{"id":16907,"date":"2026-07-31T01:29:51","date_gmt":"2026-07-31T01:29:51","guid":{"rendered":"https:\/\/pharmamachinecn.com\/?p=16907"},"modified":"2026-04-30T02:44:19","modified_gmt":"2026-04-30T02:44:19","slug":"sop-for-liquid-filling-machine","status":"publish","type":"post","link":"https:\/\/pharmamachinecn.com\/tr\/sop-for-liquid-filling-machine\/","title":{"rendered":"S\u0131v\u0131 Dolum Makinesi i\u00e7in Standart \u0130\u015flem Prosed\u00fcr\u00fc (SOP)"},"content":{"rendered":"
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S\u0131v\u0131 Dolum Makinesinin Standart \u00c7al\u0131\u015fma Prosed\u00fcr\u00fc.<\/p>

\"S\u0131v\u0131
S\u0131v\u0131 Dolum Makinesi i\u00e7in Standart \u0130\u015flem Prosed\u00fcr\u00fc.<\/strong><\/em><\/figcaption><\/figure>

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

\u00c7e\u015fitli viskozitelere sahip s\u0131v\u0131 \u00fcr\u00fcnlerin birincil ambalajlara hassas hacimsel dolumunda kullan\u0131lan S\u0131v\u0131 Dolum Makinesinin \u00c7al\u0131\u015fma Prosed\u00fcr\u00fcn\u00fc a\u00e7\u0131klamak.<\/p>

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

Bu Prosed\u00fcr, \u00fcretim departman\u0131n\u0131n s\u0131v\u0131 b\u00f6l\u00fcm\u00fcnde kurulu olan S\u0131v\u0131 Dolum Makinesinin \u00c7al\u0131\u015ft\u0131rma Prosed\u00fcr\u00fc i\u00e7in ge\u00e7erlidir.<\/p>

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

Dolum Operat\u00f6r\u00fc ve \u00dcretim Teknisyeni<\/p>

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

\u00dcretim M\u00fcd\u00fcr\u00fc.<\/p>

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

5.1 Dolum alan\u0131n\u0131 dola\u015f\u0131n ve makine g\u00f6vdesini inceleyin. Herhangi bir \u00e7al\u0131\u015fmaya ba\u015flamadan \u00f6nce, \u201cTEM\u0130ZLEND\u0130\u201d durum etiketinin \u00fcniteye sabitlendi\u011finden emin olun.<\/p>

5.2 Ekipman Kullan\u0131m Kay\u0131t Defterini doldurun. Ad\u0131n\u0131z\u0131, \u00fcr\u00fcn kodunu, tarihi ve vardiyan\u0131n ba\u015flad\u0131\u011f\u0131 tam saati kaydedin.<\/p>

5.3 \u201cTEM\u0130ZLEND\u0130\u201d durum etiketini s\u00f6k\u00fcn ve yerine \u201c\u0130\u015eLEMDE\u201d durum etiketini tak\u0131n.<\/p>

5.4 \u0130\u015flem A\u015famas\u0131ndaki Kalite G\u00fcvencesi (IPQA) biriminden bir onay belgesi talep edin. \u00dczerinde imza ve tarih bulunan onay belgesi size ula\u015fana kadar i\u015fleme devam etmeyin.<\/p>

5.5 G\u00fcvenlik Gereklilikleri:<\/strong><\/h3>

5.5.1 Bir\u00e7ok s\u0131v\u0131 \u00fcr\u00fcn alkol, u\u00e7ucu ya\u011f veya u\u00e7ucu \u00e7\u00f6z\u00fcc\u00fcler i\u00e7erir. \u00c7akmaklar, cep telefonlar\u0131 ve k\u0131v\u0131lc\u0131m \u00e7\u0131karan aletler gibi t\u00fcm tutu\u015fma kaynaklar\u0131n\u0131 dolum alan\u0131ndan uzak tutun.<\/p>

5.5.2 S\u0131v\u0131 dolum makinelerinin \u00e7evresinde kaygan zeminler ciddi bir tehlike olu\u015fturur. D\u00f6k\u00fclen s\u0131v\u0131lar\u0131 hemen silin ve alan kuruyana kadar sar\u0131 renkli \u201czemin \u0131slak\u201d uyar\u0131 levhas\u0131n\u0131 kullan\u0131n.<\/p>

5.5.3 \u00dcr\u00fcn tank\u0131n\u0131, tank\u0131n tip plakas\u0131nda belirtilen nominal s\u0131n\u0131r\u0131n \u00fczerine bas\u0131n\u00e7land\u0131rmay\u0131n. A\u015f\u0131r\u0131 bas\u0131n\u00e7, bir ba\u011flant\u0131 par\u00e7as\u0131n\u0131n y\u0131rt\u0131lmas\u0131na ve \u00fcr\u00fcn\u00fcn y\u00fcksek bas\u0131n\u00e7la p\u00fcsk\u00fcrmesine neden olabilir.<\/p>

