{"id":17439,"date":"2026-08-14T01:14:09","date_gmt":"2026-08-14T01:14:09","guid":{"rendered":"https:\/\/pharmamachinecn.com\/?p=17439"},"modified":"2026-05-12T08:07:43","modified_gmt":"2026-05-12T08:07:43","slug":"sop-for-manual-capsule-filling-machine","status":"publish","type":"post","link":"https:\/\/pharmamachinecn.com\/tr\/sop-for-manual-capsule-filling-machine\/","title":{"rendered":"Manuel Kaps\u00fcl Dolum Makinesi i\u00e7in Standart \u0130\u015flem Prosed\u00fcr\u00fc (SOP)"},"content":{"rendered":"
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Manuel Kaps\u00fcl Dolum Makinesinin Standart \u00c7al\u0131\u015fma Prosed\u00fcr\u00fc.<\/p>

\"Manuel
Manuel Kaps\u00fcl Dolum Makinesi \u0130\u00e7in Standart \u0130\u015flem Prosed\u00fcr\u00fc.<\/strong><\/em><\/figcaption><\/figure>

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

Sert jelatin kaps\u00fcllerin k\u00fc\u00e7\u00fck parti ve ara\u015ft\u0131rma \u00f6l\u00e7e\u011finde doldurulmas\u0131nda kullan\u0131lan Manuel Kaps\u00fcl Dolum Makinesinin \u00c7al\u0131\u015fma Prosed\u00fcr\u00fcn\u00fc belirlemek.<\/p>

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

Bu Prosed\u00fcr, pilot tesiste, Ara\u015ft\u0131rma ve Geli\u015ftirme (Ar-Ge) laboratuvar\u0131nda ve k\u00fc\u00e7\u00fck \u00f6l\u00e7ekli \u00fcretim alan\u0131nda kullan\u0131lan Manuel Kaps\u00fcl Dolum Makinesinin \u00c7al\u0131\u015ft\u0131rma Prosed\u00fcr\u00fc i\u00e7in ge\u00e7erlidir.<\/p>

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

Dolum Teknisyeni ve Pilot Tesis Sorumlusu<\/p>

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

Deneme Tesisi M\u00fcd\u00fcr\u00fc.<\/p>

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

5.1 \u00c7al\u0131\u015fma tezgah\u0131n\u0131 ve makine y\u00fczeyini kontrol edin. Doldurma i\u015flemine ba\u015flamadan \u00f6nce, \u00fcniteye \u201cTEM\u0130ZLENM\u0130\u015e\u201d etiketinin yap\u0131\u015ft\u0131r\u0131lm\u0131\u015f oldu\u011funu do\u011frulay\u0131n.<\/p>

5.2 \u00c7al\u0131\u015ft\u0131rma bilgilerini K\u00fc\u00e7\u00fck Parti G\u00fcnl\u00fc\u011f\u00fcne kaydedin. Operat\u00f6r\u00fcn ad\u0131n\u0131, \u00fcr\u00fcn ad\u0131n\u0131, parti kodunu, tarihi ve vardiya ba\u015flang\u0131\u00e7 saatini yaz\u0131n.<\/p>

5.3 \u201cTEM\u0130ZLEND\u0130\u201d etiketini \u00e7\u0131kar\u0131n ve makineye \u201c\u0130\u015eLEMDE\u201d etiketini yap\u0131\u015ft\u0131r\u0131n.<\/p>

5.4 \u0130\u015flem S\u0131ras\u0131nda Kalite G\u00fcvencesi (IPQA) biriminden yaz\u0131l\u0131 bir Hat Onay Belgesi al\u0131n. Bu belge olmadan \u00e7al\u0131\u015fmaya ba\u015flamay\u0131n\u0131z.<\/p>

5.5 G\u00fcvenlik ve Hijyen Hususlar\u0131:<\/strong><\/h3>

5.5.1 Bu makine elle \u00e7al\u0131\u015ft\u0131r\u0131lmaktad\u0131r ancak yine de s\u0131k\u0131\u015fma noktalar\u0131 bulunmaktad\u0131r. Y\u00fckleme plakalar\u0131 birbirine s\u00fcrt\u00fcnerek kayar ve kenarlar\u0131nda parmaklar s\u0131k\u0131\u015fabilir.<\/p>

