{"id":10803,"date":"2026-02-20T02:04:26","date_gmt":"2026-02-20T02:04:26","guid":{"rendered":"https:\/\/pharmamachinecn.com\/?p=10803"},"modified":"2025-12-25T02:20:21","modified_gmt":"2025-12-25T02:20:21","slug":"sop-for-tube-filling-machine","status":"publish","type":"post","link":"https:\/\/pharmamachinecn.com\/tr\/sop-for-tube-filling-machine\/","title":{"rendered":"T\u00fcp Dolum Makinesi i\u00e7in Standart \u0130\u015flem Prosed\u00fcr\u00fc (SOP)"},"content":{"rendered":"<div data-elementor-type=\"wp-post\" data-elementor-id=\"10803\" class=\"elementor elementor-10803\" data-elementor-post-type=\"post\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-656075b4 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"656075b4\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-78348194\" data-id=\"78348194\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-2b902b66 product-data-tab elementor-widget elementor-widget-text-editor\" data-id=\"2b902b66\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><strong><em><i>T\u00fcp Dolum Makinesinin Standart \u00c7al\u0131\u015ft\u0131rma Prosed\u00fcr\u00fc<\/i><\/em><\/strong><\/p><figure id=\"attachment_10805\" aria-describedby=\"caption-attachment-10805\" style=\"width: 1000px\" class=\"wp-caption aligncenter\"><img fetchpriority=\"high\" decoding=\"async\" class=\"size-full wp-image-10805\" src=\"https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2025\/02\/Standard-Operating-Procedure-for-Tube-Filling-Machine.jpg\" alt=\"T\u00fcp Dolum Makinesi i\u00e7in Standart \u00c7al\u0131\u015ft\u0131rma Prosed\u00fcr\u00fc\" width=\"1000\" height=\"993\" srcset=\"https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2025\/02\/Standard-Operating-Procedure-for-Tube-Filling-Machine.jpg 1000w, https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2025\/02\/Standard-Operating-Procedure-for-Tube-Filling-Machine-300x298.jpg 300w, https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2025\/02\/Standard-Operating-Procedure-for-Tube-Filling-Machine-150x150.jpg 150w, https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2025\/02\/Standard-Operating-Procedure-for-Tube-Filling-Machine-768x763.jpg 768w, https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2025\/02\/Standard-Operating-Procedure-for-Tube-Filling-Machine-12x12.jpg 12w, https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2025\/02\/Standard-Operating-Procedure-for-Tube-Filling-Machine-600x596.jpg 600w, https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2025\/02\/Standard-Operating-Procedure-for-Tube-Filling-Machine-100x100.jpg 100w\" sizes=\"(max-width: 1000px) 100vw, 1000px\" \/><figcaption id=\"caption-attachment-10805\" class=\"wp-caption-text\"><em><strong>T\u00fcp Dolum Makinesi i\u00e7in Standart \u00c7al\u0131\u015ft\u0131rma Prosed\u00fcr\u00fc.