{"id":198105,"date":"2024-10-19T12:36:43","date_gmt":"2024-10-19T12:36:43","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/aami-13408-7-2012-ra-2018\/"},"modified":"2024-10-25T05:09:55","modified_gmt":"2024-10-25T05:09:55","slug":"aami-13408-7-2012-ra-2018","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/aami\/aami-13408-7-2012-ra-2018\/","title":{"rendered":"AAMI 13408 7 2012 RA 2018"},"content":{"rendered":"

Specifies the requirements for, and offers guidance on, processes, programs and procedures for procurement, development, validation, routine control of the manufacturing process and transport for aseptically processed cell based medical products (CBMP), especially tissue engineering products (TEP\u00b4s) whose biological properties have to be kept intact to maintain their efficacy as a medical device and\/or medicinal product.<\/p>\n

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
PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
1<\/td>\nANSI\/AAMI\/ISO 13408-7:2012\/(R)2018, Aseptic processing of health care products \u2014 Part 7: Alternative processes for atypical medical devices and combination products <\/td>\n<\/tr>\n
2<\/td>\nObjectives and uses of AAMI standards and recommended practices <\/td>\n<\/tr>\n
3<\/td>\nTitle page <\/td>\n<\/tr>\n
4<\/td>\nAAMI Standard
Copyright information <\/td>\n<\/tr>\n
5<\/td>\nContents <\/td>\n<\/tr>\n
6<\/td>\nGlossary of equivalent standards <\/td>\n<\/tr>\n
9<\/td>\nCommittee representation <\/td>\n<\/tr>\n
11<\/td>\nBackground of AAMI adoption of ISO 13408-7:2012 <\/td>\n<\/tr>\n
12<\/td>\nForeword <\/td>\n<\/tr>\n
13<\/td>\nIntroduction <\/td>\n<\/tr>\n
15<\/td>\n1 Scope
2 Normative references
3 Terms and definitions <\/td>\n<\/tr>\n
16<\/td>\n4 Quality system elements
5 Aseptic process definition
5.1 General
5.2 Risk management
5.2.1 General
5.2.2 Identification of microbiological contamination risks <\/td>\n<\/tr>\n
17<\/td>\n5.2.3 Assessment of contamination risks
5.2.4 Monitoring and detection of contamination
5.2.5 Prevention of contamination
5.2.6 Use of risk assessment during the development and initial qualification of the aseptic process prior to commercial production
5.2.7 Use of risk assessment for the aseptic process simulation for process validation of commercial production
6 Manufacturing environment
7 Equipment <\/td>\n<\/tr>\n
18<\/td>\n8 Personnel
9 Manufacture of the product
10 Process simulation
10.1 General
10.2 Media selection and growth support
10.3 Simulation procedures <\/td>\n<\/tr>\n
20<\/td>\n10.4 Incubation and inspection of process simulation units <\/td>\n<\/tr>\n
21<\/td>\n10.5 Initial performance qualification
10.5.1 General
10.5.2 Numbers to be filled
10.5.3 Acceptance criteria
10.6 Periodic performance requalification
10.6.1 Scheduling requirements
10.6.2 Numbers to be filled <\/td>\n<\/tr>\n
22<\/td>\n10.6.3 Acceptance criteria
10.7 Repeat of initial performance qualification
10.8 Documentation of process simulations
10.9 Disposition of filled product
11 Test for sterility
11.1 General
11.2 Investigation of positive units from tests for sterility <\/td>\n<\/tr>\n
23<\/td>\nAnnex A (informative) Risk assessment for aseptic processing \u2014 Quality risk management method
A.1 General
A.2 Background
A.3 Risk priority number determination
A.4 Risk assessment <\/td>\n<\/tr>\n
28<\/td>\nA.5 Risk acceptance
A.6 Risk reduction
A.7 Verification of acceptability of overall residual risk
A.8 Key process parameters <\/td>\n<\/tr>\n
29<\/td>\nA.9 Process simulation design
A.9.1 Process simulation of the initial aseptic process (manual method)
A.9.2 Process simulation for the optimized aseptic process
A.10 Acceptance criteria <\/td>\n<\/tr>\n
30<\/td>\nAnnex B (informative) Selection of a sample for testing for microbial contamination
B.1 Actual product
B.2 Surrogate product <\/td>\n<\/tr>\n
32<\/td>\nAnnex C (informative) Testing options for process simulation
C.1 Testing option considerations <\/td>\n<\/tr>\n
33<\/td>\nC.2 Test methods
C.2.1 Direct contact of media with product
C.2.1.1 General considerations
C.2.1.2 Direct immersion method
C.2.1.3 In situ direct contact of media with patient contact surfaces
C.2.2 Elution\/removal methods <\/td>\n<\/tr>\n
35<\/td>\nBibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

ANSI\/AAMI\/ISO 13408-7:2012\/(R)2018 – Aseptic processing of health care products-Part 7: Alternative processes for medical devices and combination products<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
AAMI<\/b><\/a><\/td>\n2012<\/td>\n36<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":198108,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[2654],"product_tag":[],"class_list":{"0":"post-198105","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\/198105","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\/198108"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=198105"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=198105"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=198105"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}