{"id":10692,"date":"2026-02-14T02:16:02","date_gmt":"2026-02-14T02:16:02","guid":{"rendered":"https:\/\/pharmamachinecn.com\/?p=10692"},"modified":"2025-12-23T06:07:29","modified_gmt":"2025-12-23T06:07:29","slug":"sop-for-automatic-capsule-filling-machine","status":"publish","type":"post","link":"https:\/\/pharmamachinecn.com\/tr\/sop-for-automatic-capsule-filling-machine\/","title":{"rendered":"Otomatik Kaps\u00fcl Dolum Makinesi i\u00e7in Standart \u00c7al\u0131\u015fma Prosed\u00fcr\u00fc (SOP)"},"content":{"rendered":"
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Otomatik Kaps\u00fcl Dolum Makinesinin Standart \u00c7al\u0131\u015ft\u0131rma Prosed\u00fcr\u00fc<\/i><\/em><\/strong><\/p>

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

Bu Standart \u00c7al\u0131\u015fma Prosed\u00fcr\u00fc (SOP), Otomatik Kaps\u00fcl Dolum Makinesinin \u00e7al\u0131\u015ft\u0131r\u0131lmas\u0131 konusunda size yol g\u00f6sterir. Do\u011fru dolum a\u011f\u0131rl\u0131klar\u0131na, tutarl\u0131 \u00e7\u0131kt\u0131ya ve s\u0131f\u0131r kontaminasyona ihtiyac\u0131m\u0131z var. Makine bo\u015f kaps\u00fclleri al\u0131r, kapaklar\u0131 g\u00f6vdelerden ay\u0131r\u0131r, toz veya peletlerle doldurur, tekrar kapat\u0131r ve paketlemeye haz\u0131r hale getirir. Buradaki her \u015fey cGMP gerekliliklerine uygundur.<\/p>

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

Bu prosed\u00fcr, \u00fcretim departman\u0131m\u0131zdaki Otomatik Kaps\u00fcl Dolum Makinesi i\u00e7in ge\u00e7erlidir. Bu makineyi, toz form\u00fclasyonlar\u0131, peletler veya gran\u00fcllerle sert jelatin kaps\u00fclleri doldurmak i\u00e7in kullan\u0131yoruz. Makinenin i\u015fleyebilece\u011fi t\u00fcm kaps\u00fcl boyutlar\u0131n\u0131 kapsar. Burada bulacaklar\u0131n\u0131z: montaj talimatlar\u0131, \u00e7al\u0131\u015ft\u0131rma \u015fekli, i\u015flem i\u00e7i kontroller ve parti sonu prosed\u00fcrleri.<\/p>

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

Operat\u00f6rler ve \u00dcretim Kimyagerleri uygulamal\u0131 i\u015fleri yaparlar. Makineyi kurarlar, \u00fcretimi y\u00fcr\u00fct\u00fcrler ve her \u015feyi kay\u0131tlara ge\u00e7irirler. Sorunlar \u00fcst kademelere iletilir, ancak g\u00fcnl\u00fck operasyon tamamen onlar\u0131n sorumlulu\u011fundad\u0131r.<\/p>

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

\u00dcretim M\u00fcd\u00fcr\u00fc t\u00fcm sorumlulu\u011fu \u00fcstlenir. Operat\u00f6rlerin e\u011fitildi\u011finden, prosed\u00fcrlerin takip edildi\u011finden ve her \u015feyin kurallara uygun oldu\u011fundan emin olur.<\/p>

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

5.1 \u00d6ncelikle alan\u0131 inceleyin. Temiz mi? Makine \u00fczerindeki "TEM\u0130ZLENM\u0130\u015e" etiketini kontrol edin. Ba\u015flamadan \u00f6nce toz, toz kal\u0131nt\u0131s\u0131 veya \u00f6nceki partiden kalan kaps\u00fcllerin temizlenmesi gerekir.<\/p>

5.2 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 yaz\u0131n. Bunu atlamay\u0131n.<\/p>

5.3 \u201cTEM\u0130ZLEND\u0130\u201d etiketini \u00e7\u0131kar\u0131n ve yerine \u201c\u0130\u015eLEM A\u015eAMASINDA\u201d etiketini yap\u0131\u015ft\u0131r\u0131n. Mevcut parti bilgilerini ekleyin.<\/p>

