{"id":759,"date":"2026-05-06T06:55:34","date_gmt":"2026-05-06T06:55:34","guid":{"rendered":"https:\/\/isbm-blow-molding.com\/?p=759"},"modified":"2026-05-06T06:55:34","modified_gmt":"2026-05-06T06:55:34","slug":"pharmaceutical-cleanroom-isbm-eye-drops-oral-liquid-bottles","status":"publish","type":"post","link":"https:\/\/isbm-blow-molding.com\/tr\/pharmaceutical-cleanroom-isbm-eye-drops-oral-liquid-bottles\/","title":{"rendered":"\u0130la\u00e7 \u00dcretim Temiz Odas\u0131 ISBM \u2014 G\u00f6z Damlas\u0131 ve A\u011f\u0131zdan Al\u0131nan S\u0131v\u0131 \u015ei\u015feleri"},"content":{"rendered":"
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\u0130la\u00e7 Uygulamalar\u0131 \u00b7 GMP Temiz Oda M\u00fchendisli\u011fi<\/div>\n

T\u0131bbi S\u0131n\u0131f Safl\u0131k: All-Servo One-Step ISBM'nin G\u00f6z Damlas\u0131 ve Oral S\u0131v\u0131 \u015ei\u015feleri \u0130\u00e7in Kore \u0130la\u00e7 Standard\u0131 Olmas\u0131n\u0131n Nedenleri<\/h1>\n

Kore'de ila\u00e7 \u015fi\u015fesi \u00fcretimi (g\u00f6z damlas\u0131, a\u011f\u0131zdan al\u0131nan s\u0131v\u0131 ila\u00e7lar, \u015furuplar, re\u00e7etesiz sat\u0131lan form\u00fclasyonlar) tamamen iki a\u015famal\u0131 s\u00fcre\u00e7leri ge\u00e7ersiz k\u0131lan d\u00fczenleyici ve kalite gereklilikleri alt\u0131nda faaliyet g\u00f6stermektedir. KFDA Madde 6, GMP temiz oda uyumlulu\u011fu, steril dolum haz\u0131rl\u0131\u011f\u0131 ve s\u0131f\u0131r partik\u00fcl kontaminasyonu gerekliliklerinin t\u00fcm\u00fc tek bir platform \u00e7\u00f6z\u00fcm\u00fcnde birle\u015fiyor: tamamen servo tek a\u015famal\u0131 ISBM. \u0130\u015fte bunun nedenine dair m\u00fchendislik detayl\u0131 inceleme.<\/p>\n

Kore Ever-Power M\u00fchendislik Masas\u0131 \u00b7 Ansan-si, Gyeonggi-do \u00b7 G\u00fcncellenme Tarihi: 2026<\/div>\n<\/div>\n<\/header>\n

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\u00d6zetle \u2014 30 Saniyelik Karar<\/div>\n

Kore ila\u00e7 \u015fi\u015fesi \u00fcretimi<\/strong> Di\u011fer hi\u00e7bir ambalaj segmentinin ayn\u0131 anda uygulamad\u0131\u011f\u0131 gereksinimlerle kar\u015f\u0131 kar\u015f\u0131ya: KFDA Madde 6 uyumlulu\u011fu, ISO S\u0131n\u0131f 7 veya S\u0131n\u0131f 8 temiz oda uyumlulu\u011fu, steril dolum haz\u0131rl\u0131\u011f\u0131, mikron d\u00fczeyinde boyutsal hassasiyet ve KFDA\/FDA\/AB denetimleri i\u00e7in eksiksiz dok\u00fcmantasyon izlenebilirli\u011fi. Bu gereksinimler, iki a\u015famal\u0131 \u015fi\u015firme kal\u0131plama y\u00f6ntemini ve \u00e7o\u011fu b\u00fct\u00e7e dostu tek a\u015famal\u0131 platformu de\u011ferlendirme d\u0131\u015f\u0131 b\u0131rakmaktad\u0131r.<\/p>\n

Koreli Ever-Power'\u0131n tamamen servo motorlu One-Step EV platformlar\u0131<\/strong> \u00d6zellikle 100 ml'den k\u00fc\u00e7\u00fck g\u00f6z damlas\u0131 ve damlal\u0131k \u015fi\u015feleri i\u00e7in hassas HGY50-V3-EV ve 50-250 ml oral s\u0131v\u0131 \u015fi\u015feleri i\u00e7in HGY150-V4 modelleri, ila\u00e7 end\u00fcstrisi temiz oda entegrasyonu i\u00e7in \u00f6zel olarak tasarlanm\u0131\u015ft\u0131r. Hidrolik s\u0131v\u0131 gerektirmeyen \u00e7al\u0131\u015fma, ya\u011f kontaminasyonu riskini ortadan kald\u0131r\u0131r. \u00c7ift servo elektrikli s\u0131k\u0131\u015ft\u0131rma, 0,015 mm'nin alt\u0131nda ay\u0131rma hatt\u0131 hassasiyeti sa\u011flar. Entegre s\u0131cakl\u0131k kontrol\u00fc, steril s\u0131n\u0131f re\u00e7ine i\u015flemeyi destekler. Bunlar, Koreli ila\u00e7 devlerinin tercih etti\u011fi platformlard\u0131r.<\/p>\n<\/section>\n

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