SIST EN ISO 8871-2:2005
(Main)Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 2: Identification and characterization (ISO 8871-2:2003)
Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 2: Identification and characterization (ISO 8871-2:2003)
This part of ISO 8871 specifies evaluation procedures applicable to elastomeric parts used for drug containers and medical devices in order to guarantee the product identity between the samples evaluated in the (suitability test) acceptance process and the current supplies. The physical and chemical test procedures specified in this part of ISO 8871 permit the determination of the typical characteristics of rubber materials, and may serve as a basis for agreements between manufacturer and user regarding the product consistency in subsequent supplies. An appropriate set of tests is selected, depending upon the type of rubber and its application. This part of ISO 8871 does not specify other requirements for rubber materials. These are laid down in the relevant product standards.
Elastomere Teile für Parenteralia und für Geräte zur pharmazeutischen Verwendung - Teil 2: Identifizierung und Charakterisierung (ISO 8871-2:2003)
Dieser Teil von ISO 8871 legt Verfahren zur Anwendung bei elastomeren Teilen fest, die für Medikamentenbehälter und Medizinprodukte verwendet werden, um die Identität der laufenden Lieferungen des Produkts mit den im Zulassungsverfahren (Eignungsprüfung) bewerteten Proben sicherzustellen. Die durch diesen Teil von ISO 8871 zur Verfügung gestellten physikalischen und chemischen Prüfverfahren ermöglichen die Bestimmung der typischen Eigenschaften von Gummimaterialien und können als Grundlage für Vereinbarungen zwischen Hersteller und Anwender hinsichtlich der gleich bleibenden Eigenschaften des Produkts bei nachfolgenden Lieferungen dienen. Abhängig vom Typ des Gummis und seiner Anwendung ist eine geeignete Zusammenstellung von Prüfungen auszuwählen.
Dieser Teil von ISO 8871 legt keine Anforderungen an Gummimaterialien fest. Diese sind in den anwendbaren Produktnormen festgelegt.
Eléments en élastomere pour administration parentérale et dispositifs a usage pharmaceutique - Partie 2: Identification et caractérisation (ISO 8871-2:2003)
L'ISO 8871-2:2003 spécifie des modes opératoires d'évaluation applicables aux éléments en élastomère utilisés pour les articles de conditionnement des médicaments et les dispositifs médicaux afin de garantir que le produit livré est identique aux échantillons évalués lors du processus d'acceptation (de l'essai d'aptitude à l'emploi). Les modes opératoires d'essai des caractéristiques physiques et chimiques présentés dans l'ISO 8871-2:2003 permettent de déterminer les caractéristiques types des caoutchoucs et peuvent servir de base à des accords entre le fabricant et l'utilisateur en ce qui concerne la reproductibilité du produit lors des livraisons ultérieures. Un ensemble approprié d'essais est choisi en fonction du type de caoutchouc et de l'application.
L'ISO 8871-2:2003 ne spécifie pas les exigences ultérieures du caoutchouc; celles-ci sont données dans les normes appropriées du produit.
Deli iz elastomera za parenteralne farmacevtske oblike - 2. del: Identifikacija in opredelitev (ISO 8871-2:2003)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 8871-2:2005
01-marec-2005
Deli iz elastomera za parenteralne farmacevtske oblike - 2. del: Identifikacija in
opredelitev (ISO 8871-2:2003)
Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 2:
Identification and characterization (ISO 8871-2:2003)
Elastomere Teile für Parenteralia und für Geräte zur pharmazeutischen Verwendung -
Teil 2: Identifizierung und Charakterisierung (ISO 8871-2:2003)
Eléments en élastomere pour administration parentérale et dispositifs a usage
pharmaceutique - Partie 2: Identification et caractérisation (ISO 8871-2:2003)
Ta slovenski standard je istoveten z: EN ISO 8871-2:2004
ICS:
11.040.20 Transfuzijska, infuzijska in Transfusion, infusion and
injekcijska oprema injection equipment
SIST EN ISO 8871-2:2005 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 8871-2:2005
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SIST EN ISO 8871-2:2005
EUROPEAN STANDARD
EN ISO 8871-2
NORME EUROPÉENNE
EUROPÄISCHE NORM
September 2004
ICS 11.040.20 Supersedes EN ISO 8871:1997
English version
Elastomeric parts for parenterals and for devices for
pharmaceutical use - Part 2: Identification and characterization
(ISO 8871-2:2003)
Eléments en élastomère pour administration parentérale et
dispositifs à usage pharmaceutique - Partie 2: Identification
et caractérisation (ISO 8871-2:2003)
This European Standard was approved by CEN on 15 July 2004.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European
Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national
standards may be obtained on application to the Central Secretariat or to any CEN member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CEN member into its own language and notified to the Central Secretariat has the same status as the official
versions.
CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,
Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia,
Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36 B-1050 Brussels
© 2004 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 8871-2:2004: E
worldwide for CEN national Members.
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SIST EN ISO 8871-2:2005
EN ISO 8871-2:2004 (E)
Foreword
The text of ISO 8871-2:2003 has been prepared by Technical Committee ISO/TC 76
"Transfusion, infusion and injection equipment for medical and pharmaceutical use" of the
International Organization for Standardization (ISO) and has been taken over as EN ISO 8871-
2:2004 by CMC.
This European Standard shall be given the status of a national standard, either by publication of
an identical text or by endorsement, at the latest by March 2005, and conflicting national
standards shall be withdrawn at the latest by March 2005.
This document supersedes EN ISO 8871:1997.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of
the following countries are bound to implement this European Standard: Austria, Belgium,
Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary,
Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland,
Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
Endorsement notice
The text of ISO 8871-2:2003 has been approved by CEN as EN ISO 8871-2:2004 without any
modifications.
2
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SIST EN ISO 8871-2:2005
INTERNATIONAL ISO
STANDARD 8871-2
First edition
2003-10-01
Elastomeric parts for parenterals and for
devices for pharmaceutical use —
Part 2:
Identification and characterization
Éléments en élastomère pour administration parentérale et dispositifs à
usage pharmaceutique —
Partie 2: Identification et caractérisation
Reference number
ISO 8871-2:2003(E)
©
ISO 2003
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SIST EN ISO 8871-2:2005
ISO 8871-2:2003(E)
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ii © ISO 2003 — All rights reserved
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SIST EN ISO 8871-2:2005
ISO 8871-2:2003(E)
Contents Page
Foreword. iv
Introduction . v
1 Scope. 1
2 Normative references . 1
3 Tests. 1
4 Preparation of samples for testing. 3
5 Reagents and materials. 4
Annex A (informative) Identification of elastomeric material by pyrolysis IR. 5
Annex B (informative) Determination of compression set . 7
Annex C (informative) Swelling behaviour in oils . 9
Annex D (informative) Development of a fingerprint by gas chromatography . 11
Annex E (informative) Analysis of volatile components by headspace gas chromatography. 13
Annex F (informative) Determination of residual moisture . 15
Annex G (informative) Determination of a fingerprint by thermal gravimetry (TG) . 16
Bibliography . 20
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SIST EN ISO 8871-2:2005
ISO 8871-2:2003(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.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
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.
ISO 8871-2 was prepared by Technical Committee ISO/TC 76, Transfusion, infusion and injection equipment
for medical and pharmaceutical use.
Together with the other parts (see below), this part of ISO 8871 cancels and replaces ISO 8871:1990, which
has been technically revised.
ISO 8871 consists of the following parts, under the general title Elastomeric parts for parenterals and for
devices for pharmaceutical use:
Part 1: Extractables in aqueous autoclavates
Part 2: Identification and characterization
Part 3: Determination of released-particle count
Part 4: Biological requirements and test methods
Part 5: Functional requirements and testing
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SIST EN ISO 8871-2:2005
ISO 8871-2:2003(E)
Introduction
The elastomeric parts specified in the various parts of this International Standard are produced from a material
which is usually called “rubber”. However, rubber is not a unique entity, since the composition of rubber
materials may vary considerably. The base elastomer and the type of vulcanization have a major influence on
the principle characteristics of an individual rubber material, as do additives such as fillers, softeners and
pigments. These may have a significant effect on the overall properties. The effectiveness, purity, stability and
safe handling of a drug preparation may be affected adversely during manufacture, storage and administration
if the rubber part used has not been properly selected and validated (approved).