5.4 \u00dcretim Hatt\u0131 Onay Belgesi i\u00e7in IPQA'y\u0131 bulun. Belge yoksa \u00fcretim de yok.<\/p>

5.5 \u00d6nlemler:<\/strong><\/p>

5.5.1 Otomatik moda ge\u00e7meden \u00f6nce t\u00fcm koruyucu kapaklar\u0131n ve koruma mekanizmalar\u0131n\u0131n kapal\u0131 olmas\u0131 gerekir. \u00d6n paneller, arka kapaklar, hazne kapaklar\u0131 \u2013 hepsi. Makine, elinizin orada olup olmamas\u0131na ald\u0131r\u0131\u015f etmez.<\/p>

5.5.2 G\u00fcvenlik \u015falterleriyle oynamay\u0131n. Kilitleme sistemlerini devre d\u0131\u015f\u0131 b\u0131rakmay\u0131n. Bunlar sizin yaralanmaman\u0131z i\u00e7in oradad\u0131r.<\/p>

5.5.3 M\u00fchendislik onay\u0131 olmadan hi\u00e7bir de\u011fi\u015fiklik yap\u0131lamaz. Bu, kendi ba\u015f\u0131n\u0131za hi\u00e7bir \u015fey eklememeniz, \u00e7\u0131karmaman\u0131z veya "iyile\u015ftirmemeniz" anlam\u0131na gelir.<\/p>

5.5.4 Makine \u00e7al\u0131\u015f\u0131yor mu? Dokunmay\u0131n. Hi\u00e7bir ayar yapmay\u0131n, temizlemeyin, hareketli par\u00e7alar\u0131 ya\u011flamay\u0131n. \u00d6nce kapat\u0131n ve elektri\u011fi kesin.<\/p>

5.5.5 Kurulum, s\u00f6kme, bak\u0131m veya temizlik yaparken ana \u015falter KAPALI konumda kal\u0131r.<\/p>

5.5.6 Acil durdurma d\u00fc\u011fmeleri, kap\u0131 kilitlemeleri, a\u015f\u0131r\u0131 y\u00fck korumas\u0131 \u2013 bunlar\u0131n hi\u00e7birini devre d\u0131\u015f\u0131 b\u0131rakmay\u0131n.<\/p>

5.5.7 Kontrol panellerini ve y\u00fczeyleri yaln\u0131zca yumu\u015fak, kuru bir bezle silin. \u00c7\u00f6z\u00fcc\u00fcler ve su elektronik aksam\u0131 bozacakt\u0131r.<\/p>

5.5.8 G\u00fcvenlik cihazlar\u0131n\u0131n kontrol\u00fc, makine otomatik modda \u00e7al\u0131\u015f\u0131rken yap\u0131l\u0131r. Bunlar\u0131n ger\u00e7ekten \u00e7al\u0131\u015f\u0131p \u00e7al\u0131\u015fmad\u0131\u011f\u0131n\u0131 anlaman\u0131n tek yolu budur.<\/p>

5.5.9 Bu g\u00fcvenlik kontrollerini haftada bir kez ger\u00e7ekle\u015ftirin ve belgeleyin:<\/p>

5.5.9.1 Kumanda panelindeki ana g\u00fc\u00e7 d\u00fc\u011fmesine bas\u0131n. Elektrik kesiliyor mu? \u0130yi.<\/p>

5.5.9.2 Acil durdurma d\u00fc\u011fmesine bas\u0131n. Her \u015fey an\u0131nda donacakt\u0131r.<\/p>

5.5.9.3 Arka g\u00fcvenlik kapa\u011f\u0131ndaki acil durum \u015falterini deneyin. Sonu\u00e7 ayn\u0131 \u2013 makine duruyor.<\/p>

5.5.9.4 \u00d6n kap\u0131y\u0131, arka kap\u0131y\u0131, sol kap\u0131y\u0131, sa\u011f kap\u0131y\u0131 s\u0131rayla a\u00e7\u0131n. Makine her seferinde durmal\u0131d\u0131r.<\/p>