<\/strong><\/em><\/figcaption><\/figure><h2><strong><b>1.0 AMA\u00c7:<\/b><\/strong><\/h2><p>Bu Standart \u00c7al\u0131\u015fma Prosed\u00fcr\u00fc (SOP), T\u00fcp Dolum Makinesini do\u011fru \u015fekilde nas\u0131l \u00e7al\u0131\u015ft\u0131raca\u011f\u0131n\u0131z\u0131 anlatmaktad\u0131r. Tutarl\u0131 dolumlar, kontaminasyon olmamas\u0131 ve \u00fcretim hatt\u0131ndan \u00e7\u0131kt\u0131\u011f\u0131nda iyi g\u00f6r\u00fcnen t\u00fcpler istiyoruz. Makine kremler, jeller, di\u015f macunu, yap\u0131\u015ft\u0131r\u0131c\u0131lar \u2013 katlanabilir t\u00fcpe konulmas\u0131 gereken hemen hemen her \u015feyi i\u015fleyebilir. Burada cGMP&#039;ye (\u0130yi \u00dcretim Uygulamalar\u0131) uyuyoruz, bu nedenle yaz\u0131lanlara ba\u011fl\u0131 kal\u0131n.<\/p><h2><strong><b>2.0 KAPSAM:<\/b><\/strong><\/h2><p>Bu prosed\u00fcr, \u00fcretim alan\u0131m\u0131zda bulunan T\u00fcp Dolum Makinesini kapsamaktad\u0131r. Bu makine, yar\u0131 kat\u0131 ve viskoz \u00fcr\u00fcnleri \u00e7e\u015fitli boyutlardaki metal t\u00fcplere, plastik t\u00fcplere ve lamine t\u00fcplere doldurmak i\u00e7in kullan\u0131l\u0131r. Kurulumdan kapatmaya kadar her \u015feyi ele al\u0131yoruz \u2013 montaj, \u00e7al\u0131\u015ft\u0131rma, \u00e7al\u0131\u015fma s\u0131ras\u0131nda kalite kontrolleri ve bir parti bitti\u011finde yap\u0131lmas\u0131 gerekenler.<\/p><h2><strong><b>3.0 SORUMLULUK:<\/b><\/strong><\/h2><p>Operat\u00f6rler ve \u00fcretim kimyagerleri bu ekipman\u0131 her g\u00fcn \u00e7al\u0131\u015ft\u0131ran ki\u015filerdir. Bu ad\u0131mlar\u0131 izlerler ve olanlar\u0131 kay\u0131tlara ge\u00e7irirler. Bir \u015feylerin ters gitti\u011fini g\u00f6r\u00fcrlerse, bunu i\u015faretlerler.<\/p><h2><strong><b>4.0 SORUMLULUK:<\/b><\/strong><\/h2><p>\u00dcretim M\u00fcd\u00fcr\u00fc burada nihai sorumlulu\u011fu \u00fcstlenir. E\u011fitim, uyumluluk, do\u011fru ki\u015filerin do\u011fru i\u015fleri yapmas\u0131n\u0131 sa\u011flamak \u2013 bunlar\u0131n hepsi onlar\u0131n sorumlulu\u011fundad\u0131r.<\/p><h2><strong><b>5.0 \u0130\u015eLEM:<\/b><\/strong><\/h2><p>5.1 \u00c7al\u0131\u015fma alan\u0131na girin ve etraf\u0131 iyice inceleyin. Temiz mi? Makinenin \u00fczerinde &quot;TEM\u0130ZLEND\u0130&quot; etiketi olup olmad\u0131\u011f\u0131n\u0131 kontrol edin. E\u011fer son partiden kalan kal\u0131nt\u0131lar veya rastgele d\u00f6k\u00fcnt\u00fcler varsa, bu bir sorundur. Devam etmeden \u00f6nce bunlar\u0131 temizleyin.<\/p><p>5.2 Ekipman Kullan\u0131m G\u00fcnl\u00fc\u011f\u00fcn\u00fc a\u00e7\u0131n ve bilgilerinizi doldurun. Bug\u00fcn\u00fcn tarihi, saati, \u00fcr\u00fcn ad\u0131, parti numaras\u0131 ve kim oldu\u011funuz.