{"id":937,"date":"2026-05-19T07:51:41","date_gmt":"2026-05-19T07:51:41","guid":{"rendered":"https:\/\/isbm-blow-molding.com\/?p=937"},"modified":"2026-05-19T07:51:41","modified_gmt":"2026-05-19T07:51:41","slug":"isbm-korean-pharma-oral-liquid-syrup-bottle-guide","status":"publish","type":"post","link":"https:\/\/isbm-blow-molding.com\/tr\/isbm-korean-pharma-oral-liquid-syrup-bottle-guide\/","title":{"rendered":"ISBM Kore \u0130la\u00e7lar\u0131 Oral: S\u0131v\u0131 \u015eurup \u015ei\u015fe K\u0131lavuzu"},"content":{"rendered":"
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ISBM Uygulamas\u0131 \u00b7 Kore \u0130la\u00e7 Sekt\u00f6r\u00fcnde Oral S\u0131v\u0131 \u00b7 2026<\/p>\n

ISBM Kore \u0130la\u00e7lar\u0131 Oral
\nS\u0131v\u0131 \u015eurup \u015ei\u015fesi K\u0131lavuzu<\/h1>\n

Kore'de \u00fcretilen oral s\u0131v\u0131 ila\u00e7lar (\uc2dc\ub7fd (\u015furup), \ud604\ud0c1\uc561 (s\u00fcspansiyon), \uad6c\uac15\uc6a9\uc561 (oral \u00e7\u00f6zelti)), ambalaj\u0131n s\u0131radan bir \u00fcr\u00fcn de\u011fil, klinik hassasiyet gerektiren bir ara\u00e7 oldu\u011fu 580 milyar KRW'lik bir pazard\u0131r. ISBM PET ve PP oral s\u0131v\u0131 \u015fi\u015feleri, t\u00fcketici i\u00e7ecekleriyle ayn\u0131 \u00fcretim \u00f6l\u00e7e\u011finde, Kore KFDA ila\u00e7 ambalaj\u0131 uyumlulu\u011fu, \u00e7ocuk kilidi Kore yasas\u0131, dozaj hassasiyeti ve GMP izlenebilirli\u011fi standartlar\u0131n\u0131 kar\u015f\u0131lamak zorundad\u0131r.<\/p>\n

KRW 580B Oral \u0130la\u00e7 Pazar\u0131<\/span>
\nKFDA Uyumlulu\u011fu<\/span>
\nCRC Sertifikas\u0131 Gerekli<\/span><\/div>\n

Kore Ever-Power M\u00fchendislik Masas\u0131 \u00b7 Ansan-si \u00b7 May\u0131s 2026<\/p>\n<\/div>\n<\/header>\n

 <\/p>\n

<\/p>\n

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580 B KRW<\/p>\n

Kore a\u011f\u0131zdan al\u0131nan s\u0131v\u0131 ila\u00e7 pazar\u0131 2025<\/p>\n<\/div>\n

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PET \/ PP<\/p>\n

Kore'de a\u011f\u0131zdan al\u0131nan s\u0131v\u0131 \u00fcr\u00fcnlerin ambalajlanmas\u0131 i\u00e7in birincil ISBM re\u00e7ineleri.<\/p>\n<\/div>\n

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CRC<\/p>\n

Kore'de re\u00e7eteyle sat\u0131lan a\u011f\u0131zdan al\u0131nan s\u0131v\u0131 ila\u00e7lar i\u00e7in \u00e7ocuk kilidi zorunlulu\u011fu getirilmi\u015ftir.<\/p>\n<\/div>\n

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60\u2013500 ml<\/p>\n

Standart Kore oral s\u0131v\u0131 \u015fi\u015fesi hacim aral\u0131\u011f\u0131<\/p>\n<\/div>\n

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55\u2013120 KRW<\/p>\n

Premium oral s\u0131v\u0131 ISBM \u015fi\u015fe s\u00f6zle\u015fme fiyat\u0131 (100\u2013200ml)<\/p>\n<\/div>\n<\/div>\n

<\/p>\n

1. Kore Oral S\u0131v\u0131 \u0130la\u00e7 Pazar\u0131 ve ISBM Ambalajlama F\u0131rsat\u0131<\/h2>\n

Kore'de \u00fcretilen oral s\u0131v\u0131 ila\u00e7lar (\u00e7ocuk antibiyotikleri, \u00e7ocuk \u00f6ks\u00fcr\u00fck \u015furuplar\u0131, re\u00e7etesiz sat\u0131lan antasit s\u00fcspansiyonlar\u0131, demir takviyeleri ve re\u00e7eteli oral sol\u00fcsyonlar), ayn\u0131 anda iki d\u00fczenleyici \u00e7er\u00e7eveyi birle\u015ftirdikleri i\u00e7in teknik a\u00e7\u0131dan en zorlu Kore ISBM ambalaj uygulamalar\u0131ndan birini temsil etmektedir: Kore KFDA \u0130la\u00e7 \u0130\u015fleri Yasas\u0131 (\uc758\uc57d\ud488 \uc6a9\uae30\u00b7\ud3ec\uc7a5 \uae30\uc900) ve Kore \u00c7ocuk G\u00fcvenli\u011fi Ambalaj Yasas\u0131 (\uc544\ub3d9 \uc548\uc804 \ud3ec\uc7a5 \ub300\uc0c1 \uc758\uc57d\ud488 \uc9c0\uc815). \u015ei\u015fe, g\u0131da temas\u0131 testlerinden daha s\u0131k\u0131 olan ila\u00e7 migrasyon testlerinden ge\u00e7meli, boyun m\u00fchendisli\u011fi karma\u015f\u0131kl\u0131\u011f\u0131 ekleyen \u00e7ocuk kilidi (CRC) mekanizmalar\u0131n\u0131 bar\u0131nd\u0131rmal\u0131 ve Koreli eczac\u0131 veya bak\u0131c\u0131n\u0131n do\u011fru doz \u00f6l\u00e7\u00fcm\u00fc i\u00e7in kulland\u0131\u011f\u0131 derecelendirme i\u015faretlerini ta\u015f\u0131mal\u0131d\u0131r.<\/p>\n

Kore ISBM oral s\u0131v\u0131 \u015fi\u015fe \u00fcretimi, daha geni\u015f Kore ila\u00e7 ISBM ortam\u0131ndan (ki bu ortam kat\u0131 oral dozaj tablet\/kaps\u00fcl \u015fi\u015feleri ve IV ambalajlamaya odaklanmaktad\u0131r) farkl\u0131d\u0131r; oral s\u0131v\u0131 \u015fi\u015felerin farkl\u0131 uyumluluk yollar\u0131 ve farkl\u0131 ISBM m\u00fchendislik gereksinimleri vard\u0131r. Kore ila\u00e7 GMP ambalajlama \u00e7er\u00e7evesinin tamam\u0131 \u015furada yer almaktad\u0131r: Kore ila\u00e7 end\u00fcstrisi GMP \u015fi\u015fe \u00fcretim k\u0131lavuzu<\/a>.<\/p>\n

