{"id":9682,"date":"2026-01-13T02:12:39","date_gmt":"2026-01-13T02:12:39","guid":{"rendered":"https:\/\/pharmamachinecn.com\/?p=9682"},"modified":"2026-05-05T15:52:35","modified_gmt":"2026-05-05T15:52:35","slug":"sop-for-rapid-mixer-granulator","status":"publish","type":"post","link":"https:\/\/pharmamachinecn.com\/tr\/sop-for-rapid-mixer-granulator\/","title":{"rendered":"H\u0131zl\u0131 Kar\u0131\u015ft\u0131r\u0131c\u0131 Gran\u00fclat\u00f6r i\u00e7in Standart \u0130\u015flem Prosed\u00fcr\u00fc (SOP)"},"content":{"rendered":"
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\"H\u0131zl\u0131
H\u0131zl\u0131 kar\u0131\u015ft\u0131r\u0131c\u0131 gran\u00fclat\u00f6r i\u00e7in standart i\u015fletim prosed\u00fcr\u00fc (SOP).<\/strong><\/em><\/figcaption><\/figure>

1.0 AMA\u00c7:<\/b><\/strong><\/h2>

1.1 Bu belge, H\u0131zl\u0131 Kar\u0131\u015ft\u0131r\u0131c\u0131 Gran\u00fclat\u00f6r\u00fcn g\u00fcvenli ve do\u011fru \u015fekilde nas\u0131l \u00e7al\u0131\u015ft\u0131r\u0131laca\u011f\u0131n\u0131 a\u00e7\u0131klamaktad\u0131r.<\/p>

1.2 Her seferinde, her partiden tutarl\u0131 gran\u00fcller elde etmek istiyoruz.<\/p>

1.3 Bu standart i\u015fletim prosed\u00fcr\u00fcne uymak, \u00fcr\u00fcn kalitesini korur ve GMP gerekliliklerine uygun hareket etmemizi sa\u011flar.<\/p>

2.0 KAPSAM:<\/b><\/strong><\/h2>

2.1 Bu Standart \u0130\u015flem Prosed\u00fcr\u00fc (SOP), \u00fcretim departman\u0131ndaki H\u0131zl\u0131 Kar\u0131\u015ft\u0131r\u0131c\u0131 Gran\u00fclat\u00f6r\u00fc kapsamaktad\u0131r.<\/p>

2.2 RMG'yi \u00e7al\u0131\u015ft\u0131r\u0131rken, temizlerken veya bak\u0131m\u0131n\u0131 yaparken bunu kullan\u0131n.<\/p>

2.3 Bu, tablet ve kaps\u00fcller i\u00e7in t\u00fcm \u0131slak gran\u00fclasyon i\u015flemlerine uygulan\u0131r.<\/p>

2.4 RMG ile \u00e7al\u0131\u015fan t\u00fcm operat\u00f6rler ve \u00fcretim personeli bu prosed\u00fcre uymal\u0131d\u0131r.<\/p>

3.0 SORUMLULUK:<\/b><\/strong><\/h2>

3.1 Operat\u00f6r:<\/b><\/strong>\u00a0Makineyi \u00e7al\u0131\u015ft\u0131r\u0131r, s\u00fcreci izler ve \u00e7al\u0131\u015fma alan\u0131n\u0131 temiz tutar.<\/p>

3.2 \u00dcretim Kimyageri:<\/b><\/strong>\u00a0Gran\u00fclasyon i\u015flemini denetler, parti kay\u0131tlar\u0131n\u0131 do\u011frular ve ortaya \u00e7\u0131kan sorunlar\u0131 \u00e7\u00f6zer.<\/p>

3.3 IPQA:<\/b><\/strong>\u00a0Bir sonraki parti \u00f6ncesinde \u00fcretim hatt\u0131n\u0131n temizli\u011fini sa\u011flar ve temizlik durumunu kontrol eder.<\/p>

3.4 Bak\u0131m:<\/b><\/strong>\u00a0Ekipmanlar\u0131n onar\u0131mlar\u0131n\u0131 ve periyodik bak\u0131mlar\u0131n\u0131 ger\u00e7ekle\u015ftirir.<\/p>

4.0 SORUMLULUK:<\/b><\/strong><\/h2>

4.1 Bu SOP \u00dcretim Y\u00f6neticisinin m\u00fclkiyetindedir.<\/p>

4.2 \u00dcretim M\u00fcd\u00fcr\u00fc, bu prosed\u00fcrdeki de\u011fi\u015fiklikleri onaylar.<\/p>

