ISO 24166-3:2022
(Main)Snap-on bottles for metering pumps — Part 3: Plastic
Snap-on bottles for metering pumps — Part 3: Plastic
This document specifies the shape, dimensions, fill capacities and performance requirements of plastic bottles for metering pumps. It also specifies the material for the manufacturing of such containers as well as the secondary packaging. The document provides requirements for packaging of the plastic bottles and addresses nonsterile, ready to sterilize or sterile as three possible options. This document is applicable to colourless or coloured containers moulded from plastic and intended to be used in the packaging, storage or transportation of products intended for medicinal use.
Flacons avec jonc d’encliquetage pour pompes doseuses — Partie 3: Plastique
Le présent document spécifie la forme, les dimensions, les capacités de remplissage et les exigences de performance des flacons en plastique pour les pompes doseuses. Il spécifie également le matériau pour la fabrication de ces récipients ainsi que l'emballage secondaire. Le document fournit les exigences relatives à l'emballage des flacons en plastique et couvre trois options possibles: non stérile, prêt à stériliser ou stérile. Le présent document s'applique aux récipients, colorés ou non, moulés en plastique et destinés à être utilisés pour l'emballage, le stockage ou le transport de produits destinés à un usage médical.
General Information
Standards Content (Sample)
INTERNATIONAL ISO
STANDARD 24166-3
First edition
2022-08
Snap-on bottles for metering pumps —
Part 3:
Plastic
Flacons encliquetables pour pompes doseuses —
Partie 3: Plastique
Reference number
ISO 24166-3:2022(E)
© ISO 2022
---------------------- Page: 1 ----------------------
ISO 24166-3:2022(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2022
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
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
© ISO 2022 – All rights reserved
---------------------- Page: 2 ----------------------
ISO 24166-3:2022(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Symbols . 3
5 Dimensions .4
5.1 General . 4
5.2 Bottles without sealing ring . 4
5.3 Bottles with sealing ring . 5
6 Materials . 7
7 Requirements . 7
7.1 General requirements . 7
7.2 Physical requirements . 8
7.2.1 Vertical Force . . . 8
7.2.2 Particulate contaminations . 8
7.3 Chemical requirements . . 8
7.4 Sterilization . 8
8 Marking of the bottle .8
9 Packaging options . 8
9.1 General packaging requirements . 8
9.2 Packaging for nonsterile plastic bottles . 9
9.3 Ready to sterilize or sterile plastic bottles . 9
Annex A (informative) Snap-on considerations .10
Annex B (informative) Tightness test .12
Annex C (informative) Inner depth measuring .13
Annex D (informative) Vertical force measurement technical method .14
Annex E (informative) Example of a packaging configuration .17
Bibliography .18
iii
© ISO 2022 – All rights reserved
---------------------- Page: 3 ----------------------
ISO 24166-3:2022(E)
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.
A list of all parts in the ISO 24166 series can be found on the ISO website.
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 2022 – All rights reserved
---------------------- Page: 4 ----------------------
ISO 24166-3:2022(E)
Introduction
This document is part of a series of International Standards for containers made from different
materials used in combination with metering pumps for medicinal applications.
Glass containers are mainly used for that purpose. Plastic containers can be used as an alternative.
This document can be used for the development of standardized filling and assembling equipment.
Based on the dimensions of the containers, appropriate components, such as metering pumps and other
closure systems can be developed and standardized. As such this document provides important inputs
for developing entire packaging systems for medicinal applications.
Primary packaging materials are an integral part of medicinal products. Thus, depending on the
jurisdiction, the principles of the current Good Manufacturing Practices (cGMP) can apply to the
manufacturing of these components (e.g. ISO 15378).
v
© ISO 2022 – All rights reserved
---------------------- Page: 5 ----------------------
INTERNATIONAL STANDARD ISO 24166-3:2022(E)
Snap-on bottles for metering pumps —
Part 3:
Plastic
1 Scope
This document specifies the shape, dimensions, fill capacities and performance requirements of plastic
bottles for metering pumps. It also specifies the material for the manufacturing of such containers as
well as the secondary packaging.
