Kore g\u00f6z damlas\u0131 i\u00e7in LDPE s\u0131kma geri kazan\u0131m\u0131<\/p>\n
Kore'de kullan\u0131lan oftalmik g\u00f6z damlas\u0131 kaplar\u0131n\u0131n s\u0131k\u0131ld\u0131ktan sonra elastik olarak eski haline d\u00f6nmesi gerekir: Koreli kullan\u0131c\u0131 bir damla damlatt\u0131ktan sonra kab\u0131 b\u0131rakt\u0131\u011f\u0131nda, LDPE kab\u0131n damla ucunu havas\u0131z form\u00fclasyona geri \u00e7ekmesi gerekir. Bir damla damlatmak i\u00e7in s\u0131k\u0131lan HDPE veya PP kaplar b\u0131rak\u0131ld\u0131\u011f\u0131nda vakum olu\u015fturur, ancak sert duvar tamamen eski haline d\u00f6nmez ve damla ucundan hava giri\u015fine izin vererek \u00e7ok kullan\u0131ml\u0131 Kore oftalmik kab\u0131n\u0131n mikrobiyal kontaminasyon riskini art\u0131r\u0131r. 0,55-0,65 mm IBM duvar kal\u0131nl\u0131\u011f\u0131na sahip LDPE, b\u0131rak\u0131ld\u0131ktan sonra 0,5-1,0 saniye i\u00e7inde orijinal \u015fekline tamamen geri d\u00f6ner ve Kore damla ucunda hava giri\u015fini \u00f6nleyen i\u00e7 negatif bas\u0131nc\u0131 korur. Bu elastik geri d\u00f6n\u00fc\u015f \u00f6zelli\u011fi, Kore MFDS'nin Kore \u00e7ok kullan\u0131ml\u0131 oftalmik g\u00f6z damlas\u0131 kaplar\u0131 i\u00e7in LDPE'yi (HDPE veya PP de\u011fil) zorunlu k\u0131lmas\u0131 nedenidir.<\/p>\n
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LDPE IBM g\u00f6z damlas\u0131 kab\u0131 elastik geri kazan\u0131m\u0131: Kore ortam s\u0131cakl\u0131\u011f\u0131nda (23\u00b0C) 1,0 saniye i\u00e7inde orijinal hacmine 95%+ geri d\u00f6n\u00fc\u015f. Ayn\u0131 duvarda HDPE: 60-75% geri kazan\u0131m. Ayn\u0131 duvarda PP: 50-65% geri kazan\u0131m. Sadece LDPE, Kore MFDS \u00e7ok kullan\u0131ml\u0131 oftalmik kap elastik geri kazan\u0131m gereksinimini kar\u015f\u0131lamaktad\u0131r.<\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/section>\n\n\n
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B\u00d6L\u00dcM 05<\/p>\n
Burun Spreyi ve T\u00fcketici Sa\u011fl\u0131\u011f\u0131 LDPE IBM<\/h2>\n<\/div>\n<\/div>\nKore LDPE burun spreyi s\u0131kma \u015fi\u015fesi \u00fcretimi i\u00e7in IBM kal\u0131p tak\u0131m\u0131 \u2014 18\/415 burun spreyi boyun par\u00e7as\u0131, \u00b10,05 mm boyun d\u0131\u015f \u00e7ap\u0131 gerektiren Kore burun atomiz\u00f6r nozulu ba\u011flant\u0131s\u0131 i\u00e7in hassas bir \u015fekilde i\u015flenmi\u015ftir. 15-30 ml'lik (ZQ40, 9-10 bo\u015fluklu) Kore LDPE burun spreyi IBM, Kore re\u00e7etesiz burun dekonjestanlar\u0131, Kore tuzlu burun y\u0131kama sol\u00fcsyonlar\u0131 ve Kore burun alerjisi giderici \u00fcr\u00fcnlerini kapsamaktad\u0131r.<\/figcaption><\/figure>\n\n
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Kore Burun Spreyi LDPE IBM<\/p>\n
