ISO 11040-7:2024

Prefilled syringes — Part 7: Packaging systems for sterilized subassembled syringes ready for filling

This document specifies a packaging system that is used to deliver sterilized subassembled syringes ready for filling in tubs and nests. Downstream processes (processes after filling such as in house/outside transport, reprocessing) can result in specific requirements on the packaging system used to deliver sterilized subassembled syringes ready for filling. However, these requirements are not within the scope of this document. NOTE 1 Glass barrels and sterilized subassembled syringes ready for filling, plunger stoppers, and plastic barrels for injectables are specified in ISO 11040-4, ISO 11040-5 and ISO 11040-6. NOTE 2 ISO 11607-2 addresses validation requirements of sealing and packaging processes for medical devices.

Seringues préremplies — Partie 7: Systèmes d'emballage pour les seringues pré-assemblées stérilisées préremplissables

Le présent document décrit un système d'emballage utilisé pour livrer les seringues stérilisées prêtes à l'emploi préremplissables dans des barquettes et des présentoirs. Les procédés en aval (procédés postérieurs au remplissage tels que le transport en interne/à l'extérieur ou le retraitement) peuvent donner lieu à des exigences spécifiques concernant le système d'emballage utilisé pour livrer les seringues stérilisées prêtes à l'emploi préremplissables. Ces exigences ne relèvent toutefois pas du domaine d'application du présent document. NOTE 1 Les cylindres en verre et les seringues en verre stérilisées prêtes à l'emploi préremplissables, les bouchons-pistons et les cylindres en plastique pour produits injectables sont décrits dans les normes ISO 11040-4, ISO 11040-5, et ISO 11040-6. NOTE 2 L'ISO 11607-2 présente les exigences de validation pour les procédés de scellage et d'emballage des dispositifs médicaux.

General Information

• Status: Published
• Publication Date: 02-Jun-2024
• ICS: 11.040.25 - Syringes, needles an catheters
• Technical Committee: ISO/TC 76 - Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use
• Drafting Committee: ISO/TC 76 - Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use
• Current Stage: 6060 - International Standard published
• Start Date: 03-Jun-2024
• Due Date: 26-Apr-2024
• Completion Date: 03-Jun-2024

Relations

• Revises: ISO 11040-7:2015 - Prefilled syringes — Part 7: Packaging systems for sterilized subassembled syringes ready for filling
• Effective Date: 06-Jun-2022

Standards Content (Sample)

International
Standard
ISO 11040-7
Second edition
Prefilled syringes —
2024-06
Part 7:
Packaging systems for sterilized
subassembled syringes ready
for filling
Seringues préremplies —
Partie 7: Systèmes d'emballage pour les seringues pré-assemblées
stérilisées préremplissables
Reference number
ISO 11040-7:2024(en) © ISO 2024

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ISO 11040-7:2024(en)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2024
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: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland

© ISO 2024 – All rights reserved
ii

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ISO 11040-7:2024(en)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Requirements for the packaging system .3
4.1 General .3
4.2 Nest and tub configuration .4
4.3 Nest .4
4.4 Tub .5
4.5 Insert liner .5
4.6 Sealing lid .5
4.7 Protective bag .5
4.8 Additional information to be provided by the manufacturer.6
5 Marking of the tub .6
6 Labelling . 7
7 Packaging of tubs in trading units/bundles . 7
Annex A (informative) Design of nests .
...

Norme
internationale
ISO 11040-7
Deuxième édition
Seringues préremplies —
2024-06
Partie 7:
Systèmes d'emballage pour
les seringues pré-assemblées
stérilisées préremplissables
Prefilled syringes —
Part 7: Packaging systems for sterilized subassembled syringes
ready for filling
Numéro de référence
ISO 11040-7:2024(fr) © ISO 2024

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ISO 11040-7:2024(fr)
DOCUMENT PROTÉGÉ PAR COPYRIGHT
© ISO 2024
Tous droits réservés. Sauf prescription différente ou nécessité dans le contexte de sa mise en œuvre, aucune partie de cette
publication ne peut être reproduite ni utilisée sous quelque forme que ce soit et par aucun procédé, électronique ou mécanique,
y compris la photocopie, ou la diffusion sur l’internet ou sur un intranet, sans autorisation écrite préalable. Une autorisation peut
être demandée à l’ISO à l’adresse ci-après ou au comité membre de l’ISO dans le pays du demandeur.
ISO copyright office
Case postale 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Genève
Tél.: [phone]
E-mail: [e-mail]
Web: www.iso.org
Publié en Suisse

© ISO 2024 – Tous droits réservés
ii

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ISO 11040-7:2024(fr)
Sommaire Page
Avant-propos .iv
Introduction .vi
1 Domaine d'application . 1
2 Références normatives . 1
3 Termes et définitions . 2
4 Exigences relatives au système d'emballage . 3
4.1 Généralités .3
4.2 Configuration du présentoir et de la barquette .4
4.3 Présentoir.4
4.4 Barquette .5
4.5 Film séparateur . .5
4.6 Opercule de scellage .5
4.7 Sachet de protection .6
4.8 Informations supplémentaires à fournir par le fabricant .6
5 Marquage de la barquette . 6
6 Étiquetage . 7
7 Emballage des barquettes dans des unités/paquets de commercialisation . 7
Annexe A (informative) Conception des présentoirs . 8
Annexe B (in
...