<\/p>\n

2. Kore A\u011f\u0131zdan Al\u0131nan S\u0131v\u0131 \u0130la\u00e7 \u015ei\u015feleri i\u00e7in PET ve PP<\/h2>\n
\"Enjeksiyonlu
\nKore ISBM a\u011f\u0131zdan al\u0131nan s\u0131v\u0131 ila\u00e7 \u015fi\u015fesi serisi; \u015feffaf PET 100 ml \u00e7ocuk antibiyotik \u015furubu (kristal berrakl\u0131k \u00fcr\u00fcn rengini g\u00f6sterir; CRC basmal\u0131 ve \u00e7evirmeli kapak), kehribar PET 200 ml demir takviyesi a\u011f\u0131zdan al\u0131nan \u00e7\u00f6zelti (demir tuzu fotode\u011fradasyonuna kar\u015f\u0131 UV korumas\u0131), beyaz PP 120 ml antasit s\u00fcspansiyonu (magnezyum hidroksit s\u00fcspansiyonunun \u0131\u015f\u0131ktan korunmas\u0131 i\u00e7in opak) ve Kore eczanelerinde kullan\u0131m i\u00e7in PETG 60 ml hassas a\u011f\u0131zdan damlal\u0131kl\u0131 \u015fi\u015fe.<\/figcaption><\/figure>\n

Kore'de a\u011f\u0131zdan al\u0131nan s\u0131v\u0131 ila\u00e7lar i\u00e7in \u015fi\u015fe re\u00e7inesi se\u00e7imi, aktif farmas\u00f6tik bile\u015fen (API) kimyas\u0131 ve Kore G\u0131da ve \u0130la\u00e7 \u0130daresi (KFDA) ila\u00e7 kab\u0131 pozitif listesine g\u00f6re belirlenir. A\u011f\u0131zdan al\u0131nan s\u0131v\u0131lar i\u00e7in PET: Sulu a\u011f\u0131zdan al\u0131nan \u00e7\u00f6zeltiler (\u015furuplar, a\u011f\u0131zdan al\u0131nan \u00e7\u00f6zeltiler), alkol i\u00e7eren a\u011f\u0131zdan al\u0131nan s\u0131v\u0131lar (5\u201315% etanol i\u00e7eren Kore re\u00e7etesiz \u00f6ks\u00fcr\u00fck ilac\u0131) ve demir takviyesi a\u011f\u0131zdan al\u0131nan \u00e7\u00f6zeltiler (demir s\u00fclfat, demir amonyum sitrat) i\u00e7in uygundur. Amber masterbatch (demir oksit) i\u00e7eren PET: Kore'de \u0131\u015f\u0131\u011fa duyarl\u0131 a\u011f\u0131zdan al\u0131nan s\u0131v\u0131lar (demir takviyeleri, A vitamini, riboflavin) i\u00e7in gereklidir \u2014 400 nm'de UV ge\u00e7irgenli\u011fi \u226410%.<\/p>\n

Oral s\u0131v\u0131lar i\u00e7in PP: Kore antasit s\u00fcspansiyonlar\u0131 (pH 8,5\u201310,5'te magnezyum hidroksit, al\u00fcminyum hidroksit - PET'in \u00f6nerilen pH tavan\u0131 olan 9'un \u00fczerinde); Kore ibuprofen oral s\u00fcspansiyonu (Kore farmakopesine uygunluk i\u00e7in PET yerine PP gerektiren, lipofilik bir ila\u00e7 olan ibuprofen); ve Kore kaolin-pektin s\u00fcspansiyonu (\u00fcr\u00fcn g\u00f6r\u00fcn\u00fcm tutarl\u0131l\u0131\u011f\u0131 i\u00e7in beyaz PP gerektiren opak partik\u00fcl s\u00fcspansiyonu) i\u00e7in gereklidir. Kore ila\u00e7 kab\u0131 pozitif listesinde PET ve PP i\u00e7in re\u00e7ine se\u00e7imi, sistematik bir yakla\u015f\u0131m\u0131 izler. PET ve PETG re\u00e7ine se\u00e7imi k\u0131lavuzu<\/a>.<\/p>\n

<\/p>\n

3. Kore A\u011f\u0131zdan Al\u0131nan S\u0131v\u0131lar \u0130\u00e7in \u00c7ocuk Kilidi \u00d6zellikli Kapak Boyun Tasar\u0131m\u0131<\/h2>\n

Kore \u00c7ocuk G\u00fcvenli\u011fi Ambalajlama Yasas\u0131 (\uc5b4\ub9b0\uc774 \ubcf4\ud638 \ud3ec\uc7a5 \uae30\uc900), t\u00fcm re\u00e7eteli pediatrik oral s\u0131v\u0131 ila\u00e7larda ve tan\u0131mlanm\u0131\u015f konsantrasyon e\u015fiklerinin \u00fczerinde aktif farmas\u00f6tik bile\u015fen (API) i\u00e7eren belirli re\u00e7etesiz (OTC) kategorilerinde \u00e7ocuklara kar\u015f\u0131 dayan\u0131kl\u0131 kapaklar (CRC) kullan\u0131lmas\u0131n\u0131 zorunlu k\u0131lmaktad\u0131r. Kore CRC uyumlulu\u011fu, kapak mekanizmas\u0131n\u0131n Kore KFDA taraf\u0131ndan belirtilen CRC performans testini ge\u00e7mesini gerektirir: 5 dakika i\u00e7inde test edilen \u2265851 adet 33 \u00e7ocuk (42-51 ay aras\u0131) kapa\u011f\u0131 a\u00e7amazken, 5 dakika i\u00e7inde test edilen \u2265901 adet 33 yeti\u015fkin (50-70 ya\u015f aras\u0131) kapa\u011f\u0131 ba\u015far\u0131yla a\u00e7mal\u0131d\u0131r.<\/p>\n

Kore ISBM oral s\u0131v\u0131 \u015fi\u015felerinin CRC uyumlulu\u011fu i\u00e7in boyun kaplamas\u0131: Boyun profili, Kore ila\u00e7 markas\u0131 taraf\u0131ndan belirtilen \u00f6zel CRC kapatma mekanizmas\u0131na uygun olmal\u0131d\u0131r. \u0130ki yayg\u0131n Kore oral s\u0131v\u0131 CRC mekanizmas\u0131: (1) \u0130tme ve \u00e7evirme (P&T) CRC: T\u00fcketici kapa\u011f\u0131 \u00e7evirirken a\u015fa\u011f\u0131 do\u011fru itmelidir \u2014 kapa\u011f\u0131n itme mandal di\u015fine temas eden \u00f6zel bir omuz profiline sahip boyun kaplamas\u0131 gerektirir; tutarl\u0131 mandal kavrama kuvveti sa\u011flamak i\u00e7in boyun d\u0131\u015f \u00e7ap tolerans\u0131 \u00b10,03 mm'dir (standart farmas\u00f6tik \u00b10,04 mm'den daha s\u0131k\u0131). (2) K\u00fc\u00e7\u00fck Kore oral s\u0131v\u0131 \u015fi\u015feleri (60-100 ml) i\u00e7in s\u0131kma ve \u00e7evirme (S&T) CRC: T\u00fcketicinin \u00e7evirirken s\u0131kt\u0131\u011f\u0131 orta boyun b\u00f6lgesinde oval bir deformasyon b\u00f6lgesi gerektirir \u2014 boynun CRC kavrama b\u00f6lgesinde oval kesit gerektirir (\u00b10,02 mm oval sapma tolerans\u0131). Her iki CRC boyun tipi de, ISBM boyun ek par\u00e7as\u0131n\u0131n CRC tedarik\u00e7isinin detayl\u0131 boyutland\u0131rma \u00e7iziminden tasarlanmas\u0131n\u0131 gerektirir; genel boyun ek par\u00e7as\u0131 tasar\u0131mlar\u0131, testin \"\u00e7ocuk ar\u0131zas\u0131\" kriteri c\u0131rc\u0131r kavrama profilindeki \u00b10,05 mm'lik varyasyonlara duyarl\u0131 oldu\u011fundan, CRC performans testi ge\u00e7me oran\u0131na g\u00fcvenilir bir \u015fekilde ula\u015famaz.<\/p>\n