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SIST EN ISO 8871-2:2005
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SIST EN ISO 8871-2:2005
INTERNATIONAL STANDARD ISO 8871-2:2003(E)
Elastomeric parts for parenterals and for devices for
pharmaceutical use —
Part 2:
Identification and characterization
1 Scope
This part of ISO 8871 specifies evaluation procedures applicable to elastomeric parts used for drug containers
and medical devices in order to guarantee the product identity between the samples evaluated in the
(suitability test) acceptance process and the current supplies. The physical and chemical test procedures
specified in this part of ISO 8871 permit the determination of the typical characteristics of rubber materials,
and may serve as a basis for agreements between manufacturer and user regarding the product consistency
in subsequent supplies. An appropriate set of tests is selected, depending upon the type of rubber and its
application.
This part of ISO 8871 does not specify other requirements for rubber materials. These are laid down in the
relevant product standards.
2 Normative references
The following referenced documents are indispensable for the application 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 48:1994, Rubber, vulcanized or thermoplastic — Determination of hardness (hardness between 10 IRHD
and 100 IRHD)
ISO 247:1990, Rubber — Determination of ash
ISO 2781:1988, Rubber, vulcanized — Determination of density
ISO 8871-1:2003, Elastomeric parts for parenterals and for devices for pharmaceutical use — Part 1:
Extractables in aqueous autoclavates
3 Tests
3.1 General
Rubber is a complex material and not generally definable. The only property which all elastomeric materials
have in common is a special type of resilience or elasticity. When a strip of rubber is stretched, it will extend
by up to many times its original length without breaking. On release of the stretching force, it snaps back to its
original size and shape virtually unaltered. Similarly, one can squeeze it, twist it or distort it in any direction
comparatively easily, and it will spring back again to its original shape unchanged.
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SIST EN ISO 8871-2:2005
ISO 8871-2:2003(E)
Owing to its three-dimensional network, achieved by chemical cross-linking of the polymer chains during
vulcanization, rubber is practically insoluble in solvents such as tetrahydrofuran, although considerable
reversible swelling may occur; this characteristic differentiates rubber from pseudo-elastic materials, such as
poly(vinyl chloride) and certain thermoplastic elastomers.
In view of the complexity of rubber, the identity of a given elastomeric material cannot be verified just by
applying a single physical or chemical test, and a set of tests is needed for reliable identification.
The manufacturer shall guarantee that all elastomeric parts of current supplies have been produced from the
same formulation and that they exhibit the same characteristics as the samples which have been given to the
user first and the suitability of which has been proved.
3.2 Hardness
Hardness shall be determined in accordance with ISO 48.
3.3 Density
Density shall be determined in accordance with the procedure described in ISO 2781:1988, method A.
3.4 Ash
The inorganic residue after combustion shall be determined as described in ISO 247:1990, method A.
3.5 Infra-red spectrum
The infra-red spectrum shall be obtained on a pyrolysate as described in Annex A. It shall be compared with a
reference spectrum.
3.6 Compression set
The compression set indicates the degree of permanent deformation remaining after compression at a
constant deformation and defined temperature for a defined time. The compression set shall be determined in
accordance with Annex B.
3.7 Swelling
Elastomeric materials are subject to varying degrees of swelling when exposed to organic solvents; the
degree of volume and/or mass increase is primarily influenced by the type of elastomer. Swelling requires
special care when the rubber components are in contact with emulsions or oily vehicles.
The relevant procedure is specified in Annex C.
3.8 Development of a fingerprint by gas chromatography
The elastomeric materials under examination are extracted in a solvent, which does not dissolve but might
swell the rubber. The extract is injected into a gas chromatograph. The chromatogram obtained exhibits a
typical profile and can be used as a fingerprint for identification purposes. Furthermore, GC-coupling
techniques, e.g. GC-MS, may provide additional information about the composition of the extract.
