumluluk de\u011ferlendirme dok\u00fcmantasyon gereklili\u011fi: Her ISO 10993 test raporunda, spesifik re\u00e7ine s\u0131n\u0131f\u0131 (\u00fcretici, s\u0131n\u0131f tan\u0131m\u0131, parti numaras\u0131), test numunelerinin \u00fcretiminde kullan\u0131lan ISBM proses ko\u015fullar\u0131 (\u015fartland\u0131rma s\u0131cakl\u0131\u011f\u0131, \u00fcfleme bas\u0131nc\u0131, \u00e7evrim s\u00fcresi - \u00e7\u00fcnk\u00fc proses ko\u015fullar\u0131 ekstrakte edilebilir madde seviyelerini etkiler) ve test laboratuvar\u0131n\u0131n KFDA tan\u0131nma durumu belirtilmelidir. \u00dcretim numunelerinden farkl\u0131 proses ko\u015fullar\u0131nda \u00fcretilen numuneler \u00fczerinde yap\u0131lan bir biyouyumluluk testi, Kore KFDA S\u0131n\u0131f III ba\u015fvurusu i\u00e7in ge\u00e7erli de\u011fildir - bu teknik detay, biyouyumluluk testi i\u00e7in standart d\u0131\u015f\u0131 ko\u015fullarda \u00fcretilen laboratuvar numunelerini kullanan ve daha sonra ticari \u00fcretim yeterlili\u011fi s\u0131ras\u0131nda proses ko\u015fullar\u0131n\u0131 de\u011fi\u015ftiren Koreli ISBM \u00fcreticilerini yakalamaktad\u0131r.<\/p>\n<\/section>\n<p><!-- S5 --><\/p>\n<section id=\"s5\" style=\"margin: 56px 0 0; padding: 36px 0 0; border-top: 2px solid #e5e7eb;\">\n<h2 style=\"font-size: clamp(18px,2.6vw,24px); font-weight: 800; color: #075985; margin: 0 0 18px;\">5. Sterilizasyon Y\u00f6ntemi Uyumlulu\u011fu: Kore ISBM Biberon Se\u00e7enekleri ve K\u0131s\u0131tlamalar\u0131<\/h2>\n<p style=\"font-size: 16px; margin-bottom: 20px;\">Kore t\u0131bbi cihaz kaplar\u0131 ya ambalaj \u00fcreticisinde (ISBM \u015fi\u015feleri i\u00e7in daha az yayg\u0131n) ya da Kore t\u0131bbi cihaz \u015firketinin dolum tesisinde (daha yayg\u0131n) sterilize edilir. Kore ISBM ambalaj \u00fcreticilerinin, Kore t\u0131bbi cihaz m\u00fc\u015fterisinin kullanaca\u011f\u0131 sterilizasyon y\u00f6ntemini anlamalar\u0131 gerekir; \u00e7\u00fcnk\u00fc sterilizasyon ko\u015fullar\u0131 alt\u0131nda malzeme uyumlulu\u011fu, boyutsal kararl\u0131l\u0131k ve optik \u00f6zelliklerin korunmas\u0131 \u00f6nemli \u00f6l\u00e7\u00fcde farkl\u0131l\u0131k g\u00f6sterir ve hangi Kore ISBM malzemesinin teknik olarak kabul edilebilir oldu\u011funu belirler.<\/p>\n<div style=\"overflow-x: auto; margin: 0 0 20px;\">\n<table style=\"width: 100%; border-collapse: collapse; font-size: 13.5px; min-width: 520px;\">\n<thead>\n<tr style=\"background: #075985;\">\n<th style=\"color: #fff; padding: 9px 12px; text-align: left; font-weight: bold;\">Sterilizasyon Y\u00f6ntemi<\/th>\n<th style=\"color: #fff; padding: 9px 12px; text-align: center; font-weight: bold;\">Evcil hayvan<\/th>\n<th style=\"color: #fff; padding: 9px 12px; text-align: center; font-weight: bold;\">PETG<\/th>\n<th style=\"color: #fff; padding: 9px 12px; text-align: center; font-weight: bold;\">PP<\/th>\n<th style=\"color: #fff; padding: 9px 12px; text-align: left; font-weight: bold;\">Kore ISBM Notlar\u0131<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td style=\"padding: 9px 12px; border-bottom: 1px solid #bae6fd; font-weight: 600;\">EO (Etilen Oksit)<\/td>\n<td style=\"padding: 9px 12px; border-bottom: 1px solid #bae6fd; text-align: center; color: #16a34a; font-weight: bold;\">\u2713 Uyumlu<\/td>\n<td style=\"padding: 9px 12px; border-bottom: 1px solid #bae6fd; text-align: center; color: #16a34a; font-weight: bold;\">\u2713 Uyumlu<\/td>\n<td style=\"padding: 9px 12px; border-bottom: 1px solid #bae6fd; text-align: center; color: #16a34a; font-weight: bold;\">\u2713 Uyumlu<\/td>\n<td style=\"padding: 9px 12px; border-bottom: 1px solid #bae6fd;\">EO i\u015flemi \u2264 55\u00b0C \u2014 her \u00fc\u00e7\u00fc i\u00e7in de g\u00fcvenlidir. Sevkiyat \u00f6ncesinde 24-48 saat EO kal\u0131nt\u0131s\u0131n\u0131n giderilmesi gereklidir. EO kal\u0131nt\u0131s\u0131 ISO 10993-7'ye g\u00f6re do\u011frulanmal\u0131d\u0131r (cihazda \u2264 10 \u03bcg\/g EO).<\/td>\n<\/tr>\n<tr style=\"background: #f0f9ff;\">\n<td style=\"padding: 9px 12px; border-bottom: 1px solid #bae6fd; font-weight: 600;\">Gama I\u015f\u0131nlamas\u0131<\/td>\n<td style=\"padding: 9px 12px; border-bottom: 1px solid #bae6fd; text-align: center; color: #16a34a; font-weight: bold;\">\u2713 \u2264 25 kGy<\/td>\n<td style=\"padding: 9px 12px; border-bottom: 1px solid #bae6fd; text-align: center; color: #f59e0b; font-weight: bold;\">\u26a0 \u2264 15 kGy<\/td>\n<td style=\"padding: 9px 12px; border-bottom: 1px solid #bae6fd; text-align: center; color: #16a34a; font-weight: bold;\">\u2713 \u2264 50 kGy<\/td>\n<td style=\"padding: 9px 12px; border-bottom: 1px solid #bae6fd;\">PET g\u00f6r\u00fcnt\u00fclemede 25 kGy'nin \u00fczerinde kademeli olarak sararma g\u00f6r\u00fcl\u00fcr; doz 20 kGy'nin \u00fczerindeyse radyasyona dayan\u0131kl\u0131 PET (\u00f6rne\u011fin Eastman EB062) s\u0131n\u0131f\u0131 belirtilmelidir. PETG, 15 kGy'nin \u00fczerinde sararma g\u00f6sterir ve genellikle standart 25 kGy gama d\u00f6ng\u00fcleri i\u00e7in uygun de\u011fildir.<\/td>\n<\/tr>\n<tr>\n<td style=\"padding: 9px 12px; border-bottom: 1px solid #bae6fd; font-weight: 600;\">E-I\u015f\u0131n\u0131<\/td>\n<td style=\"padding: 9px 12px; border-bottom: 1px solid #bae6fd; text-align: center; color: #16a34a; font-weight: bold;\">\u2713 \u2264 25 kGy<\/td>\n<td style=\"padding: 9px 12px; border-bottom: 1px solid #bae6fd; text-align: center; color: #f59e0b; font-weight: bold;\">\u26a0 \u2264 15 kGy<\/td>\n<td style=\"padding: 9px 12px; border-bottom: 1px solid #bae6fd; text-align: center; color: #16a34a; font-weight: bold;\">\u2713 \u2264 50 kGy<\/td>\n<td style=\"padding: 9px 12px; border-bottom: 1px solid #bae6fd;\">Gama \u0131\u015f\u0131nlar\u0131na benzer \u015fekilde, elektron \u0131\u015f\u0131n\u0131 gama \u0131\u015f\u0131nlar\u0131ndan daha az derine n\u00fcfuz eder; bu durum \u00e7ok katmanl\u0131 istiflenmi\u015f ambalajlar i\u00e7in \u00f6nemlidir. Tek \u015fi\u015fe: gama etkilerine e\u015fde\u011ferdir.