Kore men\u015feli 15-30 ml LDPE IBM burun spreyi kaplar\u0131 (18\/415 boyun, Kore tipi atomiz\u00f6r nozulu): LDPE s\u0131kma kab\u0131, Kore tipi atomiz\u00f6r nozulu arac\u0131l\u0131\u011f\u0131yla burun spreyi sisini \u00fcretmek i\u00e7in s\u0131k\u0131l\u0131r. 0,60-0,70 mm duvar kal\u0131nl\u0131\u011f\u0131na sahip LDPE, Koreli t\u00fcketiciler i\u00e7in uygun s\u0131kma kuvveti sa\u011flar (tipik olarak, her p\u00fcsk\u00fcrtmede 0,1-0,15 ml \u00fcretmek i\u00e7in 2-4 N parmak s\u0131kma kuvveti). Kore MFDS re\u00e7etesiz burun dekonjestanlar\u0131 (ksilometazolin, oksimetazolin), Kore oftalmik \u00fcr\u00fcnleriyle ayn\u0131 Kore MFDS plastik kap standard\u0131na sahip LDPE IBM farmas\u00f6tik s\u0131n\u0131f\u0131 malzeme gerektirir. Kore tuzlu burun y\u0131kama sol\u00fcsyonu (sodyum klor\u00fcr 0,9-2,0%) daha d\u00fc\u015f\u00fck d\u00fczenleyici s\u0131n\u0131fland\u0131rmaya sahiptir (Kore MFDS kozmetik veya t\u0131bbi cihaz), ancak yine de s\u0131kma ergonomisi i\u00e7in LDPE IBM belirtir.<\/p>\n<\/div>\n
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Kore T\u00fcketici Sa\u011fl\u0131\u011f\u0131 LDPE IBM (50-150 ml)<\/p>\n
Kore men\u015feli 50-150 ml LDPE IBM s\u0131kma kaplar\u0131 (ZQ60, 24\/415 boyun), Kore yara y\u0131kama sol\u00fcsyonlar\u0131n\u0131 (Kore eczaneleri i\u00e7in tuzlu su veya hidrojen peroksit s\u0131kma \u015fi\u015fesi), Kore di\u015f gargaras\u0131 s\u0131kma aplikat\u00f6rlerini ve Kore spor hekimli\u011fi jel aplikat\u00f6rlerini (diklofenak jel, mentoll\u00fc so\u011futma jeli) kapsar. 50-150 ml'lik LDPE IBM, 6-8 bo\u015fluklu (5,0-5,8 s \u00e7evrim, daha b\u00fcy\u00fck formatta yeterli s\u0131kma sertli\u011fi i\u00e7in 0,7-0,8 mm duvar kal\u0131nl\u0131\u011f\u0131) ZQ60 \u00fczerinde i\u015flenerek, Kore t\u00fcketici sa\u011fl\u0131\u011f\u0131 s\u0131kma kaplar\u0131 y\u0131lda 9-11 milyon adet (Kore 2 vardiya) \u00fcretilmektedir. Kore t\u00fcketici sa\u011fl\u0131\u011f\u0131 LDPE IBM, Kore ila\u00e7 oftalmoloji sekt\u00f6r\u00fcne g\u00f6re daha d\u00fc\u015f\u00fck bir d\u00fczenleyici kademededir; LDPE s\u0131n\u0131f\u0131 ve dok\u00fcmantasyon gereksinimleri daha hafiftir, ancak Korea Ever-Power, d\u00fczenleyici kademeden ba\u011f\u0131ms\u0131z olarak t\u00fcm Kore LDPE IBM'leri i\u00e7in ayn\u0131 s\u0131f\u0131r fla\u015f \u00fcretim uygulamas\u0131n\u0131 s\u00fcrd\u00fcrmektedir.<\/p>\n<\/div>\n<\/div>\n<\/section>\n\n\n
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B\u00d6L\u00dcM 06<\/p>\n
IBM LDPE i\u00e7in ZQ Serisi Se\u00e7imi<\/h2>\n<\/div>\n<\/div>\n\n
\n\n\nZQ MODEL\u0130<\/th>\n 5-15 ml \u2605 (kav\/saat)<\/th>\n 15-30 ml (kav\/saat)<\/th>\n 50-150 ml (kav\/saat)<\/th>\n PROF\u0130L<\/th>\n<\/tr>\n<\/thead>\n \n\nEP-ZQ40 \u2605<\/td>\n 11 \/ ~23,760<\/td>\n 9-10 \/ ~14,500<\/td>\n Tavsiye edilmez<\/td>\n Koreli ila\u00e7 firmas\u0131 LDPE uzman\u0131 \u2014 g\u00f6z damlas\u0131, burun spreyi, kulak damlas\u0131 alan\u0131nda referans noktas\u0131<\/td>\n<\/tr>\n \nEP-ZQ60<\/td>\n 14 \/ ~32,400<\/td>\n 12 \/ ~18,000<\/td>\n 6-8 \/ ~9,500<\/td>\n Kore t\u00fcketici sa\u011fl\u0131\u011f\u0131 LDPE 50-150 ml \u2014 yara bak\u0131m\u0131, di\u015f, spor hekimli\u011fi s\u0131k\u0131labilir IBM<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n<\/section>\n\n\n
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M\u00dcHEND\u0130SL\u0130K SIK\u00c7A SORULAN SORULAR<\/p>\n
LDPE IBM \u2014 M\u00fchendislik Sorular\u0131<\/h2>\n<\/div>\n<\/div>\n\n