5.6 Montaj:<\/strong><\/p>

5.6.1 Kaps\u00fcl Ay\u0131r\u0131c\u0131 ve Asans\u00f6r:<\/p>

5.6.1.1 S\u0131ralama-y\u00fckseltme \u00fcnitesini makinenin kaps\u00fcl haznesine ba\u011flay\u0131n. Ba\u011flant\u0131n\u0131n s\u0131k\u0131 oldu\u011fundan emin olun.<\/p>

5.6.1.2 Bo\u015f kaps\u00fcllerinizi ay\u0131r\u0131c\u0131 haznesine bo\u015falt\u0131n. A\u015f\u0131r\u0131 doldurmay\u0131n, aksi takdirde t\u0131kanmaya neden olurlar.<\/p>

5.6.1.3 Ay\u0131klay\u0131c\u0131, yanl\u0131\u015f \u00e7aptaki t\u00fcm kaps\u00fclleri d\u0131\u015far\u0131 atar. Makine haznesine yaln\u0131zca do\u011fru boyuttaki kaps\u00fcller ge\u00e7er.<\/p>

5.6.1.4 Beslemenin ilk birka\u00e7 dakikas\u0131n\u0131 izleyin. Kaps\u00fcller topaklanmadan veya k\u00f6pr\u00fc olu\u015fturmadan sorunsuz bir \u015fekilde akmal\u0131d\u0131r.<\/p>

5.6.2 Kaps\u00fcl\u00fcn Y\u00f6nlendirilmesi ve Y\u00fcklenmesi:<\/p>

5.6.2.1 T\u00fcm kamlar\u0131 ana \u015fafta tak\u0131n. \u00c7al\u0131\u015fma s\u0131ras\u0131nda hi\u00e7bir \u015feyin kaymamas\u0131 i\u00e7in kamalar\u0131 s\u0131k\u0131n.<\/p>

5.6.2.2 Kaps\u00fcl Serbest B\u0131rakma Pimi Blo\u011funun y\u00fcksekli\u011fini ayarlay\u0131n. Her bir kanal yuvas\u0131na tam olarak bir kaps\u00fcl d\u00fc\u015fmesini istiyorsunuz. \u00c7ok y\u00fcksek olursa \u00e7ift kaps\u00fcl d\u00fc\u015fer; \u00e7ok d\u00fc\u015f\u00fck olursa bo\u015f kaps\u00fcl d\u00fc\u015fer.<\/p>

5.6.2.3 Kaps\u00fcller, rastgele y\u00f6nlendirilmi\u015f 7 dikey ray \u00fczerinde hareket eder; baz\u0131lar\u0131 kapak a\u015fa\u011f\u0131, baz\u0131lar\u0131 g\u00f6vde a\u015fa\u011f\u0131 bakar. Do\u011frultucu, hepsini g\u00f6vdeleri a\u015fa\u011f\u0131 bakacak \u015fekilde \u00e7evirir ve ard\u0131ndan segment bur\u00e7lar\u0131na y\u00fckler.<\/p>

5.6.2.4 Vakum, kapa\u011f\u0131 g\u00f6vdeden ay\u0131r\u0131r. G\u00f6vdeler alt segment bur\u00e7lar\u0131na d\u00fc\u015fer, kapaklar \u00fcst segment bur\u00e7lar\u0131nda kal\u0131r.<\/p>

5.6.2.5 \u0130ki y\u00fckleme istasyonu birlikte \u00e7al\u0131\u015farak her seferinde 14 kaps\u00fcl i\u015fliyor.<\/p>

5.6.2.6 Dozaj plakas\u0131n\u0131 alt segmentle hizalay\u0131n. Deliklerin her pozisyonda m\u00fckemmel \u015fekilde e\u015fmerkezli olmas\u0131 gerekir, aksi takdirde dolumlar\u0131n\u0131z hatal\u0131 olur.<\/p>

5.6.2.7 Z\u0131mba k\u0131lavuz plakas\u0131n\u0131, z\u0131mbalar\u0131n dozaj plakas\u0131 deliklerine serbest\u00e7e kayacak \u015fekilde ayarlay\u0131n. Burada s\u0131k\u0131\u015fma olmas\u0131 z\u0131mbalar\u0131n k\u0131r\u0131lmas\u0131 anlam\u0131na gelir.<\/p>

