SIST ISO 4802-1:2018

INTERNATIONAL ISO
STANDARD 4802-1
Third edition
2016-06-15
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 2016
© ISO 2016, Published in Switzerland
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ii © ISO 2016 – All rights reserved

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 . 6
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
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 on 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 the following URL: www.iso.org/iso/foreword.html.
The committee responsible for this document is ISO/TC 76, Transfusion, infusion and injection, and blood
processing equipment for medical and pharmaceutical use.
This third edition cancels and replaces the second edition (ISO 4802-1:2010), which has been technically
revised in particular by amending
— the subclauses on water (test water and purified water),
— the test procedure, and
— the subclause on autoclave and steam sterilizer respectively.
ISO 4802 consists of the following parts, under the general title Glassware — Hydrolytic resistance of the
interior surfaces of glass containers:
— Part 1: Determination by titration method and classification
— Part 2: Determination by flame spectrometry and classification
iv © ISO 2016 – All rights reserved

Introduction
This part of ISO 4802 is largely based on a method of test 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 now included in
this part of ISO 4802. In addition, this part of ISO 4802 contains a classification of containers other than
for injectable preparations.
According to many results of international interlaboratory tests, this part of ISO 4802 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.
INTERNATIONAL STANDARD ISO 4802-1:2016(E)
Glassware — Hydrolytic resistance of the interior surfaces
of glass containers —
Part 1:
Determination by titration method and classification
1 Scope
This part of ISO 4802 specifies:
a) a method for determining the hydrolytic resistance of the interior surfaces of glass containers
when subjected to attack by water at 121 °C ± 1 °C for 60 min ± 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 part of ISO 4802.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. 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 degrees C — Method of test and classification
ISO 720, Glass — Hydrolytic resistance of glass grains at 121 degrees 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.
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 container, made from moulded glass
Note 1 to entry: Bottles are normally thick-walled and have a capacity usually of more than 5 ml. They may be
of circular or other geometric cross-section. Bottles are sealed with a closure made from a material other than
glass, and not by flame-sealing.
3.3
brimful capacity
volume of water required to fill a container, placed on a flat, horizontal surface
3.4
container
article made from glass to be used as primary packaging material intended to come into direct contact
with the pharmaceutical preparations
EXAMPLE Bottles, vials, syringes, ampoules and cartridges. See also Figure 1.
Note 1 to entry: These containers are made from borosilicate or soda-lime-silica glass.
3.5
filling volume
defined volume of water to fill the test specimen
Note 1 to entry: For the determination of the filling volume, see 7.2. The filling volume is a test-specific quantity that
is used to compare container sets from different sources or lots. It has no relation to the nominal product volume.
3.6
borosilicate glass
silicate glass having a very high hydrolytic resistance due to its composition, containing significant
amounts of boric oxide
Note 1 to entry: Borosilicate glass contains a mass fraction of boric oxide usually between 5 % and 13 %. This
glass type can also contain aluminium oxide and/or alkaline earth oxides.
Note 2 to entry: Neutral glass is a borosilicate glass having a very high hydrolytic resistance and a high thermal
shock
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