{"id":590324,"date":"2024-11-05T21:13:03","date_gmt":"2024-11-05T21:13:03","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/iso-13408-62021\/"},"modified":"2024-11-05T21:13:03","modified_gmt":"2024-11-05T21:13:03","slug":"iso-13408-62021","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/iso\/iso-13408-62021\/","title":{"rendered":"ISO 13408-6:2021"},"content":{"rendered":"<p>This document specifies the requirements for and provides guidance on the specification, selection, qualification, bio-decontamination, validation, operation and control of isolator systems related to aseptic processing of health care products and processing of cell-based health care products.<\/p>\n<p>This document does not specify requirements for restricted access barrier systems (RABS).<\/p>\n<p>This document does not supersede or replace national regulatory requirements such as Good Manufacturing Practices (GMPs) and\/or compendia requirements that pertain in particular to national or regional jurisdictions.<\/p>\n<p>This document does not specify requirements for isolators used for sterility testing; however, some of the principles and information in this document could be applicable to this application.<\/p>\n<p>This document does not define biosafety containment requirements.<\/p>\n","protected":false},"excerpt":{"rendered":"<p><b>Aseptic processing of health care products \u2014 Part 6: Isolator systems<\/b><\/p>\n<table style=\"width: 100%\" border=\"0\" cellspacing=\"0\" cellpadding=\"0\">\n<tbody>\n<tr>\n<td>Published By<\/td>\n<td>Publication Date<\/td>\n<td>Number of Pages<\/td>\n<\/tr>\n<tr>\n<td><a href=\"https:\/\/pdfstandards.shop\/product-category\/publishers\/iso\/\"><b>ISO<\/b><\/a><\/td>\n<td>2021-04<\/td>\n<td>32<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":590334,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[154,2634],"product_tag":[],"class_list":{"0":"post-590324","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-11-080-01","7":"product_cat-iso","9":"first","10":"instock","11":"sold-individually","12":"shipping-taxable","13":"purchasable","14":"product-type-simple"},"_links":{"self":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product\/590324","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product"}],"about":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/types\/product"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media\/590334"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=590324"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=590324"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=590324"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}