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Soru 01<\/span><\/p>\nS\u0131k\u0131\u015ft\u0131rmal\u0131 kap uygulamalar\u0131nda LDPE'nin HDPE'ye g\u00f6re daha iyi elastik geri kazan\u0131m g\u00f6stermesinin molek\u00fcler nedeni nedir?<\/p>\n<\/div>\n
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LDPE ve HDPE, polimer zincir mimarilerinde temel olarak farkl\u0131l\u0131k g\u00f6sterir ve bu fark, LDPE'nin s\u0131k\u0131\u015ft\u0131rma kaplar\u0131 uygulamalar\u0131nda \u00fcst\u00fcn elastik geri kazan\u0131m\u0131n\u0131 do\u011frudan a\u00e7\u0131klar. HDPE, minimum dallanmaya sahip do\u011frusal bir polietilen zinciridir; do\u011frusal zincirler, kristaller aras\u0131nda dar amorf b\u00f6lgelerle birlikte, d\u00fczenli kristal b\u00f6lgelere (kristallik 70-80%) s\u0131k\u0131ca paketlenir. Bir HDPE IBM kab\u0131n\u0131n duvar\u0131 s\u0131k\u0131\u015ft\u0131r\u0131larak deforme edildi\u011finde, kristal b\u00f6lgeler deformasyona direnen ve deforme edici kuvvet kald\u0131r\u0131ld\u0131ktan sonra orijinal konumlar\u0131na geri d\u00f6nmeyen sert yap\u0131sal birimler gibi davran\u0131r; bu da HDPE kaplar\u0131n\u0131 Kore g\u00f6z damlas\u0131 \u00e7ok kullan\u0131ml\u0131 uygulamalar\u0131 i\u00e7in uygunsuz hale getiren kal\u0131c\u0131 deformasyona neden olur. LDPE, omurga boyunca da\u011f\u0131lm\u0131\u015f k\u0131sa ve uzun zincir dallar\u0131na sahip dallanm\u0131\u015f bir polietilendir; zincir dallar\u0131, kristal b\u00f6lgelere s\u0131k\u0131 paketlenmeyi engeller ve yaln\u0131zca 45-60% kristalli\u011fe sahip bir polimer \u00fcretir. Daha d\u00fc\u015f\u00fck kristalinite, oda s\u0131cakl\u0131\u011f\u0131nda viskoz ve elastik olan daha b\u00fcy\u00fck bir amorf polimer b\u00f6lgesi olu\u015fturur: LDPE IBM kab\u0131n\u0131n duvar\u0131 s\u0131k\u0131\u015ft\u0131r\u0131larak deforme edildi\u011finde, amorf b\u00f6lge elastik olarak (yay gibi) deforme olur ve s\u0131k\u0131\u015ft\u0131rma kuvveti kald\u0131r\u0131ld\u0131\u011f\u0131nda orijinal geometrisine geri d\u00f6ner. S\u0131k\u0131\u015ft\u0131rma s\u0131ras\u0131nda LDPE amorf b\u00f6lgesinde depolanan elastik geri kazan\u0131m enerjisi, kab\u0131 0,5-1,0 saniye i\u00e7inde orijinal \u015fekline geri d\u00f6nd\u00fcr\u00fcr ve Kore damlal\u0131k ucunda hava giri\u015fini \u00f6nleyen i\u00e7 negatif bas\u0131nc\u0131 korur. Bu molek\u00fcler mimari fark\u0131 (do\u011frusal kristal HDPE'ye kar\u015f\u0131 dall\u0131 yar\u0131 amorf LDPE), LDPE'nin Kore \u00e7ok kullan\u0131ml\u0131 oftalmik s\u0131kma kaplar\u0131 i\u00e7in yeri doldurulamaz olmas\u0131n\u0131n nedenidir: hi\u00e7bir i\u015fleme modifikasyonu veya duvar kal\u0131nl\u0131\u011f\u0131 de\u011fi\u015fikli\u011fi, HDPE'ye LDPE'nin temel polimer zinciri dallanma yap\u0131s\u0131 yoluyla sa\u011flad\u0131\u011f\u0131 elastik geri kazan\u0131m\u0131 veremez.<\/p>\n<\/div>\n<\/div>\n
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Soru 02<\/span><\/p>\nKore men\u015feli oftalmik form\u00fclasyonlarda kullan\u0131lan hangi bile\u015fenler \u00f6zel LDPE IBM uyumluluk testine tabi tutulmal\u0131d\u0131r?<\/p>\n<\/div>\n