5.5.4 CIP d\u00f6n\u00fc\u015f hatlar\u0131n\u0131 her zaman a\u00e7\u0131k tutun. T\u0131kanm\u0131\u015f bir d\u00f6n\u00fc\u015f hatt\u0131, temizlik d\u00f6ng\u00fcs\u00fc s\u0131ras\u0131nda bas\u0131n\u00e7 art\u0131\u015f\u0131na neden olabilir ve tanka zarar verebilir.<\/p>

5.5.5 Pistonlar veya pompalar \u00e7al\u0131\u015f\u0131rken asla doldurma ba\u015fl\u0131klar\u0131n\u0131n i\u00e7ine elinizi sokmay\u0131n. Her bir pistona etki eden tahrik kuvveti, hi\u00e7bir uyar\u0131 olmaks\u0131z\u0131n parma\u011f\u0131n\u0131z\u0131 s\u0131k\u0131\u015ft\u0131rabilir veya ezebilir.<\/p>

5.5.6 \u00dcr\u00fcn konsantrelerini veya temizlik maddelerini kullan\u0131rken kimyasallara dayan\u0131kl\u0131 eldivenler ve s\u0131\u00e7rama \u00f6nleyici \u00f6nl\u00fck giyin. \u00dcr\u00fcnle cilt temas\u0131 durumunda, etkilenen b\u00f6lgeyi akan su alt\u0131nda en az 15 dakika boyunca y\u0131kay\u0131n ve ilk yard\u0131m istasyonuna bildirin.<\/p>

5.5.7 A\u011f\u0131r \u00fcr\u00fcn varillerini bir el arabas\u0131 veya ikinci bir ki\u015finin yard\u0131m\u0131yla kald\u0131r\u0131n. Dolu bir 200 litrelik varil 200 kg\u2019dan fazla a\u011f\u0131rl\u0131\u011fa sahip olabilir ve tek ba\u015f\u0131na ta\u015f\u0131nmas\u0131 halinde s\u0131rt yaralanmalar\u0131na neden olabilir.<\/p>

5.5.8 Bu makine i\u00e7in standart KKD, laboratuvar \u00f6nl\u00fc\u011f\u00fc, nitril eldivenler, koruyucu g\u00f6zl\u00fck, kapal\u0131 ayakkab\u0131lar ve sa\u00e7 filtresinden olu\u015fur. S\u0131cak veya a\u015f\u0131nd\u0131r\u0131c\u0131 \u00fcr\u00fcnlerle \u00e7al\u0131\u015f\u0131rken y\u00fcz siperli\u011fi de tak\u0131n.<\/p>

5.5.9 A\u015fa\u011f\u0131daki g\u00fcvenlik devresi denetimini her hafta ger\u00e7ekle\u015ftirin ve sonu\u00e7lar\u0131n\u0131 belgelendirin:<\/p>

5.5.9.1 Ana kesiciyi kullanarak makineyi devre d\u0131\u015f\u0131 b\u0131rak\u0131n ve t\u00fcm \u201c\u00e7al\u0131\u015f\u0131yor\u201d g\u00f6stergelerinin s\u00f6nd\u00fc\u011f\u00fcn\u00fc kontrol edin.<\/p>

5.5.9.2 Acil durdurma d\u00fc\u011fmesine bas\u0131n. Pompalar, tahrik sistemi ve konvey\u00f6r tek bir hareketle durmal\u0131d\u0131r.<\/p>

5.5.9.3 Her bir koruma kap\u0131s\u0131n\u0131 s\u0131rayla a\u00e7\u0131n. Makine her seferinde g\u00fcvenli bekleme durumuna ge\u00e7melidir.<\/p>

5.5.9.4 \u00dcr\u00fcn tank\u0131ndaki d\u00fc\u015f\u00fck seviye probunu, bir miktar s\u0131v\u0131 \u00e7ekerek test edin. Prob kurudu\u011funda hat durmal\u0131d\u0131r.<\/p>

5.5.9.5 Her haftal\u0131k incelemenin ard\u0131ndan G\u00fcvenlik Denetim Kay\u0131t Defteri\u2019ni imzalay\u0131n.<\/p>

