{"id":4145,"date":"2022-12-24T16:44:27","date_gmt":"2022-12-24T13:44:27","guid":{"rendered":"https:\/\/www.medibim.com.tr\/TR\/?p=4145"},"modified":"2025-04-18T11:06:26","modified_gmt":"2025-04-18T08:06:26","slug":"partikul-izleme","status":"publish","type":"post","link":"https:\/\/www.medibim.com.tr\/TR\/temiz-oda-validasyon-ekipmanlari\/partikul-izleme\/","title":{"rendered":"Partik\u00fcl \u0130zleme"},"content":{"rendered":"\n<h1><span style=\"font-size: 14pt;\">Partik\u00fcl \u0130zleme<\/span><\/h1>\n<p>Partik\u00fcl izleme sistemleri, temiz oda niteli\u011findeki alanlar\u0131n, online, \u00e7evrim i\u00e7i olarak partik\u00fcl say\u0131mlar\u0131n\u0131n bir network a\u011f\u0131 \u00fczerinden s\u00fcreli olarak izlenmesine imkan veren partik\u00fcl say\u0131c\u0131lard\u0131r.<\/p>\n<p>SUJING Real Time 3104 Online partik\u00fcl izleme cihazlar\u0131, online olarak ba\u011fl\u0131 oldu\u011fu a\u011flar \u00fczerinden s\u00fcrekli olarak yapt\u0131\u011f\u0131 \u00f6l\u00e7\u00fcmlere ait verilerin aktar\u0131lmas\u0131na, payla\u015f\u0131lmas\u0131na ve izlenmesine imkan verir. Bu sayede temiz oda s\u00fcrekli olarak partik\u00fclasyon bak\u0131m\u0131ndan kontrol alt\u0131nda tutulmu\u015f olur.<\/p>\n<p>Sa\u011fl\u0131k hizmeti veren kurumlarda ameliyathaneler ve yo\u011fun bak\u0131mlar, ila\u00e7 end\u00fcstrisinde hijyenik ve steril \u00fcretim yapan tesisler, partik\u00fclasyonun istenmedi\u011fi di\u011fer t\u00fcm end\u00fcstriyel alanlar temiz oda olarak tan\u0131mlanan bu nitelikteki alanlara sahiptir.<\/p>\n<p>Bilindi\u011fi \u00fczere, 3 ana unsur enfeksiyon riski ta\u015f\u0131r; Hava, su ve steril olmayan y\u00fczeyler.<\/p>\n<p>Bu alanlar\u0131n temiz oda niteli\u011fini koruyabilmeleri i\u00e7in \u00f6zel havaland\u0131rma sistemleri kullan\u0131l\u0131r ve bu sistemler temiz oda i\u00e7ine girecek havay\u0131 filtre ederek temiz oda i\u00e7inde dola\u015ft\u0131ran hava \u00fcfleme ve hava tahliye sistemlerine sahiptir.<\/p>\n<p>T\u00fcm bu sistemlerin nas\u0131l tasarlanaca\u011f\u0131n\u0131, nas\u0131l kurulaca\u011f\u0131n\u0131, nas\u0131l devreye al\u0131naca\u011f\u0131n\u0131 ve nas\u0131l i\u015fletilece\u011fini belli uluslararas\u0131 ve lokal standartlar ve k\u0131lavuzlar mevcuttur.<\/p>\n<p>Bunlar\u0131n ba\u015fl\u0131ca olanlar\u0131;<\/p>\n<div>G\u00fcncel standartlar ve d\u00fczenlemeler size temiz oda izleme sistemi ihtiya\u00e7lar\u0131n\u0131z ve \u00e7\u00f6z\u00fcmleri hakk\u0131nda detayl\u0131 bilgi verebilir. Mevcut standartlar ve rehberlerin listesi \u015f\u00f6yledir:<\/div>\n<div>\u00a0<\/div>\n<div>ISO 14644-2: 2015: Temizodalar ve ilgili kontroll\u00fc ortamlar &#8211; B\u00f6l\u00fcm 2: Partik\u00fcl konsantrasyonuna g\u00f6re hava temizli\u011fi ile ilgili temizoda performans\u0131 kan\u0131tlar\u0131 sa\u011flanmas\u0131 i\u00e7in izleme<\/div>\n<div>Bu, ISO dahilinde partik\u00fcl konsantrasyonuna g\u00f6re hava temizli\u011finin izlenmesi ile ilgili mevcut tek standartt\u0131r. G\u00fcncellenmi\u015f 2015 versiyonu, \u201c\u0130zleme plan\u0131 olu\u015fturma, uygulama ve s\u00fcrd\u00fcrme\u201d konulu bir b\u00f6l\u00fcm ile risk bazl\u0131 bir yakla\u015f\u0131m sunmaktad\u0131r.<\/div>\n<div>\u00a0<\/div>\n<ul>\n<li><strong><strong>ISO 14644-2:2015 : Temiz Odalar &#8211; Partik\u00fcl konsantrasyonuna g\u00f6re temiz oda kan\u0131tlar\u0131n\u0131n sa\u011flanmas\u0131.<br \/><\/strong><\/strong>Temiz odalar\u0131n online olarak nas\u0131l izlenmesini gerekti\u011fini tarif eder.