{"id":18349,"date":"2026-09-18T00:42:15","date_gmt":"2026-09-18T00:42:15","guid":{"rendered":"https:\/\/pharmamachinecn.com\/?p=18349"},"modified":"2026-06-08T08:29:03","modified_gmt":"2026-06-08T08:29:03","slug":"sop-for-bottle-washing-machine","status":"publish","type":"post","link":"https:\/\/pharmamachinecn.com\/tr\/sop-for-bottle-washing-machine\/","title":{"rendered":"\u015ei\u015fe Y\u0131kama Makinesi Standart \u0130\u015flem Prosed\u00fcr\u00fc (SOP)"},"content":{"rendered":"
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\u015ei\u015fe Y\u0131kama Makinesinin Standart \u00c7al\u0131\u015fma Prosed\u00fcr\u00fc.<\/p>

\"\u015ei\u015fe
\u015ei\u015fe Y\u0131kama Makinesi Standart \u0130\u015flem Prosed\u00fcr\u00fc.<\/strong><\/em><\/figcaption><\/figure>

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

Dolum a\u015famas\u0131ndan \u00f6nce cam ve plastik \u015fi\u015felerin temizlenmesinde kullan\u0131lan \u015ei\u015fe Y\u0131kama Makinesinin \u00c7al\u0131\u015fma Prosed\u00fcr\u00fcn\u00fc belirlemek.<\/p>

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

Bu Prosed\u00fcr, birincil ambalaj haz\u0131rl\u0131\u011f\u0131 amac\u0131yla \u00fcretim b\u00f6l\u00fcm\u00fcnde kullan\u0131lan \u015ei\u015fe Y\u0131kama Makinesinin \u00c7al\u0131\u015fma Prosed\u00fcr\u00fcn\u00fc kapsamaktad\u0131r.<\/p>

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

Makine Operat\u00f6r\u00fc ve \u00dcretim Sorumlusu<\/p>

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

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

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

5.1 Y\u0131kama alan\u0131n\u0131 ve makine g\u00f6vdesini inceleyin. Herhangi bir \u00e7al\u0131\u015fmaya ba\u015flamadan \u00f6nce, \u201cTEM\u0130ZLENM\u0130\u015e\u201d durum etiketinin \u00fcniteye sabitlendi\u011finden emin olun.<\/p>

5.2 Ekipman Kullan\u0131m Kayd\u0131\u2019na bir giri\u015f yap\u0131n. Operat\u00f6r\u00fcn ad\u0131n\u0131, vardiyas\u0131n\u0131, tarihi ve \u00e7al\u0131\u015ft\u0131rma saatini yaz\u0131n.<\/p>

5.3 \u201cTEM\u0130ZLEND\u0130\u201d etiketini \u00e7\u0131kar\u0131n ve yerine \u201c\u0130\u015eLEMDE\u201d etiketini tak\u0131n.<\/p>

5.4 IPQA\u2019dan Hat A\u00e7ma Formunu al\u0131n. Bu form imzalan\u0131p tarih at\u0131lana kadar \u00e7al\u0131\u015fmaya ba\u015flanamaz.<\/p>

5.5 G\u00fcvenlik \u00d6nlemleri:<\/strong><\/h3>

5.5.1 Makine, s\u0131cak su ve y\u00fcksek bas\u0131n\u00e7l\u0131 bas\u0131n\u00e7l\u0131 hava kullan\u0131r. Ellerinizi ve y\u00fcz\u00fcn\u00fcz\u00fc her zaman p\u00fcsk\u00fcrtme alan\u0131ndan uzak tutun.<\/p>

5.5.2 Y\u0131kama makinesini asla yan paneller a\u00e7\u0131kken veya emniyet kilitleri atlat\u0131lm\u0131\u015f halde \u00e7al\u0131\u015ft\u0131rmay\u0131n. P\u00fcsk\u00fcrtme memelerine maruz kal\u0131nmas\u0131 durumunda yan\u0131klara neden olabilir.<\/p>

5.5.3 Makine \u00e7al\u0131\u015f\u0131rken hi\u00e7bir ko\u015fulda y\u0131kama t\u00fcneline girmeyin. \u00d6nce program\u0131 durdurun ve elektri\u011fi kesin.<\/p>