4.3 \u00dcretim M\u00fcd\u00fcr\u00fc, RMG'yi kullanmadan \u00f6nce herkesin e\u011fitim almas\u0131n\u0131 sa\u011flar.<\/p>

4.4 Herhangi bir sapma, incelenmek \u00fczere \u00dcretim M\u00fcd\u00fcr\u00fcne bildirilmelidir.<\/p>

5.0 \u0130\u015eLEM:<\/b><\/strong><\/h2>

5.1 Operasyon \u00d6ncesi Kontroller:<\/b><\/strong><\/h3>

5.1.1 \u00d6ncelikle alan\u0131 kontrol edin. Temiz mi? G\u00fczel. \u015eimdi makineyi kontrol edin. \u00dczerinde "TEM\u0130ZLEND\u0130" etiketini g\u00f6rmelisiniz.<\/p>

5.1.2 Ekipman Kullan\u0131m G\u00fcnl\u00fc\u011f\u00fcn\u00fc a\u00e7\u0131n. Tarihi, saati, \u00fcr\u00fcn ad\u0131n\u0131, parti numaras\u0131n\u0131 ve ad\u0131n\u0131z\u0131 not edin.<\/p>

5.1.3 Ba\u015far\u0131yla ger\u00e7ekle\u015ftirin \u201c"TEM\u0130ZLEND\u0130"\u201d<\/strong> Etiketin yerine "\u0130\u015eLEM A\u015eAMASINDA" etiketi koyun.<\/p>

5.1.4 Hat \u0130zin Belgesi olmadan i\u015fe ba\u015flamay\u0131n. \u00d6ncelikle IPQA'dan bir belge al\u0131n.<\/p>

5.1.5 Belgelerinizi toplay\u0131n\u2014BMR, bu SOP ve varsa kontrol listeleri. Bunlar\u0131 elinizin alt\u0131nda bulundurun.<\/p>

5.1.6 Etrafa bak\u0131n. \u00d6nceki partiden kalan bir \u015fey var m\u0131? Onu kald\u0131r\u0131n. \u00c7apraz bula\u015fma ciddi bir sorundur.<\/p>

5.1.7 Haznenin, pervanenin ve do\u011fray\u0131c\u0131n\u0131n do\u011fru \u015fekilde tak\u0131l\u0131p sabitlendi\u011fini kontrol edin.<\/p>

5.2 \u00d6nlemler:<\/b><\/strong><\/h3>

5.2.1 Kapak, \u00e7al\u0131\u015fma s\u0131ras\u0131nda kapal\u0131 kal\u0131r. Hi\u00e7bir istisna yoktur.<\/p>

5.2.2 G\u00fcvenlik kilitlemeleri sizin g\u00fcvenli\u011finiz i\u00e7indir. Bunlar\u0131 asla devre d\u0131\u015f\u0131 b\u0131rakmay\u0131n.<\/p>

5.2.3 Makinede de\u011fi\u015fiklik yapmay\u0131 m\u0131 d\u00fc\u015f\u00fcn\u00fcyorsunuz? Durun. \u00d6nce yaz\u0131l\u0131 onay al\u0131n.<\/p>

5.2.4 Pervane ve do\u011fray\u0131c\u0131 \u00e7ok h\u0131zl\u0131 d\u00f6n\u00fcyor. Ger\u00e7ekten \u00e7ok h\u0131zl\u0131. Hareket halindeyken asla elinizi i\u00e7eri sokmay\u0131n.<\/p>

5.2.5 Par\u00e7alar\u0131 takmadan, s\u00f6kmeden veya temizlemeden \u00f6nce ana g\u00fcc\u00fc kapat\u0131n. Bunu her seferinde yap\u0131n.<\/p>

5.2.6 G\u00fcvenlik cihazlar\u0131n\u0131 devre d\u0131\u015f\u0131 b\u0131rakmay\u0131n veya bunlarla oynamay\u0131n. Bunlar iste\u011fe ba\u011fl\u0131 de\u011fildir.<\/p>