<\/li>\n<li><strong><strong>EU GMP Ek 1 (EU GMP Annex 1: Manufacture of Sterile Medicinal Products) : Avrupa Birli\u011fi steril medikal \u00fcr\u00fcnlerin \u00fcretimi<br \/><\/strong><\/strong>\u00a0EU GMP Ek 1, \u201cTemizoda ve temiz hava izleme\u201d adl\u0131 bir b\u00f6l\u00fcmde, temiz oda gereklilklerini ve nas\u0131l i\u015fletilece\u011fini anlat\u0131r. <br \/>Bu d\u00f6k\u00fcman &#8211; &gt; <a href=\"https:\/\/www.gmp-compliance.org\/files\/guidemgr\/20220825_gmp-an1_en_0.pdf\" target=\"_blank\" rel=\"noopener\">bu linkten<\/a> ula\u015f\u0131labilir.<\/li>\n<li><strong>FDA Aseptic Processing Guideline K\u0131lavuzu<\/strong>. <span class=\"goog-text-highlight\">Bu k\u0131lavuz, \u00fcreticilerin aseptik i\u015fleme kullanarak steril ila\u00e7 ve biyolojik \u00fcr\u00fcnler \u00fcretirken Ajans\u0131n mevcut iyi \u00fcretim uygulamalar\u0131 (CGMP) d\u00fczenlemelerindeki (2l CFR k\u0131s\u0131m 210 ve 211) gereklilikleri kar\u015f\u0131lamas\u0131na yard\u0131mc\u0131 olmay\u0131 ama\u00e7lamaktad\u0131r. Ayr\u0131ca,<\/span>\u00a0Aseptik \u0130\u015fleme Yoluyla \u00dcretilen Steril \u0130la\u00e7 \u00dcr\u00fcnleri ile ilgili 1987 End\u00fcstri K\u0131lavuzunun (Aseptik \u0130\u015fleme K\u0131lavuzu) yerine ge\u00e7er. Bu revizyon, 1987 k\u0131lavuzunu g\u00fcnceller ve netle\u015ftirir. Bu k\u0131lavuz ile ilgili bilgilere &#8211; &gt; <a href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/sterile-drug-products-produced-aseptic-processing-current-good-manufacturing-practice\" target=\"_blank\" rel=\"noopener\">bu linkten<\/a> ula\u015f\u0131labilir.<\/li>\n<li><strong>D\u00fcnya Sa\u011fl\u0131k \u00d6rg\u00fct\u00fc (WHO) A\u015f\u0131 \u00dcretim Tesislerinde Temiz odalar\u0131n \u0130zlenmedi .<\/strong>\u00a0Bu dok\u00fcman a\u015f\u0131 imalat\u0131na \u00f6zel olarak haz\u0131rlanm\u0131\u015f gibi g\u00f6r\u00fcnse bile, i\u00e7inde rutin izleme ve \u00f6rnekleme plan\u0131 hakk\u0131nda \u00e7e\u015fitli bilgiler bulacaks\u0131n\u0131z.<\/li>\n<li><strong>PDA Teknik Raporu (TR) No.13R, \u00c7evresel \u0130zleme Program\u0131n\u0131n Temelleri.<\/strong>\u00a0PDA \u00e7ok faydal\u0131 Teknik Raporlar sunar ve TR-13R uygun izleme plan\u0131n\u0131 elde etmek i\u00e7in kullan\u0131labilecek en iyi dok\u00fcmanlardan biridir. Yerine getirmeniz gereken gereksinimleri \u00f6zetlemekle kalmaz, ayn\u0131 zamanda size \u00f6rnek bir plan ve \u00f6rnekler sunar.<\/li>\n<\/ul>\n<p>T\u00fcm bu standartlar ve genel k\u0131lavuzlar dahilinde, SUJING, temiz odalar\u0131n online olarak partik\u00fcl sat\u0131mlar\u0131n\u0131 ve bu say\u0131mlar\u0131n online olarak izlenmesini sa\u011flayan \u00e7\u00f6z\u00fcmler \u00fcretmektedir.<\/p>\n<p><span style=\"font-size: 14pt;\"><strong>SUJING Remote Time 3104 ,<\/strong> <\/span>bir temiz oda i\u00e7erisinde bir veya daha fazla noktada, partik\u00fcl konsantrasyon ve say\u0131mlar\u0131n\u0131 yaparak ba\u011fl\u0131 oldu\u011fu a\u011flar \u00fczerinden bu verilerin izlenmesini sa\u011flar.<\/p>\n<p>Genel \u00d6zellikleri:<\/p>\n<ul>\n<li>Lazer partik\u00fcl sens\u00f6r<img loading=\"lazy\" decoding=\"async\" class=\"alignright\" src=\"https:\/\/www.sj-auto.com\/photo\/sj-auto\/editor\/20210303113629_11400.jpg\" alt=\"REMOTE 3104\" width=\"289\" height=\"235\" \/><\/li>\n<li>Paslanmaz \u00e7elik g\u00f6vde<\/li>\n<li>1CFM veya 2 CFM se\u00e7imli\u00a0<\/li>\n<li>Partik\u00fcl say\u0131m\u0131, hav velositesi, s\u0131cakl\u0131k, nem, fark bas\u0131nc\u0131(opsiyonel) parametrelerini \u00f6l\u00e7er.