5.5.2 Kol sert geliyorsa asla zorlamay\u0131n. Kolun s\u0131k\u0131\u015fmas\u0131 genellikle bir kaps\u00fcl\u00fcn s\u0131k\u0131\u015ft\u0131\u011f\u0131 anlam\u0131na gelir. Daha fazla g\u00fc\u00e7 uygulamadan \u00f6nce durun ve kontrol edin.<\/p>

5.5.3 Kullan\u0131m s\u0131ras\u0131nda kol geri \u00e7ekme yay\u0131 y\u00fck alt\u0131ndad\u0131r. Sorumlunun onay\u0131 olmadan yay muhafazas\u0131n\u0131 s\u00f6kmeyin.<\/p>

5.5.4 Baz\u0131 ila\u00e7 tozlar\u0131 \u00e7ok d\u00fc\u015f\u00fck dozlarda bile g\u00fc\u00e7l\u00fc etkiye sahiptir. Tozla \u00e7al\u0131\u015fmaya ba\u015flamadan \u00f6nce, \u00fcr\u00fcn kullan\u0131m k\u0131lavuzunda belirtilen s\u0131n\u0131fta bir solunum maskesi tak\u0131n\u0131z.<\/p>

5.5.5 Kuru k\u0131\u015f aylar\u0131nda plastik y\u00fckleme plakalar\u0131nda statik elektrik birikebilir. Kaps\u00fcllerin yap\u0131\u015fmas\u0131n\u0131 \u00f6nlemek i\u00e7in her parti \u00f6ncesinde plakalar\u0131 antistatik bir bezle siliniz.<\/p>

5.5.6 Kaps\u00fcl doldurma i\u015flemi s\u0131ras\u0131nda tezgah alan\u0131nda yiyecek, i\u00e7ecek ve ki\u015fisel e\u015fyalar bulunmamal\u0131d\u0131r. A\u00e7\u0131k toz i\u015fleme s\u0131ras\u0131nda \u00fcr\u00fcnler aras\u0131nda \u00e7apraz bula\u015fma riski b\u00fcy\u00fck bir sorundur.<\/p>

5.5.7 Bo\u015f kaps\u00fcllerle \u00e7al\u0131\u015fmadan \u00f6nce ellerinizi iyice y\u0131kay\u0131n. Ciltteki ya\u011f veya nem, jelatin kabu\u011funu yumu\u015fatabilir ve s\u0131zd\u0131rmazl\u0131k sorunlar\u0131na yol a\u00e7abilir.<\/p>

5.5.8 Bu faaliyet i\u00e7in gerekli standart KKD, temiz oda giysisi veya \u00f6zel laboratuvar \u00f6nl\u00fc\u011f\u00fc, pudras\u0131z nitril eldivenler, koruyucu g\u00f6zl\u00fck, sa\u00e7 filesi ve gerekirse sakal filesi i\u00e7erir. Etkili bile\u015fiklerle yap\u0131lan t\u00fcm \u00e7al\u0131\u015fmalarda solunum cihaz\u0131 da kullan\u0131lmal\u0131d\u0131r.<\/p>

5.5.9 Her yeni parti \u00f6ncesinde a\u015fa\u011f\u0131daki tezgah ve makine kontrollerini ger\u00e7ekle\u015ftirin:<\/p>

5.5.9.1 \u00c7al\u0131\u015fma tezgah\u0131n\u0131n d\u00fcz olup olmad\u0131\u011f\u0131n\u0131 kontrol edin. Her iki tarafa da birer su terazisi yerle\u015ftirin. D\u00fcz olmayan bir tezgah, tozun d\u00fczg\u00fcn da\u011f\u0131lmamas\u0131na neden olur.<\/p>

5.5.9.2 Y\u00fckleme plakalar\u0131nda \u00e7izik, ezik veya \u00f6nceki partilerden kalan kal\u0131nt\u0131 olup olmad\u0131\u011f\u0131n\u0131 kontrol edin. Hasarl\u0131 plakalar, \u00fcretim ba\u015flamadan \u00f6nce de\u011fi\u015ftirilmelidir.<\/p>

