ISO 21882:2019
(Main)Sterile packaged ready for filling glass vials
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
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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
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting
on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address
below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
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
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www .iso .org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www .iso
.org/iso/foreword .html.
This document was prepared by Technical Committee ISO/TC 76, Transfusion, infusion and injection, and
blood processing equipment for medical and pharmaceutical use.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www .iso .org/members .html.
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
...
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
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting
on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address
below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
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
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www .iso .org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www .iso
.org/iso/foreword .html.
This document was prepared by Technical Committee ISO/TC 76, Transfusion, infusion and injection, and
blood processing equipment for medical and pharmaceutical use.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www .iso .org/members .html.
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
...
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