CRC uyumlulu\u011fu i\u00e7in gereken boyun par\u00e7as\u0131 m\u00fchendisli\u011fi hassasiyet gereksinimleri (2316 paslanmaz \u00e7elik par\u00e7a spesifikasyonu ve c\u0131rc\u0131r kavrama b\u00f6lgesi i\u00e7in elmasla parlat\u0131lm\u0131\u015f y\u00fczey dahil), Fakt\u00f6r 3 (boyun par\u00e7as\u0131 m\u00fchendisli\u011fi) kapsam\u0131 dahilindedir. 9 fakt\u00f6rl\u00fc Kore ISBM kal\u0131p se\u00e7imi k\u0131lavuzu<\/a>.<\/p>\n

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4. Kore Oral S\u0131v\u0131 ISBM i\u00e7in KFDA \u0130la\u00e7 Ambalaj\u0131 Uyumlulu\u011fu<\/h2>\n
\"Kore
Kore ISBM ila\u00e7 oral s\u0131v\u0131 \u015fi\u015fesi hassas kal\u0131p detay\u0131 \u2014 itmeli ve \u00e7evirmeli CRC boyun profili (c\u0131rc\u0131r ba\u011flant\u0131s\u0131 i\u00e7in \u00b10,03 mm d\u0131\u015f \u00e7ap), derecelendirme i\u015faretleme penceresi b\u00f6lgesi (do\u011fru etiket bask\u0131l\u0131 derecelendirmeler i\u00e7in d\u00fcz panel \u00b10,15 mm) ve \u0131\u015f\u0131\u011fa duyarl\u0131 Kore demir takviyesi oral sol\u00fcsyonu i\u00e7in kehribar renkli masterbatch giri\u015f noktas\u0131. Her \u00fc\u00e7 \u00f6zellik de ayn\u0131 ISBM \u015fi\u015fesinde ba\u011f\u0131ms\u0131z hassasiyet spesifikasyonlar\u0131 gerektirir.<\/figcaption><\/figure>\n

Kore KFDA'n\u0131n oral s\u0131v\u0131 ISBM \u015fi\u015feleri i\u00e7in ila\u00e7 kab\u0131 uyumlulu\u011fu, Kore Farmakopesi (\ub300\ud55c\uc57d\uc804) kap standard\u0131 ve KFDA ila\u00e7 kab\u0131 g\u00fcvenlik standard\u0131na (\uc758\uc57d\ud488 \uc6a9\uae30\u00b7\ud3ec\uc7a5 \uae30\uc900) uymaktad\u0131r. Kore oral s\u0131v\u0131 ISBM \u015fi\u015felerinin ila\u00e7 kayd\u0131 i\u00e7in belge gereksinimleri: (1) Kap malzemesi pozitif liste onay\u0131 \u2014 PET ve PP, Kore Farmakopesi kap malzemesi pozitif listesinde belirli migrasyon limitleriyle yer almaktad\u0131r; (2) Ekstrakt testi \u2014 \u015fi\u015fe malzemesinin 70\u00b0C'de 1 saat s\u00fcreyle sulu ekstrakt\u0131, a\u011f\u0131r metaller (\u22641 ppm), oksitlenebilir maddeler (\u22640,5 mg\/L KMnO\u2084 e\u015fde\u011feri) ve u\u00e7ucu olmayan kal\u0131nt\u0131 (\u226450 mg\/L) a\u00e7\u0131s\u0131ndan \u00f6l\u00e7\u00fclm\u00fc\u015ft\u00fcr; (3) \u0130la\u00e7 uyumluluk testi \u2014 spesifik oral s\u0131v\u0131 API, \u00fcretim \u015fi\u015fesinde Kore h\u0131zland\u0131r\u0131lm\u0131\u015f stabilite depolamas\u0131nda (40\u00b0C\/75%RH) 6 ay sonra \u22645% konsantrasyon kayb\u0131 ve \u22640,05% polimer bozunma \u00fcr\u00fcn\u00fc olu\u015fumu g\u00f6stermelidir; (4) CRC performans testi sertifikas\u0131 (CRC gerekiyorsa) \u2014 Kore KFDA spesifikasyonuna g\u00f6re test \u00e7ocuklar\u0131yla \u00fc\u00e7\u00fcnc\u00fc taraf CRC testi.<\/p>\n

ISBM \u015fi\u015fesinin duvar kal\u0131nl\u0131\u011f\u0131 da\u011f\u0131l\u0131m\u0131n\u0131 ve dolay\u0131s\u0131yla ekstrakt test sonu\u00e7lar\u0131n\u0131 etkileyen y\u00fczey alan\u0131-hacim oran\u0131n\u0131 belirleyen \u00f6n kal\u0131p tasar\u0131m\u0131, Kore oral s\u0131v\u0131 ila\u00e7 ISBM uyumlulu\u011funun temelini olu\u015fturmaktad\u0131r. \u0130lgili prensipler \u015funlard\u0131r: ISBM \u00f6n \u015fekillendirme tasar\u0131m temelleri k\u0131lavuzu<\/a>.<\/p>\n

<\/p>\n

5. Dozaj \u00d6l\u00e7\u00fcm \u0130\u015faretleme ve Etiket Paneli M\u00fchendisli\u011fi<\/h2>\n

Kore'de a\u011f\u0131zdan al\u0131nan s\u0131v\u0131 ila\u00e7 \u015fi\u015felerinde, Koreli eczac\u0131lar\u0131n, hastalar\u0131n ve bak\u0131m verenlerin dozlar\u0131 do\u011fru bir \u015fekilde \u00f6l\u00e7ebilmelerini sa\u011flayan derecelendirme i\u015faretleri bulunmas\u0131 gerekmektedir. Kore KFDA a\u011f\u0131zdan al\u0131nan s\u0131v\u0131 ila\u00e7 dozaj derecelendirme standard\u0131: 60-150 ml'lik \u015fi\u015feler i\u00e7in 2,5 ml ve 5 ml aral\u0131klarla; 150-500 ml'lik \u015fi\u015feler i\u00e7in 10 ml aral\u0131klarla derecelendirme i\u015faretleri; 20\u00b0C'de i\u015faretli hacmin \u00b15%'si kadar derecelendirme do\u011frulu\u011fu. Kore ISBM \u015fi\u015fe etiket paneli m\u00fchendisli\u011fi, derecelendirme do\u011frulu\u011fu i\u00e7in: derecelendirme i\u015faretleri etikete bas\u0131l\u0131r (\u015fi\u015fe duvar\u0131na kal\u0131planmaz - kal\u0131planm\u0131\u015f derecelendirmeler, \u00fcretimden sonra GMP taraf\u0131ndan yeniden do\u011frulanabilir olmad\u0131klar\u0131 i\u00e7in Kore ila\u00e7 etiketlemesinde izin verilmez). Kore a\u011f\u0131zdan al\u0131nan s\u0131v\u0131 ila\u00e7 derecelendirme i\u015faretlerini ta\u015f\u0131yan etiket paneli, etiket derecelendirme konumlar\u0131n\u0131n i\u015faretli derecelendirme \u00e7izgisindeki do\u011fru dolum hacmine kar\u015f\u0131l\u0131k gelmesini sa\u011flamak i\u00e7in d\u00fcz (\u00b10,15 mm d\u00fczl\u00fck) ve boyut olarak tutarl\u0131 (\u00b10,20 mm d\u0131\u015f \u00e7ap) olmal\u0131d\u0131r. Kore men\u015feli bir oral s\u0131v\u0131 \u015fi\u015fesinin, \u015fi\u015fe g\u00f6vdesinde her bir mezura i\u015fareti i\u00e7in yakla\u015f\u0131k \u00b13%'lik mezura i\u015faretleme hatas\u0131 olu\u015facakt\u0131r; bu da Kore KFDA'n\u0131n \u00b15% do\u011fruluk gereksinimine s\u0131n\u0131rda uyum sa\u011flamakta ve etiket bask\u0131 kay\u0131t varyasyonu i\u00e7in hi\u00e7bir g\u00fcvenlik pay\u0131 b\u0131rakmamaktad\u0131r. Oral s\u0131v\u0131 ila\u00e7 markalar\u0131na tedarik sa\u011flayan Koreli ISBM \u00fcreticileri, kalibre edilmi\u015f bir b\u00fcret kullanarak her bir mezura i\u015faretine kadar 20 \u00fcretim \u015fi\u015fesini doldurarak ve dolum hacmini i\u015faretli hacimle kar\u015f\u0131la\u015ft\u0131rarak mezura do\u011frulu\u011funu do\u011frulamal\u0131d\u0131r; bu do\u011frulama, Koreli ila\u00e7 markalar\u0131na sunulacak ilk \u00fcr\u00fcn raporunun bir par\u00e7as\u0131 olmal\u0131d\u0131r.<\/p>\n