<\/p><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. \u00dczerine mevcut parti bilgilerini yaz\u0131n.<\/p><p>5.4 IPQA&#039;y\u0131 bulun ve Hat Temizleme Sertifikan\u0131z\u0131 al\u0131n. Bu sertifika elinizde olmadan hi\u00e7bir \u015fey ba\u015flamaz.<\/p><h3><strong>5.5 \u00d6nlemler:<\/strong><\/h3><p>5.5.1 Otomatik moda ge\u00e7meden \u00f6nce t\u00fcm koruyucu kapaklar\u0131n kapal\u0131 olmas\u0131 gerekir. \u00d6n kap\u0131lar, arka paneller, hazne kapaklar\u0131 \u2013 hepsi. Makine bir sorun olup olmad\u0131\u011f\u0131n\u0131 bilemez, bu nedenle sizin do\u011frulaman\u0131z gerekir.<\/p><p>5.5.2 G\u00fcvenlik anahtarlar\u0131 ve kilitleme mekanizmalar\u0131 bir ama\u00e7 i\u00e7in mevcuttur. Bunlar\u0131 asla devre d\u0131\u015f\u0131 b\u0131rakmay\u0131n.<\/p><p>5.5.3 Makinede bir de\u011fi\u015fiklik yapmak m\u0131 istiyorsunuz? \u00d6ncelikle M\u00fchendislik ekibinden onay al\u0131n. Yetkisiz ayarlamalar, eklemeler veya ge\u00e7ici \u00e7\u00f6z\u00fcmler yasakt\u0131r.<\/p><p>5.5.4 Hareketli par\u00e7alar parmaklar\u0131n\u0131z\u0131 koparabilir. Makine \u00e7al\u0131\u015f\u0131yorsa hi\u00e7bir \u015feye dokunmuyorsunuz demektir. Temizlik yok, ayar yok, ya\u011flama yok. \u00d6nce g\u00fcc\u00fc kesin.<\/p><p>5.5.5 Bir \u015fey mi tak\u0131yorsunuz? Bir \u015feyi mi s\u00f6k\u00fcyorsunuz? Bak\u0131m m\u0131 yap\u0131yorsunuz? Ana \u015falter KAPALI konumuna getirilir. Nokta.<\/p><p>5.5.6 Acil durdurma butonlar\u0131, kap\u0131 sens\u00f6rleri, a\u015f\u0131r\u0131 y\u00fck devre kesicileri \u2013 hepsini aktif b\u0131rak\u0131n. G\u00fcvenlik ekipmanlar\u0131n\u0131 devre d\u0131\u015f\u0131 b\u0131rakmay\u0131n.<\/p><p>5.5.7 Kontrol panelinde toz mu var? Kuru bir bez kullan\u0131n. Yumu\u015fak bir bez. Su ve elektrikli bile\u015fenler bir araya gelmemeli, \u00e7\u00f6z\u00fcc\u00fcler de gelmemeli.<\/p><p>5.5.8 Dolum s\u0131ras\u0131nda hazne kapa\u011f\u0131n\u0131n kapal\u0131 kalmas\u0131 gerekiyor. Yukar\u0131dan bula\u015fma riski ger\u00e7ek bir sorun. Ayr\u0131ca contalar\u0131n\u0131z\u0131n \u00e7atlam\u0131\u015f veya a\u015f\u0131nm\u0131\u015f olup olmad\u0131\u011f\u0131n\u0131 da kontrol edin.<\/p><p>5.5.9 Her hafta bu g\u00fcvenlik kontrol listesini g\u00f6zden ge\u00e7irin ve kaydedin:<\/p><p>5.5.9.1 Ana \u015falterden elektri\u011fi kesebilir misiniz? Deneyin.<\/p><p>5.5.9.2 Acil durdurma d\u00fc\u011fmesine bas\u0131n. Her \u015fey hemen duruyor mu?<\/p><p>5.5.9.3 \u00c7al\u0131\u015fma d\u00f6ng\u00fcs\u00fc s\u0131ras\u0131nda koruma kapa\u011f\u0131n\u0131 hafif\u00e7e aralay\u0131n. Makine donup kalacakt\u0131r.<\/p><p>5.5.9.4 Haznedeki d\u00fc\u015f\u00fck seviye sens\u00f6r\u00fc g\u00f6revini yerine getiriyor mu? Pompay\u0131 bo\u015f \u00e7al\u0131\u015ft\u0131rmak sens\u00f6r\u00fcn h\u0131zla yanmas\u0131na neden olur.