<\/td>\n<\/tr>\n<tr style=\"background: #f0f9ff;\">\n<td style=\"padding: 9px 12px; border-bottom: 1px solid #bae6fd; font-weight: 600;\">Buharl\u0131 Otoklav (121\u00b0C)<\/td>\n<td style=\"padding: 9px 12px; border-bottom: 1px solid #bae6fd; text-align: center; color: #dc2626; font-weight: bold;\">\u2717 Uyumlu de\u011fil<\/td>\n<td style=\"padding: 9px 12px; border-bottom: 1px solid #bae6fd; text-align: center; color: #dc2626; font-weight: bold;\">\u2717 Uyumlu de\u011fil<\/td>\n<td style=\"padding: 9px 12px; border-bottom: 1px solid #bae6fd; text-align: center; color: #16a34a; font-weight: bold;\">\u2713 Uyumlu<\/td>\n<td style=\"padding: 9px 12px; border-bottom: 1px solid #bae6fd;\">PET'in erime s\u0131cakl\u0131\u011f\u0131 (Tg) ~75\u00b0C ve PETG'nin erime s\u0131cakl\u0131\u011f\u0131 (Tg) ~81\u00b0C'dir; her ikisi de 121\u00b0C'de ciddi \u015fekilde yumu\u015far. PP, otoklav uygulamalar\u0131 i\u00e7in yaln\u0131zca ISBM malzemesidir. PP ISBM, \u0131s\u0131tmal\u0131 kal\u0131p taban\u0131 ek par\u00e7alar\u0131 gerektirir; spesifikasyondan \u00f6nce makine tedarik\u00e7isiyle teyit edin.<\/td>\n<\/tr>\n<tr>\n<td style=\"padding: 9px 12px; font-weight: 600;\">UV-C (254nm)<\/td>\n<td style=\"padding: 9px 12px; text-align: center; color: #16a34a; font-weight: bold;\">\u2713 Sadece y\u00fczey<\/td>\n<td style=\"padding: 9px 12px; text-align: center; color: #16a34a; font-weight: bold;\">\u2713 Sadece y\u00fczey<\/td>\n<td style=\"padding: 9px 12px; text-align: center; color: #16a34a; font-weight: bold;\">\u2713 Sadece y\u00fczey<\/td>\n<td style=\"padding: 9px 12px;\">Sadece y\u00fczey dezenfeksiyonu i\u00e7indir \u2014 Kore S\u0131n\u0131f III\/IV kaplar i\u00e7in onaylanm\u0131\u015f sterilizasyon de\u011fildir. Kore S\u0131n\u0131f I\/II d\u00fc\u015f\u00fck riskli y\u00fczey dezenfeksiyonu i\u00e7in kullan\u0131l\u0131r. PET, UV \u0131\u015f\u0131nlar\u0131n\u0131 verimli bir \u015fekilde emer \u2014 kal\u0131n duvarl\u0131 \u015fi\u015feler i\u00e7in i\u00e7 y\u00fczey dozaj hesaplamas\u0131n\u0131 do\u011frulay\u0131n.<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n<p style=\"font-size: 16px; margin-bottom: 0;\">Koreli ISBM \u00fcreticileri, malzeme spesifikasyonuna karar vermeden \u00f6nce, teklif a\u015famas\u0131nda Koreli t\u0131bbi cihaz m\u00fc\u015fterisinden sterilizasyon y\u00f6ntemini ve do\u011frulama dozunu talep etmelidir. Kore'de S\u0131n\u0131f II IVD kab\u0131 olarak kristal berrakl\u0131\u011f\u0131nda PETG olarak teklif edilen bir \u00fcr\u00fcn, 25 kGy gama ile sterilizasyon yapan bir m\u00fc\u015fteri i\u00e7in, genellikle kal\u0131p \u00fcretiminden 6-8 ay sonra sterilizasyon do\u011frulamas\u0131nda ortaya \u00e7\u0131kan bir malzeme uyumsuzlu\u011fu sorununa yol a\u00e7ar; bu sorunda sararm\u0131\u015f PETG \u015fi\u015feler, m\u00fc\u015fterinin \u0131\u015f\u0131nlama sonras\u0131 berrakl\u0131k spesifikasyonunu kar\u015f\u0131layamaz.<\/p>\n<\/section>\n<p><!-- S6 --><\/p>\n<section id=\"s6\" style=\"margin: 56px 0 0; padding: 36px 0 0; border-top: 2px solid #e5e7eb;\">\n<h2 style=\"font-size: clamp(18px,2.6vw,24px); font-weight: 800; color: #075985; margin: 0 0 18px;\">6. Ekstraksiyon ve S\u0131z\u0131nt\u0131 Maddeleri: Kore G\u0131da ve \u0130la\u00e7 \u0130daresi'nin (KFDA) ISBM T\u0131bbi Kaplar\u0131na \u0130li\u015fkin Beklentileri<\/h2>\n<p style=\"font-size: 16px; margin-bottom: 14px;\">Ekstraksiyon ve s\u0131zma (E&amp;L) analizi, Kore ISBM S\u0131n\u0131f III t\u0131bbi cihaz kaplar\u0131 i\u00e7in en teknik a\u00e7\u0131dan zorlu dok\u00fcmantasyon gereksinimidir. Ekstraksiyon maddeleri, agresif deneysel ko\u015fullar alt\u0131nda (y\u00fcksek s\u0131cakl\u0131k, \u00e7\u00f6z\u00fcc\u00fc ekstraksiyonu) ambalaj malzemesinden sal\u0131nabilen kimyasal maddelerdir; ambalaj malzemesinden kaynaklanabilecek maksimum kimyasal maruziyeti temsil ederler. S\u0131zma maddeleri ise, normal veya stresli depolama ko\u015fullar\u0131 alt\u0131nda \u00fcr\u00fcne ger\u00e7ekten ge\u00e7en ekstraksiyon maddelerinin bir alt k\u00fcmesidir; ambalajl\u0131 \u00fcr\u00fcnden kaynaklanan ger\u00e7ek hasta veya kullan\u0131c\u0131 maruziyetini temsil ederler.<\/p>\n<p style=\"font-size: 16px; margin-bottom: 14px;\">Kore G\u0131da ve \u0130la\u00e7 \u0130daresi'nin (KFDA) Kore S\u0131n\u0131f III t\u0131bbi cihaz dosyalar\u0131ndaki birincil konteyner ISBM ambalaj\u0131na ili\u015fkin s\u0131z\u0131nt\u0131 ve ekstraksiyon beklentileri, ISO 10993-18:2020 \u00e7er\u00e7evesi (malzemelerin kimyasal karakterizasyonu) ve PQRI (\u00dcr\u00fcn Kalitesi Ara\u015ft\u0131rma Enstit\u00fcs\u00fc) 2006 s\u0131zma ve ekstraksiyon k\u0131lavuzu (Kore KFDA'n\u0131n t\u0131bbi cihaz ba\u015fvuru k\u0131lavuzunda at\u0131fta bulundu\u011fu end\u00fcstri referans standard\u0131) ile uyumludur. Koreli ISBM \u00fcreticilerinin anlamas\u0131 gereken temel analitik e\u015fikler \u015funlard\u0131r:<\/p>\n<ul style=\"margin: 0 0 20px; padding-left: 20px; display: flex; flex-direction: column; gap: 8px;\">\n<li style=\"font-size: 15px; color: #374151; line-height: 1.65;\"><strong>Kore S\u0131n\u0131f III IVD i\u00e7in Analitik De\u011ferlendirme E\u015fi\u011fi (AET):<\/strong> Tan\u0131mlanamayan herhangi bir bile\u015fi\u011fin g\u00fcnl\u00fck 0,1 \u03bcg'l\u0131k dozu, sim\u00fcle edilmi\u015f kullan\u0131m ekstraksiyonunda bu konsantrasyonun \u00fczerindeki herhangi bir ekstrakte edilebilir bile\u015fi\u011fin analitik olarak tan\u0131mlanmas\u0131n\u0131 ve bir toksikolog taraf\u0131ndan g\u00fcvenlik de\u011ferlendirmesini gerektirir. Kore IVD reaktif \u015fi\u015feleri (dolayl\u0131 hasta temas\u0131) i\u00e7in AET, genellikle do\u011frudan t\u00fcketim de\u011fil, reaktifin maksimum g\u00fcnl\u00fck hasta dozuna g\u00f6re hesaplan\u0131r; bu da oral ila\u00e7 kab\u0131 E&amp;L'ye g\u00f6re daha y\u00fcksek AET de\u011ferlerine olanak tan\u0131r.<\/li>\n<li style=\"font-size: 15px; color: #374151; line-height: 1.65;\"><strong>PET'e \u00f6zg\u00fc Kore men\u015feli ekstrakte edilebilir madde profili:<\/strong> PET'in birincil ekstrakte edilebilir bile\u015fenleri iyi tan\u0131mlanm\u0131\u015ft\u0131r: asetaldehit (AA, termal bozunma \u00fcr\u00fcn\u00fc), oligomerler (siklik PET trimer ve dimer, i\u015flem s\u0131cakl\u0131\u011f\u0131na ba\u011fl\u0131) ve bis(2-etilheksil) ftalat (DEHP - e\u011fer PET re\u00e7inesi DEHP i\u00e7eren ya\u011flay\u0131c\u0131lar kullan\u0131yorsa, ki Kore farmas\u00f6tik s\u0131n\u0131f\u0131 PET re\u00e7ineleri kullanmaz). Kore t\u0131bbi cihaz ba\u015fvurular\u0131nda, Kore KFDA onayl\u0131 g\u0131da temas\u0131 pozitif listesinden PET re\u00e7inesi belirtilmeli ve re\u00e7ine tedarik\u00e7isiyle ftalat i\u00e7eren i\u015flem yard\u0131mc\u0131 maddelerinin kullan\u0131lmad\u0131\u011f\u0131 do\u011frulanmal\u0131d\u0131r.