5.5.4 D\u00f6nen \u015fi\u015fe tutucular\u0131yla temastan ka\u00e7\u0131n\u0131n. Bu kelep\u00e7eler, aktar\u0131m a\u015famas\u0131nda parmaklar\u0131 s\u0131k\u0131\u015ft\u0131rabilir veya s\u0131k\u0131\u015ft\u0131r\u0131p s\u0131k\u0131\u015ft\u0131rabilir.<\/p>

5.5.5 Herhangi bir temizlik veya onar\u0131m i\u015fine ba\u015flamadan \u00f6nce su ve hava beslemelerini kapat\u0131n. Art\u0131k bas\u0131nc\u0131 gidermek i\u00e7in hava hatt\u0131ndaki havay\u0131 bo\u015falt\u0131n.<\/p>

5.5.6 Bas\u0131n\u00e7 tahliye vanalar\u0131na m\u00fcdahale etmeyin. Bu vanalar\u0131n ayar\u0131n\u0131 yaln\u0131zca e\u011fitimli m\u00fchendisler yapmal\u0131d\u0131r.<\/p>

5.5.7 D\u0131\u015f \u00e7er\u00e7eveyi ve dokunmatik ekran\u0131 yumu\u015fak, nemli bir bezle silin. G\u00fc\u00e7l\u00fc \u00e7\u00f6z\u00fcc\u00fcler ekran\u0131n \u00e7atlamas\u0131na neden olabilir.<\/p>

5.5.8 \u00c7al\u0131\u015fma s\u0131ras\u0131nda tam ki\u015fisel koruyucu donan\u0131m (KKD) giyiniz. Buna laboratuvar \u00f6nl\u00fc\u011f\u00fc, su ge\u00e7irmez eldivenler, koruyucu g\u00f6zl\u00fckler ve burnu kapal\u0131 ayakkab\u0131lar dahildir.<\/p>

5.5.9 A\u015fa\u011f\u0131da belirtilen g\u00fcvenlik sistemi denetimini haftal\u0131k olarak ger\u00e7ekle\u015ftirin:<\/p>

5.5.9.1 Ana kesicinin, kapat\u0131ld\u0131\u011f\u0131nda \u00fcniteye giden t\u00fcm g\u00fcc\u00fc kesti\u011fini do\u011frulay\u0131n.<\/p>

5.5.9.2 \u00d6n paneldeki acil durdurma d\u00fc\u011fmesinin makineyi bir d\u00f6ng\u00fc i\u00e7inde durdurdu\u011funu kontrol edin.<\/p>

5.5.9.3 Her bir eri\u015fim panelindeki kap\u0131 kilitleme sistemini test edin. Herhangi bir panelin a\u00e7\u0131lmas\u0131 durumunda t\u00fcm hareketler durmal\u0131d\u0131r.<\/p>

5.5.9.4 Denetim sonu\u00e7lar\u0131n\u0131 G\u00fcvenlik Sistemi G\u00fcnl\u00fc\u011f\u00fcne kaydedin ve imzalay\u0131n.<\/p>

5.6 Makine Montaj\u0131:<\/strong><\/h3>

5.6.1 Besleme Konvey\u00f6r\u00fc ve \u015ei\u015fe Y\u00fckleyici:<\/b><\/strong><\/h4>

5.6.1.1 Besleme konvey\u00f6r\u00fc, kirli \u015fi\u015feleri ambalaj a\u00e7ma istasyonundan y\u0131kama makinesinin giri\u015fine ta\u015f\u0131r. \u00c7al\u0131\u015ft\u0131rma \u00f6ncesinde kay\u0131\u015fta \u00e7atlak, cam par\u00e7alar\u0131 veya gev\u015fek par\u00e7alar bulunmamal\u0131d\u0131r.<\/p>

5.6.1.2 Bo\u015f \u015fi\u015feleri a\u011f\u0131zlar\u0131 yukar\u0131 bakacak \u015fekilde konvey\u00f6re yerle\u015ftirin. Bu, y\u0131kama d\u00f6ng\u00fcs\u00fc ba\u015flamadan \u00f6nce kirlerin \u015fi\u015fenin i\u00e7ine daha derine d\u00fc\u015fmesini engeller.<\/p>

5.6.1.3 Y\u00fckleyici kolu her bir \u015fi\u015feyi al\u0131r ve bir tutma kelep\u00e7esine yerle\u015ftirir. Kelep\u00e7enin kavrama geni\u015fli\u011finin \u015fi\u015fenizin boyun \u00e7ap\u0131na uygun oldu\u011fundan emin olun.<\/p>