\"enjeksiyon-gerdirme-\u015fi\u015firme-kal\u0131plama-uygulamas\u0131-6\"<\/p>\n

6. Kore A\u011f\u0131zdan Al\u0131nan S\u0131v\u0131 \u0130la\u00e7 Marka Manzaras\u0131<\/h2>\n
\"Kore
Kore men\u015feli Ever-Power HGY150-V4 hassas \u00fcretim platformu, Kore'de a\u011f\u0131zdan al\u0131nan s\u0131v\u0131 ila\u00e7 \u015fi\u015felerinin \u00fcretimi i\u00e7in 4 hazneli 100 ml CRC pediatrik \u015furup \u015fi\u015felerini 10 saniyelik d\u00f6ng\u00fcde (tam CRC boyun profili olu\u015fumu i\u00e7in Kore ila\u00e7 s\u0131n\u0131f\u0131 \u00fcfleme bekleme s\u00fcresi) \u00fcretiyor ve Kore'deki Dong-A, Yuhan, Hanmi ve 80'den fazla Koreli jenerik ila\u00e7 firmas\u0131n\u0131n a\u011f\u0131zdan al\u0131nan s\u0131v\u0131 ila\u00e7 tedarik s\u00f6zle\u015fmesi i\u00e7in 16 saatte y\u0131lda 16,4 milyon \u015fi\u015fe \u00fcretiyor.<\/figcaption><\/figure>\n

Kore men\u015feili oral s\u0131v\u0131 ila\u00e7lar i\u00e7in ISBM ambalaj\u0131 \u00fc\u00e7 marka kademesine tedarik edilmektedir. Kore markal\u0131 etik ila\u00e7lar (Dong-A Pharmaceutical \ub3d9\uc544\uc81c\uc57d, Yuhan Corporation \uc720\ud55c\uc591\ud589, Hanmi Pharmaceutical \ud55c\ubbf8\uc57d\ud488, Boryung Pharmaceutical \ubcf4\ub839\uc81c\uc57d oral s\u0131v\u0131lar): en y\u00fcksek uyumluluk gereksinimleri, 24-36 ayl\u0131k tedarik\u00e7i yeterlilik s\u00fcreci, ISBM tesisinin yerinde KFDA GMP denetimi, y\u0131ll\u0131k yeniden yeterlilik, 100-200 ml'lik premium oral s\u0131v\u0131lar i\u00e7in \u015fi\u015fe ba\u015f\u0131na 75-120 KRW (CRC ile). Kore jenerik\/OTC ila\u00e7lar\u0131 (Kore jenerik antibiyotikler, Kore OTC antasitler, Kore multivitamin oral s\u0131v\u0131 markalar\u0131): standart KFDA ila\u00e7 ambalaj\u0131 uyumlulu\u011fu, 12-18 ayl\u0131k yeterlilik s\u00fcreci, \u015fi\u015fe ba\u015f\u0131na 42-75 KRW. Kore hastane\/kurum eczanesi ila\u00e7 haz\u0131rlama tedari\u011fi (Kore hastane eczanesi oral s\u0131v\u0131 ila\u00e7 da\u011f\u0131t\u0131m \u015fi\u015feleri - eczac\u0131lar\u0131n ila\u00e7 haz\u0131rlamas\u0131 i\u00e7in temiz ancak GMP standartlar\u0131na uygun olmayan kaplar): en basit uyumluluk yolu (g\u0131da ile temas eden PET, ila\u00e7 haz\u0131rlama da\u011f\u0131t\u0131m \u015fi\u015feleri i\u00e7in kabul edilebilir), 3-6 ayl\u0131k yeterlilik s\u00fcresi, standart PET da\u011f\u0131t\u0131m formatlar\u0131 i\u00e7in \u015fi\u015fe ba\u015f\u0131na 28-42 KRW. Kore ila\u00e7 oral s\u0131v\u0131 ISBM kapasite planlamas\u0131 - her ila\u00e7 markas\u0131 kademesinin y\u0131ll\u0131k hacmi i\u00e7in optimum bo\u015fluk say\u0131s\u0131n\u0131n belirlenmesi - a\u015famas\u0131ndad\u0131r. Kore ISBM bo\u015fluk say\u0131s\u0131 hesaplay\u0131c\u0131s\u0131<\/a>.<\/p>\n

<\/p>\n

7. Kore A\u011f\u0131zdan Al\u0131nan S\u0131v\u0131 \u0130la\u00e7 \u015ei\u015fesi Format\u0131 \u00d6zellikleri<\/h2>\n
\n\n\n\n\n\n\n\n\n\n
\u00dcr\u00fcn<\/th>\nHacim<\/th>\nRe\u00e7ine<\/th>\nBoyun\/Kapatma<\/th>\nTemel Uyumluluk<\/th>\n<\/tr>\n<\/thead>\n
\u00c7ocuklar i\u00e7in antibiyotik \u015furubu<\/td>\n60\u2013100 ml<\/td>\n\u015eeffaf PET<\/td>\n28mm P&T CRC<\/td>\nCRC zorunludur; GMP onayl\u0131 temiz i\u00e7 mekan; farmakope \u00f6z\u00fc testi; ila\u00e7 uyumlulu\u011fu.<\/td>\n<\/tr>\n
A\u011f\u0131zdan demir takviyesi<\/td>\n100\u2013200 ml<\/td>\nAmber PET<\/td>\n28 mm CRC<\/td>\n400 nm'de UV \u226410%; demir tuzu uyumlulu\u011fu; derecelendirme \u00b15%<\/td>\n<\/tr>\n
Antiasit s\u00fcspansiyonu<\/td>\n120\u2013200 ml<\/td>\nBeyaz PP<\/td>\n38 mm \u00e7evirmeli veya CRC<\/td>\npH 9\u201310,5 i\u00e7in PP; MgOH s\u00fcspansiyonu i\u00e7in opak; viskoz d\u00f6kme i\u00e7in geni\u015f a\u011f\u0131zl\u0131.<\/td>\n<\/tr>\n
\u00c7oklu vitamin oral s\u0131v\u0131<\/td>\n100\u2013300 ml<\/td>\nAmber PET<\/td>\n28 mm standart veya CRC<\/td>\nRiboflavin ve A vitamini i\u00e7in UV korumas\u0131; KFDA sa\u011fl\u0131k fonksiyonel g\u0131da s\u0131n\u0131fland\u0131rmas\u0131<\/td>\n<\/tr>\n
Eczane ila\u00e7 haz\u0131rlama \u015fi\u015fesi<\/td>\n100\u2013500 ml<\/td>\n\u015eeffaf PET<\/td>\n28\u201338 mm vida<\/td>\nKurumsal; mezuniyet do\u011frulu\u011fu; da\u011f\u0131t\u0131m etiketi uyumlulu\u011fu; basitle\u015ftirilmi\u015f uyumluluk<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n

