{"id":3754,"date":"2017-06-05T02:43:39","date_gmt":"2017-06-04T18:43:39","guid":{"rendered":"http:\/\/e2joyl.pro11.designworks.tw\/?post_type=portfolio&#038;p=3754"},"modified":"2021-09-06T12:23:47","modified_gmt":"2021-09-06T04:23:47","slug":"steriline-isolator","status":"publish","type":"portfolio","link":"https:\/\/e2joy.com.tw\/en\/portfolio-item\/steriline-isolator\/","title":{"rendered":"Steriline cRAB &#038; Isolator"},"content":{"rendered":"\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-av_heading-1446aff681fc9c9b7970ccc9ebd2becf\">\n#top .av-special-heading.av-av_heading-1446aff681fc9c9b7970ccc9ebd2becf{\npadding-bottom:10px;\n}\nbody .av-special-heading.av-av_heading-1446aff681fc9c9b7970ccc9ebd2becf .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n.av-special-heading.av-av_heading-1446aff681fc9c9b7970ccc9ebd2becf .av-subheading{\nfont-size:15px;\n}\n<\/style>\n<div  class='av-special-heading 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data-created_by=\"avia_inline_auto\" id=\"style-css-av-av_one_fourth-0aa7055fe62c3622faec82866afbaeb2\">\n.flex_column.av-av_one_fourth-0aa7055fe62c3622faec82866afbaeb2{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-av_one_fourth-0aa7055fe62c3622faec82866afbaeb2 av_one_fourth  avia-builder-el-3  el_after_av_one_half  el_before_av_one_fourth  flex_column_table_cell av-equal-height-column av-align-bottom av-zero-column-padding  '     ><style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-av_image-f098e19eaf9f2a2f04859a7052781b51\">\n.avia-image-container.av-av_image-f098e19eaf9f2a2f04859a7052781b51 img.avia_image{\nbox-shadow:none;\n}\n.avia-image-container.av-av_image-f098e19eaf9f2a2f04859a7052781b51 .av-image-caption-overlay-center{\ncolor:#ffffff;\n}\n<\/style>\n<div  class='avia-image-container av-av_image-f098e19eaf9f2a2f04859a7052781b51 av-styling- avia-align-center  avia-builder-el-4  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src=\"https:\/\/e2joy.com.tw\/wp-content\/uploads\/2017\/06\/Italy-80x80.png\" alt='' title='Italy'  height=\"80\" width=\"80\"  itemprop=\"thumbnailUrl\" srcset=\"https:\/\/e2joy.com.tw\/wp-content\/uploads\/2017\/06\/Italy-80x80.png 80w, https:\/\/e2joy.com.tw\/wp-content\/uploads\/2017\/06\/Italy-200x200.png 200w, https:\/\/e2joy.com.tw\/wp-content\/uploads\/2017\/06\/Italy-36x36.png 36w, https:\/\/e2joy.com.tw\/wp-content\/uploads\/2017\/06\/Italy-180x180.png 180w, https:\/\/e2joy.com.tw\/wp-content\/uploads\/2017\/06\/Italy-120x120.png 120w, https:\/\/e2joy.com.tw\/wp-content\/uploads\/2017\/06\/Italy.png 250w\" sizes=\"(max-width: 80px) 100vw, 80px\" \/><\/div><\/div><\/div><br \/>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-av_hr-c9ba6ccf0e28539cef079a4b419f7f68\">\n#top .hr.hr-invisible.av-av_hr-c9ba6ccf0e28539cef079a4b419f7f68{\nheight:25px;\n}\n<\/style>\n<div  class='hr av-av_hr-c9ba6ccf0e28539cef079a4b419f7f68 hr-invisible  avia-builder-el-7  el_after_av_image  el_before_av_animated_numbers '><span class='hr-inner '><span class=\"hr-inner-style\"><\/span><\/span><\/div><br \/>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-av_animated_numbers-61249aae807e97e04a73904a8a3c07c0\">\n#top .avia-animated-number.av-av_animated_numbers-61249aae807e97e04a73904a8a3c07c0 .avia-animated-number-content{\nfont-size:20px;\n}\n<\/style>\n<div  class=\"avia-animated-number av-av_animated_numbers-61249aae807e97e04a73904a8a3c07c0 av-force-default-color avia_animate_when_visible  avia-builder-el-8  el_after_av_hr  avia-builder-el-last  \" data-timer=\"3000\"><strong class=\"heading avia-animated-number-title\"><span class='avia-animated-number-icon av-icon-before-number av-icon-char avia-iconfont avia-font-entypo-fontello' data-av_icon='\ue812' data-av_iconfont='entypo-fontello' ><\/span><span class=\"avia-single-number __av-single-number\" data-number_format=\"\" data-number=\"100\" data-start_from=\"0\">100<\/span><span class=\"avia-no-number\"> %<\/span><\/strong><div class=\"avia-animated-number-content\"><p>Italy Design &amp; Made<\/p>\n<\/div><\/div><\/p><\/div><\/div><!