5.6.1.4 Her \u015fi\u015fenin devrilmeden veya d\u00fc\u015fmeden bir kelep\u00e7eye girmesini sa\u011flayacak \u015fekilde y\u00fckleyicinin zamanlamas\u0131n\u0131 ayarlay\u0131n. Y\u00fckleyici \u00e7ok yava\u015f olursa kelep\u00e7eler bo\u015f kal\u0131r; \u00e7ok h\u0131zl\u0131 olursa \u015fi\u015feler birbirine \u00e7arpar.<\/p>

5.6.1.5 K\u0131r\u0131k veya \u00e7atlak \u015fi\u015feleri konvey\u00f6rden elle \u00e7\u0131kar\u0131n. Hasarl\u0131 camlar\u0131n y\u0131kama t\u00fcneline ula\u015fmas\u0131na izin vermeyin.<\/p>

5.6.2 Y\u0131kama T\u00fcneli ve P\u00fcsk\u00fcrtme Sistemi:<\/b><\/strong><\/h4>

5.6.2.1 Y\u0131kama t\u00fcneli birka\u00e7 a\u015famadan olu\u015fur. Her a\u015famada, tozu gidermek, kal\u0131nt\u0131lar\u0131 durulamak ve \u015fi\u015fe y\u00fczeyini sterilize etmek i\u00e7in farkl\u0131 bir p\u00fcsk\u00fcrtme i\u015flemi uygulan\u0131r.<\/p>

5.6.2.2 \u00c7al\u0131\u015ft\u0131rmadan \u00f6nce her bir p\u00fcsk\u00fcrtme ba\u015fl\u0131\u011f\u0131nda t\u0131kanma olup olmad\u0131\u011f\u0131n\u0131 kontrol edin. T\u0131kal\u0131 bir ba\u015fl\u0131k, y\u0131kama s\u0131ras\u0131nda \u015fi\u015fenin bir k\u0131sm\u0131n\u0131n y\u0131kanmamas\u0131na neden olur.<\/p>

5.6.2.3 \u015ei\u015fe kelep\u00e7eleri, \u015fi\u015feyi her bir p\u00fcsk\u00fcrtme istasyonundan ge\u00e7irerek d\u00f6nd\u00fcr\u00fcr. \u015ei\u015fenin a\u011fz\u0131 a\u015fa\u011f\u0131ya do\u011fru bakar, b\u00f6ylece su ve kal\u0131nt\u0131lar i\u00e7eride birikmek yerine d\u0131\u015far\u0131ya akar.<\/p>

5.6.2.4 Durulama a\u015famas\u0131nda i\u00e7 lans\u0131n her bir \u015fi\u015fenin boynuna girdi\u011finden emin olun. Bu lans, \u015fi\u015fenin i\u00e7ini yukar\u0131dan a\u015fa\u011f\u0131ya do\u011fru p\u00fcsk\u00fcrt\u00fcr.<\/p>

5.6.2.5 T\u00fcnelin taban\u0131ndaki tahliye hatlar\u0131n\u0131 kontrol edin. T\u0131kanm\u0131\u015f tahliye hatlar\u0131 t\u00fcneli su basmas\u0131na neden olur ve d\u00f6ng\u00fcy\u00fc durdurur.<\/p>

5.6.3 Su Beslemesi ve Pompa Kurulumu:<\/b><\/strong><\/h4>

5.6.3.1 Makine \u00fc\u00e7 farkl\u0131 su kayna\u011f\u0131ndan su \u00e7ekmektedir. Bunlar, ilk durulama i\u00e7in ham su, ana y\u0131kama i\u00e7in ar\u0131t\u0131lm\u0131\u015f su ve son durulama i\u00e7in enjeksiyon suyudur.<\/p>

5.6.3.2 \u00c7al\u0131\u015ft\u0131rmadan \u00f6nce her bir su tank\u0131ndaki seviyeyi kontrol edin. Seviyesi d\u00fc\u015f\u00fck tanklar, pompalara hava girmesine ve contalar\u0131n hasar g\u00f6rmesine neden olur.<\/p>

5.6.3.3 Giri\u015f vanalar\u0131n\u0131 s\u0131rayla a\u00e7\u0131n: \u00f6nce ham su, ard\u0131ndan ar\u0131t\u0131lm\u0131\u015f su, en son da WFI. Her bir hattaki bas\u0131n\u00e7 g\u00f6stergesinin sabitlenmesini bekleyin.<\/p>