5.5.9.3 T\u00fcm plaka hizalama pimlerinin yerinde oldu\u011funu ve serbest\u00e7e hareket etti\u011fini kontrol edin. Eksik bir pim, dolgunun merkezden sapmas\u0131na neden olur.<\/p>

5.5.9.4 Her kontrolden sonra Tezgah Do\u011frulama Kay\u0131t Defterini imzalay\u0131n.<\/p>

5.6 Makine Par\u00e7alar\u0131 ve Kurulum:<\/strong><\/h3>

5.6.1 Ana \u00dcnite ve \u00c7er\u00e7eve:<\/b><\/strong><\/h4>

5.6.1.1 Taban \u00fcnitesi, makinenin ana g\u00f6vdesidir. \u00dczerinde \u00e7al\u0131\u015ft\u0131rma kolu, plaka tutucu ve hizalama pimleri bulunur.<\/p>

5.6.1.2 Makineyle birlikte verilen kelep\u00e7eleri kullanarak taban \u00fcnitesini tezgaha sabitleyin. Gev\u015fek bir taban, kolun hareketi s\u0131ras\u0131nda yerinden kayarak kaps\u00fcl contas\u0131n\u0131 bozacakt\u0131r.<\/p>

5.6.1.3 Taban\u0131, 70% izopropil alkol ile nemlendirilmi\u015f t\u00fcy b\u0131rakmayan bir bezle silin. Kullanmadan \u00f6nce y\u00fczeyin en az iki dakika boyunca havayla kurumas\u0131n\u0131 bekleyin.<\/p>

5.6.1.4 Partinizdeki kaps\u00fcl boyutuna uygun plaka setini se\u00e7in. Yayg\u0131n olarak kullan\u0131lan plaka setleri 00, 0, 1, 2, 3 ve 4 numaral\u0131 boyutlar\u0131 kapsar.<\/p>

5.6.2 Y\u00fckleme Plakas\u0131:<\/b><\/strong><\/h4>

5.6.2.1 Doldurma plakas\u0131, doldurma i\u015flemi s\u0131ras\u0131nda kaps\u00fcl g\u00f6vdelerini dik konumda tutar. Plaka, makinenin boyutuna ba\u011fl\u0131 olarak 100 ile 300 aras\u0131nda delik i\u00e7erir.<\/p>

5.6.2.2 Y\u00fckleme plakas\u0131n\u0131 ana \u00fcniteye yerle\u015ftirin ve hizalama pimlerini yerine oturtun. Plaka, sallanmadan d\u00fcz bir \u015fekilde oturmal\u0131d\u0131r.<\/p>

5.6.2.3 Kaps\u00fcl y\u00f6nlendirme adapt\u00f6r\u00fcn\u00fc y\u00fckleme plakas\u0131n\u0131n \u00fczerine yerle\u015ftirin. Bu adapt\u00f6r, kaps\u00fclleri g\u00f6vdeleri a\u015fa\u011f\u0131 bakacak \u015fekilde deliklere y\u00f6nlendirir.<\/p>

5.6.2.4 Bo\u015f kaps\u00fclleri adapt\u00f6r\u00fcn \u00fczerine d\u00f6k\u00fcn. Her delik dolana kadar yumu\u015fak bir f\u0131r\u00e7a yard\u0131m\u0131yla kaps\u00fclleri y\u00fczey \u00fczerinde ileri geri kayd\u0131r\u0131n.<\/p>

5.6.2.5 Deliklere d\u00fc\u015fmemi\u015f kaps\u00fclleri \u00e7\u0131kar\u0131n. Bunlar\u0131 bir sonraki doldurma turu i\u00e7in bo\u015f kaps\u00fcl kab\u0131na geri koyun.<\/p>

5.6.3 Ay\u0131rma Plakas\u0131:<\/b><\/strong><\/h4>

5.6.3.1 Ay\u0131rma plakas\u0131, kaps\u00fcl kapaklar\u0131n\u0131 g\u00f6vdelerden ay\u0131r\u0131r. G\u00f6vdeler y\u00fckleme plakas\u0131nda kal\u0131rken, kapaklar ay\u0131rma plakas\u0131na ge\u00e7er.<\/p>

