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INTERNATIONAL ISO
STANDARD 4802-1
Fourth edition
2023-12
Glassware — Hydrolytic resistance
of the interior surfaces of glass
containers —
Part 1:
Determination by titration method
and classification
Verrerie — Résistance hydrolytique des surfaces internes des
récipients en verre —
Partie 1: Détermination par analyse titrimétrique et classification
Reference number
© ISO 2023
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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 . 5
7 Sample preparation .6
7.1 Sample size . 6
7.2 Determination of the filling volume . 6
7.2.1 Flat-bottomed containers ≤20 mm outer flange diameter (except ampoules,
syringes and cartridges) . 6
7.2.2 Flat-bottomed containers >20 mm outer flange diameter. 7
7.2.3 Round-bottomed containers . 7
7.2.4 Lipped containers . 7
7.2.5 Ampoules. 7
7.2.6 Syringes and cartridges . 7
8 Procedure .8
8.1 General . 8
8.2 Cleaning of samples . 8
8.3 Filling and heating . 8
8.4 Analysis of the extraction solutions . 9
8.5 Test to determine whether the containers have been surface-treated. 10
9 Expression of results .10
9.1 Determination . 10
9.2 Classification . 10
9.3 Distinction between containers of hydrolytic resistance container class HC 1 and
T
hydrolytic resistance container class HC 2 . 10
T
9.4 Designation . 11
10 Test report .11
11 Reproducibility .12
Bibliography .13
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
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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 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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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 4802-1:2016), which has been technically
revised.
The main changes are as follows:
— adding a complete description of the categories HC 1, HC 2, HC 3, HC B, HC D;
T T T T T
— aligning the autoclaving to the 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.
The European Pharmacopoeia Commission has adopted the principle of the determination by titration
and has set up a classification for glass containers for injectable preparations, which is included in this
document. In addition, this document contains a classification of containers other than for injectable
preparations.
According to international interlaboratory tests, this document specifies the test conditions in more
detail than the European Pharmacopoeia in order to increase the reproducibility of the test results. In
particular, the autoclaving cycle is described in detail.
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.
T
HC 2 glass containers are suitable for most acidic and neutral, aqueous preparations whether or not for
T
parenteral administration.
HC 3 glass containers are in general suitable for non-aqueous preparations for parenteral
T
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
T
to ISO 719).
HC D glass containers are in general suitable for lower demands on hydrolytic resistance (Container
T
Class HGB 4 and HGB 5 according to ISO 719).
v
INTERNATIONAL STANDARD ISO 4802-1:2023(E)
Glassware — Hydrolytic resistance of the interior surfaces
of glass containers —
Part 1:
Determination by titration method 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 titration
of a known aliquot portion of the extraction solution produced with hydrochloric acid solution, in
which case the resistance is inversely proportional to the volume of acid required;
b) a classification of glass containers according to the hydrolytic resistance of the interior surfaces
determined by the methods specified in this document.
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 648, Laboratory glassware — Single-volume pipettes
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 1773, Laboratory glassware — Narrow-necked boiling 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-bottomed container having stems in many different forms
Note 1 to entry: Ampoules are usually thin-walled and have a capacity normally up to 30 ml. They are intended to
be closed, after filling, by flame sealing.
3.2
bottle
flat-bottomed conta
...