5.2.7 Kontrol panelini yaln\u0131zca yumu\u015fak, kuru bir bezle silin. S\u0131v\u0131 kullanmay\u0131n.<\/p>

5.2.8 Makine uzun s\u00fcre \u00e7al\u0131\u015ft\u0131r\u0131ld\u0131\u011f\u0131nda \u0131s\u0131n\u0131r. Metal y\u00fczeylere dokunmadan \u00f6nce so\u011fumas\u0131n\u0131 bekleyin.<\/p>

5.2.9 Ki\u015fisel koruyucu ekipman zorunludur: eldiven, koruyucu g\u00f6zl\u00fck, toz maskesi. Hepsini tak\u0131n.<\/p>

5.2.10 Kab\u0131 a\u015f\u0131r\u0131 doldurmay\u0131n. Belirtilen kapasiteye uyun, aksi takdirde kalitesiz gran\u00fcller elde edersiniz.<\/p>

5.2.11 Da\u011f\u0131n\u0131k bir alan hatalara yol a\u00e7ar. D\u00fczenli tutun.<\/p>

5.3 G\u00fcvenlik Sistemi Kontrolleri:<\/b><\/strong><\/h3>

5.3.1 Bu testleri haftada bir kez \u00e7al\u0131\u015ft\u0131r\u0131n. Her \u015feyi belgeleyin.<\/p>

5.3.1.1 Ana g\u00fc\u00e7 \u015falterini deneyin. G\u00fcc\u00fc an\u0131nda kesmesi gerekir.<\/p>

5.3.1.2 Acil durdurma d\u00fc\u011fmesine bas\u0131n. Makine hemen donmal\u0131d\u0131r.<\/p>

5.3.1.3 \u00c7al\u0131\u015f\u0131r durumdayken kapa\u011f\u0131 a\u00e7\u0131n. Pervane ve do\u011fray\u0131c\u0131 hemen durmal\u0131d\u0131r.<\/p>

5.3.1.4 A\u015f\u0131r\u0131 y\u00fck r\u00f6lesini kontrol edin. A\u015f\u0131r\u0131 y\u00fck alt\u0131nda devre d\u0131\u015f\u0131 kal\u0131yor mu? Kalmas\u0131 gerekiyor.<\/p>

5.3.1.5 T\u00fcm g\u00f6sterge \u0131\u015f\u0131klar\u0131na ve alarmlara bak\u0131n. Her \u015fey yan\u0131yor ve \u00e7al\u0131\u015f\u0131yor mu?<\/p>

5.4 Makine Bile\u015fenleri:<\/b><\/strong><\/h3>

5.4.1 Kar\u0131\u015ft\u0131rma Kab\u0131:<\/b><\/strong>\u00a0B\u00fct\u00fcn i\u015flemler burada ger\u00e7ekle\u015fiyor. Tozlar i\u00e7eri giriyor, gran\u00fcller d\u0131\u015far\u0131 \u00e7\u0131k\u0131yor. Gerekirse s\u0131cakl\u0131k kontrol\u00fc i\u00e7in ceketli bir yap\u0131ya sahip.<\/p>

5.4.2 Pervane:<\/b><\/strong>\u00a0Alttaki b\u00fcy\u00fck b\u0131\u00e7ak d\u00f6n\u00fcyor ve tozlar\u0131 birbirine kar\u0131\u015ft\u0131r\u0131yor. Yuvarlanma hareketini yarat\u0131yor.<\/p>

5.4.3 Helikopter:<\/b><\/strong>\u00a0Yan duvara monte edilmi\u015f daha k\u00fc\u00e7\u00fck b\u0131\u00e7aklar, \u0131slak hamurla\u015ft\u0131rma s\u0131ras\u0131nda \u00e7ok h\u0131zl\u0131 d\u00f6nerek topaklar\u0131 par\u00e7alar.<\/p>

5.4.4 Kapak:<\/b><\/strong>\u00a0\u00c7al\u0131\u015fma s\u0131ras\u0131nda hazneyi kapat\u0131r. Ba\u011flay\u0131c\u0131 \u00e7\u00f6zelti eklemek i\u00e7in bir ba\u011flant\u0131 noktas\u0131 bulunur.<\/p>

5.4.5 Ba\u011flay\u0131c\u0131 Ekleme Ba\u011flant\u0131 Noktas\u0131:<\/b><\/strong>\u00a0Kapak \u00fczerindeki, gran\u00fclasyon s\u0131v\u0131s\u0131n\u0131 d\u00f6kt\u00fc\u011f\u00fcn\u00fcz veya p\u00fcsk\u00fcrtt\u00fc\u011f\u00fcn\u00fcz a\u00e7\u0131kl\u0131k.<\/p>