5.6.3.2 Ay\u0131rma a\u015famas\u0131nda vakum kayna\u011f\u0131n\u0131 devreye al\u0131n. Bu boyuttaki bir makine i\u00e7in k\u00fc\u00e7\u00fck bir el pompas\u0131 veya tezgah \u00fcst\u00fc vakum cihaz\u0131 uygun bir se\u00e7enektir.<\/p>

5.6.3.3 Kaps\u00fcl\u00fcn kapak taraf\u0131na vakum uygulay\u0131n. Kapaklar g\u00f6vdelerden ayr\u0131lacak ve ay\u0131rma plakas\u0131na yap\u0131\u015facakt\u0131r.<\/p>

5.6.3.4 Ay\u0131rma plakas\u0131n\u0131 tek bir d\u00fczg\u00fcn hareketle d\u00fcmd\u00fcz yukar\u0131 do\u011fru kald\u0131r\u0131n. Bu ad\u0131mda plaka e\u011filirse, kapaklar g\u00f6vdelere geri d\u00fc\u015fecektir.<\/p>

5.6.3.5 Ay\u0131rma plakas\u0131n\u0131, kapak delikleri yukar\u0131 bakacak \u015fekilde tezgah kapa\u011f\u0131n\u0131n \u00fczerine yerle\u015ftirin. Plakay\u0131, toz d\u00f6k\u00fclmelerinden ve hava ak\u0131mlar\u0131ndan uzak tutun.<\/p>

5.6.4 Toz Doldurma ve S\u0131k\u0131\u015ft\u0131rma:<\/b><\/strong><\/h4>

5.6.4.1 Dolum a\u015famas\u0131ndan \u00f6nce tozu kalibre edilmi\u015f bir terazi \u00fczerinde tart\u0131n. Toplam miktar, k\u00fc\u00e7\u00fck bir fazlal\u0131kla birlikte partinin teorik dolum miktar\u0131na uymal\u0131d\u0131r.<\/p>

5.6.4.2 Tozu, lastik bir yayma aleti veya d\u00fcz bir kart kullanarak y\u00fckleme plakas\u0131n\u0131n \u00fczerine e\u015fit bir \u015fekilde yay\u0131n. Plakan\u0131n bir ucundan di\u011fer ucuna do\u011fru s\u00fcp\u00fcrme hareketi yaparak \u00e7al\u0131\u015f\u0131n.<\/p>

5.6.4.3 Tozu s\u0131k\u0131\u015ft\u0131rma aletiyle kaps\u00fcl g\u00f6vdelerine s\u0131k\u0131\u015ft\u0131r\u0131n. Plakan\u0131n t\u00fcm y\u00fczeyine e\u015fit bas\u0131n\u00e7 uygulay\u0131n.<\/p>

5.6.4.4 Hedeflenen dolum a\u011f\u0131rl\u0131\u011f\u0131na ba\u011fl\u0131 olarak, malzeme yayma ve s\u0131k\u0131\u015ft\u0131rma ad\u0131mlar\u0131n\u0131 iki veya \u00fc\u00e7 kez tekrarlay\u0131n. A\u015f\u0131r\u0131 s\u0131k\u0131\u015ft\u0131rma, kaps\u00fcl g\u00f6vdesinin duvar\u0131n\u0131n \u00e7atlamas\u0131na neden olabilir.<\/p>

5.6.4.5 Yumu\u015fak bir f\u0131r\u00e7a yard\u0131m\u0131yla plakadaki fazla tozu temizleyin. Fazla tozu, parti sonunda hesaplama yapmak \u00fczere tart\u0131lm\u0131\u015f bir kaba toplay\u0131n.<\/p>

5.7 Kaps\u00fcllerin Kapat\u0131lmas\u0131:<\/strong><\/h3>

5.7.1 G\u00f6vdeler doldurulduktan sonra, kapaklar tekrar yerle\u015ftirilmeli ve birle\u015ftirilerek kapal\u0131 kaps\u00fcl olu\u015fturulmal\u0131d\u0131r. Manuel makine bunu tek bir kol hareketiyle ger\u00e7ekle\u015ftirir.<\/p>

