ISO 21882:2019

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 2019
© ISO 2019
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ii © ISO 2019 – All rights reserved

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 Visible particles. 4
6.4.2 Sub-visible particles . 4
6.5 Bacterial endotoxin level . 5
7 Requirements for packaging system . 5
7.1 General . 5
7.2 Nest and tub configuration . 6
7.3 Tray configuration . 6
7.4 Nest . 6
7.5 Tub and tray . 7
7.6 Insert liner . 7
7.7 Sealing lid . 7
7.8 Protective bag . 8
7.9 Information to be provided by the manufacturer . 8
8 Marking of the tub or tray . 8
9 Labelling . 9
Annex A (informative) Design of tub .10
Annex B (informative) Design of nest .11
Annex C (informative) Design of tray .12
Annex D (informative) Schematic illustrations of examples for the orientation of tubs or
trays within the protective bag .13
Annex E (informative) Sample preparation for endotoxin and particulate determination .16
Annex F (informative) Packaging configuration .19
Bibliography .20
Foreword
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blood processing equipment for medical and pharmaceutical use.
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iv © ISO 2019 – All rights reserved

Introduction
In the last few years, following the more and more urgent request for ready for filling containers,
packaging manufacturers managed to offer to the pharmaceutical industry containers already washed
and sterilized. This category of products was born about 30 years ago with the appearance on the
market of ready for filling syringes.
Only recently, the sterilized sub-assembled ready for filling syringes have been standardized by
ISO 11040-4 and ISO 11040-7, including the corresponding packaging system. These two International
Standards define the performance requirements of the glass syringes and the related test methods, as
well as the ready for filling packaging system for these syringes, also including the test methods.
ISO 8362-1 specifies the form, dimensions and capacities of bulkware glass vials.
Due to the increasing market presence of syringes ready for filling and the associated advantages of
this product for the pharmaceutical industry, the suppliers of packaging materials started to develop
systems of this type for vials.
The availability of two packaging configurations makes ready for filling glass vials suitable to be used
both in clinical trials and in mass production. Nest and tub configuration has been conceived to be used
usually with automated filling machines, while tray configuration is usually suitable for small batches
filled manually or by means of semi-automated filling machines.
This duality of packaging configurations calls for a standardization of the production processes,
materials quality and analytical methods when launching these products on the market, in order to
avoid conceiving too highly customized processes.
INTERNATIONAL STANDARD ISO 21882:2019(E)
Sterile packaged ready for filling glass vials
1 Scope
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.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies
ISO 720, Glass — Hydrolytic resistance of glass grains at 121 °C — Method of test and classification
ISO 8362-1, Injection containers and accessories — Part 1: Injection vials made of glass tubing
ISO 8362-4, Injection containers and accessories — Part 4: Injection vials made of moulded glass
ISO 10993-7, Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals
ISO 11138 (all parts), Sterilization of health care products — Biological indicators
ISO 11140 (all parts), Sterilization of health care products — Chemical indicators
ISO 11607-1, Packaging for terminally sterilized medical devices — Part 1: Requirements for materials,
sterile barrier systems and packaging sys
...