5.6 Dolum Teknolojisi Se\u00e7imi:<\/strong><\/h3>

5.6.1 Pistonlu Hacimsel Dolum:<\/b><\/strong><\/h4>

5.6.1.1 Pistonlu doldurucu, her strokta sabit bir hacim \u00e7eker. Bu y\u00f6ntem, ince s\u0131v\u0131lar ve 5000 cPs\u2019ye kadar olan orta viskoziteli \u00fcr\u00fcnler i\u00e7in uygundur.<\/p>

5.6.1.2 Ayar kadran\u0131ndan strok uzunlu\u011funu ayarlay\u0131n. Bir tam tur genellikle dozu 1 mL de\u011fi\u015ftirir; bu nedenle kadran\u0131 k\u00fc\u00e7\u00fck ad\u0131mlarla \u00e7evirin.<\/p>

5.6.1.3 Pistonlu doldurucular, \u015fi\u015feler aras\u0131nda 0,5%\u2019den az bir sapma ile son derece tekrarlanabilir dozlar sa\u011flar. Oral s\u00fcspansiyonlar, \u015furuplar ve \u00f6ks\u00fcr\u00fck kar\u0131\u015f\u0131mlar\u0131 i\u00e7in bu modu se\u00e7in.<\/p>

5.6.2 Peristaltik Pompa ile Doldurma:<\/b><\/strong><\/h4>

5.6.2.1 Peristaltik pompa, silikon t\u00fcp\u00fc s\u0131k\u0131\u015ft\u0131rmak i\u00e7in makaralar kullan\u0131r. \u00dcr\u00fcn, pompan\u0131n kendisiyle de\u011fil, yaln\u0131zca t\u00fcp ile temas eder.<\/p>

5.6.2.2 Steril \u00fcr\u00fcnler, k\u00fc\u00e7\u00fck parti \u00fcretimleri veya metal par\u00e7alarla temas etmemesi gereken herhangi bir \u00fcr\u00fcn i\u00e7in bu modu se\u00e7in.<\/p>

5.6.2.3 \u00d6nleyici bak\u0131m \u00e7izelgesinde belirtilen aral\u0131klarla silikon hortumu de\u011fi\u015ftirin. Gerilmi\u015f bir hortum, dolumlar\u0131n hatal\u0131 olmas\u0131na neden olur.<\/p>

5.6.3 Yer\u00e7ekimi ve Bas\u0131n\u00e7-Zamanl\u0131 Doldurma:<\/b><\/strong><\/h4>

5.6.3.1 Yer\u00e7ekimi dolum sistemleri, dolum ba\u015fl\u0131klar\u0131n\u0131n \u00fczerine monte edilmi\u015f bir tanktan gelen bas\u0131nca dayan\u0131r. Bu y\u00f6ntem, kolayca k\u00f6p\u00fcren, su gibi ince ak\u0131\u015fkanlar i\u00e7in uygundur.<\/p>

5.6.3.2 Dolum hacmi, \u00f6l\u00e7\u00fcl\u00fc strok yerine zaman ayarl\u0131 bir valf arac\u0131l\u0131\u011f\u0131yla kontrol edilir. Valf, dozu vermek \u00fczere belirlenen bir s\u00fcre boyunca a\u00e7\u0131l\u0131r.<\/p>

5.6.3.3 \u00c7al\u0131\u015fma s\u0131ras\u0131nda tank seviyesini sabit tutun. Seviyenin d\u00fc\u015fmesi, bas\u0131n\u00e7 y\u00fcksekli\u011fini azalt\u0131r ve \u015fi\u015fe \u015fi\u015fe dolum hacmini k\u00fc\u00e7\u00fclt\u00fcr.<\/p>

5.6.4 Ak\u0131\u015f \u00d6l\u00e7er Doldurma:<\/b><\/strong><\/h4>

5.6.4.1 Ak\u0131\u015f \u00f6l\u00e7erli doldurma sistemi, her bir doldurma hatt\u0131nda bir k\u00fctle veya manyetik ak\u0131\u015f sens\u00f6r\u00fc kullan\u0131r. Sens\u00f6r, noz\u00fclden ge\u00e7en hacmi tam olarak \u00f6l\u00e7er.<\/p>

5.6.4.2 Bu mod en y\u00fcksek do\u011frulu\u011fu sa\u011flar ve \u00fcr\u00fcn yo\u011funlu\u011fu de\u011fi\u015fti\u011finde otomatik olarak ayarlan\u0131r. Y\u00fcksek de\u011ferli \u00fcr\u00fcnler veya d\u00fczenlemelere tabi dolumlar i\u00e7in bu modu se\u00e7in.<\/p>