5.6.2.8 Hedef dolum a\u011f\u0131rl\u0131\u011f\u0131n\u0131z\u0131 elde etmek i\u00e7in delme derinli\u011fini ayarlay\u0131n. Daha derin delme, daha a\u011f\u0131r dolum anlam\u0131na gelir.<\/p>

5.6.2.9 \u00dcr\u00fcn\u00fcn\u00fcz i\u00e7in do\u011fru dozaj diski kal\u0131nl\u0131\u011f\u0131n\u0131 se\u00e7in. Yanl\u0131\u015f kal\u0131nl\u0131k, s\u00fcrekli ayarlamalar ve ar\u0131za s\u00fcreleri anlam\u0131na gelir.<\/p>

5.6.2.10 Reddetme sistemi i\u00e7in hava bas\u0131nc\u0131 0,5 ile 1,0 kg\/cm\u00b2 aras\u0131nda olmal\u0131d\u0131r. Bu, kusurlu kaps\u00fclleri reddetme kutusuna iter.<\/p>

5.6.3 Toz Dolumu:<\/strong><\/p>

5.6.3.1 Tozu ila\u00e7 haznesine y\u00fckleyin. Kar\u0131\u015ft\u0131r\u0131c\u0131, tozu otomatik olarak toz kab\u0131na ta\u015f\u0131r.<\/p>

5.6.3.2 Toz seviyesi, hazne i\u00e7inde sens\u00f6rler taraf\u0131ndan kontrol edilir. A\u00e7\u0131k\u00e7a bir sorun olmad\u0131\u011f\u0131 s\u00fcrece manuel olarak m\u00fcdahale etmeyin.<\/p>

5.6.3.3 S\u0131k\u0131\u015ft\u0131rma cihaz\u0131, dozaj diskinde 5 ard\u0131\u015f\u0131k s\u0131k\u0131\u015ft\u0131rma i\u015flemi yaparak bir toz y\u0131\u011f\u0131n\u0131 olu\u015fturur. 6. vuru\u015f, bu y\u0131\u011f\u0131n\u0131 kaps\u00fcl g\u00f6vdesine iter.<\/p>

5.6.3.4 Dozaj diskinin kal\u0131nl\u0131\u011f\u0131, tozunuzun yo\u011funlu\u011funa, hedef dolum a\u011f\u0131rl\u0131\u011f\u0131na ve ak\u0131\u015f \u00f6zelliklerine ba\u011fl\u0131d\u0131r. \u00dcr\u00fcn teknik \u00f6zellikler sayfas\u0131na bak\u0131n.<\/p>

5.6.4 Pelet Dolum Cihaz\u0131 (tak\u0131l\u0131ysa):<\/p>

5.6.4.1 Pelet dolumu hacim esas\u0131na g\u00f6re \u00e7al\u0131\u015f\u0131r. Hedef a\u011f\u0131rl\u0131\u011f\u0131n\u0131za ula\u015fmak i\u00e7in dozaj haznesinin boyutunu ayarlay\u0131n.<\/p>

5.6.4.2 Doz hacmi, sabit kap ve hareketli s\u00fcrg\u00fc blo\u011fundan gelir. Dolum a\u011f\u0131rl\u0131\u011f\u0131n\u0131 de\u011fi\u015ftirmek i\u00e7in ayar d\u00fc\u011fmesini \u00e7evirin.<\/p>

5.6.4.3 Kayd\u0131r\u0131c\u0131n\u0131n konumunu ayarlamak i\u00e7in 1 mikron \u00e7\u00f6z\u00fcn\u00fcrl\u00fc\u011fe sahip bir kadran g\u00f6stergesi bulunmaktad\u0131r. Bunu kullan\u0131n \u2013 g\u00f6z karar\u0131yla ayarlamak i\u015fe yaramayacakt\u0131r.<\/p>

5.6.4.4 Dolum mekanizmas\u0131, peletleri nazik\u00e7e i\u015fleyecek \u015fekilde tasarlanm\u0131\u015ft\u0131r. Kaplamaya zarar vermez veya ezmez.<\/p>