The document provides requirements for packaging of the plastic bottles and addresses nonsterile,
ready to sterilize or sterile as three possible options.
This document is applicable to colourless or coloured containers moulded from plastic and intended to
be used in the packaging, storage or transportation of products intended for medicinal use.
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 11607-1, Packaging for terminally sterilized medical devices — Part 1: Requirements for materials,
sterile barrier systems and packaging systems
ISO 11607-2, Packaging for terminally sterilized medical devices — Part 2: Validation requirements for
forming, sealing and assembly processes
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/
3.1
base foil
packaging component for protection of the pallet load from contamination
3.2
bottle
vial
container made of a suitable material, which is intended for packaging, storage and application of liquid
medicinal products
EXAMPLE Tubular glass, moulded glass or plastic.
1
© ISO 2022 – All rights reserved
---------------------- Page: 6 ----------------------
ISO 24166-3:2022(E)
3.3
brimful capacity
volume of water required to fill a container, placed on a flat, horizontal surface
[SOURCE: ISO 4802-1:2016, 3.3]
3.4
chemical indicator
test system that reveals change in one or more pre-defined process variables based on a chemical
change resulting from exposure to a process
[SOURCE: ISO 11139: 2018, 3.43, modified — "pre-specified" was replaced with "pre-defined", "or
physical" was deleted.]
3.5
customer
business entity that purchases bottles for metering pumps and conducts further processing or filling as
appropriate
[SOURCE: ISO 21882:2019, 3.1 modified — “sterilized ready for filling vials” was replaced with “bottles
for metering pumps”.]
3.6
dip-tube
conduit, part of the metering pump, which delivers the product from the bottle to the metering
mechanism
3.7
foil bag
gas permeable or non-permeable bag
Note 1 to entry: Foil bags can be used as sterile barrier system (3.17) or as protective packaging (3.13), depending
on final usage.
3.8
label
written, printed or graphic information appearing on the item itself, on the packaging of each item or
on the packaging of multiple items
[SOURCE: IMDRF/GRRP WG/N52: 2019, 3.17, modified – replaced "unit" and "devices" with "item"]
3.9
manufacturer
business entity that manufactures or is otherwise responsible for the manufacturing of the bottles
ready to be filled by the customer (3.4)
[SOURCE: ISO 21882:2019, 3.14 modified – “performs” was replaced with “manufactures”, “vials” was
replaced with “bottles”.]
3.10
metering pump
device actuated by the user to deliver a specific dose of liquid
3.11
packaging system
combination of a sterile barrier system and protective packaging
[SOURCE: ISO 11139:2018, 3.192]
3.12
pallet
construction for transportation and storage of goods
2
© ISO 2022 – All rights reserved
---------------------- Page: 7 ----------------------
ISO 24166-3:2022(E)
3.13
protective packaging
configuration of materials designed to prevent damage to the sterile barrier system and its contents
from the time of their assembly until the point of use
[SOURCE: ISO 11139:2018, 3.219]
3.14
sealing ring
bottle feature on top of the flange to support tightness
3.15
shipper box
protective packaging for the foil bags
3.16
snap-on bottle
container with press-fit for metering pumps
3.17
sterile barrier system
SBS
minimum package that minimizes the risk of ingress of microorganisms and allows aseptic presentation
of the sterile contents at the point of use
[SOURCE: ISO 11139:2018, 3.272]
3.18
transport cover
outside packaging layer protecting against environmental hazards and keeping the shipper boxes (3.15)
in place
4 Symbols
t bottom concavity
d outer diameter body
1
h total length
1
h length cylindrical part of the body
2
h inner depth
3
r shoulder radius
1
r bottom radius
2
s wall thickness body
1
s wall thickness bottom
2
P plastic
3
© ISO 2022 – All ri
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.