5.6.4.3 Her partinin ba\u015flang\u0131c\u0131nda her bir ak\u0131\u015f sens\u00f6r\u00fcn\u00fc kalibre edin. \u00c7o\u011fu \u00fcr\u00fcn i\u00e7in, tam \u00f6l\u00e7e\u011fin 10% ve 90% noktalar\u0131nda yap\u0131lan iki noktal\u0131 kalibrasyon yeterlidir.<\/p>

5.7 \u00dcr\u00fcn Tank\u0131 ve Besleme Sistemi:<\/h3>

5.7.1 \u00dcr\u00fcn tank\u0131, y\u00fck h\u00fccreleri \u00fczerine monte edilmi\u015f, ceketli bir paslanmaz \u00e7elik kapt\u0131r. Y\u00fck h\u00fccreleri, mevcut \u00fcr\u00fcn\u00fcn canl\u0131 a\u011f\u0131rl\u0131\u011f\u0131n\u0131 g\u00f6sterir.<\/p>

5.7.2 \u00dcr\u00fcn besleme hatt\u0131n\u0131 tank\u0131n \u00fcst k\u0131sm\u0131ndaki giri\u015f ba\u011flant\u0131 noktas\u0131na ba\u011flay\u0131n. Tri-Clamp ba\u011flant\u0131s\u0131n\u0131 \u00f6nce elle s\u0131k\u0131n, ard\u0131ndan etiketinde belirtilen tork de\u011ferine g\u00f6re bir anahtarla son s\u0131k\u0131\u015ft\u0131rmay\u0131 yap\u0131n.<\/p>

5.7.3 Tank ceketinin s\u0131cakl\u0131\u011f\u0131n\u0131 \u00fcr\u00fcn\u00fcn\u00fcz\u00fcn gerektirdi\u011fi \u015fekilde ayarlay\u0131n. S\u0131cak \u015furuplarda, dolum s\u0131ras\u0131nda viskozitenin d\u00fc\u015f\u00fck tutulmas\u0131 i\u00e7in ceket s\u0131cakl\u0131\u011f\u0131n\u0131n 40 ila 50 \u00b0C aras\u0131nda olmas\u0131 gerekir.<\/p>

5.7.4 Tank kar\u0131\u015ft\u0131r\u0131c\u0131s\u0131n\u0131 d\u00fc\u015f\u00fck h\u0131zda \u00e7al\u0131\u015ft\u0131r\u0131n. H\u0131z\u0131 kademeli olarak parti kay\u0131t belgesinde belirtilen de\u011fere y\u00fckseltin. H\u0131z\u0131n aniden art\u0131r\u0131lmas\u0131, \u00fcr\u00fcn\u00fcn tank kapa\u011f\u0131na s\u0131\u00e7ramas\u0131na neden olabilir.<\/p>

5.7.5 D\u00fc\u015f\u00fck seviye ve y\u00fcksek seviye sens\u00f6rlerinin aktif oldu\u011funu kontrol edin. Herhangi bir sens\u00f6r \u00fcr\u00fcnle temas\u0131 keserse, makine doldurma i\u015flemini duraklatacakt\u0131r.<\/p>

5.7.6 \u00dcr\u00fcn transfer pompas\u0131n\u0131n contas\u0131nda s\u0131z\u0131nt\u0131 olup olmad\u0131\u011f\u0131n\u0131 kontrol edin. Contan\u0131n yuvas\u0131n\u0131n \u0131slak olmas\u0131, de\u011fi\u015ftirilmesi gereken a\u015f\u0131nm\u0131\u015f bir mekanik contaya i\u015faret eder.<\/p>

5.7.7 \u0130lk dolumdan \u00f6nce besleme hatlar\u0131ndaki t\u00fcm havay\u0131 bo\u015falt\u0131n. Hat i\u00e7indeki hava cepleri, yetersiz doluma ve bitmi\u015f \u00fcr\u00fcnde kabarc\u0131k olu\u015fumuna neden olur.<\/p>

5.8 Nozul ve Damlama Kontrol\u00fc:<\/strong><\/h3>

5.8.1 Dolum nozullar\u0131, \u00fcr\u00fcn\u00fcn kaba girmesinden \u00f6nceki son a\u015famad\u0131r. Her bir nozul, \u00fcr\u00fcn\u00fcn viskozitesine ve kab\u0131n a\u011f\u0131z \u00e7ap\u0131na uygun olmal\u0131d\u0131r.<\/p>

5.8.2 K\u00f6p\u00fckl\u00fc \u00fcr\u00fcnler i\u00e7in dald\u0131rmal\u0131 nozul ba\u015fl\u0131\u011f\u0131n\u0131 tak\u0131n. Dolum s\u0131ras\u0131nda nozul s\u0131v\u0131 y\u00fczeyinin alt\u0131na dalar, b\u00f6ylece \u00fcr\u00fcn s\u0131\u00e7rama veya k\u00f6p\u00fck olu\u015fmadan d\u00f6k\u00fcl\u00fcr.<\/p>