5.6.5 Kaps\u00fcl\u00fcn Kapanmas\u0131 ve \u00c7\u0131kar\u0131lmas\u0131:<\/p>

5.6.5.1 Kilitleme pimleri kapaklar\u0131 g\u00f6vdelere iter ve birbirine kilitler. Kilitli uzunlu\u011fu ince ayar vidas\u0131 kullanarak ayarlay\u0131n.<\/p>

5.6.5.2 Farkl\u0131 kaps\u00fcl boyutlar\u0131 farkl\u0131 kapatma pimleri gerektirir. Kaps\u00fcl boyutunu de\u011fi\u015ftirdi\u011finizde bunlar\u0131 da de\u011fi\u015ftirin.<\/p>

5.6.5.3 Doldurulmu\u015f ve kapat\u0131lm\u0131\u015f kaps\u00fcller, f\u0131rlatma pimleri taraf\u0131ndan d\u0131\u015far\u0131 itilir ve \u00e7\u0131k\u0131\u015f olu\u011fundan a\u015fa\u011f\u0131 kayar.<\/p>

5.6.5.4 Bo\u015falt\u0131ld\u0131ktan sonra, bas\u0131n\u00e7l\u0131 hava ve vakum, bir sonraki d\u00f6ng\u00fcde tekrar y\u00fcklenmeden \u00f6nce bo\u015f bur\u00e7lar\u0131 temizler.<\/p>

5.7 \u00c7al\u0131\u015fma \u015eekli:<\/p>

5.7.1 \u015eebeke elektri\u011fini a\u00e7\u0131n. Kontrol sisteminin tamamen a\u00e7\u0131lmas\u0131n\u0131 bekleyin.<\/p>

5.7.2 Otomatik veya manuel moda ge\u00e7meden \u00f6nce, motor milindeki el \u00e7ark\u0131n\u0131 \u00e7evirin ve taret tertibat\u0131n\u0131 bir tam tur d\u00f6nd\u00fcr\u00fcn. Her \u015feyi dikkatlice izleyin. S\u0131k\u0131\u015fma olup olmad\u0131\u011f\u0131n\u0131 kontrol edin.<\/p>

5.7.3 Otomatik modda, makine ba\u015flat\u0131lmadan \u00f6nce kendi kendini kontrol eder. Tamamlanmas\u0131na izin verin.<\/p>

5.7.4 Ana Kontrol Paneli ekran\u0131nda \u015funlar bulunur: otomatik, alarm, \u00fcr\u00fcn, se\u00e7 ve \u00f6rnek se\u00e7enekleri. \u0130htiyac\u0131n\u0131z olan\u0131 se\u00e7in.<\/p>

5.7.5 Otomatik Fonksiyon Ekran\u0131 size \u015fu kontrolleri sunar:<\/p>

5.7.5.1 Ba\u015flang\u0131\u00e7:<\/strong> Bu d\u00fc\u011fmeye bast\u0131\u011f\u0131n\u0131zda makine otomatik moda ge\u00e7er. Vakum pompas\u0131 ve \u00fcfleyici otomatik olarak \u00e7al\u0131\u015fmaya ba\u015flar.<\/p>

5.7.5.2 Durdur:<\/strong> Her \u015feyi kapat\u0131yor.<\/p>

5.7.5.3 Zaman S\u0131f\u0131rlama:<\/strong> \u00c7al\u0131\u015fma s\u00fcresi sayac\u0131n\u0131 s\u0131f\u0131rlamak i\u00e7in \u00fc\u00e7 saniye bas\u0131l\u0131 tutun.<\/p>

5.7.5.4 Alarm Durumu: Bir alarm aktifse sorunun ne oldu\u011funu g\u00f6sterir. Bir \u015fey durdu\u011funda \u00f6nce buray\u0131 kontrol edin.<\/p>

5.7.5.5 \u00dcr\u00fcn Raporu:<\/strong> Toplam \u00fcretim say\u0131s\u0131n\u0131, bug\u00fcnk\u00fc say\u0131y\u0131 ve saatlik kaps\u00fcl \u00fcretim h\u0131z\u0131n\u0131 g\u00f6sterir.<\/p>