<\/li>\n<li style=\"font-size: 15px; color: #374151; line-height: 1.65;\"><strong>Proses ko\u015fullar\u0131n\u0131n Kore ISBM \u00f6z\u00fctlenebilir maddeleri \u00fczerindeki etkisi:<\/strong> Daha y\u00fcksek varil s\u0131cakl\u0131klar\u0131, PET'in termal bozulmas\u0131n\u0131 ve AA olu\u015fumunu art\u0131r\u0131r; daha uzun \u015fartland\u0131rma bekleme s\u00fcreleri, AA'n\u0131n \u00f6n kal\u0131b\u0131n i\u00e7inden \u015fi\u015fe duvar y\u00fczeyine g\u00f6\u00e7\u00fcn\u00fc art\u0131r\u0131r. Koreli ISBM \u00fcreticileri, E&amp;L test numunesi \u00fcretimi i\u00e7in kullan\u0131lan \u00fcretim proses ko\u015fullar\u0131n\u0131 belgelemeli ve onaylanm\u0131\u015f aral\u0131\u011f\u0131n \u00fczerindeki gelecekteki proses de\u011fi\u015fikliklerini \u00f6nleyen de\u011fi\u015fiklik kontrolleri uygulamal\u0131d\u0131r; bu, KFDA S\u0131n\u0131f III gereklili\u011fidir ve dijital proses kay\u0131tlar\u0131n\u0131n tutulmas\u0131n\u0131 gerektirir. <a style=\"color: #0369a1; font-weight: 600; text-decoration: none;\" href=\"https:\/\/isbm-blow-molding.com\/tr\/isbm-industry-4-automation-korean-production-guide\/\">Kore ISBM End\u00fcstri 4.0 \u00e7er\u00e7evesi<\/a> Otomatik bir yetenek olarak sa\u011flar.<\/li>\n<\/ul>\n<\/section>\n<p><!-- S7 --><\/p>\n<section id=\"s7\" style=\"margin: 56px 0 0; padding: 36px 0 0; border-top: 2px solid #e5e7eb;\">\n<h2 style=\"font-size: clamp(18px,2.6vw,24px); font-weight: 800; color: #075985; margin: 0 0 18px;\">7. Kore ISBM T\u0131bbi Cihaz Ambalajlar\u0131 i\u00e7in Temiz Oda \u00dcretim Standartlar\u0131<\/h2>\n<figure style=\"margin: 0 0 22px;\"><img decoding=\"async\" style=\"width: 100%; height: auto; border-radius: 8px; display: block;\" src=\"https:\/\/isbm-blow-molding.com\/wp-content\/uploads\/2026\/02\/injection-stretch-blow-moulding-application-1.webp\" alt=\"Kore ISBM t\u0131bbi cihaz temiz oda \u00fcretim ortam\u0131 \u2014 KFDA S\u0131n\u0131f II IVD reaktif \u015fi\u015feleri i\u00e7in ISO S\u0131n\u0131f 8 (100.000 partik\u00fcl\/m\u00b3) temiz oda ISBM \u00fcretimi; filtrelenmi\u015f laminar ak\u0131\u015fl\u0131 HVAC, operat\u00f6r temiz oda giysileri, pozitif bas\u0131n\u00e7l\u0131 oda ve Kore t\u0131bbi cihaz ambalaj\u0131 GMP uyumlulu\u011fu i\u00e7in hat i\u00e7i partik\u00fcl izleme sistemini g\u00f6stermektedir.\" \/><figcaption style=\"font-size: 12px; color: #6b7280; margin-top: 8px; text-align: center;\">Kore ISBM t\u0131bbi cihaz temiz oda \u00fcretimi \u2014 ISO S\u0131n\u0131f 8 (ISO 14644-1, \u2264 3.520.000 partik\u00fcl\/m\u00b3 \u2265 0,5 \u03bcm), Kore S\u0131n\u0131f II IVD reaktif \u015fi\u015feleri ve S\u0131n\u0131f III t\u0131bbi cihaz temas kaplar\u0131 i\u00e7in standart \u00fcretim ortam\u0131d\u0131r. ISBM i\u015flemi \u2014 kapal\u0131 bir makinede tek a\u015famal\u0131 enjeksiyon ve \u00fcfleme \u2014 iki a\u015famal\u0131 SBM'ye (\u00f6n kal\u0131plar\u0131n a\u00e7\u0131k ortam havas\u0131ndan ge\u00e7irilmesi) g\u00f6re do\u011fal olarak daha temizdir. Kore ISBM'nin kapal\u0131 i\u015fleme y\u00f6ntemi bir uyumluluk avantaj\u0131d\u0131r: \u015fi\u015fe i\u00e7i, d\u0131\u015far\u0131 at\u0131lana kadar ortam havas\u0131na maruz kalmadan \u00fcfleme bo\u015flu\u011funda \u015fekillendirilir; bu da kontroll\u00fc d\u0131\u015far\u0131 atma ortam\u0131n\u0131n nihai i\u00e7 kirlenme riskini belirledi\u011fi anlam\u0131na gelir.<\/figcaption><\/figure>\n<p style=\"font-size: 16px; margin-bottom: 14px;\">Kore KFDA GMP (\uc758\ub8cc\uae30\uae30\uc758 \uc81c\uc870 \ubc0f \ud488\uc9c8\uad00\ub9ac \uae30\uc900), t\u0131bbi cihaz \u00fcreticilerinin, \u00fcretilen cihaz\u0131n risk seviyesine uygun temiz \u00fcretim ortamlar\u0131 olu\u015fturmas\u0131n\u0131 ve s\u00fcrd\u00fcrmesini gerektirir. Kore'de birincil konteyner ISBM \u00fcretimi i\u00e7in ilgili standart ISO 14644-1'dir (Temiz odalar ve ilgili kontroll\u00fc ortamlar). Kore ISBM t\u0131bbi cihaz ambalaj \u00fcretim ortam\u0131 gereksinimleri, cihaz s\u0131n\u0131f\u0131na g\u00f6re \u015fu \u015fekildedir:<\/p>\n<ul style=\"margin: 0 0 20px; padding-left: 20px; display: flex; flex-direction: column; gap: 9px;\">\n<li style=\"font-size: 15px; color: #374151; line-height: 1.65;\"><strong>Korece S\u0131n\u0131f I (\uc2e0\uace0):<\/strong> Resmi bir temiz oda standard\u0131 gerekmemektedir; belgelenmi\u015f HVAC filtrelemesi (MERV 8 veya e\u015fde\u011feri, standart a\u00e7\u0131k fabrika hava giri\u015finin yerini alan) ve temel temizlik prosed\u00fcrlerine sahip genel bir end\u00fcstriyel \u00fcretim ortam\u0131 yeterlidir. Havada bulunan partik\u00fcllerin \u00fc\u00e7 ayda bir izlenmesi \u00f6nerilir ancak zorunlu de\u011fildir.<\/li>\n<li style=\"font-size: 15px; color: #374151; line-height: 1.65;\"><strong>Kore S\u0131n\u0131f II (\uc778\uc99d) \u2014 IVD reaktif kaplar\u0131:<\/strong> ISO 14644-1 S\u0131n\u0131f 8 \u00fcretim ortam\u0131 (\u2264 3.520.000 partik\u00fcl\/m\u00b3 \u2265 0,5 \u03bcm, eski ABD Federal Standard\u0131 209E S\u0131n\u0131f 100.000'e e\u015fde\u011fer). Pratik uygulama: \u00dcretim alan\u0131na HEPA filtreli hava beslemesi, biti\u015fik \u00fcretim d\u0131\u015f\u0131 alanlara g\u00f6re pozitif bas\u0131n\u00e7 fark\u0131 (\u2265 +15 Pa), koruyucu giysi gereksinimleri (sa\u00e7 \u00f6rt\u00fcleri, toz \u00f6nl\u00fckleri, bot k\u0131l\u0131flar\u0131) ve ISO 14644-2'ye g\u00f6re \u00fc\u00e7 ayda bir havada bulunan partik\u00fcl say\u0131m\u0131 izleme.<\/li>\n<li style=\"font-size: 15px; color: #374151; line-height: 1.65;\"><strong>Kore S\u0131n\u0131f III (\ud5c8\uac00) \u2014 do\u011frudan temasl\u0131 cihaz kaplar\u0131:<\/strong> ISBM makinesi ve \u015fi\u015fe f\u0131rlatma b\u00f6lgesi i\u00e7in ISO 14644-1 S\u0131n\u0131f 7 \u00fcretim ortam\u0131 (\u2265 0,5 \u03bcm'de \u2264 352.000 partik\u00fcl\/m\u00b3, S\u0131n\u0131f 10.000'e e\u015fde\u011fer). Tam temiz oda giysileri (tam tulum, eldiven, y\u00fcz maskesi), UV dekontaminasyonlu ge\u00e7i\u015fli malzeme giri\u015fi, s\u00fcrekli partik\u00fcl izleme (S\u0131n\u0131f 7 limitinin a\u015f\u0131lmas\u0131 durumunda ger\u00e7ek zamanl\u0131 alarm) ve y\u0131ll\u0131k temiz oda performans sertifikasyonu. ISBM f\u0131rlatma b\u00f6lgesinde S\u0131n\u0131f 7'ye ula\u015fan Kore ISBM i\u015fletmeleri, genellikle \u015fi\u015fe f\u0131rlatma konvey\u00f6r\u00fcn\u00fcn hemen \u00fczerinde yerel bir laminar ak\u0131\u015f kabini kullan\u0131r; bu, t\u00fcm ISBM makinesinin etraf\u0131na tam bir S\u0131n\u0131f 7 oda in\u015fa etmekten daha ekonomiktir.