{"id":198411,"date":"2024-10-19T12:37:50","date_gmt":"2024-10-19T12:37:50","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/aami-13408-6-2005-ra-2013\/"},"modified":"2024-10-25T05:10:52","modified_gmt":"2024-10-25T05:10:52","slug":"aami-13408-6-2005-ra-2013","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/aami\/aami-13408-6-2005-ra-2013\/","title":{"rendered":"AAMI 13408 6 2005 RA 2013"},"content":{"rendered":"

Specifies the requirements for isolator systems used for aseptic processing and offers guidance on qualification, bio-decontamination, validation, operation and control of isolator systems used for aseptic processing of health care products. The document focuses on the use of isolator systems to maintain aseptic conditions; this may include applications for hazardous materials.<\/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\n\n\n\n\n\n\n\n\n\n
PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
1<\/td>\nANSI\/AAMI\/ISO 13408-6:2005\/(R)2013, Aseptic processing of health care products \u2014 Part 6: Isolator systems <\/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
7<\/td>\nGlossary of equivalent standards <\/td>\n<\/tr>\n
9<\/td>\nCommittee representation <\/td>\n<\/tr>\n
11<\/td>\nBackground of ANSI\/AAMI adoption of ISO 13408-6:2005 <\/td>\n<\/tr>\n
13<\/td>\nForeword <\/td>\n<\/tr>\n
14<\/td>\nIntroduction <\/td>\n<\/tr>\n
15<\/td>\n1 Scope
2 Normative references
3 Terms and definitions <\/td>\n<\/tr>\n
17<\/td>\n4 Quality system elements
4.1 General
4.2 Management responsibility <\/td>\n<\/tr>\n
18<\/td>\n4.3 Design control
4.4 Measuring instruments and measuring systems
5 Design of isolator systems
5.1 General
5.2 Types of isolators
5.2.1 Closed
5.2.2 Open <\/td>\n<\/tr>\n
19<\/td>\n5.3 Materials of construction
5.4 Air-handling system
5.4.1 Air change rate
5.4.2 Air flow pattern
5.4.3 Temperature\/humidity
5.4.4 Particulate air specifications
5.4.5 Recirculation of air <\/td>\n<\/tr>\n
20<\/td>\n5.4.6 Pressure differentials
5.4.7 Filter maintenance
5.5 Operator interface
5.5.1 Isolator gloves\/sleeves
5.5.2 Suits\/half-suits
5.5.3 Access to the isolator <\/td>\n<\/tr>\n
21<\/td>\n5.6 Ancillary equipment
5.6.1 Portable and mobile equipment
5.6.2 Transfer ports
6 Facility requirements
6.1 Surrounding room classification
6.2 Process utilities <\/td>\n<\/tr>\n
22<\/td>\n7 User requirements
7.1 Product\/process application
7.2 Ergonomics
7.3 Cleaning
7.3.1 General
7.3.2 Clean-in-place
7.3.3 Manual cleaning
7.3.4 Cleaning agent <\/td>\n<\/tr>\n
23<\/td>\n7.4 Bio-decontamination
7.4.1 General
7.4.2 Sterilization-in-place
7.4.3 Selection of bio-decontamination agent <\/td>\n<\/tr>\n
24<\/td>\n7.4.4 Bio-decontamination agent generation and testing
7.4.5 Bio-decontamination parameters <\/td>\n<\/tr>\n
25<\/td>\n7.4.6 Aeration and residue limits
7.4.7 Spore log reduction
7.4.8 Surface bio-decontamination of goods
7.4.9 Surface bio-decontamination of container with sterile product
8 Validation
8.1 General <\/td>\n<\/tr>\n
26<\/td>\n8.2 Design qualification
8.3 Installation qualification
8.3.1 General
8.3.2 Installation <\/td>\n<\/tr>\n
27<\/td>\n8.4 Operational qualification <\/td>\n<\/tr>\n
28<\/td>\n8.5 Performance qualification
8.5.1 General
8.5.2 Cleaning
8.5.3 Bio-decontamination <\/td>\n<\/tr>\n
29<\/td>\n8.5.4 Process simulation tests
8.6 Review and approval of validation
8.7 Requalification <\/td>\n<\/tr>\n
30<\/td>\n9 Routine monitoring and control
9.1 Procedures
9.2 System integrity
9.3 Bio-decontamination process monitoring
9.4 Environmental monitoring
9.5 Change control <\/td>\n<\/tr>\n
31<\/td>\n9.6 Maintenance and calibration
10 Personnel training <\/td>\n<\/tr>\n
32<\/td>\nBibliography <\/td>\n<\/tr>\n
33<\/td>\nANSI\/AAMI\/ISO 13408-6:2005, Aseptic processing of health care products \u2014 Part 6: Isolator systems Amendment 1 <\/td>\n<\/tr>\n
34<\/td>\nAAMI Standard
Copyright information <\/td>\n<\/tr>\n
35<\/td>\nContents <\/td>\n<\/tr>\n
36<\/td>\nCommittee representation <\/td>\n<\/tr>\n
38<\/td>\nBackground on AAMI adoption of ISO 13408-6:2005 Amd. 1 <\/td>\n<\/tr>\n
39<\/td>\nForeword <\/td>\n<\/tr>\n
41<\/td>\nAmendment 1
\n <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

ANSI\/AAMI\/ISO 13408-6:2005\/(R)2013 & A1:2013 – Aseptic processing of health care products – Part 6: Isolator systems<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
AAMI<\/b><\/a><\/td>\n2005<\/td>\n44<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":198415,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[2654],"product_tag":[],"class_list":{"0":"post-198411","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\/198411","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\/198415"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=198411"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=198411"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=198411"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}