5.7.5.6 Veri Giri\u015fi:<\/strong> Parti parametrelerini buraya giriyorsunuz. Bunu parti kayd\u0131n\u0131za g\u00f6re doldurun.<\/p>

5.7.5.7 A\u011f\u0131rl\u0131k Ayar\u0131: Kabul edilebilir a\u011f\u0131rl\u0131k varyasyon s\u0131n\u0131rlar\u0131n\u0131, ortalama al\u0131nacak kaps\u00fcl say\u0131s\u0131n\u0131 ve \u00f6rnekleme aral\u0131klar\u0131n\u0131 ayarlay\u0131n.<\/p>

5.7.5.8 \u00d6rnek Ayarlar\u0131:<\/strong> Buraya gelmek i\u00e7in F8 tu\u015funa bas\u0131n. \u00d6rnek Al, Otomatik\/Manuel mod, Dara ve Motor A\u00e7ma\/Kapama se\u00e7enekleri mevcuttur. \u0130htiyac\u0131n\u0131z olan\u0131 se\u00e7in ve \u00f6rnekleme-tart\u0131m i\u015flemi ba\u015flas\u0131n.<\/p>

5.7.6 Kaps\u00fcl haznesini doldurun. \u00dcretim s\u0131ras\u0131nda kurumas\u0131na izin vermeyin.<\/p>

5.7.7 Ba\u015flat d\u00fc\u011fmesine bas\u0131n. \u0130lk y\u00fcz kaps\u00fcl\u00fc dikkatlice izleyin. Dolumlar\u0131n do\u011fru g\u00f6r\u00fcnd\u00fc\u011f\u00fcnden ve kaps\u00fcllerin d\u00fczg\u00fcn kapand\u0131\u011f\u0131ndan emin olun.<\/p>

5.7.8 Parti kay\u0131t plan\u0131na g\u00f6re IPQA kontrolleri i\u00e7in numuneler al\u0131n.<\/p>

5.8 Kaps\u00fcl Parlatma ve Ay\u0131rma:<\/p>

5.8.1 Doldurulmu\u015f kaps\u00fcller daha sonra parlatma ve ay\u0131rma \u00fcnitesinden ge\u00e7er.<\/p>

5.8.2 Burada iki s\u0131ralama a\u015famas\u0131 var:<\/p>

5.8.2.1 Plaka ay\u0131r\u0131c\u0131, d\u00fczg\u00fcn kapanmayan ve kapaklar\u0131 d\u00fc\u015fen gev\u015fek kaps\u00fclleri yakalar.<\/p>

5.8.2.2 Tambur ay\u0131r\u0131c\u0131, \u00e7ap sorunlar\u0131 olan kaps\u00fclleri (oval, a\u015f\u0131r\u0131 b\u00fcy\u00fck, d\u00fcz yuvarlanmayan her \u015fey) yakalar.<\/p>

5.8.3 Plaka ay\u0131r\u0131c\u0131y\u0131 \u00e7al\u0131\u015ft\u0131rma: reg\u00fclat\u00f6r d\u00fc\u011fmesini s\u0131f\u0131ra ayarlay\u0131n, g\u00fc\u00e7 anahtar\u0131n\u0131 a\u00e7\u0131n, ard\u0131ndan d\u00fc\u011fmeyi yava\u015f\u00e7a saat y\u00f6n\u00fcnde orta konuma \u00e7evirin. D\u00fczg\u00fcn bir \u015fekilde titre\u015fmeli \u2013 t\u0131k\u0131rt\u0131 olmamal\u0131. E\u011fer t\u0131k\u0131rt\u0131 varsa, voltaj\u0131 azalt\u0131n.<\/p>

5.8.4 Tambur ay\u0131r\u0131c\u0131y\u0131 \u00e7al\u0131\u015ft\u0131rma: ye\u015fil d\u00fc\u011fmeye bas\u0131n. Bo\u015faltma taraf\u0131ndan bakt\u0131\u011f\u0131n\u0131zda saat y\u00f6n\u00fcnde d\u00f6nd\u00fc\u011f\u00fcn\u00fc do\u011frulay\u0131n.<\/p>