<\/li>\n<\/ul>\n<\/section>\n<p><!-- S8 --><\/p>\n<section id=\"s8\" style=\"margin: 56px 0 0; padding: 36px 0 0; border-top: 2px solid #e5e7eb;\">\n<h2 style=\"font-size: clamp(18px,2.6vw,24px); font-weight: 800; color: #075985; margin: 0 0 18px;\">8. GMP Do\u011frulama: Kore ISBM T\u0131bbi Cihaz Hatlar\u0131 i\u00e7in IQ, OQ ve PQ<\/h2>\n<figure style=\"margin: 0 0 22px;\"><figcaption style=\"font-size: 12px; color: #6b7280; margin-top: 8px; text-align: center;\"><img loading=\"lazy\" decoding=\"async\" class=\"alignnone size-full wp-image-209\" src=\"https:\/\/isbm-blow-molding.com\/wp-content\/uploads\/2026\/02\/factory-4.webp\" alt=\"fabrika-4\" width=\"1536\" height=\"1024\" srcset=\"https:\/\/isbm-blow-molding.com\/wp-content\/uploads\/2026\/02\/factory-4.webp 1536w, https:\/\/isbm-blow-molding.com\/wp-content\/uploads\/2026\/02\/factory-4-1280x853.webp 1280w, https:\/\/isbm-blow-molding.com\/wp-content\/uploads\/2026\/02\/factory-4-980x653.webp 980w, https:\/\/isbm-blow-molding.com\/wp-content\/uploads\/2026\/02\/factory-4-480x320.webp 480w\" sizes=\"auto, (min-width: 0px) and (max-width: 480px) 480px, (min-width: 481px) and (max-width: 980px) 980px, (min-width: 981px) and (max-width: 1280px) 1280px, (min-width: 1281px) 1536px, 100vw\" \/><br \/>\nKore ISBM GMP do\u011frulama protokol\u00fc \u2014 IQ (Kurulum Yeterlili\u011fi) makinenin spesifikasyona uygun olarak kuruldu\u011funu do\u011frular; OQ (Operasyonel Yeterlilik) do\u011frulanm\u0131\u015f proses parametre aral\u0131klar\u0131n\u0131 belirler; PQ (Performans Yeterlili\u011fi) ise t\u00fcm kalite spesifikasyonlar\u0131n\u0131 kar\u015f\u0131layan nominal ko\u015fullarda tutarl\u0131 \u00fcretimi g\u00f6sterir. Kore KFDA \ud5c8\uac00 ba\u015fvurusu, ticari \u00fcretime ba\u015flamadan \u00f6nce \u00fc\u00e7 do\u011frulama a\u015famas\u0131n\u0131n da tamamlanmas\u0131n\u0131 ve belgelenmesini gerektirir; bu da Koreli ISBM \u00fcreticilerinin s\u00f6zle\u015fme g\u00f6r\u00fc\u015fmeleri a\u015famas\u0131nda planlamas\u0131 gereken bir zaman \u00e7izelgesidir ve genellikle kal\u0131p \u00fcretiminden PQ tamamlanmas\u0131na kadar 4-6 ay s\u00fcrer.<\/figcaption><\/figure>\n<p style=\"font-size: 16px; margin-bottom: 14px;\">GMP IQ\/OQ\/PQ validasyonu, Kore S\u0131n\u0131f III t\u0131bbi cihaz konteyner ISBM yeterlilik s\u00fcrecinin temelini olu\u015fturmaktad\u0131r. Her a\u015fama farkl\u0131 bir amaca hizmet eder ve KFDA \ud5c8\uac00 dosyas\u0131 i\u00e7in \u00f6zel dok\u00fcmantasyon \u00fcretir.<\/p>\n<p style=\"font-size: 16px; margin-bottom: 14px;\"><strong>IQ (Kurulum Yeterlili\u011fi):<\/strong> Kore ISBM makinesinin, kal\u0131b\u0131n\u0131n ve yard\u0131mc\u0131 ekipmanlar\u0131n\u0131n (kurutucu, so\u011futucu, bas\u0131n\u00e7l\u0131 hava sistemi) \u00fcretici spesifikasyonlar\u0131na uygun olarak kuruldu\u011funu do\u011frular. Kore KFDA S\u0131n\u0131f III i\u00e7in IQ dok\u00fcmantasyonu \u015funlar\u0131 i\u00e7erir: makine seri numaras\u0131 ve model onay\u0131, KRISS izlenebilirli\u011fine sahip t\u00fcm \u00f6l\u00e7\u00fcm cihazlar\u0131 (termokupllar, bas\u0131n\u00e7 d\u00f6n\u00fc\u015ft\u00fcr\u00fcc\u00fcler, tart\u0131 terazileri) i\u00e7in kalibrasyon sertifikalar\u0131, yard\u0131mc\u0131 tesis do\u011frulamas\u0131 (so\u011futma suyu s\u0131cakl\u0131\u011f\u0131, ak\u0131\u015f h\u0131z\u0131, \u00fcfleme havas\u0131 bas\u0131nc\u0131, makine giri\u015findeki \u00e7i\u011f noktas\u0131) ve kurulum s\u0131ras\u0131nda temiz oda ortam \u00f6l\u00e7\u00fcmleri (partik\u00fcl say\u0131s\u0131, s\u0131cakl\u0131k, nem, diferansiyel bas\u0131n\u00e7). Kore Ever-Power, Kore KFDA t\u0131bbi cihaz IQ protokol\u00fcn\u00fcn tamamlanmas\u0131 i\u00e7in gerekli t\u00fcm veri alanlar\u0131n\u0131 kapsayan makineye \u00f6zel IQ dok\u00fcmantasyon \u015fablonlar\u0131 sa\u011flar.<\/p>\n<p style=\"font-size: 16px; margin-bottom: 14px;\"><strong>OQ (Operasyonel Yeterlilik):<\/strong> Her kritik proses parametresi i\u00e7in onaylanm\u0131\u015f \u00e7al\u0131\u015fma aral\u0131klar\u0131n\u0131, prosesi parametre u\u00e7 noktalar\u0131nda test ederek ve her seviyede kabul edilebilir \u00fcr\u00fcn\u00fc do\u011frulayarak belirler. Tipik Kore ISBM OQ \u00e7al\u0131\u015fmas\u0131: \u015eartland\u0131rma s\u0131cakl\u0131\u011f\u0131, \u00fcfleme bekleme s\u00fcresi ve enjeksiyon dolum bas\u0131nc\u0131 i\u00e7in her kritik parametrenin 3 seviyesi (nominal \u2212 5%, nominal, nominal + 5%); her parametre seviyesinde 30 \u015fi\u015fe \u00f6rne\u011fi; her seviyede boyut ve kalite \u00f6l\u00e7\u00fcmleri (a\u011f\u0131rl\u0131k, boyun d\u0131\u015f \u00e7ap\u0131, bulan\u0131kl\u0131k, 5 pozisyonda duvar kal\u0131nl\u0131\u011f\u0131, g\u00f6rsel inceleme). OQ kabul kriterleri: t\u00fcm parametre seviyelerinde t\u00fcm kalite \u00f6zelliklerinin spesifikasyon dahilinde olmas\u0131 \u2014 \u00fcretimin \u00e7al\u0131\u015fmas\u0131 gereken onaylanm\u0131\u015f parametre aral\u0131klar\u0131n\u0131n belirlenmesi. Nominal \u00b1 5%'de ba\u015far\u0131s\u0131z \u00fcr\u00fcn \u00fcreten parametreler, nominal ayar noktas\u0131n\u0131n yeniden optimize edilmesini ve OQ'nun tekrarlanmas\u0131n\u0131 gerektirir \u2014 daha \u00f6nce S\u0131n\u0131f III hassasiyet toleranslar\u0131na g\u00f6re \u00fcretim yapmam\u0131\u015f Kore ISBM S\u0131n\u0131f III \u00fcreticileri i\u00e7in yayg\u0131n bir OQ bulgusudur.<\/p>\n<p style=\"font-size: 16px; margin-bottom: 0;\"><strong>PQ (Performans Yeterlili\u011fi):<\/strong> Kore ISBM prosesinin, ticari \u00f6l\u00e7ekte en az 3 ard\u0131\u015f\u0131k \u00fcretim \u00e7al\u0131\u015fmas\u0131 boyunca nominal ko\u015fullar alt\u0131nda tutarl\u0131 ve spesifikasyona uygun \u00fcr\u00fcn \u00fcretti\u011fini g\u00f6stermektedir. PQ \u00f6rnekleme plan\u0131: Her \u00e7al\u0131\u015fma i\u00e7in her kal\u0131ptan en az 125 \u015fi\u015fe (3 \u00e7al\u0131\u015fma i\u00e7in her kal\u0131ptan toplam 375 \u015fi\u015fe), boyut \u00f6l\u00e7\u00fcmleri, a\u011f\u0131rl\u0131k, bulan\u0131kl\u0131k, AQL Seviye II'ye (ANSI\/ASQ Z1.4 \/ ISO 2859-1) g\u00f6re g\u00f6rsel inceleme ve biyolojik uyumluluk numunesi \u00fcretim onay\u0131 dahil olmak \u00fczere 9 kalite \u00f6zelli\u011fi \u00f6l\u00e7\u00fclm\u00fc\u015ft\u00fcr. PQ istatistiksel analizi: Her kritik kalite \u00f6zelli\u011fi i\u00e7in proses yetene\u011fi (Cpk) \u2265 1,33 - Kore KFDA S\u0131n\u0131f III standard\u0131, onaylanm\u0131\u015f \u00fcretim yetene\u011fi i\u00e7in. EV servo ISBM Kore platformlar\u0131, nominal ko\u015fullar alt\u0131nda \u015fi\u015fe a\u011f\u0131rl\u0131\u011f\u0131 ve boyun d\u0131\u015f \u00e7ap\u0131 i\u00e7in s\u00fcrekli olarak Cpk \u2265 1,50 de\u011ferine ula\u015fmaktad\u0131r; Kore'deki hidrolik platformlar tipik olarak 1,00-1,20 Cpk de\u011ferine ula\u015f\u0131r; bu da Kore S\u0131n\u0131f III standard\u0131n\u0131n alt\u0131ndad\u0131r ve S\u0131n\u0131f III tedarikine giren Koreli ISBM \u00fcreticilerinin ba\u015far\u0131l\u0131 bir PQ tamamlama i\u00e7in \u00f6n ko\u015ful olarak s\u00fcrekli kar\u015f\u0131la\u015ft\u0131\u011f\u0131 hidrolik sistemden EV-servo sisteme y\u00fckseltmeyi gerektirir.