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LDPE IBM g\u00f6z damlas\u0131 kaplar\u0131nda bulunan Kore oftalmik form\u00fclasyonlar\u0131, d\u00f6rt bile\u015fen kategorisi i\u00e7in uyumluluk testine tabi tutulmal\u0131d\u0131r. Benzalkonyum klor\u00fcr (BAK): 0,005-0,02% konsantrasyonunda en yayg\u0131n Kore oftalmik koruyucusudur. BAK, LDPE y\u00fczeyine adsorbe olabilen katyonik bir kuaterner amonyum y\u00fczey aktif maddesidir; bu da Kore oftalmik form\u00fclasyonunda bulunan BAK konsantrasyonunu, Kore MFDS koruyucu etkinli\u011fi gereksinimleri i\u00e7in minimum inhibit\u00f6r konsantrasyonunun alt\u0131na d\u00fc\u015f\u00fcr\u00fcr. Korea Ever-Power'\u0131n teslimat \u00f6ncesi \u00fcretim denemesi, bir BAK adsorpsiyon \u00e7al\u0131\u015fmas\u0131n\u0131 i\u00e7erir: LDPE IBM kaplar\u0131 25\u00b0C'de Kore oftalmik form\u00fclasyonu ile doldurulur ve BAK konsantrasyonu, Kore oftalmik raf \u00f6mr\u00fc boyunca Kore MFDS oftalmik koruyucu spesifikasyonu i\u00e7inde kal\u0131p kalmad\u0131\u011f\u0131n\u0131 do\u011frulamak i\u00e7in 0. g\u00fcn, 30. g\u00fcn ve 90. g\u00fcn aral\u0131klarla \u00f6l\u00e7\u00fcl\u00fcr. Benzil alkol 0,5-1,0% konsantrasyonunda: alternatif Kore oftalmik koruyucu madde \u2014 benzil alkol\u00fcn daha y\u00fcksek konsantrasyonlarda LDPE ile bir miktar etkile\u015fimi vard\u0131r; 0,5%'nin \u00fczerindeki konsantrasyonlarda 40\u00b0C\/90 g\u00fcnl\u00fck h\u0131zland\u0131r\u0131lm\u0131\u015f stabilite testi ile do\u011frulanmal\u0131d\u0131r. Povidon iyot 2,5-5,0% konsantrasyonunda: Kore yara y\u0131kama ve kulak damlas\u0131. PVP-iyot kompleksi hafif oksitleyici aktiviteye sahiptir \u2014 LDPE duvar\u0131n\u0131n 40\u00b0C\/90 g\u00fcn boyunca y\u00fczey renk de\u011fi\u015fimine u\u011framad\u0131\u011f\u0131n\u0131 do\u011frulay\u0131n. \u00c7ok dozlu LDPE IBM kaplarda bulunan koruyucu i\u00e7ermeyen Kore g\u00f6z damlas\u0131: Kore tek kullan\u0131ml\u0131k ampul g\u00f6z damlas\u0131 i\u00e7in ge\u00e7erli de\u011fildir (her ampul bir kez kullan\u0131l\u0131r ve at\u0131l\u0131r), ancak LDPE IBM s\u0131kma kab\u0131nda bulunan \u00e7ok kullan\u0131ml\u0131 koruyucu i\u00e7ermeyen Kore g\u00f6z damlas\u0131, LDPE IBM kab\u0131n\u0131n s\u0131zd\u0131rmazl\u0131k b\u00fct\u00fcnl\u00fc\u011f\u00fcn\u00fcn, Kore \u00e7ok kullan\u0131ml\u0131 g\u00f6z damlas\u0131 \u00fcr\u00fcn\u00fcn\u00fcn kullan\u0131m \u00f6mr\u00fc boyunca kab\u0131n sterilitesini korudu\u011funu do\u011frulamak i\u00e7in Korea Ever-Power'\u0131n ISO 14161 sterilite koruma \u00e7al\u0131\u015fmas\u0131n\u0131 gerektirir.<\/p>\n<\/div>\n<\/div>\n
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Soru 03<\/span><\/p>\nIBM LDPE g\u00f6z damlas\u0131 kab\u0131n\u0131n damla hacmi hassasiyeti, cam g\u00f6z damlas\u0131 \u015fi\u015feleriyle nas\u0131l kar\u015f\u0131la\u015ft\u0131r\u0131l\u0131r?<\/p>\n<\/div>\n