<\/li>\n<li>Rahat kullan\u0131ml\u0131 aray\u00fcze sahip online izleme yaz\u0131l\u0131m\u0131 ile birlikte gelir.<\/li>\n<li>Tek bir PC ile 128 sens\u00f6r kontrol\u00fc sa\u011flar.<\/li>\n<\/ul>\n<p><strong>Teknik \u00d6zellikler:<\/strong><\/p>\n<table style=\"border-collapse: collapse; border: none;\" border=\"1\" width=\"631\" cellspacing=\"0\" cellpadding=\"0\">\n<tbody>\n<tr>\n<td style=\"width: 118.8pt; border: solid windowtext 1.0pt; padding: 0cm 5.4pt 0cm 5.4pt;\" valign=\"top\" width=\"158\"><span style=\"font-family: Arial, sans-serif; font-size: 16px;\">Outside Dim<\/span><\/td>\n<td style=\"width: 354.4pt; border: solid windowtext 1.0pt; border-left: none; padding: 0cm 5.4pt 0cm 5.4pt;\" valign=\"top\" width=\"473\"><span style=\"font-family: Arial, sans-serif; font-size: 16px;\">275*450*175 mm\u00b3(Wide*Deep*High)<\/span><\/td>\n<\/tr>\n<tr>\n<td style=\"width: 118.8pt; border: solid windowtext 1.0pt; border-top: none; padding: 0cm 5.4pt 0cm 5.4pt;\" valign=\"top\" width=\"158\"><span style=\"font-family: Arial, sans-serif; font-size: 16px;\">Weight<\/span><\/td>\n<td style=\"width: 354.4pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0cm 5.4pt 0cm 5.4pt;\" valign=\"top\" width=\"473\"><span style=\"font-family: Arial, sans-serif; font-size: 16px;\">4kg<\/span><\/td>\n<\/tr>\n<tr>\n<td style=\"width: 118.8pt; border: solid windowtext 1.0pt; border-top: none; padding: 0cm 5.4pt 0cm 5.4pt;\" valign=\"top\" width=\"158\"><span style=\"font-family: Arial, sans-serif; font-size: 16px;\">Max. Consumption<\/span><\/td>\n<td style=\"width: 354.4pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0cm 5.4pt 0cm 5.4pt;\" valign=\"top\" width=\"473\"><span style=\"font-family: Arial, sans-serif; font-size: 16px;\">40W<\/span><\/td>\n<\/tr>\n<tr>\n<td style=\"width: 118.8pt; border: solid windowtext 1.0pt; border-top: none; padding: 0cm 5.4pt 0cm 5.4pt;\" valign=\"top\" width=\"158\"><span style=\"font-family: Arial, sans-serif; font-size: 16px;\">Power Source<\/span><\/td>\n<td style=\"width: 354.4pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0cm 5.4pt 0cm 5.4pt;\" valign=\"top\" width=\"473\"><span style=\"font-family: Arial, sans-serif; font-size: 16px;\">DC24V<\/span><\/td>\n<\/tr>\n<tr>\n<td style=\"width: 118.8pt; border: solid windowtext 1.0pt; border-top: none; padding: 0cm 5.4pt 0cm 5.4pt;\" valign=\"top\" width=\"158\"><span style=\"font-family: Arial, sans-serif; font-size: 16px;\">Size Channels<\/span><\/td>\n<td style=\"width: 354.4pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0cm 5.4pt 0cm 5.4pt;\" valign=\"top\" width=\"473\"><span style=\"font-family: Arial, sans-serif; font-size: 16px;\">0.5, 5\u03bcm<\/span><\/td>\n<\/tr>\n<tr>\n<td style=\"width: 118.8pt; border: solid windowtext 1.0pt; border-top: none; padding: 0cm 5.4pt 0cm 5.4pt;\" valign=\"top\" width=\"158\"><span style=\"font-family: Arial, sans-serif; font-size: 16px;\">Flow Rate<\/span><\/td>\n<td style=\"width: 354.4pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0cm 5.4pt 0cm 5.4pt;\" valign=\"top\" width=\"473\"><span style=\"font-family: Arial, sans-serif; font-size: 16px;\">28.3L\/min<\/span><\/td>\n<\/tr>\n<tr>\n<td style=\"width: 118.8pt; border: solid windowtext 1.0pt; border-top: none; padding: 0cm 5.4pt 0cm 5.4pt;\" valign=\"top\" width=\"158\"><span style=\"font-family: Arial, sans-serif; font-size: 