{"id":198306,"date":"2024-10-19T12:37:27","date_gmt":"2024-10-19T12:37:27","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/aami-13408-1-2008-ra-2017-a1-2013\/"},"modified":"2024-10-25T05:10:33","modified_gmt":"2024-10-25T05:10:33","slug":"aami-13408-1-2008-ra-2017-a1-2013","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/aami\/aami-13408-1-2008-ra-2017-a1-2013\/","title":{"rendered":"AAMI 13408 1 2008 RA 2017 A1 2013"},"content":{"rendered":"

Specifies the general requirements for, and offers guidance on, processes, programs and procedures for development, validation and routine control of the manufacturing process for aseptically processed health care products.<\/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\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
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 13408-1:2008 <\/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 <\/td>\n<\/tr>\n
16<\/td>\n3 Terms and definitions <\/td>\n<\/tr>\n
21<\/td>\n4 Quality system elements
4.1 General <\/td>\n<\/tr>\n
22<\/td>\n4.2 Assignment of responsibilities
4.3 Calibration
5 Aseptic process definition
5.1 General <\/td>\n<\/tr>\n
23<\/td>\n5.2 Risk management
5.2.1 General
5.2.2 Identification of microbiological contamination risks <\/td>\n<\/tr>\n
24<\/td>\n5.2.3 Assessment of contamination risks
5.2.4 Monitoring and detection of contamination <\/td>\n<\/tr>\n
25<\/td>\n5.2.5 Prevention of contamination
6 Manufacturing environment
6.1 General <\/td>\n<\/tr>\n
26<\/td>\n6.2 Manufacturing environment design
6.2.1 General
6.2.2 Construction features <\/td>\n<\/tr>\n
27<\/td>\n6.3 Layout
6.3.1 General
6.3.2 Critical processing zone <\/td>\n<\/tr>\n
28<\/td>\n6.3.3 Direct support zones
6.3.4 Indirect support zones
6.3.5 Material airlocks, transfer hatches, and product exit openings <\/td>\n<\/tr>\n
29<\/td>\n6.3.6 Personnel airlocks
6.3.7 Ancillary areas
6.4 Material and personnel flow
6.4.1 General <\/td>\n<\/tr>\n
30<\/td>\n6.4.2 Introduction of materials and components to the APA
6.5 HVAC system
6.5.1 General <\/td>\n<\/tr>\n
31<\/td>\n6.5.2 Air handling
6.5.3 Airflow patterns
6.5.4 Temperature and relative humidity
6.5.5 HEPA (including ULPA) filters
6.5.5.1 General
6.5.5.2 HEPA filter certification <\/td>\n<\/tr>\n
32<\/td>\n6.5.5.3 Installed filter leakage test
6.5.5.4 HEPA filter failure
6.6 Cleanroom qualification
6.7 Utility services and ancillary equipment
6.7.1 General
6.7.2 Water and wastewater <\/td>\n<\/tr>\n
33<\/td>\n6.7.3 Gases
6.7.4 Vacuum utilities
6.8 Environmental and personnel monitoring programs
6.8.1 General <\/td>\n<\/tr>\n
34<\/td>\n6.8.2 Sampling for particulate monitoring
6.8.3 Sampling for microbiological environmental monitoring
6.8.4 Monitoring of personnel <\/td>\n<\/tr>\n
35<\/td>\n6.8.5 Monitoring procedures
6.8.6 Evaluation of monitoring data
6.8.6.1 Alert and action levels
6.8.6.2 Review of data and trend analysis <\/td>\n<\/tr>\n
36<\/td>\n6.8.6.3 Investigations and reports <\/td>\n<\/tr>\n
37<\/td>\n7 Equipment
7.1 Qualification
7.1.1 General
7.1.2 User requirements
7.1.3 Design qualification <\/td>\n<\/tr>\n
38<\/td>\n7.1.4 Installation qualification
7.1.5 Operational qualification
7.1.6 Performance qualification
7.1.7 Requalification <\/td>\n<\/tr>\n
39<\/td>\n7.2 Maintenance of equipment
7.2.1 Scheduled preventive maintenance
7.2.2 Unplanned maintenance <\/td>\n<\/tr>\n
40<\/td>\n8 Personnel
8.1 General
8.2 Training for APA qualification <\/td>\n<\/tr>\n
42<\/td>\n8.3 Gowning procedures
8.3.1 General
8.3.2 Gowning for entering the APA <\/td>\n<\/tr>\n