5.4.6 Tahliye Vanas\u0131:<\/b><\/strong>\u00a0Kab\u0131n dibinde bulunur. Islak gran\u00fclleri bir kaba veya tepsiye bo\u015faltmak i\u00e7in a\u00e7\u0131n.<\/p>

5.4.7 Kontrol<\/b><\/strong><\/h3>

Panel:<\/strong> Pervane h\u0131z\u0131, do\u011fray\u0131c\u0131 h\u0131z\u0131, zamanlay\u0131c\u0131, ba\u015flat\/durdur d\u00fc\u011fmeleri ve acil durdurma dahil olmak \u00fczere t\u00fcm kontrolleri bar\u0131nd\u0131r\u0131r.<\/p>

5.4.8 Amper
<\/b><\/h3>

Metre:<\/b>\u00a0<\/span>Pervane motorunun \u00e7ekti\u011fi ak\u0131m\u0131 g\u00f6sterir. Gran\u00fcl olu\u015fumunu izlemek i\u00e7in kullan\u0131\u015fl\u0131d\u0131r.<\/p>

5.5 Montaj:<\/b><\/strong><\/h3>

5.5.1 Montajdan \u00f6nce mutlaka g\u00fc\u00e7 kapat\u0131lmal\u0131d\u0131r. Her zaman.<\/p>

5.5.2 Kar\u0131\u015ft\u0131rma kab\u0131n\u0131 tabana indirin. D\u00fczg\u00fcn bir \u015fekilde oturdu\u011fundan ve yerine kilitlendi\u011finden emin olun.<\/p>

5.5.3 Pervaneyi tahrik miline tak\u0131n. \u00d6nce elle s\u0131k\u0131n, ard\u0131ndan aleti kullanarak sabitleyin. Hafif\u00e7e sallay\u0131n, kesinlikle hareket etmesine izin vermeyin.<\/p>

5.5.4 Do\u011fray\u0131c\u0131y\u0131 yan \u015fafta monte edin. S\u0131k\u0131ca kilitleyin.<\/p>

5.5.5 Kapa\u011f\u0131 \u00fcst\u00fcne yerle\u015ftirin. Kilitleme kelep\u00e7elerini tak\u0131n. Hepsini.<\/p>

5.5.6 Tahliye vanas\u0131n\u0131 kontrol edin. Kapal\u0131 m\u0131? D\u00fczg\u00fcn \u015fekilde s\u0131zd\u0131rmaz hale getirilmi\u015f mi? \u0130yi.<\/p>

5.5.7 Ba\u011flay\u0131c\u0131 p\u00fcsk\u00fcrtme sistemi kullan\u0131yorsan\u0131z, nozulu ve hortumu \u015fimdi ba\u011flay\u0131n. T\u0131kan\u0131kl\u0131k olmad\u0131\u011f\u0131ndan emin olun.<\/p>

5.5.8 T\u00fcm koruyucular yerinde mi? Kapak sens\u00f6r\u00fc \u00e7al\u0131\u015f\u0131yor mu? Devam etmeden \u00f6nce tekrar kontrol edin.<\/p>

5.6 \u00c7al\u0131\u015ft\u0131rma:<\/b><\/strong><\/h3>

5.6.1 Ana g\u00fc\u00e7 kayna\u011f\u0131n\u0131 a\u00e7\u0131n.<\/p>

5.6.2 Kontrol paneli \u0131\u015f\u0131klar\u0131 yan\u0131yor. T\u00fcm ekranlar\u0131n do\u011fru okundu\u011funu kontrol edin.<\/p>

5.6.3 Tart\u0131lan tozlar\u0131 BMR'ye g\u00f6re kaba y\u00fckleyin. Hepsini birden d\u00f6kmeyin; miktar b\u00fcy\u00fckse azar azar ekleyin.<\/p>

5.6.4 Kapa\u011f\u0131 s\u0131k\u0131ca kapat\u0131n ve kilitleyin.<\/p>

5.6.5 Kuru Kar\u0131\u015ft\u0131rma:<\/b><\/strong><\/h3>

5.6.5.1 Pervane h\u0131z\u0131n\u0131 BMR'ye g\u00f6re ayarlay\u0131n. Genellikle d\u00fc\u015f\u00fck ila orta h\u0131z.<\/p>