5.8.5 \u015eimdi dolum makinesinden kaps\u00fcl ak\u0131\u015f\u0131n\u0131 a\u00e7\u0131n.<\/p>

5.8.6 Kaps\u00fcllerin s\u0131ralama plakas\u0131 \u00fczerinde hareketini izleyin. \u00c7ok mu yava\u015f hareket ediyor veya s\u0131k\u0131\u015f\u0131yor? Titre\u015fimi biraz art\u0131r\u0131n.<\/p>

5.8.7 Gev\u015fek kapaklar plakadaki deliklerden d\u00fc\u015fer. Sa\u011flam kaps\u00fcller ise tambur ay\u0131r\u0131c\u0131ya do\u011fru ilerler.<\/p>

5.8.8 Tambur, kaps\u00fclleri s\u0131ralama plakas\u0131 \u00fczerinde d\u00f6nd\u00fcr\u00fcr. B\u00fcy\u00fck veya oval kaps\u00fcller s\u0131k\u0131\u015f\u0131r; iyi olanlar ge\u00e7er.<\/p>

5.8.9 Tamburun \u00fcst k\u0131sm\u0131na monte edilmi\u015f naylon bir f\u0131r\u00e7a, s\u0131k\u0131\u015fm\u0131\u015f ar\u0131zal\u0131 kaps\u00fclleri bir toplama tepsisine iter. Bu tepsiyi periyodik olarak bo\u015falt\u0131n.<\/p>

5.8.10 Ay\u0131klama makinesinden \u00e7\u0131kan sa\u011flam kaps\u00fcller bir sonraki ad\u0131ma haz\u0131rd\u0131r.<\/p>

5.9 \u0130\u015flem tamamland\u0131\u011f\u0131nda makineyi durdurun. Haznedeki kalan tozu \u00e7\u0131kar\u0131n ve mutabakat prosed\u00fcr\u00fcn\u00fcze g\u00f6re i\u015flem yap\u0131n.<\/p>

5.10 Makineye \u00fcr\u00fcn ve parti bilgilerini i\u00e7eren bir \u201cTEM\u0130ZLENECEK\u201d etiketi yap\u0131\u015ft\u0131r\u0131n.<\/p>

5.11 Otomatik Kaps\u00fcl Dolum Makinesini ekipman temizleme prosed\u00fcr\u00fcne uygun olarak temizleyin.<\/p>

5.12 KAYITLAR: Ekipman Kullan\u0131m Kayd\u0131, Parti \u00dcretim Kayd\u0131, Proses \u0130\u00e7i Kontrol Kayd\u0131, Temizlik Kayd\u0131.<\/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 IPQA:<\/strong> S\u00fcre\u00e7 \u0130\u00e7i Kalite G\u00fcvencesi.<\/p>

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

6.4 cGMP:<\/strong> G\u00fcncel \u0130yi \u00dcretim Uygulamalar\u0131.<\/p>\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":"

Standard Operating Procedure of Automatic Capsule Filling Machine 1.0 OBJECTIVE: This SOP walks you through operating the Automatic Capsule Filling […]<\/p>\n","protected":false},"author":1,"featured_media":10695,"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":[57],"tags":[],"class_list":["post-10692","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-capsule-filling-equipment"],"acf":[],"_links":{"self":[{"href":"https:\/\/pharmamachinecn.com\/tr\/wp-json\/wp\/v2\/posts\/10692","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=10692"}],"version-history":[{"count":4,"href":"https:\/\/pharmamachinecn.com\/tr\/wp-json\/wp\/v2\/posts\/10692\/revisions"}],"predecessor-version":[{"id":10698,"href":"https:\/\/pharmamachinecn.com\/tr\/wp-json\/wp\/v2\/posts\/10692\/revisions\/10698"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/pharmamachinecn.com\/tr\/wp-json\/wp\/v2\/media\/10695"}],"wp:attachment":[{"href":"https:\/\/pharmamachinecn.com\/tr\/wp-json\/wp\/v2\/media?parent=10692"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/pharmamachinecn.com\/tr\/wp-json\/wp\/v2\/categories?post=10692"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/pharmamachinecn.com\/tr\/wp-json\/wp\/v2\/tags?post=10692"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}