--close column table wrapper. Autoclose: 1 -->\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-av_one_half-6126cab7d8fab8d08143dd2dacdf673c\">\n.flex_column.av-av_one_half-6126cab7d8fab8d08143dd2dacdf673c{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-av_one_half-6126cab7d8fab8d08143dd2dacdf673c av_one_half  avia-builder-el-9  el_after_av_one_fourth  el_before_av_one_half  first flex_column_div av-zero-column-padding  column-top-margin'     ><p><article  class='iconbox iconbox_left av-av_icon_box-0e8fd87300d272ea1a2d11501cc78620  avia-builder-el-10  el_before_av_icon_box  avia-builder-el-first '  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class=\"iconbox_content\"><header class=\"entry-content-header\" aria-label=\"Icon: With Integration of H2O2 Vapour Generator\"><div class='iconbox_icon heading-color avia-iconfont avia-font-entypo-fontello' data-av_icon='\ue8b7' data-av_iconfont='entypo-fontello'  ><\/div><h3 class='iconbox_content_title '  itemprop=\"headline\" >With Integration of H2O2 Vapour Generator<\/h3><\/header><div class='iconbox_content_container '  itemprop=\"text\" ><\/div><\/div><footer class=\"entry-footer\"><\/footer><\/article><br \/>\n<article  class='iconbox iconbox_left av-av_icon_box-b69a4db96191bd89c965dadc58b8a340  avia-builder-el-11  el_after_av_icon_box  avia-builder-el-last '  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class=\"iconbox_content\"><header class=\"entry-content-header\" aria-label=\"Icon: Compliance with cGMP and 21CFR part 11 requirement\"><div class='iconbox_icon heading-color avia-iconfont avia-font-entypo-fontello' data-av_icon='\ue8cd' data-av_iconfont='entypo-fontello'  ><\/div><h3 class='iconbox_content_title '  itemprop=\"headline\" >Compliance with cGMP and 21CFR part 11 requirement<\/h3><\/header><div class='iconbox_content_container '  itemprop=\"text\" ><\/div><\/div><footer class=\"entry-footer\"><\/footer><\/article><\/p><\/div><\/p>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-av_one_half-0aa7055fe62c3622faec82866afbaeb2\">\n.flex_column.av-av_one_half-0aa7055fe62c3622faec82866afbaeb2{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-av_one_half-0aa7055fe62c3622faec82866afbaeb2 av_one_half  avia-builder-el-12  el_after_av_one_half  avia-builder-el-last  flex_column_div av-zero-column-padding  column-top-margin'     ><div  class='tabcontainer av-av_tab_container-0bacd910096d11a3cec6dfb538798966 top_tab  avia-builder-el-13  avia-builder-el-no-sibling '>\n<section class='av_tab_section av_tab_section av-av_tab-c8b6cd9397f0dc85099caf461193115c'  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div id='tab-id-1-tab' class='tab active_tab' role='tab' aria-selected=\"true\" tabindex=\"0\" data-fake-id='#tab-id-1' aria-controls='tab-id-1-content'  itemprop=\"headline\" ><span class='tab_icon avia-iconfont avia-font-entypo-fontello' data-av_icon='\ue81f' data-av_iconfont='entypo-fontello' ><\/span>Description<\/div><div id='tab-id-1-content' class='tab_content active_tab_content' role='tabpanel' aria-labelledby='tab-id-1-tab' aria-hidden=\"false\"><div class='tab_inner_content invers-color'  itemprop=\"text\" ><p><strong>Isolators<\/strong><\/p>\n<p>STERILINE isolators can be installed in Class C or D rooms. They can be either stand alone equipment (quality control, research and development, sampling,<br \/>\ncompounding, sterility test, etc.) or\u00a0specially designed for fully integrated\u00a0aseptic production line, in compliance\u00a0with cGMP regulations.<\/p>\n<p>The Isolators are designed for\u00a0production of sterile products, either toxic or non toxic, maintaining\u00a0uncompromised, continuous isolation\u00a0of its interior from the external\u00a0environment.<\/p>\n<p>ISO 5 environment is achieved by\u00a0HEPA filtered, unidirectional air that\u00a0vertically flows over the process area.