5.6.5.2 Kuru kar\u0131\u015ft\u0131rma s\u0131ras\u0131nda do\u011fray\u0131c\u0131y\u0131 kapal\u0131 tutun. Veya BMR'de belirtilmi\u015fse d\u00fc\u015f\u00fck h\u0131zda \u00e7al\u0131\u015ft\u0131r\u0131n.<\/p>

5.6.5.3 Parti kayd\u0131nda belirtilen s\u00fcre boyunca kar\u0131\u015ft\u0131r\u0131n. Genellikle 3 ila 5 dakika.<\/p>

5.6.5.4 Bu ad\u0131m, t\u00fcm kuru malzemeleri e\u015fit \u015fekilde kar\u0131\u015ft\u0131r\u0131r.<\/p>

5.6.6 Klas\u00f6r Ekleme:<\/b><\/strong><\/h3>

5.6.6.1 Ba\u011flay\u0131c\u0131 \u00e7\u00f6zeltiyi BMR'ye g\u00f6re haz\u0131rlay\u0131n. Gerekirse s\u00fcz\u00fcn.<\/p>

5.6.6.2 Pervane \u00e7al\u0131\u015f\u0131rken, ba\u011flay\u0131c\u0131y\u0131 yava\u015f\u00e7a giri\u015f noktas\u0131ndan ekleyin.<\/p>

5.6.6.3 Yava\u015f\u00e7a d\u00f6k\u00fcn. Hepsini birden d\u00f6kmeyin, topaklar olu\u015fur.<\/p>

5.6.6.4 P\u00fcsk\u00fcrtme sistemi kullan\u0131yorsan\u0131z, ak\u0131\u015f h\u0131z\u0131n\u0131 ayarlay\u0131n ve gerisini sisteme b\u0131rak\u0131n.<\/p>

5.6.7 Islak K\u00fctleleme:<\/b><\/strong><\/h3>

5.6.7.1 T\u00fcm ba\u011flay\u0131c\u0131 madde eklendikten sonra, BMR talimat\u0131 do\u011frultusunda pervane h\u0131z\u0131n\u0131 art\u0131r\u0131n.<\/p>

5.6.7.2 Do\u011fray\u0131c\u0131y\u0131 \u00e7al\u0131\u015ft\u0131r\u0131n. Topaklar\u0131 par\u00e7alar ve nemin e\u015fit da\u011f\u0131lmas\u0131na yard\u0131mc\u0131 olur.<\/p>

5.6.7.3 Ampermetreyi izleyin. Tanecikler olu\u015fup yo\u011funla\u015ft\u0131k\u00e7a ak\u0131m artar.<\/p>

5.6.7.4 Son noktaya ula\u015fana kadar kar\u0131\u015ft\u0131r\u0131n. Bu, zamana, ak\u0131ma veya g\u00f6rsel g\u00f6stergelere dayal\u0131 olabilir.<\/p>

5.6.7.5 A\u015f\u0131r\u0131 gran\u00fclasyon, partiyi mahveder. Hedeflenen miktara ula\u015ft\u0131\u011f\u0131n\u0131zda durun.<\/p>

5.6.8 Gran\u00fcl Bo\u015falt\u0131m\u0131:<\/b><\/strong><\/h3>

5.6.8.1 Pervaneyi ve do\u011fray\u0131c\u0131y\u0131 durdurun.<\/p>

5.6.8.2 Kapa\u011f\u0131 a\u00e7\u0131n ve gran\u00fclleri kontrol edin. Gran\u00fcller homojen g\u00f6r\u00fcnmeli ve hafif\u00e7e s\u0131k\u0131ld\u0131\u011f\u0131nda bir arada kalmal\u0131d\u0131r.<\/p>

5.6.8.3 Tahliye vanas\u0131n\u0131n alt\u0131na temiz bir kap veya tepsi yerle\u015ftirin.<\/p>

5.6.8.4 Tahliye vanas\u0131n\u0131 a\u00e7\u0131n. Gran\u00fclleri d\u0131\u015far\u0131 itmek i\u00e7in pervaneyi d\u00fc\u015f\u00fck h\u0131zda \u00e7al\u0131\u015ft\u0131r\u0131n.<\/p>

