{"id":464738,"date":"2024-10-20T10:36:36","date_gmt":"2024-10-20T10:36:36","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bs-iso-218822019\/"},"modified":"2024-10-26T19:33:34","modified_gmt":"2024-10-26T19:33:34","slug":"bs-iso-218822019","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bs-iso-218822019\/","title":{"rendered":"BS ISO 21882:2019"},"content":{"rendered":"

This document specifies the characteristics of sterile and ready for filling empty glass vials for injectable preparations, including the minimum requirements of materials, packaging systems and analytical test methods.<\/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
PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
2<\/td>\nNational foreword <\/td>\n<\/tr>\n
6<\/td>\nForeword <\/td>\n<\/tr>\n
7<\/td>\nIntroduction <\/td>\n<\/tr>\n
9<\/td>\n1 Scope
2 Normative references
3 Terms and definitions <\/td>\n<\/tr>\n
10<\/td>\n4 Quality system
4.1 General <\/td>\n<\/tr>\n
11<\/td>\n4.2 Testing
5 Process description and requirements
5.1 Washing
5.2 Drying
5.3 Packaging
5.4 Sterilization <\/td>\n<\/tr>\n
12<\/td>\n6 Requirements for glassware
6.1 General
6.2 Material
6.3 Dimensions
6.4 Particles
6.4.1 Visible particles
6.4.2 Sub-visible particles <\/td>\n<\/tr>\n
13<\/td>\n6.5 Bacterial endotoxin level
7 Requirements for packaging system
7.1 General <\/td>\n<\/tr>\n
14<\/td>\n7.2 Nest and tub configuration
7.3 Tray configuration
7.4 Nest <\/td>\n<\/tr>\n
15<\/td>\n7.5 Tub and tray
7.6 Insert liner
7.7 Sealing lid <\/td>\n<\/tr>\n
16<\/td>\n7.8 Protective bag
7.9 Information to be provided by the manufacturer
8 Marking of the tub or tray <\/td>\n<\/tr>\n
17<\/td>\n9 Labelling <\/td>\n<\/tr>\n
18<\/td>\nAnnex A (informative) Design of tub <\/td>\n<\/tr>\n
19<\/td>\nAnnex B (informative) Design of nest <\/td>\n<\/tr>\n
20<\/td>\nAnnex C (informative) Design of tray <\/td>\n<\/tr>\n
21<\/td>\nAnnex D (informative) Schematic illustrations of examples for the orientation of tubs or trays within the protective bag <\/td>\n<\/tr>\n
23<\/td>\nAnnex E (informative) Sample preparation for endotoxin and particulate determination <\/td>\n<\/tr>\n
26<\/td>\nAnnex F (informative) Packaging configuration <\/td>\n<\/tr>\n
27<\/td>\nBibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

Sterile packaged ready for filling glass vials<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
BSI<\/b><\/a><\/td>\n2019<\/td>\n28<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":464748,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[157,2641],"product_tag":[],"class_list":{"0":"post-464738","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-11-080-30","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\/464738","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\/464748"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=464738"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=464738"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=464738"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}