43<\/td>\n8.4 General employee health
9 Manufacture of the product
9.1 Attainment and maintenance of sterility
9.1.1 Component sterilization <\/td>\n<\/tr>\n
44<\/td>\n9.1.2 Depyrogenation
9.1.3 Product sterilization
9.2 Duration of the manufacturing process <\/td>\n<\/tr>\n
45<\/td>\n9.3 Aseptic manufacturing procedures
9.4 Cleaning and disinfection of facilities
9.4.1 General
9.4.2 Cleaning <\/td>\n<\/tr>\n
46<\/td>\n9.4.3 Disinfection
9.4.4 Equipment used for cleaning\/disinfection in APA <\/td>\n<\/tr>\n
47<\/td>\n9.4.5 Monitoring of cleaning and disinfection effectiveness
9.4.6 Effectiveness of disinfection procedures
9.5 Cleaning, disinfection and sterilization of equipment
9.5.1 General
9.5.2 Cleaning of equipment <\/td>\n<\/tr>\n
48<\/td>\n9.5.3 Disinfection of equipment
9.5.4 Sterilization of critical surfaces
9.5.5 Endotoxin control on critical surfaces <\/td>\n<\/tr>\n
49<\/td>\n10 Process simulation
10.1 General
10.2 Media selection and growth support
10.3 Simulation procedures <\/td>\n<\/tr>\n
50<\/td>\n10.4 Incubation and inspection of media filled units <\/td>\n<\/tr>\n
51<\/td>\n10.5 Initial performance qualification
10.5.1 General
10.5.2 Numbers to be filled
10.5.3 Acceptance criteria <\/td>\n<\/tr>\n
52<\/td>\n10.6 Periodic performance requalification
10.6.1 Scheduling requirements
10.6.2 Numbers to be filled
10.6.3 Acceptance criteria
10.7 Repeat of initial performance qualification
10.8 Documentation of process simulations <\/td>\n<\/tr>\n
53<\/td>\n10.9 Disposition of filled product <\/td>\n<\/tr>\n
54<\/td>\n11 Test for sterility
11.1 General <\/td>\n<\/tr>\n
55<\/td>\n11.2 Investigation of positive units from tests for sterility <\/td>\n<\/tr>\n
56<\/td>\nAnnex A Example of a flow chart <\/td>\n<\/tr>\n
57<\/td>\nAnnex B Typical elements of an aseptic process definition <\/td>\n<\/tr>\n
58<\/td>\nAnnex C Examples of specific risks <\/td>\n<\/tr>\n
59<\/td>\nAnnex D Comparison of classification of cleanrooms <\/td>\n<\/tr>\n
60<\/td>\nAnnex E Specification for water used in the process
E.1 Source water
E.2 Treated source water
E.3 Purified water <\/td>\n<\/tr>\n
61<\/td>\nE.4 Water for injections <\/td>\n<\/tr>\n
62<\/td>\nAnnex F Aseptic processing area <\/td>\n<\/tr>\n
63<\/td>\nBibliography <\/td>\n<\/tr>\n
65<\/td>\nANSI\/AAMI\/ISO 13408-1:2008\/(R)2017, Aseptic processing of health care products \u2014 Part 1: General requirements Amendment 1 <\/td>\n<\/tr>\n
66<\/td>\nAAMI Standard
Copyright information <\/td>\n<\/tr>\n
67<\/td>\nContents <\/td>\n<\/tr>\n
68<\/td>\nCommittee representation <\/td>\n<\/tr>\n
70<\/td>\nBackground on AAMI adoption of ISO 13408-1:2008 Amd. 1 <\/td>\n<\/tr>\n
71<\/td>\nForeword <\/td>\n<\/tr>\n
73<\/td>\nAmendment 1
\n <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

ANSI\/AAMI\/ISO 13408-1:2008\/(R)2017 & A1:2013 – Aseptic processing of health care products- Part 1: General requirements (includes Amendment 1).<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
AAMI<\/b><\/a><\/td>\n2008<\/td>\n79<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":198309,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[2654],"product_tag":[],"class_list":{"0":"post-198306","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\/198306","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\/198309"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=198306"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=198306"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=198306"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}