5.6.8.5 Gerekirse, kase duvarlar\u0131na yap\u0131\u015fm\u0131\u015f malzemeleri kaz\u0131y\u0131n.<\/p>

5.6.9 Her \u015feyi belgeleyin: ba\u015flang\u0131\u00e7 zaman\u0131, biti\u015f zaman\u0131, pervane h\u0131z\u0131, do\u011fray\u0131c\u0131 h\u0131z\u0131, kar\u0131\u015ft\u0131rma s\u00fcreleri ve t\u00fcm g\u00f6zlemler.<\/p>

5.7 \u0130\u015flem S\u0131ras\u0131ndaki Kontroller:<\/b><\/strong><\/h3>

5.7.1 BMR'de tan\u0131mlanan a\u015famalarda gran\u00fclleri kontrol edin.<\/p>

5.7.2 Kuru kar\u0131\u015ft\u0131rma i\u015fleminden sonra: homojen bir renk ve g\u00f6zle g\u00f6r\u00fcl\u00fcr topak olmamas\u0131na dikkat edin.<\/p>

5.7.3 Islak k\u00fctleleme s\u0131ras\u0131nda: k\u00fc\u00e7\u00fck bir numuneyi s\u0131k\u0131n. \u015eeklini korumal\u0131 ancak kolayca par\u00e7alanmal\u0131d\u0131r.<\/p>

5.7.4 Son gran\u00fcller: gerekirse g\u00f6r\u00fcn\u00fcm\u00fcn\u00fc, dokusunu ve nemini kontrol edin.<\/p>

5.7.5 T\u00fcm g\u00f6zlemleri s\u00fcre\u00e7 i\u00e7i kontrol formlar\u0131na kaydedin.<\/p>

5.7.6 Bir gariplik mi fark ettiniz? Hemen durun ve amirinizi aray\u0131n.<\/p>

5.8 Kapatma Prosed\u00fcr\u00fc:<\/b><\/strong><\/h3>

5.8.1 T\u00fcm gran\u00fcllerin kaptan bo\u015falt\u0131ld\u0131\u011f\u0131ndan emin olun.<\/p>

5.8.2 Pervaneyi ve do\u011fray\u0131c\u0131y\u0131 tamamen durdurun.<\/p>

5.8.3 Ana g\u00fc\u00e7 kayna\u011f\u0131n\u0131 kapat\u0131n.<\/p>

5.8.4 Islak gran\u00fclleri BMR'ye g\u00f6re kurutma tepsilerine veya ak\u0131\u015fkan yatakl\u0131 kurutucuya aktar\u0131n.<\/p>

5.8.5 BMR ve Ekipman Kullan\u0131m G\u00fcnl\u00fc\u011f\u00fcn\u00fc doldurun. Bo\u015f alan b\u0131rakmay\u0131n.<\/p>

5.9 Temizleme Prosed\u00fcr\u00fc:<\/b><\/strong><\/h3>

5.9.1 G\u00fc\u00e7 ba\u011flant\u0131s\u0131n\u0131 kesin. Burada k\u0131sayol yok.<\/p>

5.9.2 Kapa\u011f\u0131 a\u00e7\u0131n ve kapta kalan t\u00fcm malzemeleri \u00e7\u0131kar\u0131n.<\/p>

5.9.3 Pervaneyi \u00e7\u0131kar\u0131n. Do\u011fray\u0131c\u0131y\u0131 da \u00e7\u0131kar\u0131n.<\/p>

5.9.4 Hazneyi, pervaneyi, do\u011fray\u0131c\u0131y\u0131 ve kapa\u011f\u0131 ar\u0131t\u0131lm\u0131\u015f suyla y\u0131kay\u0131n. Yap\u0131\u015fkan kal\u0131nt\u0131lar\u0131 ovarak temizleyin.<\/p>

5.9.5 Temizlik prosed\u00fcr\u00fcnde belirtilmi\u015fse, onayl\u0131 bir temizlik maddesi kullanarak y\u0131kama i\u015flemiyle devam edin.<\/p>

5.9.6 Her \u015feyi ar\u0131t\u0131lm\u0131\u015f suyla iyice durulay\u0131n. Sabun kal\u0131nt\u0131s\u0131 kalmamal\u0131d\u0131r.<\/p>