<\/p><h3><strong>5.6 Montaj:<\/strong><\/h3><p>5.6.1 Hazne ve \u00dcr\u00fcn Besleme Sistemi:<\/p><p>5.6.1.1 Hazneyi monte etmeden \u00f6nce kontrol edin. Temiz mi? Kuru mu? \u00d6nceki kullan\u0131mdan kalan kir yok mu? \u0130yi.<\/p><p>5.6.1.2 \u00c7er\u00e7eve \u00fczerindeki yerine kald\u0131r\u0131n. \u00c7al\u0131\u015fma s\u0131ras\u0131nda kaymamas\u0131 i\u00e7in s\u0131k\u0131ca sabitleyin.<\/p><p>5.6.1.3 Baz\u0131 \u00fcr\u00fcnlerin do\u011fru \u015fekilde akmas\u0131 i\u00e7in \u0131s\u0131ya ihtiya\u00e7 vard\u0131r. E\u011fer \u00fcr\u00fcn\u00fcn\u00fcz de bunlardan biriyse, ceketli hazneyi s\u0131cakl\u0131k kontrol \u00fcnitesine ba\u011flay\u0131n ve hedef s\u0131cakl\u0131\u011f\u0131n\u0131z\u0131 ayarlay\u0131n.<\/p><p>5.6.1.4 Her contay\u0131 ve O-ringi dikkatlice kontrol edin. Tek bir k\u00f6t\u00fc conta bile \u00fcr\u00fcn\u00fcn olmamas\u0131 gereken yerlerden s\u0131zmas\u0131na neden olabilir.<\/p><p>5.6.1.5 Besleme hatt\u0131n\u0131 hazneden dozaj pompas\u0131na ba\u011flay\u0131n. Hat i\u00e7inde s\u0131k\u0131\u015fm\u0131\u015f havay\u0131 bo\u015falt\u0131n.<\/p><p>5.6.2 Dozajlama ve Dolum Tertibat\u0131:<\/p><p>5.6.2.1 Dozaj silindirinizi ihtiyac\u0131n\u0131z olan dolum hacmiyle e\u015fle\u015ftirin. Yanl\u0131\u015f boyut, t\u00fcm g\u00fcn makineyle m\u00fccadele etmek anlam\u0131na gelir.<\/p><p>5.6.2.2 Boru \u00e7ap\u0131n\u0131za uygun dolum ba\u015fl\u0131\u011f\u0131n\u0131 tak\u0131n. \u00c7ok b\u00fcy\u00fck olan girmeyecektir, \u00e7ok k\u00fc\u00e7\u00fck olan ise etrafa bula\u015facakt\u0131r.<\/p><p>5.6.2.3 Memenin derinli\u011fini t\u00fcp\u00fcn dibine yak\u0131n bir yere ula\u015facak \u015fekilde ayarlay\u0131n. Havan\u0131n d\u0131\u015far\u0131 at\u0131lmas\u0131 i\u00e7in alttan yukar\u0131ya do\u011fru doldurma y\u00f6ntemini kullanmal\u0131s\u0131n\u0131z, i\u00e7eride hava hapsolmas\u0131n\u0131 de\u011fil.<\/p><p>5.6.2.4 T\u00fcm ba\u011flant\u0131 elemanlar\u0131n\u0131 s\u0131k\u0131n, ancak a\u015f\u0131r\u0131 s\u0131kmay\u0131n. Meme ucunu yanl\u0131\u015f takmak pahal\u0131 bir hatad\u0131r.<\/p><p>5.6.2.5 Meme ucunun hizalamas\u0131n\u0131 g\u00f6rsel olarak kontrol edin. Borunun tam ortas\u0131nda olmal\u0131d\u0131r.<\/p><h3><strong>5.6.3 Boru Ta\u015f\u0131ma Sistemi:<\/strong><\/h3><p>5.6.3.1 Boru \u00e7ap\u0131n\u0131za uygun boru kapaklar\u0131n\u0131 tak\u0131n. Bunlar genellikle boyutlar\u0131na g\u00f6re etiketlenmi\u015ftir.<\/p><p>5.6.3.2 Her bir kab\u0131, d\u00f6ner tabla veya konvey\u00f6r ceplerine s\u0131k\u0131ca yerle\u015ftirin. Gev\u015fek kaplar, t\u00fcplerin s\u0131k\u0131\u015fmas\u0131na neden olur.<\/p><p>5.6.3.3 Y\u00f6nlendirme istasyonu, t\u00fcpleri a\u00e7\u0131k u\u00e7lar\u0131 yukar\u0131 bakacak \u015fekilde \u00e7evirir. \u00c7al\u0131\u015ft\u0131\u011f\u0131ndan emin olmak i\u00e7in birka\u00e7\u0131n\u0131 elle ge\u00e7irin.