{"id":415346,"date":"2024-10-20T06:04:40","date_gmt":"2024-10-20T06:04:40","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bs-en-iso-13408-62021\/"},"modified":"2024-10-26T11:17:59","modified_gmt":"2024-10-26T11:17:59","slug":"bs-en-iso-13408-62021","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bs-en-iso-13408-62021\/","title":{"rendered":"BS EN ISO 13408-6:2021"},"content":{"rendered":"

This document specifies the requirements for and provides guidance on the specification, selection, qualification, bio-decontamination, validation, operation and control of isolator systems related to aseptic processing of health care products and processing of cell-based health care products.<\/p>\n

This document does not specify requirements for restricted access barrier systems (RABS).<\/p>\n

This document does not supersede or replace national regulatory requirements such as Good Manufacturing Practices (GMPs) and\/or compendia requirements that pertain in particular to national or regional jurisdictions.<\/p>\n

This document does not specify requirements for isolators used for sterility testing; however, some of the principles and information in this document could be applicable to this application.<\/p>\n

This document does not define biosafety containment requirements.<\/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
PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
2<\/td>\nNational foreword <\/td>\n<\/tr>\n
6<\/td>\nEuropean foreword <\/td>\n<\/tr>\n
8<\/td>\nAnnex ZA (informative) Relationship between this European Standard and the essential requirements of Directive 90\/385\/EEC [OJ L 189] aimed to be covered <\/td>\n<\/tr>\n
10<\/td>\nAnnex ZB (informative) Relationship between this European Standard and the essential requirements of Directive 93\/42\/EEC [OJ L 169] aimed to be covered <\/td>\n<\/tr>\n
12<\/td>\nAnnex ZC (informative) Relationship between this European Standard and the essential requirements of Directive 98\/79\/EC [OJ L 331] aimed to be covered <\/td>\n<\/tr>\n
14<\/td>\nAnnex ZD (informative) Relationship between this European Standard and the General Safety and Performance requirements of Regulation (EU) 2017\/745 aimed to be covered <\/td>\n<\/tr>\n
17<\/td>\nAnnex ZE (informative) Relationship between this European Standard and the General Safety and Performance Requirements of Regulation (EU) 2017\/746 aimed to be covered <\/td>\n<\/tr>\n
21<\/td>\nForeword <\/td>\n<\/tr>\n
22<\/td>\nIntroduction <\/td>\n<\/tr>\n
23<\/td>\n1 Scope
2 Normative references
3 Terms and definitions <\/td>\n<\/tr>\n
25<\/td>\n4 Quality system elements
5 Basic principle of isolator systems
5.1 General <\/td>\n<\/tr>\n
26<\/td>\n5.2 Negative pressure isolators
6 Isolator system specification
6.1 General
6.2 Risk management
6.2.1 General <\/td>\n<\/tr>\n
27<\/td>\n6.2.2 Negative pressure isolator systems
6.3 User requirement specification
7 Design of isolator systems
7.1 General <\/td>\n<\/tr>\n
28<\/td>\n7.2 Materials of construction
7.3 Air-handling system
7.3.1 General
7.3.2 Air change rate
7.3.3 Airflow pattern <\/td>\n<\/tr>\n
29<\/td>\n7.3.4 Temperature\/humidity
7.3.5 Particulate air specifications
7.3.6 Recirculation of air
7.3.7 Pressure differentials
7.4 Operator interface
7.4.1 Isolator gloves\/sleeves <\/td>\n<\/tr>\n
30<\/td>\n7.4.2 Suits\/half-suits
7.4.3 Access to the isolator\/transfer systems
7.4.4 Devices acting as transfer ports <\/td>\n<\/tr>\n
31<\/td>\n7.5 Ancillary isolator equipment
7.5.1 Portable and mobile equipment
7.6 Surrounding room classification
7.7 Process utilities
8 Validation
8.1 General <\/td>\n<\/tr>\n
32<\/td>\n8.2 Design qualification
8.2.1 General
8.2.2 Product\/process application
8.2.3 Ergonomics
8.2.4 Cleaning <\/td>\n<\/tr>\n
33<\/td>\n8.2.5 Bio-decontamination
8.2.6 Selection of bio-decontamination agent
8.2.7 Development and validation of bio-decontamination processes <\/td>\n<\/tr>\n
34<\/td>\n8.2.8 Bio-decontamination agent generation and testing
8.2.9 Bio-decontamination parameters <\/td>\n<\/tr>\n
35<\/td>\n8.2.10 Aeration and residue limits
8.2.11 Log reduction
8.2.12 Surface bio-decontamination of items <\/td>\n<\/tr>\n
36<\/td>\n8.2.13 Development and validation of sterilization processes
8.3 Installation qualification
8.3.1 General
8.3.2 Installation <\/td>\n<\/tr>\n
37<\/td>\n8.4 Operational qualification
8.5 Performance qualification
8.5.1 General <\/td>\n<\/tr>\n
38<\/td>\n8.5.2 Cleaning
8.5.3 Bio-decontamination
8.5.4 Process simulation tests
8.6 Review and approval of validation
8.7 Requalification <\/td>\n<\/tr>\n
39<\/td>\n9 Routine monitoring and control
9.1 Procedures
9.2 System integrity
9.3 Bio-decontamination process monitoring <\/td>\n<\/tr>\n
40<\/td>\n9.4 Environmental monitoring
9.5 Change control
9.6 Maintenance and calibration
10 Personnel training <\/td>\n<\/tr>\n
42<\/td>\nAnnex A (informative) Devices acting as transfer ports for portable and mobile equipment <\/td>\n<\/tr>\n
45<\/td>\nAnnex B (informative) Isolator system \u2014 Explanation of terms used and flow of air and material <\/td>\n<\/tr>\n
46<\/td>\nAnnex C (informative) Isolator system \u2014 Direct\/indirect product contact surfaces <\/td>\n<\/tr>\n
47<\/td>\nBibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

Aseptic processing of health care products – Isolator systems<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
BSI<\/b><\/a><\/td>\n2021<\/td>\n48<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":415356,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[154,2641],"product_tag":[],"class_list":{"0":"post-415346","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-11-080-01","7":"product_cat-bsi","9":"first","10":"instock","11":"sold-individually","12":"shipping-taxable","13":"purchasable","14":"product-type-simple"},"_links":{"self":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product\/415346","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\/415356"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=415346"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=415346"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=415346"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}