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LDPE IBM g\u00f6z damlas\u0131 kab\u0131n\u0131n damla hacmi hassasiyeti, cam oftalmik flakonlarla k\u0131yasland\u0131\u011f\u0131nda olduk\u00e7a iyidir ve \u00fc\u00e7 IBM yap\u0131sal avantaj\u0131 sayesinde bir\u00e7ok durumda daha tutarl\u0131d\u0131r. IBM boyun ucu hassasiyeti: 13\/415 damlal\u0131k ucu deli\u011fi, t\u00fcm 11 ZQ40 bo\u015flu\u011funda \u00b10,02 mm \u00e7ap tutarl\u0131l\u0131\u011f\u0131yla enjeksiyon kal\u0131b\u0131nda olu\u015fturulur. Cam oftalmik flakon damlal\u0131k ucu deli\u011fi, cam t\u00fcp\u00fcn ate\u015fle parlat\u0131lmas\u0131yla olu\u015fturulur; delik \u00e7ap\u0131 varyasyonu, bir cam partisinde \u00b10,05-0,10 mm'dir ve orant\u0131l\u0131 damla hacmi varyasyonu \u00fcretir. LDPE IBM kab\u0131 s\u0131k\u0131\u015ft\u0131rma tutarl\u0131l\u0131\u011f\u0131: Tutarl\u0131 IBM kab\u0131 duvar kal\u0131nl\u0131\u011f\u0131 (t\u00fcm bo\u015fluklarda \u00f6n \u015fekillendirme at\u0131\u015f a\u011f\u0131rl\u0131\u011f\u0131 \u00b12%), tutarl\u0131 s\u0131k\u0131\u015ft\u0131rma uyumlulu\u011fu (birim kuvvet ba\u015f\u0131na duvar sapmas\u0131) \u00fcretir; Koreli kullan\u0131c\u0131lar\u0131n 2,5 N'lik s\u0131k\u0131\u015ft\u0131rma kuvveti, t\u00fcm LDPE IBM \u00fcretim kaplar\u0131nda 28-32 \u00b5l damla hacmi varyasyonu \u00fcretir. Cam flakon s\u0131kma: Cam flakonlar, hacim varyasyonuna ek bir kaynak olu\u015fturan ayr\u0131 bir LDPE veya silikon kau\u00e7uk damlal\u0131k ampul\u00fc d\u00fczene\u011fi gerektirir. IBM bo\u015fluktan bo\u015flu\u011fa s\u0131f\u0131r \u00e7apak: IBM, Kore oftalmik dolumu s\u0131ras\u0131nda Kore damlal\u0131k ucu a\u011fz\u0131n\u0131 t\u0131kayabilecek taban k\u0131rp\u0131nt\u0131 par\u00e7ac\u0131klar\u0131 \u00fcretmez. Cam flakonlarda, Kore dolum hatlar\u0131n\u0131n oftalmik dolumdan \u00f6nce hava ile durulama yoluyla temizlemesi gereken, ate\u015fle parlat\u0131lm\u0131\u015f taban kenar\u0131 kal\u0131nt\u0131lar\u0131 olabilir. Korea Ever-Power, teslimat \u00f6ncesi \u00fcretim denemesinden elde edilen her bo\u015fluktan 10 kap \u00fczerinde 20 s\u0131kma damla hacmi \u00f6l\u00e7\u00fcm\u00fc yaparak LDPE IBM g\u00f6z damlas\u0131 damla hacmini do\u011frular; bu, 11 bo\u015flu\u011fun tamam\u0131nda ve 20 s\u0131kma d\u00f6ng\u00fcs\u00fcn\u00fcn tamam\u0131nda damla ba\u015f\u0131na 25-45 \u00b5l spesifikasyonunun korundu\u011funu do\u011frular.<\/p>\n<\/div>\n<\/div>\n
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Soru 04<\/span><\/p>\nLDPE ve HDPE, malzeme de\u011fi\u015ftirme i\u015flemi yap\u0131larak ayn\u0131 ZQ40 makinesinde i\u015flenebilir mi?<\/p>\n<\/div>\n
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Evet \u2014 LDPE ve HDPE, \u00fcretim a\u015famalar\u0131 aras\u0131nda varil s\u0131cakl\u0131\u011f\u0131 de\u011fi\u015fimi ve temizleme i\u015flemi ile ayn\u0131 ZQ40 makinesinde \u00e7al\u0131\u015ft\u0131r\u0131labilir. HDPE'den LDPE'ye ge\u00e7i\u015f protokol\u00fc: (1) varil s\u0131cakl\u0131\u011f\u0131 ayar noktalar\u0131n\u0131 HDPE aral\u0131\u011f\u0131ndan (195-220\u00b0C) LDPE aral\u0131\u011f\u0131na (170-200\u00b0C) d\u00fc\u015f\u00fcr\u00fcn; (2) kal\u0131p so\u011futucu s\u0131cakl\u0131\u011f\u0131n\u0131 HDPE kal\u0131p ayar\u0131ndan (16-24\u00b0C) LDPE kal\u0131p ayar\u0131na (8-15\u00b0C) d\u00fc\u015f\u00fcr\u00fcn; (3) temizleme \u00e7\u0131kt\u0131s\u0131 HDPE \u00e7izgileri veya kirlenmesi olmadan tutarl\u0131 bir LDPE eriyi\u011fi g\u00f6sterene kadar, varili LDPE i\u015fleme s\u0131cakl\u0131\u011f\u0131nda 5-8 at\u0131\u015f boyunca LDPE re\u00e7inesi ile temizleyin; (4) enjeksiyon bas\u0131nc\u0131 ayar noktas\u0131n\u0131 HDPE aral\u0131\u011f\u0131ndan (80-120 MPa) LDPE aral\u0131\u011f\u0131na (60-90 MPa) d\u00fc\u015f\u00fcr\u00fcn. Ge\u00e7i\u015f s\u00fcresi: HDPE ba\u015flang\u0131\u00e7 \u200b\u200bnoktas\u0131ndan LDPE aral\u0131\u011f\u0131nda varil s\u0131cakl\u0131\u011f\u0131n\u0131n stabilizasyonu i\u00e7in yakla\u015f\u0131k 25-35 dakika (s\u0131cakl\u0131k, varil sistemlerinde art\u0131\u015ftan daha yava\u015f d\u00fc\u015fer). Kore ila\u00e7 end\u00fcstrisi i\u00e7in LDPE \u00fcretiminde, ayn\u0131 ZQ40 makinesinde HDPE \u00fcretiminin hemen ard\u0131ndan Korea Ever-Power, Kore MFDS ila\u00e7 konteyneri \u00fcretimi i\u00e7in LDPE \u00fcretim kalitesini ilan etmeden \u00f6nce, tam varil temizli\u011fini sa\u011flamak amac\u0131yla 10-15 adet Kore ila\u00e7 standard\u0131 LDPE temizleme at\u0131\u015f\u0131 daha ger\u00e7ekle\u015ftirir; bu i\u015flem, nozuldaki temizleme at\u0131\u015flar\u0131n\u0131n g\u00f6rsel incelemesiyle LDPE eriyik ak\u0131\u015f\u0131nda s\u0131f\u0131r HDPE kontaminasyonu oldu\u011funu do\u011frular.<\/p>\n<\/div>\n<\/div>\n
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Soru 05<\/span><\/p>\nKore'de LDPE IBM oftalmik kaplar i\u00e7in MFDS dok\u00fcmantasyon gereksinimleri nelerdir?<\/p>\n<\/div>\n
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Kore MFDS oftalmik ila\u00e7 kab\u0131 dok\u00fcmantasyonu, LDPE IBM kaplar\u0131 i\u00e7in Kore MFDS oral s\u0131v\u0131 ila\u00e7 IBM kaplar\u0131yla ayn\u0131 \u00e7er\u00e7eveyi izler, ancak ek olarak oftalmi\u011fe \u00f6zg\u00fc gereksinimler de i\u00e7erir. Korea Ever-Power, eksiksiz Kore MFDS oftalmik LDPE IBM dok\u00fcmantasyon paketini sa\u011flar: (1) LDPE malzeme beyan\u0131 \u2014 LDPE \u00fcreticisi ve s\u0131n\u0131f\u0131, yo\u011funluk, MI, antioksidan katk\u0131 maddesi paketi (kayganla\u015ft\u0131r\u0131c\u0131 madde i\u00e7ermez, Kore Farmakopesi'nde k\u0131s\u0131tlanm\u0131\u015f katk\u0131 maddeleri i\u00e7ermez), Kore MFDS limitlerinin alt\u0131nda a\u011f\u0131r metal i\u00e7eri\u011fi; (2) IBM \u00fcretim s\u00fcreci beyan\u0131 \u2014 s\u0131f\u0131r fla\u015f \u00fcretimi (ZQ40 makinesi, \u00e7ekirdek \u00e7ubuk IBM mimarisi), LDPE g\u00f6vde s\u0131cakl\u0131k aral\u0131\u011f\u0131, kal\u0131p s\u0131cakl\u0131\u011f\u0131, ISO 14644 \u00fcretim ortam\u0131 s\u0131n\u0131fland\u0131rmas\u0131; (3) boyut raporu \u2014 bo\u015fluk ba\u015f\u0131na boyun d\u0131\u015f \u00e7ap\u0131, bo\u015fluk ba\u015f\u0131na damlal\u0131k ucu a\u011f\u0131z \u00e7ap\u0131, kap y\u00fcksekli\u011fi, taban d\u00fczl\u00fc\u011f\u00fc, bo\u015fluk ba\u015f\u0131na 6 \u00f6l\u00e7\u00fcm noktas\u0131nda duvar kal\u0131nl\u0131\u011f\u0131, bo\u015fluk