<\/p><p>5.6.3.4 Tareti elle bir tam tur d\u00f6nd\u00fcr\u00fcn. Herhangi bir s\u0131k\u0131\u015fma veya p\u00fcr\u00fczl\u00fc nokta olup olmad\u0131\u011f\u0131n\u0131 kontrol edin.<\/p><p>5.6.3.5 T\u00fcp haznesini doldurun ve birka\u00e7\u0131n\u0131n ge\u00e7i\u015fini izleyin. Tak\u0131lmadan, d\u00fczg\u00fcn bir \u015fekilde kaplara d\u00fc\u015fmeleri gerekir.<\/p><h3><strong>5.6.4 S\u0131zd\u0131rmazl\u0131k \u0130stasyonu Kurulumu:<\/strong><\/h3><p>5.6.4.1 Metal borular s\u0131k\u0131\u015ft\u0131r\u0131l\u0131r. Plastik ve laminatlar \u0131s\u0131 ile yap\u0131\u015ft\u0131r\u0131l\u0131r. Kulland\u0131\u011f\u0131n\u0131z i\u015fleme uygun aletleri tak\u0131n.<\/p><p>5.6.4.2 S\u0131k\u0131\u015ft\u0131rma i\u015flemi i\u00e7in, \u00e7ene bas\u0131nc\u0131n\u0131 boru teknik \u00f6zellik sayfas\u0131ndaki talimatlara g\u00f6re ayarlay\u0131n. \u00c7ok hafif olursa s\u0131z\u0131nt\u0131 olur; \u00e7ok a\u011f\u0131r olursa boru \u00e7atlar.<\/p><p>5.6.4.3 Is\u0131 yal\u0131t\u0131m\u0131 i\u00e7in s\u0131cakl\u0131\u011f\u0131 ayarlay\u0131n. Laminat t\u00fcpler genellikle 380\u00b0C ila 420\u00b0C aras\u0131nda bir s\u0131cakl\u0131\u011fa ihtiya\u00e7 duyar. \u00dcreticinin verilerini kontrol edin.<\/p><p>5.6.4.4 Bekleme s\u00fcresini ayarlay\u0131n \u2013 s\u0131zd\u0131rmazl\u0131k malzemesinin ne kadar s\u00fcreyle bekleyece\u011fini belirleyin. Daha kal\u0131n t\u00fcpler daha uzun s\u00fcre gerektirir.<\/p><p>5.6.4.5 Toplu kodlay\u0131c\u0131y\u0131, k\u0131vr\u0131m veya contan\u0131n do\u011fru noktas\u0131na gelecek \u015fekilde monte edin. Bir hurda t\u00fcp \u00fczerinde test edin.<\/p><p>5.6.4.6 Do\u011fru kodlama kal\u0131b\u0131n\u0131 veya m\u00fcrekkep \u015feridini parti numaran\u0131z, \u00fcretim tarihiniz ve son kullanma tarihinizle y\u00fckleyin.<\/p><h3><strong>5.7 \u00c7al\u0131\u015fma \u015eekli:<\/strong><\/h3><p>5.7.1 Ana \u015falteri a\u00e7\u0131n. Kontrol panelinin ba\u015flatma i\u015flemlerini tamamlamas\u0131n\u0131 bekleyin.<\/p><p>5.7.2 Makineyi manuel olarak bir tam d\u00f6ng\u00fc boyunca \u00e7al\u0131\u015ft\u0131r\u0131n. Her istasyonu izleyin. Herhangi bir sorun var m\u0131? 500 t\u00fcp \u00e7al\u0131\u015ft\u0131rd\u0131ktan sonra de\u011fil, \u015fimdi d\u00fczeltin.<\/p><p>5.7.3 \u00dcr\u00fcn\u00fc hazneye yava\u015f\u00e7a d\u00f6k\u00fcn. H\u0131zl\u0131ca d\u00f6kmek kar\u0131\u015f\u0131ma hava katar ve hava kabarc\u0131klar\u0131 d\u00fczensiz dolum anlam\u0131na gelir.<\/p><p>5.7.4 Dolum a\u011f\u0131rl\u0131\u011f\u0131n\u0131z\u0131 kontrol panelinden girin. Parti kayd\u0131 size hedef de\u011feri g\u00f6sterir. Kabul edilebilir tolerans \u015fudur:<strong> genellikle \u00b12%<\/strong>.