<\/p>\n<\/section>\n<p><!-- FAQ --><\/p>\n<section style=\"margin: 56px 0 0; padding: 36px 0 0; border-top: 2px solid #075985;\">\n<h2 id=\"faq\" style=\"font-size: clamp(19px,2.8vw,25px); font-weight: 800; color: #075985; margin: 0 0 24px;\">S\u0131k\u00e7a Sorulan Sorular<\/h2>\n<div style=\"display: flex; flex-direction: column; gap: 2px;\">\n<div style=\"border: 1px solid #bae6fd; border-radius: 8px 8px 0 0; overflow: hidden;\">\n<div style=\"background: #f0f9ff; padding: 14px 20px; border-bottom: 1px solid #bae6fd;\">\n<p style=\"font-size: 15px; font-weight: bold; color: #075985; margin: 0;\">S1 \u2014 Kore'de S\u0131n\u0131f II IVD t\u0131bbi cihaz ambalaj tedarikine girmek i\u00e7in minimum Kore ISBM yat\u0131r\u0131m\u0131 ne kadard\u0131r?<\/p>\n<\/div>\n<div style=\"padding: 16px 20px;\">\n<p style=\"font-size: 15px; color: #374151; margin: 0; line-height: 1.7;\">Koreli bir ISBM \u00fcreticisinin, Kore onayl\u0131 bir t\u0131bbi cihaz \u00fcreticisine Kore S\u0131n\u0131f II IVD reaktif konteyner tedarik\u00e7isi olarak nitelendirilmesi i\u00e7in gereken minimum yat\u0131r\u0131m d\u00f6rt bile\u015fenden olu\u015fmaktad\u0131r. (1) ISO 13485:2016'ya kalite sistemi y\u00fckseltmesi: ISO 9001:2015 kapsam\u0131nda faaliyet g\u00f6steren Koreli ISBM \u00fcreticileri, Koreli akredite bir belgelendirme kurulu\u015fu ile 6-9 ay i\u00e7inde 8-15 milyon KRW kar\u015f\u0131l\u0131\u011f\u0131nda ISO 13485 y\u00fckseltmesini (eksiklik analizi, dok\u00fcmantasyon revizyonu, denetim, belgelendirme) ger\u00e7ekle\u015ftirebilirler. ISO 13485, KFDA onayl\u0131 s\u00fcre\u00e7 gereksinimlerinde referans al\u0131nan Kore t\u0131bbi cihaz kalite y\u00f6netim standard\u0131d\u0131r. (2) \u00dcretim numunelerinde ISO 10993-5 sitotoksisite testi: KTR veya KCL'de 1,5-3 milyon KRW; Kore onayl\u0131 kurulu\u015funun gerektirdi\u011fi biyouyumluluk sertifikas\u0131n\u0131 \u00fcretir. (3) \u00dcretim ortam\u0131n\u0131n ISO 14644-1 S\u0131n\u0131f 8'e y\u00fckseltilmesi: 80-120 m\u00b2'lik bir Kore ISBM \u00fcretim alan\u0131 i\u00e7in, HEPA filtreleme iyile\u015ftirmesi ve pozitif bas\u0131n\u00e7 y\u00f6netimi: do\u011frulama dahil 15-30 milyon KRW. (4) GMP dok\u00fcmantasyon sistemi: parti kay\u0131tlar\u0131, ekipman kalibrasyon program\u0131, re\u00e7ine ve masterbatch tedarik\u00e7i yeterlili\u011fi, y\u0131ll\u0131k y\u00f6netim incelemesi. S\u0131f\u0131rdan uygulanmas\u0131 durumunda: dok\u00fcmantasyon geli\u015ftirme ve personel e\u011fitimi i\u00e7in 5-10 milyon KRW. Toplam minimum yat\u0131r\u0131m: 12-18 ay i\u00e7inde 30-58 milyon KRW. Buna kar\u015f\u0131l\u0131k gelen ticari fayda: Kore S\u0131n\u0131f II IVD t\u0131bbi cihaz konteyner fiyatland\u0131rmas\u0131 tipik olarak \u015fi\u015fe ba\u015f\u0131na 45-120 KRW'dir - e\u015fde\u011fer Kore emtia ambalaj\u0131na g\u00f6re \u015fi\u015fe ba\u015f\u0131na 2-4 kat daha y\u00fcksek kar marj\u0131 - ve Kore t\u0131bbi cihaz \u00fcreticisi s\u00f6zle\u015fmeleri tipik olarak 3-5 y\u0131ll\u0131k tedarik anla\u015fmalar\u0131d\u0131r ve Kore emtia ambalaj pazarlar\u0131nda bulunmayan gelir istikrar\u0131 sa\u011flar.<\/p>\n<\/div>\n<\/div>\n<div style=\"border: 1px solid #bae6fd; border-top: none; overflow: hidden;\">\n<div style=\"background: #f0f9ff; padding: 14px 20px; border-bottom: 1px solid #bae6fd;\">\n<p style=\"font-size: 15px; font-weight: bold; color: #075985; margin: 0;\">S2 \u2014 Kore'deki t\u0131bbi cihaz mevzuat\u0131na uygunluk a\u00e7\u0131s\u0131ndan, Kore ISBM tek a\u015famal\u0131 i\u015flem s\u00fcreci, iki a\u015famal\u0131 SBM s\u00fcrecinden nas\u0131l farkl\u0131l\u0131k g\u00f6sterir?<\/p>\n<\/div>\n<div style=\"padding: 16px 20px;\">\n<p style=\"font-size: 15px; color: #374151; margin: 0; line-height: 1.7;\">Kore'de kullan\u0131lan tek a\u015famal\u0131 ISBM i\u015flemi, Kore t\u0131bbi cihaz uygulamalar\u0131 i\u00e7in iki a\u015famal\u0131 SBM'ye (\u00f6nceden \u00fcretilmi\u015f preformlardan germe \u015fi\u015firme kal\u0131plama) g\u00f6re iki uyumluluk avantaj\u0131na sahiptir. Birincisi, ayr\u0131 ayr\u0131 do\u011frulama gerektiren daha az i\u015flem ad\u0131m\u0131: iki a\u015famal\u0131 SBM, preform enjeksiyon kal\u0131plamas\u0131n\u0131n (enjeksiyon kal\u0131plama makinesi i\u00e7in IQ\/OQ\/PQ) ayr\u0131 bir GMP do\u011frulamas\u0131 ve yeniden \u0131s\u0131tmal\u0131 SBM i\u015fleminin ayr\u0131 bir GMP do\u011frulamas\u0131 gerektirir; bu da ISO 14644 kapsam\u0131nda nitelendirilmek i\u00e7in iki ayr\u0131 do\u011frulama \u00e7al\u0131\u015fmas\u0131, iki ekipman kalibrasyon seti ve iki \u00fcretim ortam\u0131 anlam\u0131na gelir. Kore'de kullan\u0131lan tek a\u015famal\u0131 ISBM, her iki ad\u0131m\u0131 da tek bir do\u011frulanm\u0131\u015f i\u015flemde, tek bir IQ\/OQ\/PQ protokol\u00fcyle birle\u015ftirerek do\u011frulama \u00e7abas\u0131n\u0131 yakla\u015f\u0131k olarak yar\u0131ya indirir. \u0130kincisi, preform envanteri ve elle\u00e7leme uyumluluk gereksinimi yoktur: iki a\u015famal\u0131 SBM, nitelikli bir ortamda saklanmas\u0131, parti numaras\u0131yla izlenmesi ve saklama s\u00fcresi s\u0131n\u0131rlar\u0131 a\u00e7\u0131s\u0131ndan kontrol edilmesi gereken ara bir preform envanteri olu\u015fturur (PET preformlar, \u015fi\u015firilmeden \u00f6nce \u00e7ok uzun s\u00fcre saklan\u0131rsa kristalli\u011finde bozulmaya u\u011frar). Kore'nin tek a\u015famal\u0131 ISBM sistemi, \u00f6n kal\u0131p depolama uyumluluk gereksinimini tamamen ortadan kald\u0131r\u0131r; \u00f6n kal\u0131p \u00fcretilir ve ayn\u0131 d\u00f6ng\u00fcde hemen \u015fi\u015firilir, b\u00f6ylece \u00e7evresel kontroller, parti takibi veya raf \u00f6mr\u00fc y\u00f6netimi gerektiren ara \u00fcr\u00fcn bulunmaz. Kore ila\u00e7 ISBM'si i\u00e7in bu avantaj iyi bilinmektedir. Kore t\u0131bbi cihaz ISBM'si i\u00e7in de ayn\u0131 derecede \u00f6nemlidir; Kore S\u0131n\u0131f III \ud5c8\uac00 ba\u015fvuru dok\u00fcmantasyonu, bireysel do\u011frulama gerektiren kritik i\u015flem ad\u0131mlar\u0131n\u0131n say\u0131s\u0131n\u0131n azalt\u0131lmas\u0131yla basitle\u015ftirilir ve iki a\u015famal\u0131 \u00fcretim s\u00fcreci yeterlili\u011fine k\u0131yasla IQ\/OQ\/PQ zaman \u00e7izelgesi 2-4 ay k\u0131sal\u0131r.