{"id":3933,"date":"2023-05-08T11:12:19","date_gmt":"2023-05-08T09:12:19","guid":{"rendered":"https:\/\/www.pharmaeducationcenter.it\/uncategorized\/rabs-and-isolators-in-the-production-of-sterile-drugs\/"},"modified":"2026-04-02T16:44:35","modified_gmt":"2026-04-02T14:44:35","slug":"rabs-and-isolators-in-the-production-of-sterile-drugs","status":"publish","type":"product","link":"https:\/\/www.pharmaeducationcenter.it\/en\/trainings\/quality-and-process\/rabs-and-isolators-in-the-production-of-sterile-drugs\/","title":{"rendered":"RABS and isolators in the production of sterile drugs"},"content":{"rendered":"<p>Production sites and processes are changing rapidly to adapt to the increasingly stringent requests of regulatory bodies which push towards the use of safer technologies.<\/p>\n<p>One of the focal points of the new Annex 1 will be the push towards the implementation of more modern technologies &#8220;Barrier systems however must be properly designed, decontaminated, operated and maintained in order to ensure effective contamination control&#8221;. Many companies need to innovate and optimize to be compliant with increasingly challenging regulatory requirements. PEC, on this day, wants to address the topic in question, with a practical and experience slant, offering a technical insight into the 2 technologies most widespread today in the production of tailings, comparing their strengths and weaknesses, in order to know how to manage them the best way to achieve and maintain the Sterility Assurance of the product. Spekaers will help you clarify doubts by answering practical questions in an enriching exchange.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Production sites and processes are changing rapidly to adapt to the increasingly stringent requests of regulatory bodies which push towards the use of safer technologies.<\/p>\n","protected":false},"featured_media":2880,"template":"","meta":{"_acf_changed":false,"site-sidebar-layout":"default","site-content-layout":"default","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":"default","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-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":"","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-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":"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":""},"mobile":{"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":""}},"_joinchat":[]},"product_brand":[],"product_cat":[114,117,113,118],"product_tag":[],"class_list":{"0":"post-3933","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-quality-and-process","7":"product_cat-corsi-di-formazione","8":"product_cat-quality-process","9":"product_cat-trainings","10":"desktop-align-left","11":"tablet-align-left","12":"mobile-align-left","13":"ast-product-gallery-layout-horizontal-slider","14":"ast-product-gallery-with-no-image","15":"ast-magnify-disabled","16":"ast-product-single-variable","18":"first","19":"instock","20":"taxable","21":"shipping-taxable","22":"purchasable","23":"product-type-variable"},"acf":{"corso_new_label":false,"corso_promo_label":false,"corso_pdf_programma":"","corso_programma":"09:30 \u2013 12:30 MORNING SESSION\r\n14:00 \u2013 17:00 AFTERNOON SESSION\r\n\r\nRABS - MORNING SESSION\r\n\r\n<strong><em>Patrizia Muscas, Sterility Assurance Senior Consultant \u2013 Eli Lilly Italy<\/em><\/strong>\r\n<ul>\r\n \t<li>Strengths of RABS technology<\/li>\r\n \t<li>Critical points to consider when choosing the technology:<\/li>\r\n<\/ul>\r\n\u2013 functionality, safety, compliance, maintenance, costs, versatility\r\n<ul>\r\n \t<li>Criteria for choosing the number\/position of glove accesses<\/li>\r\n \t<li>Classification and Monitoring:<\/li>\r\n<\/ul>\r\n- normative requirements\r\n\u2013 choice of points\r\n\u2013 technologies (alternative systems-potential)\r\n<ul>\r\n \t<li>RABS gloves:\r\n\u2013 choice of points\r\n\u2013 typologies\r\n\u2013 certification\r\n\u2013 microbiological checks<\/li>\r\n<\/ul>\r\n\u2013 Integrity testing\r\n\u2013 replacement frequencies\r\n<ul>\r\n \t<li>RABS sanitization:\r\n\u2013 frequencies\r\n\u2013 choice of reagents<\/li>\r\n<\/ul>\r\n<ul>\r\n \t<li>Validation Highlights:\r\n\u2013 Smoke test\r\n\u2013 medium fill\r\n\u2013 operator validation\r\n\u2013 types of interventions grade A\/B, material handling from class B within the RABS<\/li>\r\n<\/ul>\r\n<ul>\r\n \t<li>Cases of out-of-bounds deviation and approaches to their management<\/li>\r\n<\/ul>\r\n&nbsp;\r\n\r\nISOLATOR - AFTERNOON SESSION\r\n\r\n<strong><em>Andrea Pranti, Qualification Transformation Engineering Manager \u2013 GSK Vaccines \u2013 Siena<\/em><\/strong>\r\n<ul>\r\n \t<li>Strengths of the Isolator technology and types:<\/li>\r\n<\/ul>\r\n\u2013 functionality, safety, compliance, maintenance, costs, versatility\r\n<ul>\r\n \t<li>Material introduction and outfeed systems: IN and OUT ports<\/li>\r\n \t<li>Classification and Monitoring:<\/li>\r\n<\/ul>\r\n- normative requirements\r\n\u2013 choice of points\r\n\u2013 technologies (systems \u2013 alternative potential)\r\n<ul>\r\n \t<li>Isolator Gloves:<\/li>\r\n<\/ul>\r\n\u2013 choice of points\r\n\u2013 typologies\r\n\u2013 certification\r\n\u2013 microbiological checks\r\n\u2013 integrity tests\r\n\u2013 replacement frequencies\r\n<ul>\r\n \t<li>Biodecontamination: modalities and problems<\/li>\r\n \t<li>Validation Highlights:<\/li>\r\n<\/ul>\r\n\u2013 smoke test\r\n\u2013 medium fill\r\n\u2013 operator validation\r\n<ul>\r\n \t<li>Cases of out-of-bounds deviation and approaches to their management<\/li>\r\n<\/ul>","corso_target":"Sterility Assurance Manager, QP, Quality Operations, Microbiology Manager, Maintenance and Engineering Manager, Production Manager.","corso_competenze":[{"corso_competenze_item":"The regulatory requirements related to Environmental Monitoring"},{"corso_competenze_item":"The sampling methods and techniques, and how to validate them"},{"corso_competenze_item":"Perform microbiological and particulate validation of environments"},{"corso_competenze_item":"Have the opportunity to discuss and clarify doubts with experts."}]},"_links":{"self":[{"href":"https:\/\/www.pharmaeducationcenter.it\/en\/wp-json\/wp\/v2\/product\/3933","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.pharmaeducationcenter.it\/en\/wp-json\/wp\/v2\/product"}],"about":[{"href":"https:\/\/www.pharmaeducationcenter.it\/en\/wp-json\/wp\/v2\/types\/product"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.pharmaeducationcenter.it\/en\/wp-json\/wp\/v2\/media\/2880"}],"wp:attachment":[{"href":"https:\/\/www.pharmaeducationcenter.it\/en\/wp-json\/wp\/v2\/media?parent=3933"}],"wp:term":[{"taxonomy":"product_brand","embeddable":true,"href":"https:\/\/www.pharmaeducationcenter.it\/en\/wp-json\/wp\/v2\/product_brand?post=3933"},{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/www.pharmaeducationcenter.it\/en\/wp-json\/wp\/v2\/product_cat?post=3933"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/www.pharmaeducationcenter.it\/en\/wp-json\/wp\/v2\/product_tag?post=3933"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}