ba\u015f\u0131na a\u011f\u0131rl\u0131k \u00b12%; (4) \u00c7\u0131kar\u0131labilir ve S\u0131zd\u0131r\u0131labilir \u00c7al\u0131\u015fma \u2014 Kore Farmakopesi oftalmik form\u00fclasyon ko\u015fullar\u0131nda (0,9% salin, 25\u00b0C\/90 g\u00fcn ve 50\u00b0C\/14 g\u00fcn h\u0131zland\u0131r\u0131lm\u0131\u015f) LDPE IBM kab\u0131n\u0131n sulu ekstraksiyonu, Kore MFDS oftalmik kap E&L limitleri a\u00e7\u0131s\u0131ndan analiz edilmi\u015ftir; (5) Damla Hacmi Do\u011frulamas\u0131 \u2014 2,5 N s\u0131k\u0131\u015ft\u0131rma kuvvetinde bo\u015fluk ba\u015f\u0131na 20 s\u0131k\u0131\u015ft\u0131rma damla hacmi testi, damla ba\u015f\u0131na 25-45 \u00b5l spesifikasyonunu do\u011frulamaktad\u0131r; (6) Elastik Geri Kazan\u0131m Testi \u2014 30% hacim yer de\u011fi\u015ftirme s\u0131k\u0131\u015ft\u0131rmas\u0131ndan sonra 23\u00b0C'de 1,0 saniye i\u00e7inde kap duvar\u0131n\u0131n \u226595% orijinal hacmine geri d\u00f6n\u00fc\u015f\u00fc. Bu eksiksiz paket, teslimat \u00f6ncesi \u00fcretim denemesinin tamamlanmas\u0131ndan sonra 10 i\u015f g\u00fcn\u00fc i\u00e7inde Korea Ever-Power taraf\u0131ndan yay\u0131nlan\u0131r, Korea Ever-Power kalite y\u00f6netimi taraf\u0131ndan imzalan\u0131r ve Kore ila\u00e7 \u015firketinin Kore MFDS ila\u00e7 \u00fcr\u00fcn\u00fc kay\u0131t dosyas\u0131na dahil edilmeye haz\u0131rd\u0131r.<\/p>\n<\/div>\n<\/div>\n
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Soru 06<\/span><\/p>\nLDPE IBM kaplar\u0131, Kore'de koruyucu madde i\u00e7ermeyen oftalmik uygulamalar i\u00e7in sterilize edilebilir mi?<\/p>\n<\/div>\n
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Kore'de koruyucu madde i\u00e7ermeyen oftalmik uygulamalar i\u00e7in kullan\u0131lan LDPE IBM kaplar\u0131, her biri i\u00e7in \u00f6nemli i\u015flem k\u0131s\u0131tlamalar\u0131 olan iki Kore farmas\u00f6tik uyumlu sterilizasyon y\u00f6ntemi kullan\u0131larak sterilize edilebilir. Etilen oksit (EtO) sterilizasyonu: Kore MFDS, LDPE oftalmik kaplar i\u00e7in onaylanm\u0131\u015ft\u0131r. LDPE, EtO gaz\u0131na ge\u00e7irgendir; gaz, kab\u0131n duvar\u0131na n\u00fcfuz eder ve i\u00e7 y\u00fczeyi sterilize eder. EtO sterilizasyonundan sonra, Kore farmas\u00f6tik standart havaland\u0131rma protokol\u00fc ile EtO kal\u0131nt\u0131s\u0131 Kore Farmakopesi limitlerinin (EtO \u22641 ppm, etilen klorohidrin \u22641 ppm) alt\u0131na d\u00fc\u015f\u00fcr\u00fclmelidir. Korea Ever-Power'\u0131n Kore MFDS onayl\u0131 oftalmik LDPE IBM kaplar\u0131, Korea Ever-Power \u00fcretim dok\u00fcman\u0131nda EtO sterilizasyonu i\u00e7in onaylanm\u0131\u015ft\u0131r. Gama \u0131\u015f\u0131nlamas\u0131: Kore MFDS, LDPE oftalmik kaplar i\u00e7in gama \u0131\u015f\u0131nlamas\u0131n\u0131 (25-50 kGy) kabul etmektedir. LDPE, 25 kGy'de gama \u0131\u015f\u0131nlar\u0131na kar\u015f\u0131 stabildir; Kore MFDS oftalmik kap gama doz aral\u0131\u011f\u0131nda \u00f6nemli bir molek\u00fcler a\u011f\u0131rl\u0131k azalmas\u0131 veya mekanik \u00f6zellik de\u011fi\u015fikli\u011fi g\u00f6zlenmez. Bununla birlikte, LDPE gama \u0131\u015f\u0131nlamas\u0131, polimerde yava\u015f yava\u015f karbonil