ISO 23416:2023
(Main)General specifications and testing methods for temperature-sensitive medicinal packages in good distribution practice principles
General specifications and testing methods for temperature-sensitive medicinal packages in good distribution practice principles
This document describes the general specifications of temperature-sensitive medicinal packaging based on the principles of good distribution practice (GDP). It also specifies test methods to validate the package performance for temperature-sensitive medicinal products. This covers the procedures of temperature-recording and testing methods on the performance of insulated containers such as dimensions, weights, storage capacity and robustness in temperature-controlling. This document does not guarantee the quality and safety of all medicinal products. Under special circumstances where the weight or the characteristics of the products and environment show specific conditions, agreements are followed. This document does not cover the active packaging system, but only covers the passive packaging system able to control the desired temperature without any power sources.
Spécifications générales et méthodes d'essais relatives aux emballages de médicaments thermosensibles selon les principes de bonnes pratiques de distribution
General Information
Standards Content (Sample)
INTERNATIONAL ISO
STANDARD 23416
First edition
2023-01
General specifications and testing
methods for temperature-sensitive
medicinal packages in good
distribution practice principles
Spécifications générales et méthodes d'essais relatives aux emballages
de médicaments thermosensibles selon les principes de bonnes
pratiques de distribution
Reference number
ISO 23416:2023(E)
© ISO 2023
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ISO 23416:2023(E)
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© ISO 2023
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ISO 23416:2023(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General specifications . 3
4.1 General . 3
4.2 Physical performance . 3
4.3 Dimensional stability . 3
4.4 Safety. 4
4.5 Thermal performance . 4
5 Preparing a packaging system .4
5.1 General considerations before packing . 4
5.2 Temperature-recording equipment . 4
5.3 Packing into the heat insulated containers . 4
6 Test procedure .5
6.1 Thermal performance . 5
6.1.1 Temperature profiling . 5
6.1.2 Location of temperature sensors . 5
6.1.3 Temperature-recording . 6
6.2 Storage and weight capacity . 8
6.2.1 Storage capacity measurement . 8
6.2.2 Weight measurement . 11
6.3 Robustness test . 11
7 Test Report .12
Annex A (informative) Example of performance test of insulated container for a
temperature-sensitive medicinal product .13
Bibliography .16
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ISO 23416:2023(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
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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).
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www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 122, Packaging.
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.
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ISO 23416:2023(E)
Introduction
Good distribution practice (GDP) is considered as an essential aspect of compliance for all temperature-
sensitive medicinal products and to ensure systematic distribution.
Temperature-sensitive medicinal products are susceptible to temperature changes. Those products
can become less effective or destroyed when exposed to excessive environments. They need to be kept
within a specific range of temperatures from the place of manufacture to the point of administration
to the users. Despite increasing awareness and the need of safe handling, transport and storage of
temperature-sensitive medicinal products, an international standard of testing methods for their
packaging is in great need.
For temperature-sensitive products, qualified equipment like thermal packaging, temperature-
controlled containers or temperature-controlled vehicles should be used to ensure correct transport
conditions are maintained between the manufacturer, the wholesale distributor and the customer.
In case of temperature-controlled vehicles, the temperature monitoring equipment used during
transport/storage should be maintained and calibrated at regular intervals. Temperature mapping
under representative conditions should be carried out first and should take into consideration seasonal
variations if relevant.
Harmonized methods can be a guideline to maintain the recommended temperature range inside an
insulated container and physical performance. This document works through enhancing the capacity
to distribute and handle the products effectively. This document is intended for anyone involved in
transport, storage and handling of them, especially manufacturers, importers, distributor, wholesalers,
transporter, etc.
Test methods are based on Australia National Temperature-sensitive Pharmaceutical Storage Guidelines
Strive for 5 (2nd Edition), Guidelines on the international packaging and shipping of temperature-
sensitive vaccines (WHO/IVB/04.23 Annex 1 and WHO/PQS/E004/CB01-VP.3), ISO 22982-1 and
ISO 22982-2.
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INTERNATIONAL STANDARD ISO 23416:2023(E)
General specifications and testing methods for
temperature-sensitive medicinal packages in good
distribution practice principles
1 Scope
This document describes the general specifications of temperature-sensitive medicinal packaging
based on the principles of good distribution practice (GDP). It also specifies test methods to validate
the package performance for temperature-sensitive medicinal products. This covers the procedures
of temperature-recording and testing methods on the performance of insulated containers such as
dimensions, weights, storage capacity and robustness in temperature-controlling.