<\/p>\n<\/div>\n<\/div>\n<div style=\"border: 1px solid #bae6fd; border-top: none; overflow: hidden;\">\n<div style=\"background: #f0f9ff; padding: 14px 20px; border-bottom: 1px solid #bae6fd;\">\n<p style=\"font-size: 15px; font-weight: bold; color: #075985; margin: 0;\">S3 \u2014 Gama \u0131\u015f\u0131nlamas\u0131, Kore ISBM PET t\u0131bbi cihaz \u015fi\u015felerinin ekstrakte edilebilir madde profilini de\u011fi\u015ftirir mi?<\/p>\n<\/div>\n<div style=\"padding: 16px 20px;\">\n<p style=\"font-size: 15px; color: #374151; margin: 0; line-height: 1.7;\">Evet \u2014 gama \u0131\u015f\u0131nlamas\u0131, PET'te, \u0131\u015f\u0131nlamadan \u00f6nce mevcut olan termal bozunma \u00fcr\u00fcnlerine ek olarak, radyasyon kaynakl\u0131 bozunma \u00fcr\u00fcnlerinin farkl\u0131 bir k\u00fcmesini \u00fcreten serbest radikaller olu\u015fturur. 25 kGy'de Kore ISBM PET'inden elde edilen birincil radyasyon kaynakl\u0131 ekstrakte edilebilir maddeler \u015funlard\u0131r: (1) Artan asetaldehit (gama \u0131\u015f\u0131nlamas\u0131, PET zincirindeki ek ester ba\u011flar\u0131n\u0131 k\u0131rarak, ISBM i\u015fleminden kaynaklanan termal AA'n\u0131n \u00fczerinde ek AA a\u00e7\u0131\u011fa \u00e7\u0131kar\u0131r); (2) Vinil alkol oligomerleri (terminal vinil gruplar\u0131n\u0131n gama ile par\u00e7alanmas\u0131); (3) Y\u00fckselen PET siklik oligomerleri (radyasyon, zincir par\u00e7alanmas\u0131ndan ek oligomer olu\u015fumunu te\u015fvik eder). Gama ile sterilize edilmi\u015f Kore KFDA S\u0131n\u0131f III t\u0131bbi cihaz kaplar\u0131 i\u00e7in, radyasyon kaynakl\u0131 ekstrakte edilebilir maddeler, hastalar\u0131n maruz kald\u0131\u011f\u0131 kab\u0131n ger\u00e7ek kimyasal profilinin bir par\u00e7as\u0131 oldu\u011fundan, E&amp;L \u00e7al\u0131\u015fmas\u0131 \u0131\u015f\u0131nlanm\u0131\u015f numuneler \u00fczerinde yap\u0131lmal\u0131d\u0131r \u2014 \u0131\u015f\u0131nlanmam\u0131\u015f \u00fcretim numuneleri \u00fczerinde de\u011fil. Koreli ISBM \u00fcreticileri, E&amp;L \u00e7al\u0131\u015fmalar\u0131n\u0131 \u0131\u015f\u0131nlanmam\u0131\u015f \u015fi\u015feler \u00fczerinde ger\u00e7ekle\u015ftirip daha sonra gama \u0131\u015f\u0131nlar\u0131yla sterilize ettiklerinde, Kore G\u0131da ve \u0130la\u00e7 \u0130daresi (KFDA) onay dosyalar\u0131nda (\ud5c8\uac00) bir eksiklik ortaya \u00e7\u0131kmaktad\u0131r. Bu eksiklik, KFDA incelemesi s\u0131ras\u0131nda belirginle\u015fmekte ve \u0131\u015f\u0131nlanm\u0131\u015f numuneler \u00fczerinde tekrarlanan bir E&amp;L \u00e7al\u0131\u015fmas\u0131 yap\u0131lmas\u0131n\u0131 gerektirerek onay s\u00fcrecini 3-6 ay geciktirmektedir. E&amp;L test protokol\u00fcnde, numunelerin ekstraksiyondan \u00f6nce maksimum ama\u00e7lanan dozda \u0131\u015f\u0131nlanmas\u0131 gerekti\u011fi ba\u015ftan belirtilmelidir; bu, tekrarlanan \u00e7al\u0131\u015fma maliyetini ve onay gecikmesini \u00f6nleyecektir.<\/p>\n<\/div>\n<\/div>\n<div style=\"border: 1px solid #bae6fd; border-top: none; overflow: hidden;\">\n<div style=\"background: #f0f9ff; padding: 14px 20px; border-bottom: 1px solid #bae6fd;\">\n<p style=\"font-size: 15px; font-weight: bold; color: #075985; margin: 0;\">Soru 4 \u2014 Kore ISBM PET'indeki asetaldehit, t\u0131bbi cihaz reaktiflerinin kalitesini nas\u0131l etkiler?<\/p>\n<\/div>\n<div style=\"padding: 16px 20px;\">\n<p style=\"font-size: 15px; color: #374151; margin: 0; line-height: 1.7;\">Kore ISBM PET \u015fi\u015felerinden t\u0131bbi cihaz reaktiflerine asetaldehit (AA) ge\u00e7i\u015fi, \u00f6zellikle AA'n\u0131n enzim aktif b\u00f6lgeleriyle reaksiyona girebildi\u011fi enzim bazl\u0131 tan\u0131 reaktifleri ve AA'n\u0131n Maillard reaksiyonlar\u0131 yoluyla antikor proteinleriyle reaksiyona girerek test duyarl\u0131l\u0131\u011f\u0131n\u0131 azaltabildi\u011fi imm\u00fcnolojik test reaktifleri olmak \u00fczere, belirli Kore IVD reaktif kategorileri i\u00e7in \u00f6nemli bir kalite sorunudur. \u00d6l\u00e7\u00fclebilir Kore IVD reaktif performans d\u00fc\u015f\u00fc\u015f\u00fcne neden olan AA ge\u00e7i\u015f e\u015fi\u011fi, spesifik reaktif matrisine ba\u011fl\u0131d\u0131r; enzim bazl\u0131 IVD reaktifleri, depolanan reaktifte 15 ppb'nin \u00fczerindeki AA konsantrasyonlar\u0131nda performans d\u00fc\u015f\u00fc\u015f\u00fc g\u00f6sterirken, imm\u00fcnolojik test reaktifleri genellikle Kore ISBM PET AA seviyelerinde (ortam s\u0131cakl\u0131\u011f\u0131nda, 3 ay depolama s\u00fcresinde 100 ml PET \u015fi\u015fede 1-8 ppb ba\u015fl\u0131k alan\u0131 AA) etkilenmez. Koreli IVD tan\u0131 \u015firketlerine tedarik sa\u011flayan Koreli ISBM \u00fcreticileri, ticari ko\u015fullarda (\u015fartland\u0131rma s\u0131cakl\u0131\u011f\u0131, varil s\u0131cakl\u0131\u011f\u0131, \u00e7evrim s\u00fcresi) \u00fcretilen \u015fi\u015felerdeki \u00f6l\u00e7\u00fclen ba\u015f bo\u015flu\u011fu AA de\u011ferini Koreli t\u0131bbi cihaz m\u00fc\u015fterisinin form\u00fclasyon ekibine a\u00e7\u0131klamal\u0131 ve t\u00fcm ticari \u00fcretimde proses parametre kontrolleri ve y\u0131ll\u0131k do\u011frulama testleri yoluyla AA'y\u0131 kararla\u015ft\u0131r\u0131lan limitin alt\u0131nda tutmay\u0131 taahh\u00fct etmelidir. Kore t\u0131bbi cihaz PET \u015fi\u015felerinde AA'y\u0131 azaltmak i\u00e7in ba\u015fl\u0131ca ISBM parametre kald\u0131ra\u00e7lar\u0131 \u015funlard\u0131r: varil s\u0131cakl\u0131\u011f\u0131n\u0131 en aza indirmek (hedef 265\u00b0C b\u00f6lge 1, 280\u00b0C+ de\u011fil), varilde kalma s\u00fcresini en aza indirmek (duraklamalar s\u0131ras\u0131nda PET'i varilde 10 dakikadan fazla s\u0131cakl\u0131kta b\u0131rakmay\u0131n) ve \u015fartland\u0131rma bekleme s\u00fcresini en aza indirmek (maksimum de\u011fil, kalite i\u00e7in yeterli minimum).