5.7.2 Ay\u0131rma plakas\u0131n\u0131 y\u00fckleme plakas\u0131n\u0131n \u00fczerine geri yerle\u015ftirin. Ana \u00fcnitedeki hizalama pimlerini kullanarak iki plakay\u0131 hizalay\u0131n.<\/p>

5.7.3 Her bir kapa\u011f\u0131n, kendisine kar\u015f\u0131l\u0131k gelen g\u00f6vdenin tam \u00fczerine oturdu\u011funu kontrol edin. Yanl\u0131\u015f hizalanm\u0131\u015f bir plaka, kapatma hareketi s\u0131ras\u0131nda kaps\u00fclleri ezebilir.<\/p>

5.7.4 \u00c7al\u0131\u015ft\u0131rma kolunu tek bir d\u00fczg\u00fcn hareketle a\u015fa\u011f\u0131 do\u011fru itin. Kol, kapaklar\u0131 g\u00f6vdelere yerle\u015ftirir ve her bir kaps\u00fcl\u00fc kilitler.<\/p>

5.7.5 Kolu alt konumda \u00fc\u00e7 saniye boyunca tutun. Bu bekleme s\u00fcresi, kaps\u00fcl kilit halkalar\u0131n\u0131n tam olarak yerine oturmas\u0131n\u0131 sa\u011flar.<\/p>

5.7.6 Kolu serbest b\u0131rak\u0131n ve kendi kendine \u00fcst konuma d\u00f6nmesine izin verin. Kolu yukar\u0131 do\u011fru zorlamay\u0131n.<\/p>

5.7.7 Ay\u0131rma plakas\u0131n\u0131 kald\u0131r\u0131n. Kapal\u0131 kaps\u00fcller, y\u00fckleme plakas\u0131ndaki deliklerde kalacakt\u0131r.<\/p>

5.7.8 Y\u00fckleme plakas\u0131n\u0131 temiz bir tepsinin \u00fczerine e\u011fin. Plakan\u0131n kenar\u0131na hafif\u00e7e vurun ve haz\u0131r kaps\u00fclleri serbest b\u0131rak\u0131n.<\/p>

5.8 A\u011f\u0131rl\u0131k Kontroller:<\/strong><\/h3>

5.8.1 \u0130lk 10 kapal\u0131 kaps\u00fcl\u00fc kalibre edilmi\u015f bir mikroterazide tart\u0131n. Her bir a\u011f\u0131rl\u0131\u011f\u0131 A\u011f\u0131rl\u0131k Kontrol Kay\u0131t Defteri\u2019ne kaydedin.<\/p>

5.8.2 Her bir a\u011f\u0131rl\u0131\u011f\u0131, parti kay\u0131tlar\u0131nda belirtilen hedef dolum a\u011f\u0131rl\u0131\u011f\u0131yla kar\u015f\u0131la\u015ft\u0131r\u0131n. Ara\u015ft\u0131rma \u00e7al\u0131\u015fmalar\u0131 i\u00e7in manuel dolumda tolerans genellikle \u00b15%\u2019dir.<\/p>

5.8.3 S\u0131n\u0131r\u0131n d\u0131\u015f\u0131na \u00e7\u0131kan kaps\u00fcl say\u0131s\u0131 ikiden fazla olursa, partiyi durdurun ve s\u0131k\u0131\u015ft\u0131rma bas\u0131nc\u0131n\u0131 ayarlay\u0131n. Ayarlamadan sonra a\u011f\u0131rl\u0131k kontrol\u00fcn\u00fc tekrarlay\u0131n.<\/p>

5.8.4 Doldurulmu\u015f her plakadan rastgele se\u00e7ilen 20 kaps\u00fcl\u00fcn a\u011f\u0131rl\u0131\u011f\u0131n\u0131 \u00f6l\u00e7\u00fcn. Numuneyi, kontrol t\u00fcm delik konumlar\u0131n\u0131 kapsayacak \u015fekilde plaka \u00fczerine da\u011f\u0131t\u0131n.<\/p>