5.8.3 Dald\u0131rma h\u0131z\u0131n\u0131 dolum h\u0131z\u0131na uyacak \u015fekilde ayarlay\u0131n. Yava\u015f dald\u0131rma, ta\u015fmaya neden olur. H\u0131zl\u0131 dald\u0131rma ise \u00fcr\u00fcn y\u00fczeyinde kabarc\u0131klar olu\u015fmas\u0131na yol a\u00e7ar.<\/p>

5.8.4 Her d\u00f6ng\u00fcn\u00fcn sonunda damlama \u00f6nleyici valfin tamamen kapand\u0131\u011f\u0131ndan emin olun. S\u0131z\u0131nt\u0131 yapan bir valf, dolumlar aras\u0131nda \u00fcr\u00fcn\u00fcn damlamas\u0131na ve \u015fi\u015fenin d\u0131\u015f k\u0131sm\u0131n\u0131n kirlenmesine neden olur.<\/p>

5.8.5 Her vardiya ba\u015flang\u0131c\u0131nda her bir nozul ucunda \u00fcr\u00fcn birikimi olup olmad\u0131\u011f\u0131n\u0131 kontrol edin. Kurumu\u015f kal\u0131nt\u0131lar ak\u0131\u015f yolunu t\u0131kayabilir ve dolumun eksik kalmas\u0131na neden olabilir.<\/p>

5.8.6 Kap boyutunu her de\u011fi\u015ftirdi\u011finizde nozul setini de\u011fi\u015ftirin. Geni\u015f a\u011f\u0131zl\u0131 bir \u015fi\u015fede k\u00fc\u00e7\u00fck bir nozul kullanmak, i\u00e7 duvarda s\u0131\u00e7rama izlerine neden olur.<\/p>

5.9 \u00dcr\u00fcn De\u011fi\u015fimi:<\/strong><\/h3>

5.9.1 \u00dcr\u00fcn de\u011fi\u015fimi s\u0131ras\u0131nda t\u00fcm temas eden par\u00e7alar\u0131n tamamen temizlenmesi gerekir. Herhangi bir ad\u0131m\u0131n atlanmas\u0131, \u00fcr\u00fcnler aras\u0131nda \u00e7apraz bula\u015fma riskini do\u011furur.<\/p>

5.9.2 Tankta kalan t\u00fcm \u00fcr\u00fcn\u00fc alt \u00e7\u0131k\u0131\u015ftan bo\u015falt\u0131n. Geri kazan\u0131labilir \u00fcr\u00fcn\u00fc, kalite g\u00fcvencesi incelemesi i\u00e7in etiketli bir kapta toplay\u0131n.<\/p>

5.9.3 Tank\u0131, besleme hatlar\u0131n\u0131 ve nozullar\u0131 ar\u0131t\u0131lm\u0131\u015f suyla \u00fc\u00e7 dakika boyunca durulay\u0131n. Durulama suyu, tahliye noktas\u0131ndan berrak bir \u015fekilde akmal\u0131d\u0131r.<\/p>

5.9.4 Ana kontrol panelinden CIP d\u00f6ng\u00fcs\u00fcn\u00fc ba\u015flat\u0131n. D\u00f6ng\u00fc, s\u0131cak kostik y\u0131kama, durulama, asit y\u0131kama, durulama ve enjeksiyon suyu ile son durulama a\u015famalar\u0131n\u0131 ger\u00e7ekle\u015ftirecektir.<\/p>

5.9.5 Son durulama suyunun iletkenlik de\u011ferini kontrol edin. Santimetre ba\u015f\u0131na 1,3 mikrosiemens\u2019in alt\u0131ndaki bir de\u011fer, temizlik maddelerinin yeterince uzakla\u015ft\u0131r\u0131ld\u0131\u011f\u0131n\u0131 teyit eder.<\/p>

5.9.6 CIP d\u00f6ng\u00fcs\u00fcn\u00fcn ard\u0131ndan \u00fc\u00e7 temas y\u00fczeyinden numune al\u0131n ve bu numuneleri mikrobiyoloji laboratuvar\u0131na biyoy\u00fck testi i\u00e7in g\u00f6nderin.<\/p>

5.9.7 De\u011fi\u015fim matrisinde belirtiliyorsa, nozul setini, hortumlar\u0131 ve contalar\u0131 de\u011fi\u015ftirin. Baz\u0131 \u00fcr\u00fcnlerde, tam bir temizlikten sonra bile yeni temas par\u00e7alar\u0131 gerekir.<\/p>