<\/p>\n

8. Kore Oral S\u0131v\u0131 \u0130la\u00e7 ISBM \u00dcretim Ekonomisi<\/h2>\n

Kore'de HGY150-V4-EV modelinde, 4 bo\u015fluklu 100 ml'lik CRC pediatrik \u015furup (tam CRC boyun profili olu\u015fumu i\u00e7in 10 saniyelik d\u00f6ng\u00fc) i\u00e7in kullan\u0131lan oral s\u0131v\u0131 ila\u00e7 ISBM sistemi, g\u00fcnde 16 saat \u00e7al\u0131\u015farak y\u0131lda yakla\u015f\u0131k 16,4 milyon \u015fi\u015fe \u00fcretiyor. Kore markal\u0131 etik ila\u00e7 tedari\u011fi i\u00e7in \u015fi\u015fe ba\u015f\u0131na 88 KRW fiyatla, bu makine ba\u015f\u0131na y\u0131ll\u0131k 1,44 milyar KRW gelir anlam\u0131na geliyor ve Kore ISBM gelir kademeleri aras\u0131nda en y\u00fckseklerden biri. Bununla birlikte, Kore oral s\u0131v\u0131 ila\u00e7 ISBM yat\u0131r\u0131m\u0131, uyumluluk a\u00e7\u0131s\u0131ndan ek bir maliyet gerektiriyor: KFDA ila\u00e7 kab\u0131 tesisi kayd\u0131 (3-6 ay), y\u0131ll\u0131k yeniden yeterlilik maliyeti (15-35 milyon KRW\/y\u0131l), GMP s\u0131n\u0131f\u0131 \u00fcretim ortam\u0131 bak\u0131m\u0131 (\u00e7\u0131karma b\u00f6lgesinde temiz oda veya e\u015fde\u011feri) ve CRC boyun ek par\u00e7as\u0131 premium kal\u0131plama (standart boyun ek par\u00e7as\u0131na k\u0131yasla kal\u0131p ba\u015f\u0131na 10-20 milyon KRW ek kal\u0131plama maliyeti). Koreli ISBM \u00fcreticisinin oral s\u0131v\u0131 ila\u00e7 uyumlulu\u011fu yat\u0131r\u0131m\u0131n\u0131n toplam geri \u00f6deme s\u00fcresi: 1,44 milyar KRW gelir, 185 milyon KRW makine yat\u0131r\u0131m\u0131 + 55 milyon KRW CRC kal\u0131p + 25 milyon KRW KFDA onay\u0131 = toplam 265 milyon KRW yat\u0131r\u0131m. Bu yat\u0131r\u0131m, Kore markal\u0131 ila\u00e7 tedarikinin ba\u015flamas\u0131ndan itibaren 3 ay i\u00e7inde tamamen geri kazan\u0131ld\u0131; bu, herhangi bir uygulama kategorisindeki en h\u0131zl\u0131 Kore ISBM yat\u0131r\u0131m geri d\u00f6n\u00fc\u015f profillerinden biridir.<\/p>\n

\"Kore
Kore ISBM ila\u00e7 oral s\u0131v\u0131 \u015fi\u015fe GMP \u00fcretim ortam\u0131 \u2014 temiz bo\u015faltma alan\u0131, parti onay dok\u00fcman\u0131 (Kalite Kontrol Uzman\u0131 imzal\u0131 CoA) ve \u00fcretim istasyonunda sergilenen KFDA ila\u00e7 kab\u0131 uygunluk sertifikas\u0131. Koreli markal\u0131 ila\u00e7 m\u00fc\u015fterileri, bu \u00fcretim ortam\u0131n\u0131 do\u011frudan de\u011ferlendiren y\u0131ll\u0131k yerinde GMP denetimleri ger\u00e7ekle\u015ftiriyor; makinede g\u00f6r\u00fclebilen fiziksel temizlik ve dok\u00fcmantasyon disiplini, parti CoA's\u0131ndaki boyut verileri kadar \u00f6nemlidir.<\/figcaption><\/figure>\n

S\u0131k\u00e7a Sorulan Sorular<\/h2>\n
\n
\n

S1 \u2014 Kore'de hangi API kategorileri her zaman kehribar renkli PET oral s\u0131v\u0131 \u015fi\u015feleri gerektirir?<\/p>\n

Fotolabil olan ve kehribar rengi PET veya kehribar rengi cam kaplarda saklanmas\u0131 gereken Kore oral s\u0131v\u0131 API kategorileri \u015funlard\u0131r: demir bile\u015fikleri (demir s\u00fclfat, demir amonyum sitrat, demir glukonat - standart dozlarda UV \u0131\u015f\u0131nlar\u0131na maruz kald\u0131ktan sonra 48-72 saat i\u00e7inde \u00e7\u00f6z\u00fcnmeyen demir \u00e7\u00f6keltisine foto-oksitlenir); riboflavin (B2 vitamini - 6000 l\u00fcks \u0131\u015f\u0131kta \u015feffaf camda 2 saatlik yar\u0131 \u00f6m\u00fcrle 400 nm'de foto-de\u011fi\u015fime u\u011frar); A ve D vitaminleri (ya\u011fda \u00e7\u00f6z\u00fcnen vitaminler, su i\u00e7inde ya\u011f em\u00fclsiyonu oral s\u0131v\u0131larda - 4 haftal\u0131k \u015feffaf kapta perakende sat\u0131\u015fta \u226520% etki kayb\u0131yla 320-400 nm'de foto-oksitlenir); ve baz\u0131 Kore antibiyotik s\u00fcspansiyonlar\u0131 (doksisiklin hiklat oral s\u00fcspansiyon - 350-420 nm'de foto-de\u011fi\u015fime u\u011frar, Kore farmakopesi kehribar rengi kab\u0131n zorunlu oldu\u011funu belirtir). Kore ISBM kehribar rengi PET \u015fi\u015feler i\u00e7in, 400 nm'de \u226410% UV ge\u00e7irgenlik spesifikasyonu, \u0131\u015f\u0131\u011fa duyarl\u0131 oral s\u0131v\u0131 korumas\u0131 i\u00e7in Kore farmakopesinden t\u00fcretilen standart hedef de\u011ferdir. Standart PET oral s\u0131v\u0131 duvar kal\u0131nl\u0131\u011f\u0131nda (0,25\u20130,30 mm) 400 nm'de \u226410% UV i\u00e7in Kore kehribar rengi masterbatch demir oksit y\u00fcklemesi: PET ta\u015f\u0131y\u0131c\u0131da yakla\u015f\u0131k 0,7\u20131,1% LDR demir oksit masterbatch \u2014 Kore ila\u00e7 markas\u0131n\u0131n ilk \u00fcr\u00fcn teslimat\u0131ndan \u00f6nce \u00fcretim \u015fi\u015felerinde UV ge\u00e7irgenlik \u00f6l\u00e7\u00fcm\u00fc ile do\u011frulanmal\u0131d\u0131r.<\/p>\n<\/div>\n