5.6.3.4 Her bir hatta p\u00fcsk\u00fcrtme bas\u0131nc\u0131n\u0131 parti kay\u0131tlar\u0131na g\u00f6re ayarlay\u0131n. Standart aral\u0131k, d\u0131\u015f p\u00fcsk\u00fcrtmeler i\u00e7in 1,5 ila 2,5 kg\/cm\u00b2 ve i\u00e7 p\u00fcsk\u00fcrtme u\u00e7lar\u0131 i\u00e7in 2,5 ila 3,5 kg\/cm\u00b2\u2019dir.<\/p>

5.6.3.5 WFI hatt\u0131n\u0131n s\u0131cakl\u0131\u011f\u0131n\u0131n 80 \u00b0C veya \u00fczerinde kald\u0131\u011f\u0131n\u0131 do\u011frulay\u0131n. Daha d\u00fc\u015f\u00fck s\u0131cakl\u0131ktaki su, sterilizasyon \u015fartnamelerine uymayacakt\u0131r.<\/p>

5.6.4 Hava \u00dcfleyici ve Kurutma B\u00f6l\u00fcm\u00fc:<\/b><\/strong><\/h4>

5.6.4.1 Kurutma b\u00f6l\u00fcm\u00fc, \u015fi\u015fedeki kal\u0131nt\u0131 suyu gidermek i\u00e7in filtrelenmi\u015f bas\u0131n\u00e7l\u0131 hava kullan\u0131r. Islak \u015fi\u015feler dolum hatt\u0131na ge\u00e7emez.<\/p>

5.6.4.2 Hava hatt\u0131ndaki HEPA filtresinde toz birikimi olup olmad\u0131\u011f\u0131n\u0131 kontrol edin. Bas\u0131n\u00e7 d\u00fc\u015f\u00fc\u015f\u00fc de\u011feri ayar noktas\u0131n\u0131n \u00fczerindeyse filtreyi de\u011fi\u015ftirin.<\/p>

5.6.4.3 Kurutma p\u00fcsk\u00fcrtme u\u00e7lar\u0131 i\u00e7in hava bas\u0131nc\u0131n\u0131 ayarlay\u0131n (Standart: 2,0 ila 3,0 kg\/cm\u00b2). Daha y\u00fcksek bas\u0131n\u00e7 daha h\u0131zl\u0131 kurutma sa\u011flar, ancak hafif \u015fi\u015felerin devrilmesine neden olabilir.<\/p>

5.6.4.4 Kurutma memesi \u015fi\u015fenin boynuna girer ve a\u015fa\u011f\u0131 do\u011fru hava \u00fcfler. Bu kuvvet, i\u00e7 duvardan ve tabandan damlac\u0131klar\u0131 uzakla\u015ft\u0131r\u0131r.<\/p>

5.6.4.5 Havaland\u0131rma fan\u0131n\u0131n \u00e7al\u0131\u015ft\u0131\u011f\u0131n\u0131 kontrol edin. Nemli hava t\u00fcnelden d\u0131\u015far\u0131 \u00e7\u0131kmal\u0131d\u0131r; aksi takdirde temiz \u015fi\u015felerin \u00fczerinde yo\u011fu\u015fur.<\/p>

5.7 Y\u0131kama Program\u0131 Ayarlar\u0131:<\/strong><\/h3>

5.7.1 Tam bir y\u0131kama d\u00f6ng\u00fcs\u00fc d\u00f6rt a\u015famadan olu\u015fur: \u00f6n durulama, ana y\u0131kama, ar\u0131t\u0131lm\u0131\u015f durulama ve WFI son durulama. Her a\u015faman\u0131n kendine \u00f6zg\u00fc bekleme s\u00fcresi ve bas\u0131nc\u0131 vard\u0131r.<\/p>

5.7.2 Kontrol ekran\u0131nda her bir a\u015faman\u0131n d\u00f6ng\u00fc s\u00fcrelerini girin. Bu de\u011ferler, paketlenmekte olan \u00fcr\u00fcn i\u00e7in onaylanm\u0131\u015f re\u00e7eteyle uyumlu olmal\u0131d\u0131r.<\/p>