<\/p>\n<\/div>\n<\/div>\n<div style=\"border: 1px solid #bae6fd; border-top: none; overflow: hidden;\">\n<div style=\"background: #f0f9ff; padding: 14px 20px; border-bottom: 1px solid #bae6fd;\">\n<p style=\"font-size: 15px; font-weight: bold; color: #075985; margin: 0;\">S5 \u2014 Kore S\u0131n\u0131f III KFDA sertifikas\u0131 al\u0131nd\u0131ktan sonra hangi Kore ISBM de\u011fi\u015fiklik kontrol gereksinimleri ge\u00e7erlidir?<\/p>\n<\/div>\n<div style=\"padding: 16px 20px;\">\n<p style=\"font-size: 15px; color: #374151; margin: 0; line-height: 1.7;\">Kore KFDA onayl\u0131 t\u0131bbi cihaz ambalajlar\u0131, ambalaj spesifikasyonu Koreli cihaz \u00fcreticisinin onay dosyas\u0131nda (\ud5c8\uac00) yer ald\u0131ktan sonra, Koreli ISBM ambalaj \u00fcreticisini ba\u011flayan de\u011fi\u015fiklik kontrol gerekliliklerine tabidir. Kore KFDA de\u011fi\u015fiklik bildirimi (\u00f6nemine ba\u011fl\u0131 olarak \ubcc0\uacbd\ud5c8\uac00 veya \ubcc0\uacbd\uc2e0\uace0) ve potansiyel olarak Kore KFDA incelemesi ve yeniden onay\u0131n\u0131 gerektiren ISBM ambalaj\u0131ndaki de\u011fi\u015fiklikler \u015funlard\u0131r: re\u00e7ine s\u0131n\u0131f\u0131 veya \u00fcreticisindeki de\u011fi\u015fiklikler; renklendirici veya masterbatch spesifikasyonundaki de\u011fi\u015fiklikler; ISBM makinesindeki de\u011fi\u015fiklikler (model, seri numaras\u0131, konum); OQ'da belirlenen onaylanm\u0131\u015f aral\u0131\u011f\u0131n d\u0131\u015f\u0131nda \u00f6nemli proses parametre de\u011fi\u015fiklikleri; ve onay dosyas\u0131nda onaylanm\u0131\u015f tolerans\u0131n \u00fczerinde boyut spesifikasyon de\u011fi\u015fiklikleri. Genellikle KFDA de\u011fi\u015fiklik bildirimi gerektirmeyen (ancak dahili de\u011fi\u015fiklik kontrol dok\u00fcmantasyonu gerektiren) de\u011fi\u015fiklikler \u015funlard\u0131r: aral\u0131k i\u00e7i proses parametre ayarlamalar\u0131, ISBM operat\u00f6r sertifikasyon de\u011fi\u015fiklikleri, onaylanm\u0131\u015f temiz oda s\u0131n\u0131f\u0131n\u0131 koruyan veya a\u015fan \u00fcretim ortam\u0131 iyile\u015ftirmeleri. Kore'de ISBM ambalaj \u00fcreticileri, onaylanm\u0131\u015f t\u0131bbi cihaz ambalajlama s\u00fcre\u00e7lerini de\u011fi\u015ftirilebilir olarak ele al\u0131rlarsa (\u00f6rne\u011fin, de\u011fi\u015fiklik kontrol\u00fc olmadan varil s\u0131cakl\u0131klar\u0131n\u0131 ayarlamak, tedarik\u00e7i onay\u0131 olmadan re\u00e7ine kalitelerini de\u011fi\u015ftirmek veya KFDA'ya bildirimde bulunmadan ISBM makinelerini tesisler aras\u0131nda ta\u015f\u0131mak gibi), cihaz \u00fcreticisinin bir sonraki KFDA denetiminde ortaya \u00e7\u0131kan ve ambalaj tedarik\u00e7isine kar\u015f\u0131 d\u00fczeltici i\u015flem gerekliliklerini tetikleyen Kore KFDA uyumluluk eksiklikleri yarat\u0131rlar. Pratik sonu\u00e7: Kore S\u0131n\u0131f III t\u0131bbi cihaz tedarikine giren ISBM \u00fcreticileri, t\u0131bbi cihaz s\u00f6zle\u015fmesi i\u00e7in \u00f6zel bir makine, kal\u0131p ve re\u00e7ine tedarik zinciri tahsis etmeli ve resmi inceleme ve gerekti\u011finde Kore KFDA bildirimi olmadan herhangi bir de\u011fi\u015fikli\u011fi \u00f6nleyen bir de\u011fi\u015fiklik kontrol sistemi olu\u015fturmal\u0131d\u0131r.<\/p>\n<\/div>\n<\/div>\n<div style=\"border: 1px solid #bae6fd; border-radius: 0 0 8px 8px; overflow: hidden;\">\n<div style=\"background: #f0f9ff; padding: 14px 20px; border-bottom: 1px solid #bae6fd;\">\n<p style=\"font-size: 15px; font-weight: bold; color: #075985; margin: 0;\">S6 \u2014 Kore ISBM boyut hassasiyeti, Kore t\u0131bbi cihaz kaplar\u0131n\u0131n boyun d\u0131\u015f \u00e7ap\u0131 uyumlulu\u011fu a\u00e7\u0131s\u0131ndan camla nas\u0131l kar\u015f\u0131la\u015ft\u0131r\u0131l\u0131r?<\/p>\n<\/div>\n<div style=\"padding: 16px 20px;\">\n<p style=\"font-size: 15px; color: #374151; margin: 0; line-height: 1.7;\">Kore ISBM PET ve PETG \u015fi\u015feleri, 4 bo\u015fluklu \u00fcretimde \u00b10,04 mm (4-sigma, EV servo platformu) boyun d\u0131\u015f \u00e7ap\u0131 boyut hassasiyetine ula\u015f\u0131r; bu, farmas\u00f6tik s\u0131n\u0131f cam \u015fi\u015fe boyun d\u0131\u015f \u00e7ap\u0131 hassasiyetine (cam kal\u0131plama i\u015flemine ve boyun boyutuna ba\u011fl\u0131 olarak tipik olarak \u00b10,05\u20130,10 mm) e\u015fde\u011fer veya ondan daha \u00fcst\u00fcnd\u00fcr. Kapatma mekanizmas\u0131n\u0131n (ge\u00e7meli kapak, luer konnekt\u00f6r, septum) s\u0131zd\u0131rmaz bir \u015fekilde kapanmas\u0131 i\u00e7in boyun d\u0131\u015f \u00e7ap\u0131 tolerans\u0131na ba\u011fl\u0131 oldu\u011fu Kore t\u0131bbi cihaz uygulamalar\u0131nda, Kore ISBM'nin \u00b10,04 mm hassasiyeti, cam\u0131n \u00b10,05\u20130,10 mm'lik hassasiyetine k\u0131yasla daha tutarl\u0131 bir kapatma performans\u0131 sa\u011flar ve ayr\u0131ca \u00fcretimde her bo\u015fluk i\u00e7in niceliksel olarak do\u011frulanabilme avantaj\u0131na sahiptir (cam \u00fcreticileri boyut sertifikasyonunu istatistiksel \u00f6rnek d\u00fczeyinde sa\u011flar, bo\u015fluk ba\u015f\u0131na de\u011fil). Kore t\u0131bbi cihaz kaplar\u0131 i\u00e7in cam\u0131n Kore ISBM PET\/PETG'ye g\u00f6re avantaj sa\u011flad\u0131\u011f\u0131 iki gereklilik \u015funlard\u0131r: (1) Y\u00fcksek derecede \u0131\u015f\u0131\u011fa duyarl\u0131 reaktifler i\u00e7in UV bariyeri \u2014 kehribar renkli cam, 450 nm'nin alt\u0131ndaki UV \u0131\u015f\u0131nlar\u0131n\u0131n \u2265,91'ini bloke eder; kehribar renkli PET veya kehribar renkli PETG, -991'ini bloke eder ancak do\u011frulanm\u0131\u015f ana kar\u0131\u015f\u0131m ve migrasyon testi gerektirir; (2) Su buhar\u0131 ge\u00e7irgenlik oran\u0131 (WVTR) \u2014 cam\u0131n WVTR'si s\u0131f\u0131rd\u0131r; PET'in WVTR'si 38\u00b0C\/901 TP3T RH'de yakla\u015f\u0131k 1,5-3,0 g\u00b7mm\/m\u00b2\u00b7g\u00fcn'd\u00fcr \u2014 standart Kore laboratuvar depolamas\u0131nda (15-30\u00b0C) \u00e7o\u011fu sulu IVD reaktifi i\u00e7in kabul edilebilir ancak 18+ ayl\u0131k raf \u00f6mr\u00fc boyunca atmosferik nem emiliminden kaynaklanan seyreltmeye duyarl\u0131 reaktifler i\u00e7in nem bariyeri ile kapat\u0131lmay\u0131 gerektirir.<\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/section>\n<p><!-- CTA --><\/p>\n<div style=\"background: linear-gradient(135deg,#020c1a 0%,#0369a1 100%); border-radius: 10px; padding: clamp(30px,5vw,50px) clamp(20px,4vw,40px); text-align: center; margin: 56px 0 48px;\">\n<p style=\"font-size: 10px; font-weight: bold; letter-spacing: 2px; text-transform: uppercase; color: #7dd3fc; margin: 0 0 12px;\">T\u0131bbi Cihaz Kalifikasyon Deste\u011fi<\/p>\n<h2 style=\"font-size: clamp(18px,3vw,26px); font-weight: 800; color: #fff; margin: 0 0 14px;\">Kore G\u0131da ve \u0130la\u00e7 \u0130daresi (KFDA) S\u0131n\u0131f II veya S\u0131n\u0131f III T\u0131bbi Cihaz Ambalajlama sekt\u00f6r\u00fcne mi giriyorsunuz? GMP Validasyonu, ISO 10993 veya IQ\/OQ\/PQ deste\u011fine mi ihtiyac\u0131n\u0131z var?