\n

S2 \u2014 Kore G\u0131da ve \u0130la\u00e7 \u0130daresi'nin (KFDA) bir ila\u00e7 \u00fcr\u00fcn\u00fc i\u00e7in yeni bir oral s\u0131v\u0131 \u015fi\u015fesini tescil ettirme s\u00fcreci nedir?<\/p>\n

Kore KFDA ila\u00e7 \u00fcr\u00fcn kayd\u0131, \u00fcr\u00fcn kay\u0131t dosyas\u0131nda birincil kab\u0131n belirtilmesini gerektirir. Yeni bir oral s\u0131v\u0131 \u015fi\u015fesi i\u00e7in ISBM \u015fi\u015fe tedarik\u00e7isi \u015funlar\u0131 sa\u011flar: (1) malzeme spesifikasyonu (PET veya PP re\u00e7ine s\u0131n\u0131f\u0131, pozitif liste onay\u0131, tedarik\u00e7i Uygunluk Beyan\u0131); (2) ekstrakt test sonucu (Kore Farmakopesi kap standard\u0131na uygun 70\u00b0C\/1 saatte sulu ekstrakt); (3) ila\u00e7 uyumluluk testi (API konsantrasyon stabilitesini ve 0,05%'nin \u00fczerinde bozunma \u00fcr\u00fcnlerinin yoklu\u011funu do\u011frulayan 40\u00b0C\/75%RH'de 6 ayl\u0131k h\u0131zland\u0131r\u0131lm\u0131\u015f stabilite); (4) kap spesifikasyon sayfas\u0131 (boyut \u00e7izimleri, nominal hacim, malzeme, kapak spesifikasyonu); (5) CRC performans test sertifikas\u0131 (CRC gerekiyorsa - Kore KFDA taraf\u0131ndan tan\u0131nan bir CRC test laboratuvar\u0131ndan). Kore KFDA ila\u00e7 \u00fcr\u00fcn kay\u0131t incelemesi, yeni NCE (yeni kimyasal madde) \u00fcr\u00fcnler i\u00e7in 12-18 ay ve kap malzemesi t\u00fcr\u00fc ve hacmi referans \u00fcr\u00fcnle ayn\u0131 olan jenerik \u00fcr\u00fcn kayd\u0131 i\u00e7in 3-6 ay s\u00fcrer. Kore'de, PET ve PP re\u00e7inelerini KFDA'dan (Kenya G\u0131da ve \u0130la\u00e7 \u0130daresi) 3 y\u0131l ge\u00e7erli bir ekstrakt test sertifikas\u0131yla \u00f6n yeterlilikten ge\u00e7irmi\u015f ISBM \u00fcreticileri, ila\u00e7 markas\u0131 m\u00fc\u015fterilerine Kore \u00fcr\u00fcn kayd\u0131 i\u00e7in gerekli belgeleri ilk \u00fcr\u00fcn onay\u0131ndan sonra 4-8 hafta i\u00e7inde sa\u011flayabilirler; oysa her yeni ila\u00e7 m\u00fc\u015fterisi i\u00e7in yeni ekstrakt testi yapt\u0131rmak zorunda olan \u00fcreticiler i\u00e7in bu s\u00fcre 3-6 ay s\u00fcrmektedir.<\/p>\n<\/div>\n

\n

S3 \u2014 Kore ISBM CRC oral s\u0131v\u0131 \u015fi\u015fe \u00fcretimi, standart ki\u015fisel bak\u0131m pompa \u015fi\u015fe \u00fcretiminden nas\u0131l farkl\u0131l\u0131k g\u00f6sterir?<\/p>\n

Kore ISBM CRC oral s\u0131v\u0131 \u015fi\u015fe \u00fcretimi, ki\u015fisel bak\u0131m pompa \u015fi\u015fe \u00fcretiminden be\u015f a\u00e7\u0131dan farkl\u0131l\u0131k g\u00f6sterir. Birincisi, boyun hassasiyeti: CRC P&T mekanizmas\u0131, ki\u015fisel bak\u0131m losyon pompalar\u0131nda \u00b10,04\u20130,05 mm'ye kar\u015f\u0131l\u0131k, boyun d\u0131\u015f \u00e7ap\u0131nda \u00b10,03 mm hassasiyet gerektirir (ayn\u0131 fiziksel nedenden dolay\u0131 Kore toner pompalar\u0131yla ayn\u0131d\u0131r - zorlamal\u0131 ge\u00e7me mekanizmas\u0131n\u0131n d\u0131\u015f \u00e7ap varyasyonuna duyarl\u0131l\u0131\u011f\u0131). \u0130kincisi, s\u00fcre\u00e7 do\u011frulama dok\u00fcmantasyonu: CRC \u015fi\u015feleri, t\u00fcm bo\u015fluklarda ve t\u00fcm \u00fcretim partilerinde CRC kavrama kuvvetinin tutarl\u0131 oldu\u011funu g\u00f6steren belgelenmi\u015f s\u00fcre\u00e7 do\u011frulamas\u0131 gerektirir - ki\u015fisel bak\u0131m pompa \u015fi\u015felerinde bu gerekli de\u011fildir. \u00dc\u00e7\u00fcnc\u00fcs\u00fc, CRC performans testi: Kore KFDA taraf\u0131ndan belirtilen, \u00e7ocuklarla (42-51 ayl\u0131k) yap\u0131lan CRC testi, Kore ila\u00e7 markas\u0131n\u0131n ger\u00e7ek kapa\u011f\u0131 kullan\u0131larak \u00fcretim \u015fi\u015felerinde ger\u00e7ekle\u015ftirilmelidir - bu testin planlanmas\u0131 ve tamamlanmas\u0131, Kore KFDA taraf\u0131ndan tan\u0131nan bir CRC test tesisinde 3-4 ay s\u00fcrer. D\u00f6rd\u00fcnc\u00fcs\u00fc, \u00fcretim ortam\u0131: Kore ila\u00e7 firmas\u0131 CRC oral s\u0131v\u0131lar\u0131, GMP belgeli bir \u00fcretim ortam\u0131 (temiz alan s\u0131n\u0131fland\u0131rmas\u0131, pozitif bas\u0131n\u00e7, personel hijyen standard\u0131) gerektirir; bu, ki\u015fisel bak\u0131m pompa \u015fi\u015feleri i\u00e7in gerekli de\u011fildir. Be\u015fincisi, parti onay\u0131: Kore CRC oral s\u0131v\u0131 \u015fi\u015feleri, Kore ila\u00e7 markas\u0131na teslim edilmeden \u00f6nce bir parti onay\u0131 a\u015famas\u0131ndan (numune saklama, CoA d\u00fczenleme, QP imzas\u0131) ge\u00e7er; ki\u015fisel bak\u0131m pompa \u015fi\u015feleri ise yaln\u0131zca standart boyutlu CoA'ya g\u00f6re teslim edilir. Kore CRC oral s\u0131v\u0131 \u015fi\u015felerinin e\u015fde\u011fer ki\u015fisel bak\u0131m pompa \u015fi\u015felerine g\u00f6re 3-4 kat daha y\u00fcksek s\u00f6zle\u015fme fiyat\u0131, bu be\u015f ek kalite sistemi gereksinimini yans\u0131tmaktad\u0131r.<\/p>\n<\/div>\n

