{"id":408588,"date":"2024-10-20T05:31:26","date_gmt":"2024-10-20T05:31:26","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bsi-22-30397817-dc\/"},"modified":"2024-10-26T10:04:00","modified_gmt":"2024-10-26T10:04:00","slug":"bsi-22-30397817-dc","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bsi-22-30397817-dc\/","title":{"rendered":"BSI 22\/30397817 DC"},"content":{"rendered":"

PDF Catalog<\/h4>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n
PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
7<\/td>\nForeword <\/td>\n<\/tr>\n
8<\/td>\nIntroduction <\/td>\n<\/tr>\n
9<\/td>\n1 Scope
2 Normative references
3 Terms and definitions <\/td>\n<\/tr>\n
14<\/td>\n4 General considerations
5 Risk management for microbiological contamination
5.1 Risk management in manufacturing process <\/td>\n<\/tr>\n
16<\/td>\n5.2 Risk management in microbial testing
6 Selection of a fit-for-purpose assay
6.1 General <\/td>\n<\/tr>\n
17<\/td>\n6.2 Assay selection
6.3 Kit or system selection <\/td>\n<\/tr>\n
18<\/td>\n6.4 Considerations for various test types <\/td>\n<\/tr>\n
19<\/td>\n6.5 User requirement specifications
6.5.1 General
6.5.2 Speed
6.5.3 Sample volume
6.5.4 In-process versus final release testing
6.5.5 Specificity <\/td>\n<\/tr>\n
20<\/td>\n6.5.6 Sensitivity
7 Validation
7.1 General concepts <\/td>\n<\/tr>\n
21<\/td>\n7.2 Selection of microorganisms for validation <\/td>\n<\/tr>\n
22<\/td>\n7.3 Quality by design of method validation
7.4 Revalidation method <\/td>\n<\/tr>\n
23<\/td>\n7.5 System validation
7.6 Use of reference material in validation
7.7 Acceptance criteria of targeted validation parameters <\/td>\n<\/tr>\n
24<\/td>\n7.8 Precision
7.9 Detection limit
7.10 Accuracy <\/td>\n<\/tr>\n
25<\/td>\n7.11 Robustness
7.12 Ruggedness
8 Points to take into account for the use and application of rapid microbial tests
8.1 Number and type of samples
8.2 Testing environment <\/td>\n<\/tr>\n
26<\/td>\n8.3 Sensitivity
8.4 Specificity (organism detection)
8.5 Comparable test data <\/td>\n<\/tr>\n
27<\/td>\n9 Investigation of positive sterility results
10 Training <\/td>\n<\/tr>\n
28<\/td>\n11 Documentation
12 Reporting <\/td>\n<\/tr>\n
29<\/td>\nAnnex\u20acA (informative) Exemplary Framework for identifying microbial contamination <\/td>\n<\/tr>\n
30<\/td>\nAnnex\u20acB (informative) Risk analysis with Cellular Therapeutic Products related to input materials – Donor selection <\/td>\n<\/tr>\n
31<\/td>\nAnnex\u20acC (informative) Risk analysis with Cellular Therapeutic Products related to input materials – Cell transformation and expansion <\/td>\n<\/tr>\n
33<\/td>\nAnnex\u20acD (informative) Risk analysis with Cellular Therapeutic related to input materials – Packaging storage and administration <\/td>\n<\/tr>\n
34<\/td>\nAnnex\u20acE (informative) Risk-based classification for monitoring practices for Cellular Therapeutic Product manufacturing <\/td>\n<\/tr>\n
35<\/td>\nAnnex\u20acF (informative) Validation of rapid microbial test methods <\/td>\n<\/tr>\n
37<\/td>\nAnnex\u20acG (informative) Microorganisms for validation of rapid microbial test methods <\/td>\n<\/tr>\n
41<\/td>\nAnnex\u20acH (informative) Methods for rapid microbial testing <\/td>\n<\/tr>\n
47<\/td>\nAnnex\u20acI (normative) Environmental control <\/td>\n<\/tr>\n
48<\/td>\nBibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

BS ISO 24190. Biotechnology. Analytical Methods. Risk based approach for design and validation of methods for rapid microbial detection in bioprocesses<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
BSI<\/b><\/a><\/td>\n2022<\/td>\n50<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":408595,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[2641],"product_tag":[],"class_list":{"0":"post-408588","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-bsi","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\/408588","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\/408595"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=408588"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=408588"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=408588"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}