{"id":10137,"date":"2026-01-27T02:12:00","date_gmt":"2026-01-27T02:12:00","guid":{"rendered":"https:\/\/pharmamachinecn.com\/?p=10137"},"modified":"2025-12-10T02:24:14","modified_gmt":"2025-12-10T02:24:14","slug":"sop-for-capsule-polishing-machine","status":"publish","type":"post","link":"https:\/\/pharmamachinecn.com\/tr\/sop-for-capsule-polishing-machine\/","title":{"rendered":"Kaps\u00fcl Parlatma Makinesi i\u00e7in SOP"},"content":{"rendered":"
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\"Kaps\u00fcl
Kaps\u00fcl Cilalama Makinas\u0131n\u0131n standart \u00e7al\u0131\u015fma prosed\u00fcr\u00fc.<\/b><\/strong><\/figcaption><\/figure>

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

1.1 Bu belge personele Kaps\u00fcl Parlatma Makinesinin do\u011fru \u015fekilde nas\u0131l \u00e7al\u0131\u015ft\u0131r\u0131laca\u011f\u0131n\u0131 anlat\u0131r.<\/p>

1.2 Her partinin her seferinde ayn\u0131 \u015fekilde cilalanmas\u0131n\u0131 istiyoruz.<\/p>

1.3 Bu SOP'ye uyulmas\u0131 \u00fcr\u00fcn\u00fcn g\u00fcvenli kalmas\u0131n\u0131 ve GMP kurallar\u0131na uygun olmas\u0131n\u0131 sa\u011flar.<\/p>

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

2.1 Bu SOP \u00fcretim b\u00f6l\u00fcm\u00fcndeki Kaps\u00fcl Parlatma Makinesini kapsamaktad\u0131r.<\/p>

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

2.3 Dolum a\u015famas\u0131ndan sonra parlatma gerektiren t\u00fcm dolu sert jelatin kaps\u00fcller i\u00e7in ge\u00e7erlidir.<\/p>

2.4 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, proses i\u00e7i kontrolleri yapar ve alan\u0131 temiz tutar.<\/p>

3.2 \u00dcretim Kimyageri:<\/b><\/strong>\u00a0Operasyonu denetler, parti kay\u0131tlar\u0131n\u0131 kontrol eder ve ortaya \u00e7\u0131kan sorunlarla ilgilenir.<\/p>

3.3 IPQA:<\/b><\/strong>\u00a0Bir sonraki partiden \u00f6nce hat temizli\u011fini sa\u011flar ve temizli\u011fi do\u011frular.<\/p>

3.4 Bak\u0131m:<\/b><\/strong>\u00a0Makinenin ar\u0131zalar\u0131n\u0131 giderir ve planl\u0131 bak\u0131m\u0131n\u0131 yapar.<\/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\u00fcrde yap\u0131lacak de\u011fi\u015fiklikleri onaylar.<\/p>

4.3 \u00dcretim M\u00fcd\u00fcr\u00fc, personelin makineye dokunmadan \u00f6nce uygun e\u011fitimi ald\u0131\u011f\u0131ndan emin olur.<\/p>

4.4 Herhangi bir sapma \u00dcretim M\u00fcd\u00fcr\u00fcn\u00fcn incelemesine sunulur.<\/p>

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

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

5.1.1 \u0130lk olarak, alan\u0131n temiz g\u00f6r\u00fcnd\u00fc\u011f\u00fcnden emin olun. Makine de temiz olmal\u0131d\u0131r. Haz\u0131rsa "TEM\u0130ZLEND\u0130" etiketini g\u00f6receksiniz.<\/p>

5.1.2 Ekipman Kullan\u0131m G\u00fcnl\u00fc\u011f\u00fcn\u00fc al\u0131n. Bug\u00fcn\u00fcn tarihini, saatini, kulland\u0131\u011f\u0131n\u0131z \u00fcr\u00fcn\u00fc, parti numaras\u0131n\u0131 ve ad\u0131n\u0131z\u0131 not edin.<\/p>

5.1.3 \u015eimdi "TEM\u0130ZLEND\u0130" etiketini \u00e7\u0131kar\u0131n. Bunun yerine "\u0130\u015eLEM A\u015eAMASINDA" etiketi yap\u0131\u015ft\u0131r\u0131n.<\/p>