\n

S4 \u2014 Kore ISBM proses parametrelerinden hangisi CRC mandal\u0131n\u0131n kavrama kuvveti tutarl\u0131l\u0131\u011f\u0131n\u0131 en \u00e7ok etkiler?<\/p>\n

Kore ISBM CRC oral s\u0131v\u0131 \u015fi\u015fesi mandal\u0131n\u0131n kavrama kuvveti tutarl\u0131l\u0131\u011f\u0131 (d\u00f6nd\u00fcrme m\u00fcmk\u00fcn olmadan \u00f6nce P&T CRC mandal\u0131n\u0131 kavramak i\u00e7in gereken a\u015fa\u011f\u0131 do\u011fru itme kuvveti), boyun biti\u015fi d\u0131\u015f \u00e7ap varyasyonuna en duyarl\u0131d\u0131r. CRC mandal kavrama kuvveti, boyun d\u0131\u015f \u00e7ap\u0131yla yakla\u015f\u0131k olarak do\u011frusal orant\u0131l\u0131d\u0131r; boyun d\u0131\u015f \u00e7ap\u0131ndaki 0,04 mm'lik bir art\u0131\u015f, standart Kore P&T CRC yay sabitiyle mandal kuvvetini yakla\u015f\u0131k 12\u201318% art\u0131r\u0131r. Kore KFDA CRC spesifikasyonunda, ya\u015fl\u0131 yeti\u015fkinlerin 90%'sinin ba\u015far\u0131l\u0131 bir \u015fekilde a\u00e7mas\u0131 gerekti\u011fi belirtilmi\u015ftir: a\u00e7ma torku, Kore ya\u015fl\u0131 kavrama g\u00fcc\u00fc e\u015fi\u011fini (yakla\u015f\u0131k 25 N\u00b7cm) a\u015fmamal\u0131d\u0131r; bu da kavrama kuvveti ya\u015fl\u0131 yeti\u015fkin a\u00e7ma kapasitesini a\u015fmadan \u00f6nce izin verilen maksimum boyun d\u0131\u015f \u00e7ap varyasyonunu belirler. Bu k\u0131s\u0131tlama, Kore ISBM CRC boyun d\u0131\u015f \u00e7ap\u0131n\u0131n yaln\u0131zca minimum fonksiyonel kavrama (\u00e7ocuk eri\u015fimini \u00f6nleme) i\u00e7in de\u011fil, ayn\u0131 zamanda maksimum fonksiyonel s\u0131n\u0131r (ya\u015fl\u0131 yeti\u015fkin eri\u015fimine izin verme) i\u00e7in de \u00b10,03 mm'de tutulmas\u0131 gerekti\u011fi anlam\u0131na gelir. Kore ISBM prosesinde boyun d\u0131\u015f \u00e7ap\u0131 tutarl\u0131l\u0131\u011f\u0131n\u0131 en do\u011frudan belirleyen parametre, boyun b\u00f6lgesindeki \u015fartland\u0131rma istasyonu s\u0131cakl\u0131k homojenli\u011fidir: boyun b\u00f6lgesinde \u00b11\u00b0C'lik bir \u015fartland\u0131rma s\u0131cakl\u0131\u011f\u0131 de\u011fi\u015fimi, yakla\u015f\u0131k \u00b10,025 mm boyun d\u0131\u015f \u00e7ap\u0131 de\u011fi\u015fimine neden olur; bu da 0,005 mm g\u00fcvenlik pay\u0131 ile \u00b10,03 mm tolerans dahilindedir, ancak tutarl\u0131 Kore CRC performans\u0131 i\u00e7in \u2264\u00b11\u00b0C \u015fartland\u0131rma hassasiyeti zorunlu bir gerekliliktir.<\/p>\n<\/div>\n

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S5 \u2014 Kore'de \u00fcretilen a\u011f\u0131zdan al\u0131nan s\u0131v\u0131 ila\u00e7lar i\u00e7in kullan\u0131lan ISBM \u015fi\u015felerinin GMP standard\u0131na uygunlu\u011fu nas\u0131l do\u011frulan\u0131yor?<\/p>\n

Kore ISBM oral s\u0131v\u0131 ila\u00e7 \u015fi\u015fesi \u00fcretimi GMP validasyonu, Kore KFDA'n\u0131n ila\u00e7 birincil ambalaj malzemesi \u00fcretimi i\u00e7in GMP k\u0131lavuzuna (\uc6d0\ub8cc \uc758\uc57d\ud488 \uc6a9\uae30\u00b7\ud3ec\uc7a5\uc7ac GMP) uygun olarak ger\u00e7ekle\u015ftirilir. Validasyon program\u0131 \u00fc\u00e7 yeterlilik a\u015famas\u0131n\u0131 kapsar. IQ (Kurulum Yeterlili\u011fi): ISBM makinesinin kurulumunun (elektrik, mekanik, bas\u0131n\u00e7l\u0131 hava) spesifikasyonlara uygunlu\u011funu do\u011frulamak; kritik aletleri (s\u0131cakl\u0131k sens\u00f6rleri, bas\u0131n\u00e7 g\u00f6stergeleri, \u00e7evrim zamanlay\u0131c\u0131) kalibre etmek; QP taraf\u0131ndan imzalanan Kore ISBM makinesi yeterlilik IQ protokol\u00fcn\u00fc belgelemek. OQ (Operasyonel Yeterlilik): ISBM makinesinin 3 ayr\u0131 \u00e7al\u0131\u015ft\u0131rmada valide edilmi\u015f \u00e7al\u0131\u015fma aral\u0131klar\u0131nda \u00e7al\u0131\u015ft\u0131\u011f\u0131n\u0131 g\u00f6stermek; kritik kalite \u00f6zelliklerini (boyun d\u0131\u015f \u00e7ap\u0131, a\u011f\u0131rl\u0131k, duvar kal\u0131nl\u0131\u011f\u0131, CRC ba\u011flant\u0131 kuvveti) 3 parametre u\u00e7 noktas\u0131nda (nominal, d\u00fc\u015f\u00fck, y\u00fcksek) \u00f6l\u00e7mek; nominal ve d\u00fc\u015f\u00fck-u\u00e7 ko\u015fullarda CRC performans testinin ba\u015far\u0131l\u0131 oldu\u011funu do\u011frulamak. PQ \u200b\u200b(Performans Yeterlili\u011fi): Nominal Kore GMP \u00fcretim ko\u015fullar\u0131nda 3 ard\u0131\u015f\u0131k \u00fcretim partisi; 100% proses i\u00e7i g\u00f6rsel muayene kayd\u0131; her parti i\u00e7in boyutlu CoA; numune saklama (parti ba\u015f\u0131na 10 \u015fi\u015fe, 1 y\u0131l + raf \u00f6mr\u00fc boyunca saklan\u0131r); kritik \u00f6zellikler i\u00e7in proses yeterlili\u011fi Cpk \u2265 1,33. Toplam 150-250 sayfal\u0131k Kore GMP IQ\/OQ\/PQ do\u011frulama dok\u00fcmantasyonu, Kore markal\u0131 oral s\u0131v\u0131 ila\u00e7 ISBM tedari\u011fi i\u00e7in giri\u015f fiyat\u0131d\u0131r \u2014 GMP do\u011frulama deneyimi olmayan Koreli ISBM \u00fcreticileri, ilk Kore oral s\u0131v\u0131 ila\u00e7 GMP do\u011frulamalar\u0131 i\u00e7in genellikle bir Kore ila\u00e7 do\u011frulama dan\u0131\u015fmanl\u0131k firmas\u0131yla (GMP Uyumluluk Grubu, Kore \u0130la\u00e7 \u00dcreticileri Birli\u011fi do\u011frulama hizmeti) \u00e7al\u0131\u015f\u0131rlar.<\/p>\n<\/div>\n