5.9.7 Dezenfeksiyon i\u00e7in 70% IPA ile silin.<\/p>

5.9.8 Yeniden montajdan \u00f6nce t\u00fcm par\u00e7alar\u0131 tamamen kurulay\u0131n. Nem paslanmaya ve kirlenmeye neden olur.<\/p>

5.9.9 Makinenin d\u0131\u015f y\u00fczeylerini nemli bir bezle temizleyin, ard\u0131ndan kurulay\u0131n.<\/p>

5.9.10 Her \u015fey kuruduktan sonra pervaneyi ve do\u011fray\u0131c\u0131y\u0131 tekrar monte edin.<\/p>

5.9.11 Kalite Kontrol birimini arayarak inceleme yapt\u0131r\u0131n. Onayland\u0131ktan sonra "TEM\u0130ZLEND\u0130" etiketini yap\u0131\u015ft\u0131r\u0131n.<\/p>

5.9.12 T\u00fcm temizlik detaylar\u0131n\u0131 Ekipman Temizlik G\u00fcnl\u00fc\u011f\u00fcne kaydedin.<\/p>

5.10 Sorun Giderme:<\/b><\/strong><\/h3>

5.10.1 Topakl\u0131 tanecikler:<\/b><\/strong>\u00a0Ba\u011flay\u0131c\u0131 \u00e7ok mu h\u0131zl\u0131 eklendi? Do\u011fray\u0131c\u0131 \u00e7al\u0131\u015fm\u0131yor mu? Bir dahaki sefere ikisini de kontrol edin.<\/p>

5.10.2 Tanecikler \u00e7ok \u0131slak:<\/b><\/strong>\u00a0\u00c7ok fazla ba\u011flay\u0131c\u0131 madde kullan\u0131lm\u0131\u015f. Ya da ba\u011flay\u0131c\u0131 madde eklendikten sonra kar\u0131\u015ft\u0131rma i\u015flemi \u00e7ok uzun s\u00fcre devam etmi\u015f.<\/p>

5.10.3 Tanecikler \u00e7ok kuru veya toz halinde:<\/b><\/strong>\u00a0Yeterli ba\u011flay\u0131c\u0131 yok. Ya da ba\u011flay\u0131c\u0131 iyi da\u011f\u0131t\u0131lmam\u0131\u015f.<\/p>

5.10.4 Pervane d\u00f6nm\u00fcyor:<\/b><\/strong>\u00a0G\u00fc\u00e7 kayna\u011f\u0131n\u0131 kontrol edin. A\u015f\u0131r\u0131 y\u00fck r\u00f6lesine bak\u0131n. Acil durdurma d\u00fc\u011fmesine bas\u0131ld\u0131 m\u0131?<\/p>

5.10.5 Helikopter d\u00f6nm\u00fcyor:<\/b><\/strong>\u00a0Pervane ile ayn\u0131 kontrolleri yap\u0131n. Ayr\u0131ca do\u011fray\u0131c\u0131n\u0131n do\u011fru \u015fekilde kilitlendi\u011finden emin olun.<\/p>

5.10.6 Tahliye vanas\u0131 s\u0131k\u0131\u015fm\u0131\u015f:<\/b><\/strong>\u00a0Muhtemelen malzeme birikmesinden kaynaklan\u0131yor. Elle temizleyin.<\/p>

5.10.7 Ola\u011fand\u0131\u015f\u0131 ses veya titre\u015fim:<\/b><\/strong>\u00a0Hemen durun. Gev\u015fek par\u00e7alar veya a\u015f\u0131nm\u0131\u015f rulmanlar olabilir.<\/p>

5.11 Ameliyat Sonras\u0131:<\/b><\/strong><\/h3>

5.11.1 \u0130\u015flem tamamland\u0131 m\u0131? Makineye \u201cTEM\u0130ZLENECEK\u201d etiketini yap\u0131\u015ft\u0131r\u0131n.<\/p>

5.11.2 RMG'yi B\u00f6l\u00fcm 5.9'daki talimatlara g\u00f6re temizleyin.<\/p>

5.11.3 Gerekli t\u00fcm evraklar\u0131 tamamlay\u0131n\u2014Ekipman Kullan\u0131m Kayd\u0131, BMR, gerekirse sapma raporlar\u0131.<\/p>