5.8.5 Her bir plaka i\u00e7in ortalama, minimum ve maksimum a\u011f\u0131rl\u0131\u011f\u0131 kaydedin. Minimum ve maksimum de\u011ferler aras\u0131ndaki geni\u015f fark, doldurma s\u0131ras\u0131nda tozun d\u00fczensiz da\u011f\u0131ld\u0131\u011f\u0131n\u0131 g\u00f6sterir.<\/p>

5.8.6 A\u011f\u0131rl\u0131\u011f\u0131 eksik veya fazla olan kaps\u00fclleri bir yeniden i\u015fleme kab\u0131na ay\u0131r\u0131n. Bunlar\u0131 kusursuz \u00fcr\u00fcnlerle kar\u0131\u015ft\u0131rmay\u0131n.<\/p>

5.9 G\u00f6zle \u0130nceleme:<\/strong><\/h3>

5.9.1 Haz\u0131rlanan kaps\u00fclleri, siyah ka\u011f\u0131tla kapl\u0131 temiz bir inceleme tepsisine d\u00f6k\u00fcn. Koyu renkli arka plan, kusurlar\u0131n daha kolay fark edilmesini sa\u011flar.<\/p>

5.9.2 Muayene s\u0131ras\u0131nda \u015fu kusurlar\u0131 kontrol edin:<\/p>

5.9.2.1 D\u00fczg\u00fcn bir \u015fekilde kilitlenmemi\u015f, ezilmi\u015f veya \u00e7atlam\u0131\u015f kaps\u00fcller.<\/p>

5.9.2.2 Kapa\u011f\u0131 g\u00f6vdeye tam olarak oturmam\u0131\u015f a\u00e7\u0131k kaps\u00fcller.<\/p>

5.9.2.3 D\u0131\u015f kabu\u011funda g\u00f6zle g\u00f6r\u00fcl\u00fcr toz bulunan, lekeli veya tozlu kaps\u00fcller.<\/p>

5.9.2.4 Tam kilitlenme uzunlu\u011funa kadar kapanmayan k\u0131sa kaps\u00fcller.<\/p>

5.9.2.5 A\u015f\u0131r\u0131 kol kuvveti nedeniyle deforme olmu\u015f veya b\u00fck\u00fclm\u00fc\u015f kaps\u00fcller.<\/p>

5.9.3 Kusurlu kaps\u00fclleri ay\u0131rma kab\u0131na koyun. Her bir kusur t\u00fcr\u00fcne ili\u015fkin say\u0131y\u0131 Denetim Formunda s\u00fcrekli olarak kaydedin.<\/p>

5.9.4 \u0130yi durumdaki kaps\u00fclleri temiz ve kuru bir bezin i\u00e7inde nazik\u00e7e yuvarlayarak parlat\u0131n. Bu ad\u0131m, d\u0131\u015f kabuktan gev\u015fek tozlar\u0131 temizler.<\/p>

5.9.5 Parlat\u0131lm\u0131\u015f kaps\u00fclleri 100'l\u00fck gruplar halinde say\u0131n ve bunlar\u0131 nihai kaba aktar\u0131n. Kab\u0131 parti kodu ve kaps\u00fcl say\u0131s\u0131 ile etiketleyin.<\/p>

5.10 Mutabakat:<\/strong><\/h3>

5.10.1 Parti sonunda t\u00fcm reddedilen kaps\u00fclleri say\u0131n ve tart\u0131n. Toplam say\u0131y\u0131 ve a\u011f\u0131rl\u0131\u011f\u0131 parti kay\u0131t formuna kaydedin.<\/p>

5.10.2 Dolum a\u015famalar\u0131nda toplanan fazla tozu tart\u0131n. Bu de\u011feri mutabakat \u00e7al\u0131\u015fma sayfas\u0131na ekleyin.<\/p>