The relevant procedure is specified in Annex D.
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SIST EN ISO 8871-2:2005
ISO 8871-2:2003(E)
3.9 Detection of volatile substances by gas chromatography
Elastomeric materials may release volatile substances. These may originate from one of the following
categories of material:
oligomers or process aids present in the base polymer;
stabilizers or antioxidants;
softeners.
The relevant procedure is specified in Annex E.
3.10 Determination of residual moisture
During treatments typical for the pharmaceutical industry, elastomeric parts can absorb moisture in
considerable quantities. During storage of the drug unit, the trapped moisture may be released and absorbed
by the drug product, thus reducing the effectiveness of the drug (critical case: Iyophilized drugs). The nature of
the absorption and desorption processes is affected by the composition of the rubber, the type of treatment
(e.g. steam autoclaving) and the efficiency of any subsequent drying process.
The relevant procedure is specified in Annex F.
3.11 Determination of fingerprint by thermogravimetric analysis (TGA)
Elastomeric parts are composed of components which can be classified relative to their performance under
thermal treatment, as follows:
base polymers;
inorganic fillers;
substances volatile at elevated temperatures;
carbon black.
The relevant procedure is specified in Annex G.
3.12 Determination of extractables in aqueous autoclavates
Elastomeric materials may release substances of undetermined nature in water. For the general assessment
of the chemical cleanliness of closures, the determination of overall parameters such as oxidizable materials
and electrical conductivity can be used.
The relevant test procedures are specified in ISO 8871-1.
4 Preparation of samples for testing
4.1 Treatment before testing
Since the various test procedures may require different pretreatments, such treatment is specified in each
annex.
It is generally assumed that samples of rubber parts will be provided in a clean state in accordance with the
state of the art. In order to avoid recontamination, they shall be contained in protective packaging. Any
particular treatment or method of packaging to be carried out by the manufacturer shall be subject to
agreement between the manufacturer and the customer.
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SIST EN ISO 8871-2:2005
ISO 8871-2:2003(E)
4.2 Number of samples needed for the tests
Due to the large number of tests in this part of ISO 8871 and their complexity, usually not all of the tests are
performed in each investigation. For this reason, the number of samples needed shall be agreed on between
the manufacturer and the test laboratory. Each annex specifies the number of samples which are necessary to
perform that specific test.
5 Reagents and materials
5.1 Use only reagents of recognized analytical grade and purified water prepared by distillation or by other
suitable means. The conductivity of the water used shall not exceed 3,0 µS/cm.
NOTE Purified water as specified by various national pharmacopoeias corresponds to grade 1 or 2 of ISO 3696.
5.2 All glass equipment shall be made from borosilicate glass.
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SIST EN ISO 8871-2:2005
ISO 8871-2:2003(E)
Annex A
(informative)
Identification of elastomeric material by pyrolysis IR
A.1 General
When rubber parts are exposed to dry heat with restricted access to oxygen, the elastomeric matrix is
thermally disintegrated and the rubber is converted into polymer fragments which appear in the form of vapour
or oils of various viscosities.
These oily products are used to produce an IR spectrum which can serve to identify the original rubber
material.
A.2 Reagents and materials
A.2.1 Dry, filtered acetone, to clean the KBr discs.
A.2.2 Indicator paper.
A.2.3 Copper wire.
A.2.4 Acetone.
A.2.5 Trichloromethane.
A.2.6 Sodium sulfate, anhydrous.
A.3 Apparatus
−1 −1
A.3.1 IR spectrometer, to produce IR spectra in the range from 400 cm to 4 000 cm and from 0 % to
100 % transmission.
A.3.2 Potassium bromide (KBr) discs, including spacers and clamps.
A.3.3 Desiccator.
A.3.4 Bunsen burner.
A.3.5 Test tubes, for the pyrolysis process.
A.3.6 Soxhlet extraction apparatus (optional).
A.4 Sample preparation
Cut about 3 g of a rubber part into pieces of about 3 mm × 3 mm.
Optionally, extract the rubber pellets thus produced with acetone in a Soxhlet extractor under reflux for 8 h.
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