5.7.3 \u00d6n durulama i\u015flemi, ortam s\u0131cakl\u0131\u011f\u0131ndaki ham su kullan\u0131larak ger\u00e7ekle\u015ftirilir. Bu i\u015flemin amac\u0131, gev\u015fek toz ve ambalaj liflerini temizlemektir.<\/p>

5.7.4 Ana y\u0131kama a\u015famas\u0131nda 40 ila 50 \u00b0C s\u0131cakl\u0131ktaki ar\u0131t\u0131lm\u0131\u015f su kullan\u0131l\u0131r. Bu a\u015famada, cam \u00fcretim s\u00fcrecinden kalan eser miktardaki kirleticiler ve kal\u0131nt\u0131lar giderilir.<\/p>

5.7.5 Ana y\u0131kama i\u015fleminin ard\u0131ndan ar\u0131t\u0131lm\u0131\u015f suyla durulama yap\u0131l\u0131r. Bu i\u015flem, y\u0131kama a\u015famas\u0131ndan kalan kal\u0131nt\u0131lar\u0131 taze ar\u0131t\u0131lm\u0131\u015f suyla temizler.<\/p>

5.7.6 WFI son durulama i\u015flemi 80 ila 90 \u00b0C'de ger\u00e7ekle\u015ftirilir. Bu a\u015fama, \u015fi\u015feyi sterilize eder ve enjeksiyonluk \u00fcr\u00fcnler i\u00e7in endotoksin s\u0131n\u0131r de\u011ferini kar\u015f\u0131lar.<\/p>

5.7.7 Toplam d\u00f6ng\u00fc s\u00fcresi, \u015fi\u015fe ba\u015f\u0131na 90 ile 180 saniye aras\u0131nda de\u011fi\u015fmektedir. Daha k\u0131sa d\u00f6ng\u00fcler, \u00fcr\u00fcn kal\u0131nt\u0131s\u0131 riskini beraberinde getirir. Daha uzun d\u00f6ng\u00fcler ise ek bir fayda sa\u011flamadan \u00fcretim hatt\u0131n\u0131 yava\u015flat\u0131r.<\/p>

5.7.8 Vardiya ba\u015flang\u0131c\u0131nda her a\u015fama i\u00e7in bas\u0131nc\u0131, s\u0131cakl\u0131\u011f\u0131 ve bekleme s\u00fcresini kaydedin. \u00c7al\u0131\u015fma s\u00fcresince bu kontrol\u00fc her iki saatte bir tekrarlay\u0131n.<\/p>

5.8 Y\u0131kama \u0130\u015fleminin Ba\u015flat\u0131lmas\u0131:<\/strong><\/h3>

5.8.1 Ana panele anahtar \u015falteri ile g\u00fc\u00e7 verin. HMI a\u00e7\u0131lacak ve ana ekran g\u00f6r\u00fcnt\u00fclenecektir.<\/p>

5.8.2 HMI \u00fczerindeki \u00fcr\u00fcn listesinden \u015fi\u015fe boyutunu se\u00e7in. Makine, do\u011fru bas\u0131n\u00e7, s\u00fcre ve kelep\u00e7e konumlar\u0131n\u0131 i\u00e7eren uygun tarifi y\u00fckleyecektir.<\/p>

5.8.3 Ekrandaki her bir re\u00e7ete de\u011ferini imzal\u0131 parti kayd\u0131yla kar\u015f\u0131la\u015ft\u0131r\u0131n. Herhangi bir de\u011fer spesifikasyonlar\u0131n d\u0131\u015f\u0131nda ise \u00fcretim ba\u015flat\u0131lamaz.<\/p>

5.8.4 \u0130lk \u015fi\u015fe girmeden \u00f6nce su hatlar\u0131n\u0131 haz\u0131rlay\u0131n. \u015ei\u015fe koymadan iki dakika boyunca kuru bir d\u00f6ng\u00fc \u00e7al\u0131\u015ft\u0131r\u0131n. Bu i\u015flem, \u00f6nceki partiden kalan bayat suyu temizler.<\/p>

5.8.5 \u201c\u00c7evrim Ba\u015flat\u201d d\u00fc\u011fmesine bas\u0131n. Konvey\u00f6r \u00e7al\u0131\u015fmaya ba\u015flayacak ve \u015fi\u015feler teker teker t\u00fcnele girecektir.<\/p>

5.8.6 Kurutucudan \u00e7\u0131kan ilk 10 \u015fi\u015feyi izleyin. Her birini \u0131\u015f\u0131k alt\u0131nda inceleyerek damlac\u0131k, iz veya lif olup olmad\u0131\u011f\u0131n\u0131 kontrol edin.<\/p>