t\u00fcrlerine ayr\u0131\u015fan peroksit radikalleri \u00fcretir; Kore MFDS, gama ile sterilize edilmi\u015f Kore oftalmik LDPE IBM kaplar\u0131 i\u00e7in, karbonil g\u00f6\u00e7\u00fcn\u00fcn Kore MFDS oftalmik ekstraksiyon limitlerinin alt\u0131nda oldu\u011funu do\u011frulamak amac\u0131yla gama \u0131\u015f\u0131nlamas\u0131 sonras\u0131 ekstraksiyon testi yap\u0131lmas\u0131n\u0131 \u015fart ko\u015fmaktad\u0131r. Buharl\u0131 otoklavlama (121\u00b0C): LDPE IBM kaplar\u0131yla uyumlu DE\u011e\u0130LD\u0130R; LDPE, 121\u00b0C'de \u00f6nemli \u00f6l\u00e7\u00fcde yumu\u015far ve LDPE IBM oftalmik kaplar\u0131 Kore farmas\u00f6tik otoklav ko\u015fullar\u0131nda deforme olur. Kore LDPE IBM kaplar\u0131 i\u00e7in buharl\u0131 sterilizasyon \u00f6nerilmez; Kore MFDS uyumlu sterilizasyon se\u00e7enekleri EtO veya gama \u0131\u015f\u0131nlar\u0131d\u0131r.<\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/section>\n
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LDPE IBM SORGULAMASI \u00b7 KOREA EVER-POWER<\/p>\n
Kore'de LDPE IBM Squeeze Konteyner \u00dcretimi Planlan\u0131yor mu?<\/h2>\n Korea Ever-Power, ZQ40 ve ZQ60 makinelerinde LDPE IBM g\u00f6z damlas\u0131, burun spreyi ve s\u0131kma da\u011f\u0131t\u0131c\u0131 \u00fcretimi sa\u011flamakta olup, Kore MFDS ila\u00e7 ambalaj dok\u00fcmantasyonu, damla hacmi do\u011frulamas\u0131, elastik geri kazan\u0131m testi ve ekstraksiyon ve s\u0131z\u0131nt\u0131 \u00e7al\u0131\u015fmalar\u0131 deste\u011fi sunmaktad\u0131r.<\/p>\n
LDPE IBM Dan\u0131\u015fmanl\u0131\u011f\u0131 Talebi \u2192<\/span><\/a><\/p>\n<\/div>\n<\/div>\n <\/p>\n
Edit\u00f6r: Cxm<\/em><\/p>\n<\/div>\n<\/div>","protected":false},"excerpt":{"rendered":"LDPE IBM \u00b7 SOFT-SQUEEZE \u00b7 DROP DISPENSER \u00b7 KOREA EVER-POWER ZQ SERIES LDPE IBM: Soft-Squeeze Container Production Guide LDPE IBM produces the soft-squeeze drop dispensers, nasal spray squeeze bottles and pharmaceutical ophthalmic squeeze containers that require elastic recovery after squeezing \u2014 a container property unique to LDPE among IBM materials. Korea Ever-Power ZQ40 and ZQ60 […]<\/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":[26],"tags":[],"class_list":["post-1120","post","type-post","status-publish","format-standard","hentry","category-application-of-isbm"],"_links":{"self":[{"href":"https:\/\/isbm-blow-molding.com\/tr\/wp-json\/wp\/v2\/posts\/1120","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=1120"}],"version-history":[{"count":2,"href":"https:\/\/isbm-blow-molding.com\/tr\/wp-json\/wp\/v2\/posts\/1120\/revisions"}],"predecessor-version":[{"id":1123,"href":"https:\/\/isbm-blow-molding.com\/tr\/wp-json\/wp\/v2\/posts\/1120\/revisions\/1123"}],"wp:attachment":[{"href":"https:\/\/isbm-blow-molding.com\/tr\/wp-json\/wp\/v2\/media?parent=1120"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/isbm-blow-molding.com\/tr\/wp-json\/wp\/v2\/categories?post=1120"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/isbm-blow-molding.com\/tr\/wp-json\/wp\/v2\/tags?post=1120"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}