5.1.4 Hat Temizleme Sertifikas\u0131 olmadan i\u015fe ba\u015flayamazs\u0131n\u0131z. IPQA'dan bir tane edinin.<\/p>

5.1.5 Bazal Metabolizma Oran\u0131n\u0131z\u0131 (BMR) ald\u0131n\u0131z m\u0131? Bu SOP'yi ald\u0131n\u0131z m\u0131? \u0130htiyac\u0131n\u0131z olan herhangi bir kontrol listesi var m\u0131? Tamam. Bunlar\u0131 yan\u0131n\u0131zda bulundurun.<\/p>

5.1.6 Bir \u015fey daha: Son partiden hi\u00e7bir \u015feyin ortal\u0131kta kalmad\u0131\u011f\u0131ndan emin olun. Kar\u0131\u015f\u0131kl\u0131klar b\u00fcy\u00fck ba\u015f a\u011fr\u0131lar\u0131na neden olur.<\/p>

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

5.2.1 Koruyucular\u0131n bir amac\u0131 vard\u0131r. Makine \u00e7al\u0131\u015f\u0131rken onlar\u0131 kapal\u0131 tutun.<\/p>

5.2.2 Emniyet \u015falterleri mi? Bunlar\u0131 atlatmay\u0131 akl\u0131n\u0131zdan bile ge\u00e7irmeyin.<\/p>

5.2.3 Makinede bir de\u011fi\u015fiklik mi yapmak istiyorsunuz? \u00d6nce onay al\u0131n. \u0130stisna yok.<\/p>

5.2.4 \u00d6nemli bir nokta: Hareketli par\u00e7alar size zarar verebilir. Makine \u00e7al\u0131\u015f\u0131rken asla hi\u00e7bir \u015feye dokunmay\u0131n, tamir etmeyin, ayarlamay\u0131n veya ya\u011flamay\u0131n.<\/p>

5.2.5 Makine \u00fczerinde mi \u00e7al\u0131\u015f\u0131yorsunuz? Par\u00e7alar\u0131 m\u0131 tak\u0131yorsunuz? Par\u00e7alar\u0131na ay\u0131r\u0131yor musunuz? Temizliyor musunuz? Her seferinde ana \u015falteri kapat\u0131n.<\/p>

5.2.6 Bu emniyet cihazlar\u0131 a\u00e7\u0131k kal\u0131r. Nokta.<\/p>

5.2.7 Y\u00fczey ve kontrol paneli i\u00e7in yumu\u015fak ve kuru bir bez en iyi sonucu verecektir. Hepsi bu kadar.<\/p>

5.2.8 Kaps\u00fcllerde statik elektrik birikmesi \u015fakaya gelmez. Cihaz\u0131 \u00e7al\u0131\u015ft\u0131rmadan \u00f6nce topraklay\u0131n.<\/p>

5.2.9 Ki\u015fisel koruyucu ekipmanlar\u0131n\u0131z\u0131 (eldiven, koruyucu g\u00f6zl\u00fck, toz maskesi) kullan\u0131n. Bunlardan hi\u00e7birini atlamay\u0131n.<\/p>

5.2.10 Hazneyi a\u015f\u0131r\u0131 doldurma d\u00fcrt\u00fcs\u00fcne kar\u015f\u0131 koyun. Nominal kapasiteye sad\u0131k kal\u0131n.<\/p>

5.2.11 Da\u011f\u0131n\u0131kl\u0131k sizi yava\u015flat\u0131r. \u00c7al\u0131\u015fma alan\u0131n\u0131zda yaln\u0131zca ihtiyac\u0131n\u0131z olan \u015feyleri bulundurun.<\/p>

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

5.3.1 Haftada bir kez bu testleri uygulay\u0131n. Bulgular\u0131n\u0131z\u0131 yaz\u0131n.<\/p>

5.3.1.1 Ana g\u00fc\u00e7 anahtar\u0131n\u0131 kapat\u0131n. Elektrik hemen kesilmelidir.<\/p>

5.3.1.2 Acil durdurma d\u00fc\u011fmesine bas\u0131n. Her \u015fey durmal\u0131.<\/p>

5.3.1.3 \u00c7al\u0131\u015f\u0131rken emniyet kapa\u011f\u0131n\u0131 a\u00e7\u0131n. Makine donmal\u0131d\u0131r.<\/p>

