{"id":1579,"date":"2020-09-23T11:03:16","date_gmt":"2020-09-23T11:03:16","guid":{"rendered":"https:\/\/lightweb.dev\/s\/key2compliance\/product\/biocleaning-cleaning-and-decontamination-of-surfaces\/"},"modified":"2026-04-14T15:54:43","modified_gmt":"2026-04-14T13:54:43","slug":"biocleaning-cleaning-and-decontamination-of-surfaces","status":"publish","type":"product","link":"https:\/\/lightweb.dev\/s\/key2compliance\/product\/biocleaning-cleaning-and-decontamination-of-surfaces\/","title":{"rendered":"Decontamination process &#8211; Barrier Technology and Premises &#8211; Course"},"content":{"rendered":"<ul>\n<li>Understanding the GMP Requirements about cleaning and disinfection in cleanrooms<\/li>\n<li>Integrate the requirements of the Draft Annex 1 2020<\/li>\n<li>Design a Biocleaning program adapted to premises and its activities<\/li>\n<\/ul>\n<h4>Course content<\/h4>\n<p><strong>European and American Regulations<\/strong><\/p>\n<p><strong>European GMPs<br \/>\n<\/strong>&#8211; Eudralex &#8211; EU Guidelines for GMP &#8211; Vol 4 \u2013 Part 1 \u2013 GMP Basic Requirements for Medicinal Products<br \/>\n&#8211; Eudralex &#8211; EU Guidelines for GMP &#8211; Vol 4 \u2013 Annex 1 \u2013 Manufacture of Sterile Medicinal Products<br \/>\n&#8211; Eudralex &#8211; EU Guidelines for GMP for Medicinal Products for Humans and Veterinary Use &#8211; Vol 4 &#8211; Annex 15 \u2013 Production and Validation<\/p>\n<p><label><strong><label>American <\/label>GMPs Regulations<br \/>\n<\/strong><\/label>&#8211; FDA \u201cGuidance for Industry Sterile Drug Products Produced by Aseptic processing \u2013 Current Good Manufacturing Practice (September 2004)\u201d<br \/>\n&#8211; PDA \u201cTechnical Report No.70 Fundamentals of cleaning and Disinfection Programs for Aseptic Manufacturing Facilities\u201d<\/p>\n<p><strong>Contaminants concerned:<br \/>\n<\/strong>&#8211; Particles, Microorganisms<br \/>\n&#8211; Chemical residuals of ancillary products (detergents, disinfectants,\u2026)<\/p>\n<p><strong>The different steps of Decontamination process:<br \/>\n<\/strong>&#8211; Cleaning<br \/>\n&#8211; Disinfection and Bio-Decontamination<\/p>\n<p><strong>Good practices of cleaning and desinfection:<br \/>\n<\/strong>&#8211; Feedback on actual cases<\/p>\n<p><strong>Characteristics of different tools and storage conditions in production:<br \/>\n<\/strong><em>&#8211; Wipes, brooms, nebulizates or vaporization<\/em><\/p>\n<p><strong>Decontamination Validation<\/strong><br \/>\n<strong>Practices after a shutdown<\/strong><br \/>\n<strong>Specific case applicable for Barrier Technology<\/strong><br \/>\n<strong>Validation of disinfectant:<br \/>\n<\/strong>Validation studies should demonstrate the suitability and effectiveness of disinfectants in the specific manner<strong><br \/>\n<\/strong><\/p>\n<h3>Learning objectives<\/h3>\n<p>\u2022 Better understanding of the GMP context to clean and disinfect premises and non critical surfaces in classified areas and apparatus.<br \/>\n\u2022 Master the choice of methods to put in place and adapt them to GMP requirements.<br \/>\n\u2022 Design a Biocleaning program adapted to premises and its activities.<br \/>\n\u2022 Give innovative practices in order to put in place practical methods.<\/p>\n<h3>Who should attend<\/h3>\n<p>This training is intended to Managers and Operators in charge of Disinfection operations in cleanrooms : Quality Support, Production and Sterility Assurance Departments.<\/p>\n<p>#5125<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Understanding the GMP Requirements about cleaning and disinfection in cleanrooms, Integrate the requirements of the Draft Annex 1 2020, Design a Biocleaning program adapted to premises and its activities<\/p>\n","protected":false},"featured_media":1580,"template":"","meta":{"_acf_changed":false,"wds_primary_product_brand":0,"wds_primary_product_cat":0},"product_brand":[],"product_cat":[18],"product_tag":[109,108],"class_list":{"0":"post-1579","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-in-house","7":"product_tag-cleanrooms-and-cleaning","8":"product_tag-sterile-products","9":"pa_industry-pharmaceuticals","10":"pa_language-english","11":"pa_level-intermediate","12":"pa_region-eu-us","14":"first","15":"instock","16":"virtual","17":"taxable","18":"product-type-simple"},"acf":[],"_links":{"self":[{"href":"https:\/\/lightweb.dev\/s\/key2compliance\/wp-json\/wp\/v2\/product\/1579","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/lightweb.dev\/s\/key2compliance\/wp-json\/wp\/v2\/product"}],"about":[{"href":"https:\/\/lightweb.dev\/s\/key2compliance\/wp-json\/wp\/v2\/types\/product"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/lightweb.dev\/s\/key2compliance\/wp-json\/wp\/v2\/media\/1580"}],"wp:attachment":[{"href":"https:\/\/lightweb.dev\/s\/key2compliance\/wp-json\/wp\/v2\/media?parent=1579"}],"wp:term":[{"taxonomy":"product_brand","embeddable":true,"href":"https:\/\/lightweb.dev\/s\/key2compliance\/wp-json\/wp\/v2\/product_brand?post=1579"},{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/lightweb.dev\/s\/key2compliance\/wp-json\/wp\/v2\/product_cat?post=1579"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/lightweb.dev\/s\/key2compliance\/wp-json\/wp\/v2\/product_tag?post=1579"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}