5.10.3 Toplam toz miktar\u0131n\u0131 a\u015fa\u011f\u0131daki \u015fekilde hesaplay\u0131n: uygun kaps\u00fcllerdeki toz (uygun kaps\u00fcl say\u0131s\u0131 \u00d7 hedef dolum a\u011f\u0131rl\u0131\u011f\u0131) + reddedilen kaps\u00fcllerdeki toz (reddedilen kaps\u00fcl say\u0131s\u0131 \u00d7 ortalama dolum a\u011f\u0131rl\u0131\u011f\u0131) + fazla toz + y\u00fczeylerde kalan toz.<\/p>

5.10.4 Mutabakat\u0131n kabul edilebilmesi i\u00e7in, hesaplanan toplam toz miktar\u0131, ba\u015flang\u0131\u00e7 toz a\u011f\u0131rl\u0131\u011f\u0131yla \u00b12% aral\u0131\u011f\u0131 i\u00e7inde uyumlu olmal\u0131d\u0131r. Bu aral\u0131\u011f\u0131n d\u0131\u015f\u0131na \u00e7\u0131k\u0131lmas\u0131, ara\u015ft\u0131r\u0131lmas\u0131 gereken bir kayba i\u015faret eder.<\/p>

5.10.5 Ayr\u0131ca, kullan\u0131lm\u0131\u015f bo\u015f kaps\u00fcllerin say\u0131m\u0131n\u0131 da yap\u0131n. Ba\u015flang\u0131\u00e7 kaps\u00fcl say\u0131s\u0131, iyi kaps\u00fcller + reddedilen kaps\u00fcller + depoya iade edilen kullan\u0131lmam\u0131\u015f kaps\u00fcllerin toplam\u0131na e\u015fit olmal\u0131d\u0131r.<\/p>

5.10.6 Toplu Mutabakat Formunu doldurun ve tamamlanm\u0131\u015f kaps\u00fcl numuneleriyle birlikte Kalite G\u00fcvencesi birimine teslim edin.<\/p>

5.11 \u00c7apraz Kontaminasyon Kontrol\u00fc:<\/strong><\/h3>

5.11.1 Manuel kaps\u00fcl doldurma i\u015flemi ortam havas\u0131na a\u00e7\u0131kt\u0131r. Bu durum, partiler aras\u0131 \u00e7apraz kontaminasyonun kontrol\u00fcn\u00fc son derece \u00f6nemli hale getirir.<\/p>

5.11.2 M\u00fcmk\u00fcn oldu\u011funca her \u00fcr\u00fcn i\u00e7in ayr\u0131 bir plaka seti kullan\u0131n. Her plaka setini \u00fcr\u00fcn koduyla etiketleyin.<\/p>

5.11.3 Plakalar\u0131n farkl\u0131 \u00fcr\u00fcnler aras\u0131nda ortak kullan\u0131lmas\u0131 gerekiyorsa, ortak ekipman temizli\u011fi SOP\u2019sine uyun. Bir sonraki partiye ba\u015flamadan \u00f6nce bir swab testi yap\u0131n.<\/p>

5.11.4 \u00c7al\u0131\u015fma tezgah\u0131nda her seferinde yaln\u0131zca bir \u00fcr\u00fcnle \u00e7al\u0131\u015f\u0131n. Yeni bir \u00fcr\u00fcn \u00e7al\u0131\u015fma tezgah\u0131na gelmeden \u00f6nce, \u00f6nceki \u00fcr\u00fcnden kalan t\u00fcm izleri temizleyin.<\/p>

5.11.5 Her parti \u00fcretimden sonra tezg\u00e2h\u0131, makine g\u00f6vdesini ve aletleri silin. Her silme i\u015flemi i\u00e7in yeni temizlik bezleri kullan\u0131n.<\/p>

5.11.6 Farkl\u0131 \u00fcr\u00fcn partileri aras\u0131nda laboratuvar \u00f6nl\u00fc\u011f\u00fcn\u00fcz\u00fc ve eldivenlerinizi de\u011fi\u015ftirin. Bu k\u00fc\u00e7\u00fck \u00f6nlem, bir\u00e7ok \u00e7apraz bula\u015fma vakas\u0131n\u0131 \u00f6nler.<\/p>

5.12 Parti Sonu:<\/strong><\/h3>

5.12.1 Y\u00fckleme plakas\u0131ndan kalan t\u00fcm tozu, fazla toz haznesine f\u0131r\u00e7ayla temizleyin. Son miktar\u0131 tart\u0131n ve kayda ge\u00e7irin.<\/p>

