ISO 21881:2019

Sterile packaged ready for filling glass cartridges

This document specifies the characteristics of sterile and ready for filling empty glass cartridges for injectable preparations, including the minimum requirements of materials, packaging systems and analytical test methods.

Cartouches 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 21881
First edition
2019-10
Sterile packaged ready for filling glass
cartridges
Cartouches en verre préremplissables sous emballage stérile
Reference number
ISO 21881:2019(E)
©
ISO 2019

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ISO 21881:2019(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2019
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ii © ISO 2019 – All rights reserved

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ISO 21881:2019(E)

Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Quality system . 3
4.1 General . 3
4.2 Testing . 3
5 Process description and requirements . 3
5.1 Washing . 3
5.2 Drying . 3
5.3 Lubrication . 3
5.4 Capping and crimping . 4
5.5 Plunger insertion . 4
5.6 Packaging . 4
5.7 Sterilization . 4
6 Requirements for glassware . 4
6.1 General . 4
6.2 Material .
...