5.3.1.4 A\u015f\u0131r\u0131 y\u00fck r\u00f6lesi - gerekti\u011finde devre d\u0131\u015f\u0131 kal\u0131yor mu? Test edin.<\/p>

5.3.1.5 G\u00f6sterge \u0131\u015f\u0131klar\u0131na ve alarmlara bir g\u00f6z at\u0131n. Hepsi \u00e7al\u0131\u015f\u0131yor mu? Harika.<\/p>

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

5.4.1 Giri\u015f Hunisi:<\/b><\/strong>\u00a0Kaps\u00fcller buraya konur. Do\u011frudan dolum makinesinden veya bir saklama kab\u0131ndan gelirler.<\/p>

5.4.2 Parlatma F\u0131r\u00e7as\u0131 Tak\u0131m\u0131:<\/b><\/strong>\u00a0Yumu\u015fak k\u0131llar\u0131n etrafta d\u00f6nd\u00fc\u011f\u00fcn\u00fc hayal edin. Her kaps\u00fclden tozu ve kiri temizliyorlar.<\/p>

5.4.3 Parlatma Odas\u0131:<\/b><\/strong>\u00a0\u0130\u015fte sihrin ger\u00e7ekle\u015fti\u011fi yer bu kapal\u0131 b\u00f6l\u00fcm. Kaps\u00fcller yuvarlan\u0131yor ve f\u0131r\u00e7a temas\u0131yla parlatma i\u015flemi ger\u00e7ekle\u015fiyor.<\/p>

5.4.4 Vakum Sistemi:<\/b><\/strong>\u00a0Cilalama s\u0131ras\u0131nda toz her yere u\u00e7u\u015fuyor. Vakum hepsini emerek kaps\u00fcllerin tekrar kaplanmas\u0131n\u0131 engelliyor.<\/p>

5.4.5 Bo\u015faltma Olu\u011fu:<\/b><\/strong>\u00a0Parlak kaps\u00fcller buradan \u00e7\u0131kar. Sonraki durak: paketleme veya ileri i\u015flem.<\/p>

5.4.6 Kontrol Paneli:<\/b><\/strong>\u00a0Ba\u015flat d\u00fc\u011fmesi, durdur d\u00fc\u011fmesi, h\u0131zl\u0131 arama, acil durdurma, g\u00f6sterge \u0131\u015f\u0131klar\u0131; hepsi burada ya\u015f\u0131yor.<\/p>

5.4.7 H\u0131z Kontrol Cihaz\u0131:<\/b><\/strong>\u00a0Farkl\u0131 kaps\u00fcller farkl\u0131 f\u0131r\u00e7a h\u0131zlar\u0131 gerektirir. Bu kadran, ince ayar yapman\u0131z\u0131 sa\u011flar.<\/p>

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

5.5.1 Makineyi kapat\u0131n. Montaj\u0131 her zaman makine \u00e7al\u0131\u015fmaz durumdayken ba\u015flat\u0131n.<\/p>

5.5.2 Hangi f\u0131r\u00e7alar kaps\u00fcl boyutunuza uygun? Onlar\u0131 al\u0131n. Ama durun, k\u0131llar\u0131n\u0131 inceleyin. E\u011frilmi\u015f veya y\u0131pranm\u0131\u015f m\u0131 g\u00f6r\u00fcn\u00fcyorlar? At\u0131n ve yenilerini al\u0131n.<\/p>

5.5.3 F\u0131r\u00e7alar\u0131 yuvalar\u0131na yerle\u015ftirin. K\u0131p\u0131rday\u0131n. F\u0131r\u00e7alar hareket etmemelidir.<\/p>

5.5.4 Giri\u015f haznesi \u00fcstte kayar. Kaps\u00fcllerin hazneye do\u011frudan d\u00fc\u015fmesini sa\u011flayacak \u015fekilde hizalay\u0131n.<\/p>

5.5.5 Bo\u015faltma olu\u011funu \u00e7\u0131k\u0131\u015fa tak\u0131n.<\/p>

5.5.6 Vakum hortumunun s\u0131k\u0131 bir \u015fekilde tak\u0131lmas\u0131 gerekir. Gev\u015fek ba\u011flant\u0131lar, zay\u0131f emi\u015f g\u00fcc\u00fc anlam\u0131na gelir.<\/p>