16px;\">Environmental<\/span><\/td>\n<td style=\"width: 354.4pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0cm 5.4pt 0cm 5.4pt;\" valign=\"top\" width=\"473\"><span style=\"font-size: 16px; font-family: Arial, sans-serif;\">Temperature:10\u2103-40\u2103; Humidity:20%-90%RH; Atmosphere Pressure:86-106Kpa<\/span><\/td>\n<\/tr>\n<tr>\n<td style=\"width: 118.8pt; border: solid windowtext 1.0pt; border-top: none; padding: 0cm 5.4pt 0cm 5.4pt;\" valign=\"top\" width=\"158\"><span style=\"font-family: Arial, sans-serif; font-size: 16px;\">Cycles<\/span><\/td>\n<td style=\"width: 354.4pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0cm 5.4pt 0cm 5.4pt;\" valign=\"top\" width=\"473\"><span style=\"font-family: Arial, sans-serif; font-size: 16px;\">Selectable(1s-24h)<\/span><\/td>\n<\/tr>\n<tr>\n<td style=\"width: 118.8pt; border: solid windowtext 1.0pt; border-top: none; padding: 0cm 5.4pt 0cm 5.4pt;\" valign=\"top\" width=\"158\"><span style=\"font-family: Arial, sans-serif; font-size: 16px;\">Zero Court<\/span><\/td>\n<td style=\"width: 354.4pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0cm 5.4pt 0cm 5.4pt;\" valign=\"top\" width=\"473\"><span style=\"font-family: Arial, sans-serif; font-size: 16px;\">&lt;=10min<\/span><\/td>\n<\/tr>\n<tr>\n<td style=\"width: 118.8pt; border: solid windowtext 1.0pt; border-top: none; padding: 0cm 5.4pt 0cm 5.4pt;\" valign=\"top\" width=\"158\"><span style=\"font-family: Arial, sans-serif; font-size: 16px;\">Data Output<\/span><\/td>\n<td style=\"width: 354.4pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0cm 5.4pt 0cm 5.4pt;\" valign=\"top\" width=\"473\"><span style=\"font-family: Arial, sans-serif; font-size: 16px;\">RS485(modbus) or 4-20mA<\/span><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>Daha fazla bilgi i\u00e7in l\u00fctfen bizi aray\u0131n\u0131z ya da a\u015fa\u011f\u0131da verilen Bilgi Talep formunu doldurarak bize iletiniz.<\/p>\n<p>Medibim Biyomedikal<br \/>0212.4382046 &#8211; info@medibim.com.tr<\/p>\n<hr \/>\n<p>B\u0130LG\u0130 TALEP FORMU<\/p>\n<p>\u00a0<\/p>\n\n\n<div class=\"everest-forms\"><div class=\"evf-container default\" id=\"evf-3315\"><form id=\"evf-form-3315\" class=\"everest-form\" data-formid=\"3315\" data-ajax_submission=\"0\" data-keyboard_friendly_form=\"0\" data-form_state_type=\"\" method=\"post\" enctype=\"multipart\/form-data\" action=\"\/TR\/wp-json\/wp\/v2\/posts\/4145\"><div class=\"evf-field-container\"><input type=\"hidden\" id=\"_wpnonce3315\" name=\"_wpnonce3315\" value=\"3b4efc8b0b\" \/><input 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s\u00fcreli<\/p>\n","protected":false},"author":18,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"colormag_page_container_layout":"default_layout","colormag_page_sidebar_layout":"default_layout","footnotes":""},"categories":[38],"tags":[1430,1429,105],"class_list":["post-4145","post","type-post","status-publish","format-standard","hentry","category-temiz-oda-validasyon-ekipmanlari","tag-online-particle","tag-partikul-izleme","tag-temiz-oda"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.6 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Partik\u00fcl \u0130zleme - Medibim Biyomedikal Metroloji ve Kalibrasyon<\/title>\n<meta name=\"description\" content=\"Temiz Oda Validasyon Ekipmanlar\u0131 - Partik\u00fcl \u0130zleme - Medibim Biyomedikal Metroloji ve Kalibrasyon\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, 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