ISO 21882:2019

Sterile packaged ready for filling glass vials

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.

Flacons en verre préremplissables sous emballage stérile

General Information

• Status: Published
• Publication Date: 17-Oct-2019
• ICS: 11.080.30 - Sterilized packaging
• Technical Committee: ISO/TC 76 - Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use
• Drafting Committee: ISO/TC 76/WG 2 - Rigid container systems and related accessories for parenterals and injectables
• Current Stage: 9020 - International Standard under periodical review
• Start Date: 15-Apr-2024
• Completion Date: 15-Apr-2024

Standards Content (Sample)

INTERNATIONAL ISO
STANDARD 21882
First edition
2019-10
Sterile packaged ready for filling
glass vials
Flacons en verre préremplissables sous emballage stérile
Reference number
ISO 21882:2019(E)
©
ISO 2019

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ISO 21882:2019(E)

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© ISO 2019
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ii © ISO 2019 – All rights reserved

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ISO 21882:2019(E)

Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Quality system . 2
4.1 General . 2
4.2 Testing . 3
5 Process description and requirements . 3
5.1 Washing . 3
5.2 Drying . 3
5.3 Packaging . 3
5.4 Sterilization . 3
6 Requirements for glassware . 4
6.1 General . 4
6.2 Material . 4
6.3 Dimensions . 4
6.4 Particles . 4
6.4.1 Visibl
...