5.8.7 Herhangi bir \u015fi\u015fe g\u00f6rsel kontrolden ge\u00e7emezse, onu reddedilenler tepsisine koyun. Kontrolden ge\u00e7emeyen \u015fi\u015feleri ikinci bir y\u0131kama yap\u0131lmadan \u00fcretim hatt\u0131na geri g\u00f6ndermeyin.<\/p>

5.8.8 HMI \u00fczerindeki \u00e7\u0131k\u0131\u015f sayac\u0131, kurutucudan \u00e7\u0131kan her \u015fi\u015feyle birlikte g\u00fcncellenir. Bu say\u0131y\u0131, parti hedefinizle kar\u015f\u0131la\u015ft\u0131rarak takip edin.<\/p>

5.9 \u0130\u015flem S\u0131ras\u0131nda Yap\u0131lan Kontroller:<\/strong><\/h3>

5.9.1 \u00c7\u0131k\u0131\u015f konvey\u00f6r\u00fcnden her 30 dakikada bir numune \u015fi\u015fesi al\u0131n. \u015ei\u015fenin y\u00fczeyiyle cilt temas\u0131n\u0131 \u00f6nlemek i\u00e7in temiz ma\u015fa kullan\u0131n.<\/p>

5.9.2 Numune \u015fi\u015fesini parlak bir \u0131\u015f\u0131\u011f\u0131n alt\u0131na tutun. \u015ei\u015fenin i\u00e7inde su lekeleri, kal\u0131nt\u0131lar veya g\u00f6zle g\u00f6r\u00fcl\u00fcr par\u00e7ac\u0131klar olup olmad\u0131\u011f\u0131na bak\u0131n.<\/p>

5.9.3 Saatte bir \u015fi\u015fe \u00fczerinde s\u00fcr\u00fcnt\u00fc testi yap\u0131n. S\u00fcr\u00fcnt\u00fcy\u00fc biyoy\u00fck analizi i\u00e7in mikrobiyoloji laboratuvar\u0131na g\u00f6nderin.<\/p>

5.9.4 WFI hatt\u0131n\u0131n s\u0131cakl\u0131\u011f\u0131n\u0131 her 15 dakikada bir kontrol edin. 80 \u00b0C\u2019nin alt\u0131ndaki de\u011ferlerde hatt\u0131n durdurulmas\u0131 ve tesisat ekibine haber verilmesi gerekir.<\/p>

5.9.5 Yan paneldeki p\u00fcsk\u00fcrtme bas\u0131n\u00e7 g\u00f6stergelerini izleyin. Bas\u0131n\u00e7ta ani bir d\u00fc\u015f\u00fc\u015f, filtrenin t\u0131kanm\u0131\u015f oldu\u011funu veya pompa contas\u0131n\u0131n a\u015f\u0131nm\u0131\u015f oldu\u011funu g\u00f6sterir.<\/p>

5.9.6 \u0130\u015flem s\u0131ras\u0131nda elde edilen t\u00fcm sonu\u00e7lar\u0131 parti kayd\u0131na i\u015flenmelidir. Aral\u0131\u011f\u0131n d\u0131\u015f\u0131nda kalan her t\u00fcrl\u00fc \u00f6l\u00e7\u00fcm de\u011feri, kalite g\u00fcvencesi incelemesi i\u00e7in i\u015faretlenmelidir.<\/p>

5.10 Kontrol Paneli Kullan\u0131m\u0131:<\/strong><\/h3>

5.10.1 Duvardaki ana \u015falteri ve ard\u0131ndan kontrol paneli ay\u0131r\u0131c\u0131 \u015falterini a\u00e7\u0131n.<\/p>

5.10.2 HMI ana ekran\u0131nda be\u015f sekme bulunur: Ana Sayfa, Tarif, D\u00f6ng\u00fc, Trend ve Rapor. Her sekme, belirli bir g\u00f6rev i\u00e7in bir dizi kontrol \u00f6\u011fesi i\u00e7erir.<\/p>

5.10.3 \u201cAna Sayfa\u201d sekmesi, makinenin anl\u0131k durumunu g\u00f6sterir. Bu sekmede pompa durumu, tank seviyeleri ve mevcut d\u00f6ng\u00fc ad\u0131m\u0131 g\u00f6r\u00fcnt\u00fclenir.<\/p>