5.9.8 Kalite G\u00fcvencesi (QA) birimi makineyi kullan\u0131ma uygun hale getirene kadar yeni \u00fcr\u00fcn\u00fc y\u00fcklemeyin. Bu onay, swab testi ve durulama iletkenlik kontrol\u00fcnden tatmin edici sonu\u00e7lar elde edildikten sonra verilir.<\/p>

5.10 HMI Gezinme:<\/strong><\/h3>

5.10.1 \u0130nsan-Makine Aray\u00fcz\u00fc, operat\u00f6r seviyesine monte edilmi\u015f 15 in\u00e7lik bir renkli dokunmatik ekran kullan\u0131r. Ekran, h\u0131zl\u0131 veri aktar\u0131m\u0131 i\u00e7in fiber optik kablo arac\u0131l\u0131\u011f\u0131yla PLC\u2019ye ba\u011flan\u0131r.<\/p>

5.10.2 Ana panel a\u00e7\u0131ld\u0131ktan sonra, ikincil etkinle\u015ftirme d\u00fc\u011fmesiyle aray\u00fcz\u00fcn g\u00fcc\u00fcn\u00fc a\u00e7\u0131n. Ba\u015flatma i\u015flemi yakla\u015f\u0131k 60 saniye s\u00fcrer.<\/p>

5.10.3 Kendinize \u00f6zel kullan\u0131c\u0131 kimli\u011finiz ve \u015fifrenizle oturum a\u00e7\u0131n. Sistem, rol\u00fcn\u00fcze g\u00f6re (Operat\u00f6r, Teknisyen, S\u00fcperviz\u00f6r veya M\u00fchendis) eri\u015fim haklar\u0131n\u0131 atar.<\/p>

5.10.4 Ana ekranda be\u015f kutucuk g\u00f6r\u00fcnt\u00fclenir: Toplu Ayar, Dolum Kontrol\u00fc, CIP\/SIP, Veri E\u011filimi ve Denetim \u0130zi. Herhangi bir kutucu\u011fa dokunarak ilgili b\u00f6l\u00fcme girebilirsiniz.<\/p>

5.10.4.1 Parti Ayarlar\u0131: Mevcut \u00fcretim i\u00e7in \u00fcr\u00fcn kodunu, parti numaras\u0131n\u0131, hedef hacmi ve hat h\u0131z\u0131n\u0131 i\u00e7erir.<\/p>

5.10.4.2 Dolum Kontrol\u00fc: Her bir kafan\u0131n anl\u0131k dolum durumunu, duraklatma, devam ettirme ve iptal etme kontrolleriyle birlikte g\u00f6sterir.<\/p>

5.10.4.3 CIP\/SIP: Partiler aras\u0131nda otomatik temizlik ve buhar d\u00f6ng\u00fclerini \u00e7al\u0131\u015ft\u0131r\u0131r ve izler.<\/p>

5.10.4.4 Veri E\u011filimi: Son 24 saatteki dolum hacmi, s\u0131cakl\u0131k ve tank seviyesini grafik olarak g\u00f6sterir.<\/p>

5.10.4.5 Denetim \u0130zi: T\u00fcm operat\u00f6r eylemlerinin, parametre de\u011fi\u015fikliklerinin ve ar\u0131za olaylar\u0131n\u0131n tahrif edilemez bir kayd\u0131n\u0131 g\u00f6sterir.<\/p>

5.10.5 Ekran\u0131n \u00fcst k\u0131sm\u0131ndaki alarm \u00e7ubu\u011fu, uyar\u0131lar i\u00e7in sar\u0131, kritik ar\u0131zalar i\u00e7in ise k\u0131rm\u0131z\u0131 renge d\u00f6ner. \u00c7al\u0131\u015fmaya devam etmeden \u00f6nce k\u0131rm\u0131z\u0131 alarmlar\u0131 giderin.<\/p>

5.10.6 Vardiyan\u0131z\u0131n sonunda HMI'dan \u00e7\u0131k\u0131\u015f yap\u0131n. Herhangi bir etkinlik alg\u0131lanmazsa ekran 60 saniye i\u00e7inde kilitlenecektir.<\/p>

5.11 \u00dcretim Serisi:<\/strong><\/h3>

5.11.1 Toplu \u0130\u015flem Ayarlar\u0131 ekran\u0131nda tank seviyesinin, ceket s\u0131cakl\u0131\u011f\u0131n\u0131n ve kar\u0131\u015ft\u0131r\u0131c\u0131 h\u0131z\u0131n\u0131n hepsinin ye\u015fil renkte oldu\u011funu do\u011frulay\u0131n.<\/p>