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S6 \u2014 ISBM i\u00e7in Kore KFDA ila\u00e7 ambalaj\u0131 uyumlulu\u011fu ile Kore g\u0131da temas\u0131 uyumlulu\u011fu aras\u0131ndaki fark nedir?<\/p>\n

Kore ila\u00e7 ambalaj\u0131 uyumlulu\u011fu (\uc758\uc57d\ud488 \uc6a9\uae30\u00b7\ud3ec\uc7a5 \uae30\uc900) ve Kore g\u0131da temas\u0131 uyumlulu\u011fu (\uc2dd\ud488 \uc6a9\uae30 \uae30\uc900) her ikisi de PET ve PP ISBM \u015fi\u015felerini d\u00fczenler ancak be\u015f temel noktada farkl\u0131l\u0131k g\u00f6sterir. Migrasyon limitleri: Kore ila\u00e7 standard\u0131, ayn\u0131 maddeler i\u00e7in Kore g\u0131da temas\u0131 standard\u0131ndan yakla\u015f\u0131k 2 kat daha kat\u0131d\u0131r (\u00f6rne\u011fin: u\u00e7ucu olmayan kal\u0131nt\u0131 limiti ila\u00e7 i\u00e7in 50 mg\/L, g\u0131da temas\u0131 i\u00e7in 200 mg\/L). Test s\u0131cakl\u0131\u011f\u0131: Kore ila\u00e7 ekstraksiyon testi 70\u00b0C\/1 saat iken, Kore g\u0131da temas\u0131 testi 60\u00b0C\/30 dakikad\u0131r \u2014 daha y\u00fcksek ila\u00e7 s\u0131cakl\u0131\u011f\u0131, hareketli maddelerin ekstraksiyonunu h\u0131zland\u0131r\u0131r ve bu da ila\u00e7 testini do\u011fal olarak daha hassas hale getirir. Pozitif liste kapsam\u0131: Kore ila\u00e7 ambalaj\u0131 pozitif listesi, Kore g\u0131da temas\u0131 listesinde yer alan ancak ayn\u0131 konsantrasyonda Kore ila\u00e7 ambalajlar\u0131nda yasaklanan maddeleri (UV stabilizat\u00f6rleri, belirli antioksidanlar) i\u00e7erir; bu da Kore ISBM ila\u00e7 \u00fcreticilerinin, standart PET re\u00e7ine g\u0131da s\u0131n\u0131f\u0131 katk\u0131 maddesi ambalajlar\u0131n\u0131n Kore ila\u00e7 ambalaj\u0131 yasakl\u0131 listesinde yer alan herhangi bir madde i\u00e7ermedi\u011fini do\u011frulamalar\u0131n\u0131 gerektirir. GMP \u00fcretim ortam\u0131: Kore ila\u00e7 ambalajlar\u0131, GMP belgeli bir \u00fcretim ortam\u0131 gerektirir; Kore g\u0131da temas\u0131 ISBM'nin e\u015fde\u011fer bir GMP \u00fcretim gereksinimi yoktur. CRC uyumlulu\u011fu: Kore ila\u00e7 ambalajlar\u0131 CRC gerektirebilir (belirli ila\u00e7 kategorileri i\u00e7in yasal gereklilik); Kore g\u0131da ambalajlar\u0131 asla CRC gerektirmez. PET veya PP ISBM \u015fi\u015feleri i\u00e7in Kore g\u0131da temas\u0131 uyumlulu\u011funa sahip Kore ISBM \u00fcreticileri, otomatik olarak Kore ila\u00e7 ambalaj\u0131 uyumlulu\u011funa sahip de\u011fildir; ila\u00e7 uyumluluk yolu i\u00e7in her zaman ayr\u0131 test ve belgeleme gereklidir.<\/p>\n<\/div>\n<\/div>\n

\n

\u0130la\u00e7 A\u011f\u0131zdan Al\u0131nan S\u0131v\u0131 Ambalaj Deste\u011fi<\/p>\n

Koreli bir ila\u00e7 markas\u0131, GMP onayl\u0131 CRC oral s\u0131v\u0131 ISBM \u015fi\u015felerine mi ihtiya\u00e7 duyuyor?<\/h2>\n

Korean Ever-Power, Kore markal\u0131 oral s\u0131v\u0131 ISBM tedari\u011fi i\u00e7in KFDA ila\u00e7 \u00f6z\u00fct\u00fc testi, CRC P&T boyun hassasiyeti \u00b10,03 mm, GMP IQ\/OQ\/PQ do\u011frulama dok\u00fcmantasyonu, amber UV masterbatch ve HGY150-V4-EV platformu sa\u011flamaktad\u0131r.<\/p>\n

\u0130la\u00e7 Oral S\u0131v\u0131 Kons\u00fcltasyonu Talebi<\/a><\/p>\n<\/div>\n

\n

\u0130lgili Kaynaklar<\/p>\n


\n\u0130la\u00e7 Platformu<\/span>
\nKore Ever-Power HGY150-V4-EV<\/span>
\nCRC oral s\u0131v\u0131 boyun d\u0131\u015f \u00e7ap\u0131 i\u00e7in EV servo hassasiyeti \u00b10,03 mm; GMP onayl\u0131 \u00fcretim ortam\u0131 entegrasyonu; Kore GMP standard\u0131nda 4 hazneli 100 ml pediatrik ila\u00e7.<\/span>
\n<\/a>
\n
\nMakine Yelpazesi<\/span>
\n4 \u0130stasyonlu ISBM Menzili<\/span>
\nHGY150-V4-EV, 60\u2013100 ml'lik CRC pediatrik farmakolojik \u00fcr\u00fcnden, 200\u2013500 ml'lik yeti\u015fkin oral s\u0131v\u0131 ve kurumsal ila\u00e7 haz\u0131rlama formatlar\u0131na kadar de\u011fi\u015fen form\u00fcllerle sunulmaktad\u0131r.<\/span>
\n<\/a>
\n
\nCRC \u0130la\u00e7 Aletleri<\/span>
\n\u00d6zel ISBM Kal\u0131p Tasar\u0131m\u0131<\/span>
\nKoreli ila\u00e7 firmas\u0131 CRC oral s\u0131v\u0131 kal\u0131plar\u0131 \u2014 P&T ve S&T boyun ek par\u00e7alar\u0131, marka kapak tedarik\u00e7isinden bask\u0131, derecelendirme paneli d\u00fczl\u00fc\u011f\u00fc \u00b10,15 mm, kehribar ana kar\u0131\u015f\u0131m\u0131n\u0131n UV uyumluluk do\u011frulamas\u0131.<\/span>
\n<\/a><\/div>\n<\/section>\n

 <\/p>\n