FINAL DRAFT
International
Standard
ISO/FDIS 11040-7
ISO/TC 76
Prefilled syringes —
Secretariat: DIN
Part 7:
Voting begins on:
2024-03-14
Packaging systems for sterilized
subassembled syringes ready for
Voting terminates on:
2024-05-09
filling
Seringues préremplies —
Partie 7: Systèmes d'emballage pour les seringues pré-assemblées
stérilisées préremplissables
RECIPIENTS OF THIS DRAFT ARE INVITED TO SUBMIT,
WITH THEIR COMMENTS, NOTIFICATION OF ANY
RELEVANT PATENT RIGHTS OF WHICH THEY ARE AWARE
AND TO PROVIDE SUPPOR TING DOCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO-
LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE
MADE IN NATIONAL REGULATIONS.
Reference number
ISO/FDIS 11040-7:2024(en) © ISO 2024

---------------------- Page: 1 ----------------------
FINAL DRAFT
ISO/FDIS 11040-7:2024(en)
International
Standard
ISO/FDIS 11040-7
ISO/TC 76
Prefilled syringes —
Secretariat: DIN
Part 7:
Voting begins on:
Packaging systems for sterilized
subassembled syringes ready
Voting terminates on:
for filling
Seringues préremplies —
Partie 7: Systèmes d'emballage pour les seringues pré-assemblées
stérilisées préremplissables
RECIPIENTS OF THIS DRAFT ARE INVITED TO SUBMIT,
COPYRIGHT PROTECTED DOCUMENT
WITH THEIR COMMENTS, NOTIFICATION OF ANY
RELEVANT PATENT RIGHTS OF WHICH THEY ARE AWARE
AND TO PROVIDE SUPPOR TING DOCUMENTATION.
© ISO 2024
IN ADDITION TO THEIR EVALUATION AS
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO-
LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
or ISO’s member body in the country of the requester.
TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE
MADE IN NATIONAL REGULATIONS.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland Reference number
ISO/FDIS 11040-7:2024(en) © ISO 2024

© ISO 2024 – All rights reserved
ii

---------------------- Page: 2 ----------------------
ISO/FDIS 11040-7:2024(en)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Requirements for the packaging system .3
4.1 General .3
4.2 Nest and tub configuration .4
4.3 Nest .4
4.4 Tub .5
4.5 Insert liner .
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ISO/FDIS 11040-7:2024(E)
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ISO /TC 76
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Secretariat: DIN
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Date: 2024-02-0228
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Prefilled syringes —
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Part 7:
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Packaging systems for sterilized subassembled syringes ready for
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filling
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Seringues préremplies —
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Partie 7: Systèmes d'emballage pour les seringues pré-assemblées stérilisées préremplissables
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ISO/FDIS 11040-7:2024(Een) Formatted: Font: 11 pt
Formatted: Font: 11 pt
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© ISO 2024
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All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication
Gutter: 0 cm, Header distance from edge: 1.27 cm,
may be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying,
Footer distance from edge: 0.5 cm
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. Formatted: Default Paragraph Font
Formatted: Default Paragraph Font
ISO copyright office
Formatted: Indent: Left: 0 cm, Right: 0 cm, Space
CP 401 • Ch. de Blandonnet 8
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CH-1214 Vernier, Geneva
between Latin and Asian text, Adjust space between
Phone: + 41 22 749 01 11
Asian text and numbers
EmailE-mail: [e-mail]
Website: www.iso.orgwww.iso.org
Formatted: French (Switzerland)
Formatted: French (Switzerland)
Published in Switzerland
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Formatted: English (United Kingdom)
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ii © ISO 2024 – All rights reserved
© ISO 2024 – All rights reserved

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ISO/FDIS 11040-7:2024(Een) Formatted: Font: 11 pt
Formatted: Font: 11 pt
Formatted: HeaderCentered, Left, Space After: 0 pt,
Contents
Line spacing: single
Formatted: Adjust space between Latin and Asian text,
Foreword . v
Adjust space between Asian text and numbers, Tab
Introduction . vii stops: Not at 17.2 cm
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Requirements for the packaging system . 3
4.1 General . 3
4.2 Nest and tub configuration . 4
4.3 Nest .
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