5.5.7 Koruyucular\u0131 ve kapaklar\u0131 \u015fimdi tekrar tak\u0131n. Her \u015feyi s\u0131k\u0131n.<\/p>

5.5.8 Cilalama yata\u011f\u0131 a\u00e7\u0131s\u0131na bir g\u00f6z at\u0131n. \u00c7ok d\u00fcz olursa kaps\u00fcller d\u00fczg\u00fcn yuvarlanmaz. \u00c7ok dik olursa kaps\u00fcller \u00e7ok h\u0131zl\u0131 u\u00e7ar. Do\u011fru g\u00f6r\u00fcnene kadar ayarlay\u0131n.<\/p>

5.5.9 \u00c7\u0131kanlar\u0131 toplamak i\u00e7in alt\u0131na temiz bir kap koyun.<\/p>

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

5.6.1 Ana g\u00fc\u00e7\u2014a\u00e7\u0131n.<\/p>

5.6.2 S\u00fcp\u00fcrgeyi \u00e7al\u0131\u015ft\u0131r\u0131n. Elinizi portun yak\u0131n\u0131nda tutun. G\u00fc\u00e7l\u00fc bir emi\u015f hissediyor musunuz? Tamamd\u0131r.<\/p>

5.6.3 BA\u015eLAT\u2019a bas\u0131n. F\u0131r\u00e7alar d\u00f6nmeye ba\u015flar.<\/p>

5.6.4 Birka\u00e7 dakika bo\u015fta \u00e7al\u0131\u015ft\u0131r\u0131n. Garip sesler mi duyuyorsunuz? Tuhaf titre\u015fimler mi? Devam etmeden \u00f6nce durup inceleyin.<\/p>

5.6.5 F\u0131r\u00e7a h\u0131z\u0131n\u0131 ayarlama zaman\u0131. Genellikle 200 ila 400 RPM aras\u0131 bir h\u0131z yeterlidir. Daha k\u00fc\u00e7\u00fck kaps\u00fcller genellikle daha yava\u015f u\u00e7ta daha iyi sonu\u00e7 verir.<\/p>

5.6.6 \u015eimdi hazneye birka\u00e7 kaps\u00fcl koyun. Kolay gelsin. Sabit bir damlama, b\u00fcy\u00fck bir y\u0131\u011f\u0131n\u0131 d\u00f6kmekten iyidir.<\/p>

5.6.7 Yolculuklar\u0131n\u0131 izleyin. Ak\u0131\u015f d\u00fczg\u00fcn m\u00fc? S\u0131k\u0131\u015fma veya t\u0131kan\u0131kl\u0131k yok mu? M\u00fckemmel.<\/p>

5.6.8 Birka\u00e7 cilal\u0131 kaps\u00fcl\u00fc \u00e7\u0131kar\u0131n ve inceleyin:<\/p>

5.6.8.1 Hala yap\u0131\u015fm\u0131\u015f toz var m\u0131? Olmamal\u0131.<\/p>

5.6.8.2 \u00c7izik veya ezik var m\u0131? Hay\u0131r, kabul edilemez.<\/p>

5.6.8.3 \u00c7atlam\u0131\u015f veya a\u00e7\u0131lm\u0131\u015f m\u0131? Bu bir sorun.<\/p>

5.6.8.4 G\u00fczel parlak bir y\u00fczey mi? \u0130stedi\u011fimiz bu.<\/p>

5.6.9 Sonu\u00e7lar iyi de\u011fil mi? H\u0131z\u0131 ayarlay\u0131n veya besleme h\u0131z\u0131n\u0131 yava\u015flat\u0131n.<\/p>

5.6.10 Parlat\u0131lm\u0131\u015f kaps\u00fclleri etiketli kaplarda toplay\u0131n. Parti kay\u0131tlar\u0131nda belirtilenleri takip edin.<\/p>

5.6.11 Toz torbas\u0131 m\u0131 \u015fi\u015fiyor? Bo\u015falt\u0131n. Dolu torbalar emi\u015f g\u00fcc\u00fcn\u00fc azalt\u0131r.<\/p>

5.6.12 Ba\u015flang\u0131\u00e7 ve biti\u015f saatlerinizi BMR'ye not edin. Garip bir \u015fey oldu mu? Onu da yaz\u0131n.<\/p>