5.12.2 Kullan\u0131lmam\u0131\u015f bo\u015f kaps\u00fclleri bo\u015f kaps\u00fcl deposuna geri koyun. Geri koydu\u011funuz kaps\u00fcllere tarih ve kalan adedi belirten bir etiket yap\u0131\u015ft\u0131r\u0131n.<\/p>

5.12.3 Plaka setini ana \u00fcniteden s\u00f6k\u00fcn. S\u0131k\u0131\u015fm\u0131\u015f plakalar\u0131 zorlamay\u0131n. Bir plaka \u00e7\u0131km\u0131yorsa, bak\u0131m birimine bildirin.<\/p>

5.12.4 Kullan\u0131lm\u0131\u015f t\u00fcm tabaklar\u0131, temizlik alan\u0131 i\u00e7in ayr\u0131lm\u0131\u015f y\u0131kama sepetine koyun.<\/p>

5.12.5 Ana \u00fcniteyi 70% IPA ile silin. Kol mente\u015fesine ve hizalama pimlerine \u00f6zellikle dikkat edin.<\/p>

5.12.6 Makineye \u201cTEM\u0130ZLENMEL\u0130\u201d etiketini yap\u0131\u015ft\u0131r\u0131n.<\/p>

5.12.7 Manuel Kaps\u00fcl Dolum Makinesini, belirlenen temizlik SOP\u2019sine uygun olarak temizleyin.<\/p>

5.13 KAYITLAR:<\/strong><\/h3>

5.13.1 K\u00fc\u00e7\u00fck Parti G\u00fcnl\u00fc\u011f\u00fc.<\/p>

5.13.2 Test Tezgah\u0131 Do\u011frulama Kayd\u0131.<\/p>

5.13.3 A\u011f\u0131rl\u0131k Kontrol Kayd\u0131.<\/p>

5.13.4 Toplu Mutabakat Tablosu.<\/p>

5.13.5 Denetim Formu.<\/p>

5.13.6 Temizlik Kayd\u0131.<\/p>

6.0 KISALTMALAR:<\/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 QA:<\/strong> 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 Ar-Ge:<\/strong> Ara\u015ft\u0131rma ve Geli\u015ftirme.<\/p>

Referanslar:<\/strong><\/h2>

Kaps\u00fcl Parlatma Makinesi i\u00e7in SOP<\/strong><\/em><\/span><\/a>.<\/p>

Kaps\u00fcl Sayma Makinesinin Kurulumu, \u00c7al\u0131\u015ft\u0131r\u0131lmas\u0131 ve Kapat\u0131lmas\u0131 i\u00e7in Standart \u0130\u015flem Prosed\u00fcr\u00fc (SOP).<\/strong><\/span><\/em><\/a>.<\/p>

Kaps\u00fcl Dolum Makinesi i\u00e7in Standart \u0130\u015flem Prosed\u00fcr\u00fc.<\/strong><\/em><\/span><\/a><\/p>

Otomatik Kaps\u00fcl Dolum Makinesi i\u00e7in Standart \u0130\u015flem Prosed\u00fcr\u00fc.<\/strong><\/em><\/span><\/a><\/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 Manual Capsule Filling Machine. 1.0 OBJECTIVE: To lay down the Operating Procedure of Manual Capsule Filling […]<\/p>\n","protected":false},"author":1,"featured_media":17467,"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-17439","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\/17439","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=17439"}],"version-history":[{"count":0,"href":"https:\/\/pharmamachinecn.com\/tr\/wp-json\/wp\/v2\/posts\/17439\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/pharmamachinecn.com\/tr\/wp-json\/wp\/v2\/media\/17467"}],"wp:attachment":[{"href":"https:\/\/pharmamachinecn.com\/tr\/wp-json\/wp\/v2\/media?parent=17439"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/pharmamachinecn.com\/tr\/wp-json\/wp\/v2\/categories?post=17439"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/pharmamachinecn.com\/tr\/wp-json\/wp\/v2\/tags?post=17439"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}