5.11.2 Manuel modda, etiketlenmi\u015f beherlere be\u015f deneme dolumu ger\u00e7ekle\u015ftirin. Her bir beheri kalibre edilmi\u015f bir terazi \u00fczerinde tart\u0131n ve hedef de\u011ferle kar\u015f\u0131la\u015ft\u0131r\u0131n.<\/p>

5.11.3 Ortalama a\u011f\u0131rl\u0131k \u00b11% tolerans aral\u0131\u011f\u0131n\u0131n d\u0131\u015f\u0131na \u00e7\u0131karsa, HMI \u00fczerindeki dolum parametresini ayarlay\u0131n. Be\u015f numunenin tamam\u0131 tolerans aral\u0131\u011f\u0131 i\u00e7ine girene kadar testi tekrarlay\u0131n.<\/p>

5.11.4 Test dolumlar\u0131 ba\u015far\u0131yla tamamland\u0131\u011f\u0131nda makineyi Otomatik moda ge\u00e7irin. \u0130\u015flemi ba\u015flatmak i\u00e7in Dolum Kontrol ekran\u0131ndaki Ba\u015flat d\u00fc\u011fmesine dokunun.<\/p>

5.11.5 \u00c7\u0131k\u0131\u015f noktas\u0131nda doldurulan ilk 30 kab\u0131 izleyin. Her birini dolum seviyesi, kabarc\u0131k olu\u015fumu ve nozul damlama izleri a\u00e7\u0131s\u0131ndan inceleyin.<\/p>

5.11.6 Her 30 dakikada bir, \u00fcretim s\u00fcrecindeki be\u015f kapl\u0131k bir numune al\u0131n. Her numuneyi tart\u0131n ve sonucu Parti \u00dcretim Kayd\u0131\u2019na kaydedin.<\/p>

5.11.7 Dolum hacminde herhangi bir sapma olup olmad\u0131\u011f\u0131n\u0131 g\u00f6rmek i\u00e7in Veri E\u011filimi ekran\u0131n\u0131 izleyin. S\u00fcrekli bir d\u00fc\u015f\u00fc\u015f, filtrenin t\u0131kanmakta oldu\u011funu veya pompa contas\u0131n\u0131n a\u015f\u0131nmakta oldu\u011funu g\u00f6sterir.<\/p>

5.11.8 Spesifikasyonlara uymayan herhangi bir numuneyi derhal vardiya amirine bildirin. Amirinizin onay\u0131 olmadan \u00fcretim s\u0131ras\u0131nda dolum parametrelerini de\u011fi\u015ftirmeyin.<\/p>

5.12 Reddedilenler ve Geri Kazan\u0131m:<\/strong><\/h3>

5.12.1 Makine, \u00e7\u0131k\u0131\u015f konvey\u00f6r\u00fc boyunca iki adet eleme istasyonuna sahiptir. Her istasyon, belirli bir kontrolden ge\u00e7emeyen kaplar\u0131 d\u0131\u015far\u0131 itmektedir.<\/p>

5.12.2 \u0130lk istasyonda bir kontrol tart\u0131s\u0131 kullan\u0131lmaktad\u0131r. \u00dcst veya alt a\u011f\u0131rl\u0131k s\u0131n\u0131r\u0131n\u0131n d\u0131\u015f\u0131nda kalan herhangi bir kap, reddetme tepsisine d\u00fc\u015fer.<\/p>

5.12.3 \u0130kinci istasyonda dolum seviyesi kameras\u0131 kullan\u0131lmaktad\u0131r. Kamera, hava kabarc\u0131klar\u0131, k\u00f6p\u00fck tabakas\u0131 veya d\u00fc\u015f\u00fck menisk\u00fcs bulunan kaplar\u0131 eler.<\/p>

5.12.4 Reddedilen kaplar\u0131 \u00fcretimden sonraki bir saat i\u00e7inde ay\u0131r\u0131n:<\/p>

5.12.4.1 Dolgusu yetersiz olan kaplar elle doldurulabilir ve yeniden denetlendikten sonra \u00fcretim hatt\u0131na geri g\u00f6nderilebilir.<\/p>

5.12.4.2 A\u015f\u0131r\u0131 doldurulmu\u015f kaplar, bir sonraki alt partiye kar\u0131\u015ft\u0131r\u0131lmak \u00fczere geri kazan\u0131m tank\u0131na bo\u015falt\u0131lmal\u0131d\u0131r.<\/p>

5.12.4.3 G\u00f6rsel olarak kusurlu kaplar, kalite g\u00fcvencesi birimi taraf\u0131ndan de\u011ferlendirilmek \u00fczere bir kenara ayr\u0131l\u0131r.<\/p>