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

5.7.1 BMR, ne s\u0131kl\u0131kla numune alman\u0131z gerekti\u011fini g\u00f6sterir. Buna uyun.<\/p>

5.7.2 G\u00f6rsel kontrol: barut kal\u0131nt\u0131s\u0131, hasar, genel g\u00f6r\u00fcn\u00fcm. G\u00f6zlerinizi kullan\u0131n.<\/p>

5.7.3 A\u00e7\u0131lan veya \u00e7atlayan kaps\u00fcller g\u00f6rd\u00fcn\u00fcz m\u00fc? Bunlar\u0131 \u00e7ekip \u00e7\u0131kar\u0131n.<\/p>

5.7.4 Reddedilenleri say\u0131n. Say\u0131y\u0131 belgelendirin.<\/p>

5.7.5 \u0130\u015flem a\u015famas\u0131ndaki formlar\u0131n doldurulmas\u0131 gerekmektedir. Unutmay\u0131n.<\/p>

5.7.6 Bir \u015feyler ger\u00e7ekten ters mi g\u00f6r\u00fcn\u00fcyor? Hemen y\u00f6neticinize bildirin. Beklemeyin.<\/p>

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

5.8.1 Art\u0131k kaps\u00fcl girmeyecek. Geride kalanlar\u0131n yolculuklar\u0131n\u0131 tamamlamalar\u0131na izin verin.<\/p>

5.8.2 Bir veya iki dakika bo\u015fta \u00e7al\u0131\u015ft\u0131r\u0131ld\u0131\u011f\u0131nda hazne tamamen bo\u015fal\u0131r.<\/p>

5.8.3 DUR'a bas\u0131n. F\u0131r\u00e7alar yava\u015f yava\u015f kapan\u0131r.<\/p>

5.8.4 Vakum kapal\u0131.<\/p>

5.8.5 Ana g\u00fc\u00e7 kapal\u0131.<\/p>

5.8.6 Bitmi\u015f kaps\u00fcllerinizin bulundu\u011fu kab\u0131 BMR'nin belirtti\u011fi yere g\u00f6t\u00fcr\u00fcn.<\/p>

5.8.7 Evrak i\u015fleri s\u00fcresi. BMR ve Ekipman Kullan\u0131m Kayd\u0131'n\u0131n her ikisinin de girilmesi gerekir.<\/p>

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

5.9.1 Fi\u015fini \u00e7ekin. Cidden. Herhangi bir \u015feye dokunmadan \u00f6nce g\u00fc\u00e7 ba\u011flant\u0131s\u0131n\u0131 kesin.<\/p>

5.9.2 \u0130\u00e7eride saklanan kalan kaps\u00fclleri \u00e7\u0131kar\u0131n.<\/p>

5.9.3 F\u0131r\u00e7alar\u0131 \u00e7ekip \u00e7\u0131kar\u0131n. Toz birikintilerini temizlemek i\u00e7in bas\u0131n\u00e7l\u0131 hava veya yumu\u015fak bir f\u0131r\u00e7a kullan\u0131n.<\/p>

5.9.4 Hazneyi, hazneyi ve olu\u011fu vakumlay\u0131n. Ard\u0131ndan, 70% IPA ile nemlendirilmi\u015f bir bezle her \u015feyi silin.<\/p>

5.9.5 D\u0131\u015f y\u00fczeylere de ayn\u0131 i\u015flem uygulan\u0131r: bez art\u0131 IPA.<\/p>

5.9.6 Toz toplama torbas\u0131n\u0131 bo\u015falt\u0131n. Bu s\u0131rada hazneyi de temizleyin.<\/p>

5.9.7 Her \u015fey kurudu mu? Her \u015feyi tekrar birle\u015ftirin.<\/p>

5.9.8 Kalite G\u00fcvence ekibini incelemeye \u00e7a\u011f\u0131r\u0131n. Onay verdiklerinde, "TEM\u0130ZLEND\u0130" etiketini yap\u0131\u015ft\u0131r\u0131n.<\/p>

5.9.9 Ekipman Temizlik G\u00fcnl\u00fc\u011f\u00fcne temizli\u011finizi kaydedin.<\/p>

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

5.10.1 Kaps\u00fcllerin \u00fczerinde hala toz var:<\/b><\/strong>\u00a0Belki de f\u0131r\u00e7alar a\u015f\u0131nm\u0131\u015ft\u0131r? Ya da h\u0131z\u0131 art\u0131rmay\u0131 deneyebilirsiniz. Daha yava\u015f besleme de i\u015fe yarar.<\/p>

