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INTERNATIONAL ISO
STANDARD 4802-2
Fourth edition
2023-12
Glassware — Hydrolytic resistance
of the interior surfaces of glass
containers —
Part 2:
Determination by flame spectrometry
and classification
Verrerie — Résistance hydrolytique des surfaces internes des
récipients en verre —
Partie 2: Détermination par spectrométrie de flamme et classification
Reference number
© ISO 2023
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Published in Switzerland
ii
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Principle . 4
5 Reagents . 4
6 Apparatus . 6
7 Sample preparation .7
7.1 Sample size . 7
7.2 Determination of the filling volume . 7
7.2.1 Flat-bottomed containers ≤20 mm outer flange diameter (except ampoules,
syringes and cartridges) . 7
7.2.2 Flat-bottomed containers >20 mm outer flange diameter. 7
7.2.3 Round-bottomed containers . 8
7.2.4 Lipped containers . 8
7.2.5 Ampoules. 8
7.2.6 Syringes and cartridges . 8
8 Procedure .9
8.1 General . 9
8.2 Cleaning of samples . 9
8.3 Filling and heating . 9
8.4 Analysis of the extraction solutions . 10
8.4.1 Containers of hydrolytic resistance container classes HC 1, HC 2 and
F F
HC B or those known to be made from borosilicate glass . 10
F
8.4.2 Containers of hydrolytic resistance container classes HC 3 and HC D, or
F F
those known to be made from soda-lime-silica glass. 10
8.5 Test to determine whether the containers have been surface-treated. 11
9 Expression of results .12
9.1 Determination . 12
9.2 Classification .12
9.3 Distinction between containers of hydrolytic resistance container class HC 1 and
F
hydrolytic resistance container class HC 2 . 13
F
9.4 Designation . 13
10 Test report .13
11 Reproducibility .13
Bibliography .15
iii
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 document 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).
ISO draws attention to the possibility that the implementation of this document may involve the use
of (a) patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed
patent rights in respect thereof. As of the date of publication of this document, ISO had not received
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such patent rights.
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
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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.
This fourth edition cancels and replaces the third edition (ISO 4802-2:2016), which has been technically
revised.
The main changes are as follows:
— the explanation of the hydrolytic classes HC 1, HC 2, HC 3, HC B, HC D for different glass types;
F F F F F
— clarification of needed properties of purified water and test water;
— harmonization of the samples cleaning and the autoclavation process with Ph.Eur.;
— including containers up to 0,5 ml filling volume.
A list of all parts in the ISO 4802 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
Introduction
This document is largely based on a test method approved by the International Commission on Glass
(ICG), Technical Committee 2, Chemical Durability and Analysis, for measuring the hydrolytic resistance
of the interior surfaces of glass containers.
This document contains a classification which is related to but not equivalent to the classification set up
in ISO 4802-1 for the titration method.
The hydrolytic resistance of the inner glass surface is evaluated by determination of the released
alkali reacting ions. According to their hydrolytic resistance, glass containers are classified in defined
categories.
HC 1 glass containers are suitable for most preparations whether or not for parenteral administration.
F
HC 2 glass containers are suitable for most acidic and neutral, aqueous preparations whether or not for
F
parenteral administration.
HC 3 glass containers are in general suitable for non-aqueous preparations for parenteral
F
administration, for powders for parenteral administration (except for freeze-dried preparations) and
for preparations not for parenteral administration.
HC B glass containers are in general suitable for drinking ampoules (Container Class HGB 2 according
F
to ISO 719).
HC D glass containers are in general suitable for lower demands on hydrolytic resistance (Container
F
Class HGB 4 and HGB 5 according to ISO 719).
v
INTERNATIONAL STANDARD ISO 4802-2:2023(E)
Glassware — Hydrolytic resistance of the interior surfaces
of glass containers —
Part 2:
Determination by flame spectrometry and classification
1 Scope
This document specifies:
a) a method for determining the hydrolytic resistance of the interior surfaces of glass containers
when subjected to attack by water at (121 ± 1) °C for (60 ± 1) min. The resistance is measured by
determining the amount of sodium and other alkali metal or alkaline earth oxides in the extraction
solution using flame atomic emission or absorption spectrometry (flame spectrometry);
b) a classification of glass containers according to the hydrolytic resistance of the interior surfaces
determined by the methods specified in this document.
The test method specified in this document might not be applicable to containers whose surfaces have
been treated for functional modifications, e.g. silicone (e.g. containers that are ready for direct filling).
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 385, Laboratory glassware — Burettes
ISO 719, Glass — Hydrolytic resistance of glass grains at 98 °C — Method of test and classification
ISO 720, Glass — Hydrolytic resistance of glass grains at 121 °C — Method of test and classification
ISO 1042, Laboratory glassware — One-mark volumetric flasks
ISO 3819, Laboratory glassware — Beakers
ISO 9187-1, Injection equipment for medical use — Part 1: Ampoules for injectables
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
ampoule
small, normally flat-bo
...