5.12.5 Vardiya sonunda Reddetme G\u00fcnl\u00fc\u011f\u00fcne kategoriye g\u00f6re reddetme say\u0131s\u0131n\u0131 kaydedin. Reddetme say\u0131s\u0131nda art\u0131\u015f e\u011filimi g\u00f6r\u00fclmesi durumunda, 24 saat i\u00e7inde durumun ara\u015ft\u0131r\u0131lmas\u0131 gerekir.<\/p>

5.13 Kapatma Ad\u0131mlar\u0131:<\/strong><\/h3>

5.13.1 Doldurma Kontrol ekran\u0131ndaki \u201cDur\u201d d\u00fc\u011fmesine bas\u0131n. Bir sonraki ad\u0131ma ge\u00e7meden \u00f6nce konvey\u00f6r \u00fczerindeki t\u00fcm kaplar\u0131n hatt\u0131 tamamen terk etmesini bekleyin.<\/p>

5.13.2 Tankta kalan \u00fcr\u00fcn\u00fc, etiketlenmi\u015f bir geri kazan\u0131m variline bo\u015falt\u0131n. Varili kapat\u0131n ve karantina alan\u0131na g\u00f6nderin.<\/p>

5.13.3 Ceket \u0131s\u0131t\u0131c\u0131s\u0131n\u0131 kapat\u0131n ve tank\u0131n oda s\u0131cakl\u0131\u011f\u0131na so\u011fumas\u0131n\u0131 bekleyin.<\/p>

5.13.4 Art\u0131k \u00fcr\u00fcn\u00fc temizlemek i\u00e7in t\u00fcm \u00fcr\u00fcn hatlar\u0131n\u0131 iki dakika boyunca ar\u0131t\u0131lm\u0131\u015f suyla y\u0131kay\u0131n.<\/p>

5.13.5 Makineyi HMI \u00fczerinden G\u00fcvenli Bekleme moduna ge\u00e7irin. Bu modda sistemdeki bas\u0131n\u00e7 bo\u015falt\u0131l\u0131r ve t\u00fcm pistonlar ba\u015flang\u0131\u00e7 konumuna getirilir.<\/p>

5.13.6 Makine gece boyunca \u00e7al\u0131\u015fmayacaksa, ana \u015falterden ana g\u00fcc\u00fc kapat\u0131n ve kilitleyin.<\/p>

5.13.7 \u015eunu tak\u0131n: \u201cTEM\u0130ZLENECEK\u201d<\/strong> makinedeki etiket.<\/p>

5.13.8 S\u0131v\u0131 Dolum Makinesini, belirlenen temizlik SOP\u2019sine uygun olarak temizleyin.<\/p>

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

5.14.1 Ekipman Kullan\u0131m Kayd\u0131.<\/p>

5.14.2 Seri \u00dcretim Kayd\u0131.<\/p>

5.14.3 G\u00fcvenlik Denetim Kayd\u0131.<\/p>

5.14.4 Reddedilenler G\u00fcnl\u00fc\u011f\u00fc.<\/p>

5.14.5 CIP D\u00f6ng\u00fcs\u00fc Kayd\u0131.<\/p>

5.14.6 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 CIP:<\/strong> Yerinde Temizleme.<\/p>

6.6 SIP:<\/strong> Yerinde Buharla Sterilizasyon.<\/p>

6.7 HMI:<\/strong> \u0130nsan Makine Aray\u00fcz\u00fc.<\/p>

6.8 PLC:<\/strong> Programlanabilir Mant\u0131k Denetleyicisi.<\/p>

6,9 cPs:<\/strong> Sentipoise.<\/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 Liquid Filling Machine. 1.0 OBJECTIVE: To describe the Operating Procedure of Liquid Filling Machine used for […]<\/p>\n","protected":false},"author":1,"featured_media":16926,"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":[56],"tags":[],"class_list":["post-16907","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-packaging-equipment"],"acf":[],"_links":{"self":[{"href":"https:\/\/pharmamachinecn.com\/tr\/wp-json\/wp\/v2\/posts\/16907","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=16907"}],"version-history":[{"count":0,"href":"https:\/\/pharmamachinecn.com\/tr\/wp-json\/wp\/v2\/posts\/16907\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/pharmamachinecn.com\/tr\/wp-json\/wp\/v2\/media\/16926"}],"wp:attachment":[{"href":"https:\/\/pharmamachinecn.com\/tr\/wp-json\/wp\/v2\/media?parent=16907"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/pharmamachinecn.com\/tr\/wp-json\/wp\/v2\/categories?post=16907"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/pharmamachinecn.com\/tr\/wp-json\/wp\/v2\/tags?post=16907"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}