5.11.4 Alan\u0131 temiz ve bir sonraki parti i\u00e7in haz\u0131r b\u0131rak\u0131n.<\/p>

5.12 Kay\u0131tlar:<\/b><\/strong><\/h3>

5.12.1 Ekipman Kullan\u0131m G\u00fcnl\u00fc\u011f\u00fc.<\/p>

5.12.2 Ekipman Temizleme Kay\u0131t Defteri.<\/p>

5.12.3 Parti \u00dcretim Kayd\u0131.<\/p>

5.12.4 Devam Eden \u00c7ek Kay\u0131tlar\u0131.<\/p>

5.12.5 Sapma Raporlar\u0131 (uygulanabilir oldu\u011funda).<\/p>

6.0 KISALTMALAR:<\/b><\/strong><\/h2>

6.1 Standart \u0130\u015flem Prosed\u00fcr\u00fc (SOP):<\/strong> Standart \u0130\u015fletme Prosed\u00fcr\u00fc.<\/p>

6.2 BMR:<\/strong> Parti \u00dcretim Kayd\u0131.<\/p>

6.3 IPQA:<\/strong> S\u00fcre\u00e7 \u0130\u00e7i Kalite G\u00fcvencesi.<\/p>

6.4 Ki\u015fisel Koruyucu Ekipman (PPE):<\/strong> Ki\u015fisel Koruyucu Ekipman.<\/p>

6.5 IPA:<\/strong> \u0130zopropil Alkol.<\/p>

6.6 RMG:<\/strong> H\u0131zl\u0131 Kar\u0131\u015ft\u0131r\u0131c\u0131 Gran\u00fclat\u00f6r.<\/p>

6.7 Kalite G\u00fcvencesi:<\/strong> Kalite G\u00fcvencesi.<\/p>

6.8 GMP:<\/strong> \u0130yi \u00dcretim Uygulamalar\u0131.<\/p>

7.0 KAYNAKLAR:<\/b><\/strong><\/h2>

7.1 \u00dcreticinin Ekipman K\u0131lavuzu<\/p>

7.2 GMP Y\u00f6nergeleri<\/p>

7.3 Dahili Kalite Sistemi Belgeleri<\/p>

7.4 Temizlik Do\u011frulama Protokol\u00fc<\/p>

8.0 REV\u0130ZYON GE\u00c7M\u0130\u015e\u0130:<\/b><\/strong><\/h2>
Revizyon No.<\/b><\/strong><\/td>Tarih<\/b><\/strong><\/td>De\u011fi\u015fikli\u011fin A\u00e7\u0131klamas\u0131<\/b><\/strong><\/td>Taraf\u0131ndan haz\u0131rland\u0131<\/b><\/strong><\/td>Onaylayan<\/b><\/strong><\/td><\/tr>
00<\/td>GG\/AA\/YYYY<\/td>\u0130lk S\u00fcr\u00fcm<\/td>\u00a0<\/td>\u00a0<\/td><\/tr><\/tbody><\/table><\/div>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>","protected":false},"excerpt":{"rendered":"

1.0 OBJECTIVE: 1.1 This document explains how to operate the Rapid Mixer Granulator safely and correctly. 1.2 We want consistent […]<\/p>\n","protected":false},"author":1,"featured_media":9684,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"categories":[83],"tags":[],"class_list":["post-9682","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-granulation-equipment"],"acf":[],"_links":{"self":[{"href":"https:\/\/pharmamachinecn.com\/tr\/wp-json\/wp\/v2\/posts\/9682","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/pharmamachinecn.com\/tr\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/pharmamachinecn.com\/tr\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/pharmamachinecn.com\/tr\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/pharmamachinecn.com\/tr\/wp-json\/wp\/v2\/comments?post=9682"}],"version-history":[{"count":5,"href":"https:\/\/pharmamachinecn.com\/tr\/wp-json\/wp\/v2\/posts\/9682\/revisions"}],"predecessor-version":[{"id":17065,"href":"https:\/\/pharmamachinecn.com\/tr\/wp-json\/wp\/v2\/posts\/9682\/revisions\/17065"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/pharmamachinecn.com\/tr\/wp-json\/wp\/v2\/media\/9684"}],"wp:attachment":[{"href":"https:\/\/pharmamachinecn.com\/tr\/wp-json\/wp\/v2\/media?parent=9682"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/pharmamachinecn.com\/tr\/wp-json\/wp\/v2\/categories?post=9682"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/pharmamachinecn.com\/tr\/wp-json\/wp\/v2\/tags?post=9682"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}