This document does not guarantee the quality and safety of all medicinal products. Under special
circumstances where the weight or the characteristics of the products and environment show specific
conditions, agreements are followed. This document does not cover the active packaging system, but
only covers the passive packaging system able to control the desired temperature without any power
sources.
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 21067-1, Packaging — Vocabulary — Part 1: General terms
ISO 22982-1, Transport packaging — Temperature-controlled transport packages for parcel shipping —
Part 1: General requirements
ISO 22982-2, Transport Packaging — Temperature controlled transport packages for parcel shipping —
Part 2: General specifications of testing
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 21067-1 and the following
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
good distribution practice
GDP
part of quality assurance which ensures that quality of medicinal products is maintained throughout
all stages of the supply chain from the site of manufacturer to the pharmacy or person authorized or
entitled to supply medicinal products to the public
[SOURCE: Guidelines of the European Commission, Annex of 2013/C343/01]
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ISO 23416:2023(E)
3.2
medicinal products
medicine intended for human use or veterinary product administered to any animals, presented in its
finished dosage form or as a starting material for use in such a dosage form, that is subject to control by
medicinal legislation in both the exporting state and the importing state
[SOURCE: WHO Technical Report Series No.908, Annex 7, modified.]
3.3
temperature-sensitive medicinal product
medicinal product whose quality may be adversely affected by temperature extremes
3.4
temperature-controlled
sequence of transportation events, from the manufacture to the end-user, which maintains temperature-
sensitive products within approved temperature specifications
Note 1 to entry: Maintaining temperature control during these transportation events assures that product
quality is maintained.
3.5
temperature-recording
continuous measurement to record temperature
3.6
data logger
electronic or mechanical data recorder provided with sensor(s) for measuring the temperature
3.7
coolant
heat-absorbing medium or process
[SOURCE: ISO 15779:2011, 3.11]
3.8
phase changing material
PCM
material with a high heat of fusion that allows it to store or release thermal energy as a form of melting
and solidifying at a certain temperature
[SOURCE: ISO 22982-2:2021, 3.2, modified]
3.9
insulated container
thermal container having no devices for cooling and/or heating, either permanently installed or
attached
[SOURCE: ISO 830:1999, 4.2.2.1.1, modified — NOTE has been removed.]
3.10
controlled temperature chamber
room or equipment where the temperature uniformity is maintained within a qualified range to ensure
product is preserved
EXAMPLE Freezers, refrigerators, cold rooms and stability chamber.
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ISO 23416:2023(E)
3.11
validation
confirmation process, through the provision of objective evidence, that the requirements for a specific
intended use or application have been fulfilled
Note 1 to entry: The objective evidence needed for a validation is the result of a test or other form of determination
such as performing alternative calculations or reviewing documents.
Note 2 to entry: The word “validated” is used to designate the corresponding status.
Note 3 to entry: The use conditions for validation can be real or simulated.
[SOURCE: ISO 11139:2018, 3.313]
4 General specifications
4.1 General
Temperature-sensitive medicinal packages that require constant temperature during transportation
shall be capable of adequately protecting the components of the drug product in the agreed transport
environment prior to application.
Temperature-sensitive medicinal packages shall have no adverse effect on the quality of the product, the
immediate container and secondary packaging of the medicine and shall offer adequate protection from
external environment and contamination. The selection of containers and packaging material shall be
based on storage and transportation requirements of the medicinal product. The space required for the
amount of medicinal products, the expected external temperature extremes, the estimated maximum
transportation time including transit process at customs, etc., are also important elements to consider
as well as the qualification and the validation of the shipping containers.
The container shall be labelled appropriately to:
— identify the product accurately;
— ensure the correct and proper handling and storage conditions of the product; and
— provide special precautions or warnings if needed.
If the expiration date is different, depending on the storage conditions of the product, this shall
be checked. Special conditions and requirements shall be taken into consideration. Appropriate
information shall be added for specific products (e.g. Advanced Therapy Medicinal Products (ATMPs),
medicinal products derived from blood, immunological medicinal products, narcotic/psychotropic
substances, radio-medicinals, etc.).
The container shall meet the basic requirements of 4.2, 4.3, 4.4 and 4.5 in terms of appearance,
performance and stability.
4.2 Physical performance
A package/container shall prove its physical reliability throughout the supply chain. Robus
...
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