5.10.4 \u201cTarif\u201d sekmesi, bir y\u0131kama tarifini y\u00fcklemenize, d\u00fczenlemenize veya kaydetmenize olanak tan\u0131r. Yaln\u0131zca y\u00f6netici eri\u015fim hakk\u0131na sahip kullan\u0131c\u0131lar kaydedilmi\u015f bir tarifi d\u00fczenleyebilir.<\/p>

5.10.5 \u201cD\u00f6ng\u00fc\u201d sekmesi \u00e7al\u0131\u015fmay\u0131 kontrol eder. Bu sekmede Ba\u015flat, Durdur, Duraklat ve S\u0131f\u0131rla d\u00fc\u011fmelerinin yan\u0131 s\u0131ra her a\u015fama i\u00e7in manuel devre d\u0131\u015f\u0131 b\u0131rakma se\u00e7ene\u011fi bulunur.<\/p>

5.10.6 \"Trend\" sekmesi, son bir saatteki bas\u0131n\u00e7 ve s\u0131cakl\u0131\u011f\u0131n ger\u00e7ek zamanl\u0131 grafi\u011fini g\u00f6sterir. Bu g\u00f6r\u00fcn\u00fcm\u00fc, proses de\u011ferlerindeki sapmalar\u0131 tespit etmek i\u00e7in kullan\u0131n.<\/p>

5.10.7 \u201cRapor\u201d sekmesi, vardiya \u00f6zetini yazd\u0131r\u0131r. Rapor, y\u0131kanan toplam \u015fi\u015fe say\u0131s\u0131n\u0131, reddedilenleri, duru\u015f olaylar\u0131n\u0131 ve ortalama d\u00f6ng\u00fc s\u00fcresini listeler.<\/p>

5.10.8 Kurulum denemeleri ve p\u00fcsk\u00fcrtme testleri i\u00e7in Manuel modu kullan\u0131n. Manuel mod, tam bir d\u00f6ng\u00fc \u00e7al\u0131\u015ft\u0131rmadan tek seferde bir pompay\u0131 veya bir istasyonu \u00e7al\u0131\u015ft\u0131rman\u0131za olanak tan\u0131r.<\/p>

5.10.9 Alarmlar, HMI'n\u0131n \u00fcst k\u0131sm\u0131ndaki k\u0131rm\u0131z\u0131 bir \u015feritte g\u00f6r\u00fcnt\u00fclenir. Her alarm\u0131n bir ar\u0131za kodu vard\u0131r. Alarm\u0131 silmeden \u00f6nce, makine k\u0131lavuzunda bu kodu kontrol edin.<\/p>

5.10.10 Vardiyan\u0131z\u0131n sonunda HMI'dan \u00e7\u0131k\u0131\u015f yap\u0131n. Bir sonraki operat\u00f6r, herhangi bir i\u015flem yapmadan \u00f6nce kendi kimlik bilgileriyle oturum a\u00e7mal\u0131d\u0131r.<\/p>

5.11 Reddedilen \u0130\u015flemlerin \u0130\u015flenmesi:<\/strong><\/h3>

5.11.1 \u00c7\u0131k\u0131\u015f noktas\u0131nda yap\u0131lan g\u00f6rsel kontrolden ge\u00e7emeyen her \u015fi\u015fe, reddedilenler tepsisine y\u00f6nlendirilir.<\/p>

5.11.2 Makine ayr\u0131ca konvey\u00f6r \u00fczerinde otomatik bir reddetme kap\u0131s\u0131na sahiptir. Bu kap\u0131, bir sens\u00f6r\u00fcn belirli bir \u015fi\u015fe i\u00e7in y\u0131kama a\u015famas\u0131nda d\u00fc\u015f\u00fck bas\u0131n\u00e7 tespit etmesi durumunda devreye girer.<\/p>

5.11.3 Reddedilen \u015fi\u015feleri iki gruba ay\u0131r\u0131n:<\/h4>

5.11.3.1 \u0130kinci bir y\u0131kama d\u00f6ng\u00fcs\u00fcyle yeniden i\u015flenebilen \u015fi\u015feler.<\/p>

5.11.3.2 \u00c7atlak, k\u0131r\u0131k veya derin lekeler bulunan ve at\u0131lmas\u0131 gereken \u015fi\u015feler.<\/p>

