{"id":463881,"date":"2024-10-20T10:31:17","date_gmt":"2024-10-20T10:31:17","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/aami-cr513-2024\/"},"modified":"2024-10-26T19:23:56","modified_gmt":"2024-10-26T19:23:56","slug":"aami-cr513-2024","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/aami\/aami-cr513-2024\/","title":{"rendered":"AAMI CR513 2024"},"content":{"rendered":"

This consensus report provides guidance on simplified approaches for validation and routine control of single-use systems used for pharmaceutical and biopharmaceutical manufacturing sterilized by radiation.<\/p>\n

PDF Catalog<\/h4>\n\n\n\n\n\n\n\n\n\n\n\n\n\n
PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
1<\/td>\nAAMI CR513:2024; Guidance on radiation sterilization validation and routine control of single-use systems used for pharmaceutical and biopharmaceutical manufacturing <\/td>\n<\/tr>\n
3<\/td>\nTitle page <\/td>\n<\/tr>\n
4<\/td>\nAAMI Consensus Report <\/td>\n<\/tr>\n
5<\/td>\nCopyright information
Contents <\/td>\n<\/tr>\n
6<\/td>\nTask Group representation <\/td>\n<\/tr>\n
9<\/td>\n1 Purpose
1.1 Scope
2 References and resources <\/td>\n<\/tr>\n
10<\/td>\n3 Terms and definitions
4 Definition and maintenance of product families for dose establishment and dose auditing
4.1 Representative product
4.1.1 Master product <\/td>\n<\/tr>\n
11<\/td>\n4.1.2 Equivalent product
4.1.3 Simulated product
5 Selection and testing of product for establishing the sterilization dose
5.1 Selection of product to be tested
5.2 Sample item portion (SIP) <\/td>\n<\/tr>\n
12<\/td>\n6 Sterile claim
7 Transfer of dose between radiation types
8 Application of dose
8.1 Application of verification dose to SUSs
8.2 Application of sterilization dose to SUSs <\/td>\n<\/tr>\n
13<\/td>\n9 Risk assessment
9.1 Risk assessment for SAL
9.2 Risk assessment for simplification of SUSs for testing
10 Guidance on release and independent verification for the user
10.1 SUS release information <\/td>\n<\/tr>\n
14<\/td>\n10.2 SUS user information
11 Regulatory aspects <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

AAMI CR513:2024 Guidance on radiation validation and routine maintenance for single-use systems used for pharmaceutical and biopharmaceutical manufacturing<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
AAMI<\/b><\/a><\/td>\n2024<\/td>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":463886,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[2654],"product_tag":[],"class_list":{"0":"post-463881","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-aami","8":"first","9":"instock","10":"sold-individually","11":"shipping-taxable","12":"purchasable","13":"product-type-simple"},"_links":{"self":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product\/463881","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\/463886"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=463881"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=463881"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=463881"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}