<\/p><p>5.7.5 Bu parametreleri HMI ekran\u0131nda ayarlay\u0131n:<\/p><p>5.7.5.1 Dolum Hacmi: Hedef a\u011f\u0131rl\u0131\u011fa ula\u015fana kadar piston hareketini ayarlay\u0131n. Birka\u00e7 deney t\u00fcp\u00fcyle deney yap\u0131n ve a\u011f\u0131rl\u0131klar\u0131n\u0131 \u00f6l\u00e7\u00fcn.<\/p><p>5.7.5.2 Makine H\u0131z\u0131: Kal\u0131n \u00fcr\u00fcnler daha yava\u015f, ince \u00fcr\u00fcnler ise daha h\u0131zl\u0131 i\u015flenir. Tipik h\u0131z aral\u0131\u011f\u0131 dakikada 25 ila 60 t\u00fcpt\u00fcr.<\/p><p>5.7.5.3 S\u0131zd\u0131rmazl\u0131k S\u0131cakl\u0131\u011f\u0131: Sadece laminatlar i\u00e7in. \u00d6nerilen ayardan ba\u015flay\u0131n ve s\u0131zd\u0131rmazl\u0131k sa\u011flam\u0131yorsa ince ayar yap\u0131n.<\/p><p>5.7.5.4 S\u0131zd\u0131rmazl\u0131k S\u00fcresi: \u00c7enelerin ne kadar s\u00fcreyle kenetlendi\u011fini g\u00f6sterir. Boru malzemesinin kal\u0131nl\u0131\u011f\u0131na g\u00f6re ayarlay\u0131n.<\/p><p>5.7.5.5 S\u0131k\u0131\u015ft\u0131rma Bas\u0131nc\u0131: Metal borular i\u00e7in. \u00c7atlak olmayan d\u00fczg\u00fcn k\u0131vr\u0131mlar elde edene kadar bas\u0131nc\u0131 art\u0131r\u0131n veya azalt\u0131n.<\/p><p>5.7.5.6 Saya\u00e7: S\u0131f\u0131rla. Hedef parti miktar\u0131n\u0131z\u0131 girin.<\/p><p>5.7.6 T\u00fcp haznesinin dolu oldu\u011fundan emin olun. T\u00fcplerin birbirine yap\u0131\u015fmad\u0131\u011f\u0131n\u0131 veya deforme olmad\u0131\u011f\u0131n\u0131 kontrol edin.<\/p><p>5.7.7 BA\u015eLAT d\u00fc\u011fmesine bas\u0131n. Makine buradan itibaren kontrol\u00fc devral\u0131r:<\/p><p>5.7.7.1 \u015earj\u00f6rden bir t\u00fcp al\u0131r.<\/p><p>5.7.7.2 Barda\u011fa b\u0131rak\u0131r ve a\u00e7\u0131k ucu yukar\u0131 gelecek \u015fekilde yerle\u015ftirir.<\/p><p>5.7.7.3 Dolum istasyonuna i\u015faret eder ve nozulu a\u015fa\u011f\u0131 indirir.<\/p><p>5.7.7.4 P\u00fcsk\u00fcrtme ucu yukar\u0131 do\u011fru geri \u00e7ekilirken \u00fcr\u00fcn p\u00fcsk\u00fcrt\u00fcr.<\/p><p>5.7.7.5 S\u0131k\u0131\u015ft\u0131rma veya \u0131s\u0131 yal\u0131t\u0131m\u0131 i\u00e7in s\u0131zd\u0131rmazl\u0131k istasyonuna ge\u00e7er.<\/p><p>5.7.7.6 Kapal\u0131 uca parti kodunu yazd\u0131r\u0131r.<\/p><p>5.7.7.7 Bitmi\u015f t\u00fcp\u00fc \u00e7\u0131k\u0131\u015f konvey\u00f6r\u00fcne f\u0131rlat\u0131r.<\/p><p>5.7.8 Hemen numune al\u0131n ve dolum a\u011f\u0131rl\u0131klar\u0131n\u0131 kontrol edin. Contalar\u0131 inceleyin. Kodlar\u0131 okuyun. Herhangi bir sorun varsa, \u00fcr\u00fcn\u00fc israf etmeden \u00f6nce durun ve ayarlama yap\u0131n.<\/p><p>5.7.9 \u00c7al\u0131\u015fma boyunca makineyi g\u00f6zlemleyin. Kritik okumalar\u0131, belirtilen aral\u0131klarla parti kay\u0131t formunuza kaydedin.