5.11.4 Bo\u015f \u015fi\u015feleri cam at\u0131klar i\u00e7in ayr\u0131lm\u0131\u015f \u00e7\u00f6p kutusuna at\u0131n. K\u0131r\u0131k camlar\u0131 genel \u00e7\u00f6plerle kar\u0131\u015ft\u0131rmay\u0131n.<\/p>

5.11.5 Y\u00fcksek bir reddedilme oran\u0131, bir s\u00fcre\u00e7 sorununa i\u015faret eder. Reddedilen \u00fcr\u00fcn say\u0131s\u0131 parti kay\u0131t\u0131nda belirtilen s\u0131n\u0131r\u0131 a\u015farsa, \u00fcretim hatt\u0131n\u0131 durdurun.<\/p>

5.11.6 Her vardiya sonunda reddedilen \u00fcr\u00fcn say\u0131s\u0131n\u0131 bildirin. Her grup i\u00e7in reddedilme oran\u0131n\u0131 ve ana nedeni de belirtin.<\/p>

5.12 Kapatma Prosed\u00fcr\u00fc:<\/strong><\/h3>

5.12.1 HMI \u00fczerindeki \u201c\u00c7evrim Sonu\u201d d\u00fc\u011fmesine bas\u0131n. Makine, durmadan \u00f6nce t\u00fcnelde kalan \u015fi\u015felerin y\u0131kama i\u015flemini tamamlayacakt\u0131r.<\/p>

5.12.2 Su giri\u015f vanalar\u0131n\u0131 ters s\u0131rayla kapat\u0131n: \u00d6nce WFI, sonra ar\u0131t\u0131lm\u0131\u015f su, ard\u0131ndan ham su. Bu, hatlar aras\u0131nda geri ak\u0131\u015f\u0131 \u00f6nler.<\/p>

5.12.3 Her bir su tank\u0131n\u0131 alt \u00e7\u0131k\u0131\u015ftan bo\u015falt\u0131n. Tankta kalan su, bir gecede mikroorganizmalar\u0131n \u00fcremesine neden olabilir.<\/p>

5.12.4 Hava hatt\u0131n\u0131 havaland\u0131r\u0131n ve birikmi\u015f bas\u0131nc\u0131 tahliye vanas\u0131 arac\u0131l\u0131\u011f\u0131yla bo\u015falt\u0131n.<\/p>

5.12.5 Panodan ve duvar \u015falterinden ana g\u00fcc\u00fc kesin.<\/p>

5.12.6 Makineye \u201cTEM\u0130ZLENECEK\u201d etiketini yap\u0131\u015ft\u0131r\u0131n.<\/p>

5.12.7 \u015ei\u015fe Y\u0131kama Makinesini, belirlenen temizlik SOP\u2019sine uygun olarak temizleyin.<\/p>

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

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

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

5.13.3 \u0130\u015flem Kontrol G\u00fcnl\u00fc\u011f\u00fc.<\/p>

5.13.4 G\u00fcvenlik Sistemi G\u00fcnl\u00fc\u011f\u00fc.<\/p>

5.13.5 Reddetme ve Yeniden \u0130\u015fleme Kayd\u0131.<\/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 HEPA:<\/strong> Y\u00fcksek Verimli Partik\u00fcl Hava Filtresi.<\/p>

6.6 WFI:<\/strong> Enjeksiyonluk Su.<\/p>

6.7 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":"

Standard operating procedure of Bottle Washing Machine. 1.0 OBJECTIVE: To define the Operating Procedure of Bottle Washing Machine used for […]<\/p>\n","protected":false},"author":1,"featured_media":18500,"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-18349","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\/18349","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=18349"}],"version-history":[{"count":1,"href":"https:\/\/pharmamachinecn.com\/tr\/wp-json\/wp\/v2\/posts\/18349\/revisions"}],"predecessor-version":[{"id":22798,"href":"https:\/\/pharmamachinecn.com\/tr\/wp-json\/wp\/v2\/posts\/18349\/revisions\/22798"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/pharmamachinecn.com\/tr\/wp-json\/wp\/v2\/media\/18500"}],"wp:attachment":[{"href":"https:\/\/pharmamachinecn.com\/tr\/wp-json\/wp\/v2\/media?parent=18349"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/pharmamachinecn.com\/tr\/wp-json\/wp\/v2\/categories?post=18349"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/pharmamachinecn.com\/tr\/wp-json\/wp\/v2\/tags?post=18349"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}