<\/h2>\n<p style=\"font-size: 15px; color: #e0f2fe; max-width: 480px; margin: 0 auto 26px; line-height: 1.65;\">Korean Ever-Power, Kore G\u0131da ve \u0130la\u00e7 \u0130daresi (KFDA) S\u0131n\u0131f II\/III dok\u00fcmantasyon \u015fablonlar\u0131, GMP IQ\/OQ\/PQ protokol geli\u015ftirme, biyouyumluluk numunesi \u00fcretimi, KFDA Ek 11 uyumlulu\u011fu i\u00e7in EV servo proses kayd\u0131 ve Kore t\u0131bbi cihaz ambalaj\u0131 yeterlilik belgesi i\u00e7in temiz oda ISBM devreye alma hizmetleri sunmaktad\u0131r.<\/p>\n<p><a style=\"display: inline-block; background: #f97316; color: #fff; padding: 14px 36px; border-radius: 6px; text-decoration: none; font-weight: bold; font-size: 15px;\" href=\"https:\/\/isbm-blow-molding.com\/tr\/contact-us\/\">T\u0131bbi Cihaz Kalifikasyon Deste\u011fi Talebi<\/a><\/p>\n<\/div>\n<p><!-- RELATED RESOURCES --><\/p>\n<section style=\"margin-bottom: 56px;\">\n<p style=\"font-size: 10.5px; font-weight: bold; letter-spacing: 2px; text-transform: uppercase; color: #075985; margin-bottom: 16px;\">\u0130lgili Kaynaklar<\/p>\n<div style=\"display: flex; flex-wrap: wrap; gap: 16px;\">\n<div style=\"background: #fff; border: 1.5px solid #bae6fd; border-top: 4px solid #075985; border-radius: 8px; padding: 18px 20px;\"><span style=\"display: block; font-size: 9px; font-weight: bold; color: #f97316; letter-spacing: 1.5px; text-transform: uppercase; margin-bottom: 8px;\">\u00dcst\u00fcn T\u0131bbi S\u0131n\u0131f<\/span><br \/>\n<span style=\"display: block; font-size: 15px; font-weight: bold; color: #1e3a8a; margin-bottom: 8px; line-height: 1.3;\">Enjeksiyonlu Gerdirme \u015ei\u015firme Kal\u0131plama Makinesi HGY150-V4-EV<\/span><br \/>\n<span style=\"display: block; font-size: 13px; color: #6b7280; line-height: 1.55;\">Tamamen elektrikli EV servo \u00b7 KFDA Ek 11 GMP veri kayd\u0131 \u00b7 S\u0131n\u0131f III PQ gereksinimi i\u00e7in Cpk \u2265 1,50 \u00b7 Kore t\u0131bbi cihaz IQ\/OQ\/PQ dok\u00fcmantasyon paketi mevcuttur.<\/span><\/div>\n<p>&nbsp;<\/p>\n<div style=\"background: #fff; border: 1.5px solid #bae6fd; border-top: 4px solid #075985; border-radius: 8px; padding: 18px 20px;\"><span style=\"display: block; font-size: 9px; font-weight: bold; color: #f97316; letter-spacing: 1.5px; text-transform: uppercase; margin-bottom: 8px;\">S\u0131n\u0131f II IVD Platformu<\/span><br \/>\n<span style=\"display: block; font-size: 15px; font-weight: bold; color: #1e3a8a; margin-bottom: 8px; line-height: 1.3;\">Enjeksiyonlu Gerdirme \u015ei\u015firme Kal\u0131plama Makinesi HGY200-V4<\/span><br \/>\n<span style=\"display: block; font-size: 13px; color: #6b7280; line-height: 1.55;\">\u00c7oklu re\u00e7ineli PET \/ PETG \/ PP \u00b7 \u00b10,04 mm boyun d\u0131\u015f \u00e7ap\u0131 hassasiyeti \u00b7 Kore S\u0131n\u0131f II ISO 13485 uyumlu \u00b7 Radyasyona dayan\u0131kl\u0131 PET s\u0131n\u0131f\u0131 onaylanm\u0131\u015f \u00b7 IVD reaktif \u015fi\u015fesi 15\u2013500 ml.<\/span><\/div>\n<p>&nbsp;<\/p>\n<div style=\"background: #fff; border: 1.5px solid #bae6fd; border-top: 4px solid #075985; border-radius: 8px; padding: 18px 20px;\"><span style=\"display: block; font-size: 9px; font-weight: bold; color: #f97316; letter-spacing: 1.5px; text-transform: uppercase; margin-bottom: 8px;\">Y\u00fcksek Hacimli T\u0131bbi<\/span><br \/>\n<span style=\"display: block; font-size: 15px; font-weight: bold; color: #1e3a8a; margin-bottom: 8px; line-height: 1.3;\">Enjeksiyonlu Gerdirme \u015ei\u015firme Kal\u0131plama Makinesi HGY250-V4<\/span><br \/>\n<span style=\"display: block; font-size: 13px; color: #6b7280; line-height: 1.55;\">B\u00fcy\u00fck IVD reaktif kiti \u015fi\u015fe \u00fcretimi \u00b7 6 hazneli Kore S\u0131n\u0131f II \u00e7\u0131k\u0131\u015f \u00b7 Temiz oda uyumlu f\u0131rlatma sistemi \u00b7 B\u00fcy\u00fck tan\u0131 reaktif kaplar\u0131 i\u00e7in geni\u015f a\u011f\u0131zl\u0131 86 mm boyun.<\/span><\/div>\n<p>&nbsp;<\/p>\n<\/div>\n<\/section>\n<p>&nbsp;<\/p>\n<footer style=\"text-align: center; padding: 32px 0 24px; border-top: 1px solid #e5e7eb;\">\n<p style=\"font-size: 12px; color: #9ca3af; margin: 0;\">Edit\u00f6r: Cxm<\/p>\n<\/footer>\n<\/div>\n<p>&nbsp;<\/p>","protected":false},"excerpt":{"rendered":"<p>Application of ISBM \u00b7 Medical Device Packaging \u00b7 Korean ISBM 2026 ISBM Medical Device Bottle Production: Korean Regulatory Guide Korean medical device packaging is the highest-compliance ISBM application \u2014 where every bottle must be biocompatibility-tested, sterilisation-validated, dimensionally qualified to GMP IQ\/OQ\/PQ standards, and manufactured in a documented clean environment. Korean ISBM producers who enter this [&hellip;]<\/p>","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_et_pb_use_builder":"","_et_pb_old_content":"","_et_gb_content_width":"","footnotes":""},"categories":[24],"tags":[],"class_list":["post-966","post","type-post","status-publish","format-standard","hentry","category-technical-deep-dive"],"_links":{"self":[{"href":"https:\/\/isbm-blow-molding.com\/tr\/wp-json\/wp\/v2\/posts\/966","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/isbm-blow-molding.com\/tr\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/isbm-blow-molding.com\/tr\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/isbm-blow-molding.com\/tr\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/isbm-blow-molding.com\/tr\/wp-json\/wp\/v2\/comments?post=966"}],"version-history":[{"count":1,"href":"https:\/\/isbm-blow-molding.com\/tr\/wp-json\/wp\/v2\/posts\/966\/revisions"}],"predecessor-version":[{"id":967,"href":"https:\/\/isbm-blow-molding.com\/tr\/wp-json\/wp\/v2\/posts\/966\/revisions\/967"}],"wp:attachment":[{"href":"https:\/\/isbm-blow-molding.com\/tr\/wp-json\/wp\/v2\/media?parent=966"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/isbm-blow-molding.com\/tr\/wp-json\/wp\/v2\/categories?post=966"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/isbm-blow-molding.com\/tr\/wp-json\/wp\/v2\/tags?post=966"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}