<\/p><h3><strong>5.8 S\u00fcre\u00e7 \u0130\u00e7i Kalite Kontrolleri:<\/strong><\/h3><p>5.8.1 \u00dcretim ba\u015flang\u0131c\u0131nda, ortas\u0131nda ve sonunda a\u011f\u0131rl\u0131k kontrol\u00fc i\u00e7in t\u00fcpleri \u00e7ekin. Ayr\u0131ca, \u00fcretim kayd\u0131n\u0131n gerektirdi\u011fi s\u0131kl\u0131kta da \u00f6l\u00e7\u00fcm yap\u0131n.<\/p><p>5.8.2 Doldurulmu\u015f t\u00fcpleri iyice s\u0131k\u0131n. S\u0131zd\u0131rmazl\u0131k alan\u0131na dikkat edin. Herhangi bir \u00fcr\u00fcn s\u0131z\u0131nt\u0131s\u0131, t\u00fcp\u00fcn reddedilmesi ve makine ayar\u0131 yap\u0131lmas\u0131 anlam\u0131na gelir.<\/p><p>5.8.3 Numunelerinizdeki her parti kodunu okuyun. Kodlar okunakl\u0131, eksiksiz ve do\u011fru yerde olmal\u0131d\u0131r.<\/p><p>5.8.4 Kozmetik sorunlara dikkat edin \u2013 t\u00fcp g\u00f6vdesinde ezikler, \u00e7izilmi\u015f bask\u0131, yamuk k\u0131vr\u0131mlar, deforme olmu\u015f omuzlar.<\/p><p>5.8.5 Her \u015feyi kaydedin. Zaman, sonu\u00e7lar, ba\u015f harfleriniz. Belgeleme yoksa, ger\u00e7ekle\u015fmemi\u015ftir.<\/p><p>5.9 \u00dcretim miktar\u0131 hedeflendi\u011finde makineyi durdurun. Haznedeki kalan \u00fcr\u00fcn\u00fc kep\u00e7e yard\u0131m\u0131yla al\u0131n ve verim mutabakat prosed\u00fcr\u00fcn\u00fcze g\u00f6re i\u015flem yap\u0131n.<\/p><p>5.10 Yap\u0131\u015ft\u0131r\u0131n <strong>\u201cTEM\u0130ZLENECEK\u201d<\/strong> Makinenin \u00fczerine etiket yap\u0131\u015ft\u0131r\u0131n. Temizlik ekibinin neyle kar\u015f\u0131 kar\u015f\u0131ya oldu\u011funu bilmesi i\u00e7in \u00fcr\u00fcn ad\u0131n\u0131 ve parti numaras\u0131n\u0131 ekleyin.<\/p><p>5.11 T\u00fcp Dolum Makinesi Temizleme Prosed\u00fcr\u00fc&#039;ne g\u00f6re ekipman\u0131 temizleyin. Farkl\u0131 \u00fcr\u00fcnler farkl\u0131 temizlik maddeleri gerektirebilir.<\/p><h3><strong>5.12 KAYIT:<\/strong><\/h3><p>Ekipman Kullan\u0131m Kayd\u0131, Parti \u00dcretim Kayd\u0131, Proses \u0130\u00e7i Kontrol Kayd\u0131, Temizlik Kayd\u0131.<\/p><h2><strong><b>6.0 KISALTMALAR:<\/b><\/strong><\/h2><p><strong>6.1 Standart \u0130\u015flem Prosed\u00fcr\u00fc (SOP):<\/strong> Standart \u0130\u015fletme Prosed\u00fcr\u00fc.<\/p><p><strong>6.2 IPQA:<\/strong> S\u00fcre\u00e7 \u0130\u00e7i Kalite G\u00fcvencesi.<\/p><p><strong>6.3 BMR:<\/strong> Parti \u00dcretim Kayd\u0131.<\/p><p><strong>6.4 cGMP:<\/strong> G\u00fcncel \u0130yi \u00dcretim Uygulamalar\u0131.<\/p><p><strong>6.5 HMI:<\/strong> \u0130nsan Makine Aray\u00fcz\u00fc.<\/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":"<p>Standard Operating Procedure of Tube Filling Machine 1.0 OBJECTIVE: This SOP tells you how to run the Tube Filling Machine [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":10805,"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 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