5.10.2 Kaps\u00fcller s\u0131k\u0131\u015f\u0131yor:<\/b><\/strong>\u00a0F\u0131r\u00e7alarda hasar olup olmad\u0131\u011f\u0131n\u0131 kontrol edin. Daha yava\u015f besleyin. Ayr\u0131ca kaps\u00fcller nemli mi? Nem, yap\u0131\u015fmaya neden olur.<\/p>

5.10.3 Her yer toz i\u00e7inde:<\/b><\/strong>\u00a0Elektrik s\u00fcp\u00fcrgesi zorlan\u0131yor mu? Torban\u0131n bo\u015falt\u0131lmas\u0131 gerekebilir. Ayr\u0131ca contalara da g\u00f6z at\u0131n.<\/p>

5.10.4 S\u00fcrt\u00fcnme veya tak\u0131rt\u0131 sesleri:<\/b><\/strong>\u00a0Dur. Hemen. Bir \u015fey gev\u015femi\u015f veya y\u0131pranm\u0131\u015f. Tekrar ko\u015fmadan \u00f6nce bul.<\/p>

5.10.5 Hi\u00e7 a\u00e7\u0131lm\u0131yor:<\/b><\/strong>\u00a0G\u00fc\u00e7 ger\u00e7ekten ba\u011fland\u0131 m\u0131? Acil durdurma d\u00fc\u011fmesi a\u00e7\u0131ld\u0131 m\u0131? G\u00fcvenlik kilitleri devrede mi?<\/p>

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

5.11.1 Parti bitti mi? \u201cTEM\u0130ZLENECEK\u201d etiketi \u00e7\u0131k\u0131yor.<\/p>

5.11.2 Temizlik i\u00e7in B\u00f6l\u00fcm 5.9'u izleyin.<\/p>

5.11.3 T\u00fcm dok\u00fcmanlar\u0131 tamamlay\u0131n. Ekipman Kullan\u0131m G\u00fcnl\u00fc\u011f\u00fc, BMR, herhangi bir terslik varsa sapma raporlar\u0131.<\/p>

5.11.4 S\u0131radaki ki\u015fiye alan\u0131 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 G\u00fcnl\u00fc\u011f\u00fc<\/p>

5.12.3 Toplu \u00dcretim Kayd\u0131<\/p>

5.12.4 \u0130\u015flem S\u0131ras\u0131ndaki Kontrol Kay\u0131tlar\u0131<\/p>

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

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

6.1 SOP: Standart \u0130\u015fletim Prosed\u00fcr\u00fc<\/p>

6.2 BMR: Toplu \u00dcretim Kayd\u0131<\/p>

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

6.4 KKD: Ki\u015fisel Koruyucu Donan\u0131m<\/p>

6.5 IPA: \u0130zopropil Alkol<\/p>

6,6 RPM: Dakikadaki Devir Say\u0131s\u0131<\/p>

6.7 QA: Kalite G\u00fcvencesi<\/p>

6.8 GMP: \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>

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 tells staff how to run the Capsule Polishing Machine the right way. 1.2 We want […]<\/p>\n","protected":false},"author":1,"featured_media":10139,"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":[61],"tags":[],"class_list":["post-10137","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-pharmaceutical-technology"],"acf":[],"_links":{"self":[{"href":"https:\/\/pharmamachinecn.com\/tr\/wp-json\/wp\/v2\/posts\/10137","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=10137"}],"version-history":[{"count":7,"href":"https:\/\/pharmamachinecn.com\/tr\/wp-json\/wp\/v2\/posts\/10137\/revisions"}],"predecessor-version":[{"id":10145,"href":"https:\/\/pharmamachinecn.com\/tr\/wp-json\/wp\/v2\/posts\/10137\/revisions\/10145"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/pharmamachinecn.com\/tr\/wp-json\/wp\/v2\/media\/10139"}],"wp:attachment":[{"href":"https:\/\/pharmamachinecn.com\/tr\/wp-json\/wp\/v2\/media?parent=10137"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/pharmamachinecn.com\/tr\/wp-json\/wp\/v2\/categories?post=10137"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/pharmamachinecn.com\/tr\/wp-json\/wp\/v2\/tags?post=10137"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}