<\/p>\n<p>Pressure difference between the\u00a0interior and the exterior is maintained\u00a0by the exhaust fan. The exhaust air is\u00a0HEPA filtered by BIBO filters.<\/p>\n<p><strong>cRAB<\/strong><\/p>\n<p>STERILINE closed Restricted Access Barrier Systems (cRABS) are designed for the production of sterile products, either toxic or non-toxic.<\/p>\n<p>These systems provide protection for operator from product and for product from operator and they prevent contamination by keeping the production process enclosed in a confined area.<\/p>\n<p>The cRABS enclose a space where HEPA filtered, unidirectional air vertically flows over the process area. Pressure difference between the\u00a0interior and the exterior is maintained by the exhaust fan. The exhaust air is HEPA filtered by \u201cBag-in Bag-out\u201d (BIBO) filters.<\/p>\n<p>cRABS must be installed in Class B rooms.<\/p>\n<\/div><\/div><\/section>\n<section class='av_tab_section av_tab_section av-av_tab-bdd5d9a8fb28e25030919c158b7fa287'  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div id='tab-id-2-tab' class='tab' role='tab' aria-selected=\"false\" tabindex=\"0\" data-fake-id='#tab-id-2' aria-controls='tab-id-2-content'  itemprop=\"headline\" ><span class='tab_icon avia-iconfont avia-font-entypo-fontello' data-av_icon='\ue812' data-av_iconfont='entypo-fontello' ><\/span>Features<\/div><div id='tab-id-2-content' class='tab_content' role='tabpanel' aria-labelledby='tab-id-2-tab' aria-hidden=\"true\"><div class='tab_inner_content invers-color'  itemprop=\"text\" ><p class=\"prodotti_testo\">The STERILINE isolators main features are:<\/p>\n<ul>\n<li class=\"prodotti_testo\">AISI316L stainless steel for metal contact surfaces with finishes of at least Ra=0,5\u00b5m;<\/li>\n<li class=\"prodotti_testo\">AISI304L stainless steel for panels, guards, etc. not in contact with the product and sanitizing solution;<\/li>\n<li class=\"prodotti_testo\">AISI316L stainless steel for cleaning solution piping with tri-clamp fittings;<\/li>\n<li class=\"prodotti_testo\">Doors made of thick security glass and sealed with inflatable gaskets. Gaskets are made of either silicone, Viton or EPDM;<\/li>\n<li class=\"prodotti_testo\">VHP sanitization by condensation or by VHP in vapour status;<\/li>\n<li class=\"prodotti_testo\">Gloves are incorporated into the design for aseptic applications. The quantity and position of gloves is determined during the mock-up test;<\/li>\n<li class=\"prodotti_testo\">Rapid Transfer Ports (RTP) are available in 105mm, 190mm, 270mm, 350mm diameters;<\/li>\n<li class=\"prodotti_testo\">CIP of the internal surfaces is achieved by means of spray gun fed by WFI or WFI mixed with inactivation agent;<\/li>\n<li class=\"prodotti_testo\">Continuous monitoring of viable and non viable particles.<\/li>\n<\/ul>\n<p class=\"prodotti_testo\">The integrated control system of isolators is composed of PLC and touch screen operation panel for operator interface (HMI). The electrical cabinet can be located in the technical area, while the HMI is located close to the process unit. 21CFR Part11 compliance is achieved by means of a separate PC.<\/p>\n<\/div><\/div><\/section>\n<\/div><\/div>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":8,"featured_media":3763,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"tags":[173,161,193,174,106,138,194,195,183,143,141,170],"portfolio_entries":[68,72,630],"class_list":["post-3754","portfolio","type-portfolio","status-publish","has-post-thumbnail","hentry","tag-cf-21-part-11","tag-cgmp","tag-crab","tag-gamp","tag-isolator","tag-pharma","tag-rab","tag-steriline","tag-183","tag-143","tag-141","tag-170","portfolio_entries-pharmaceutical","portfolio_entries-sterile-filling","portfolio_entries-sterility-testing-isolator"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Steriline cRAB &amp; 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