EN ISO 8871:1997
(Main)Elastomeric parts for aqueous parenteral preparations (ISO 8871:1990)
Elastomeric parts for aqueous parenteral preparations (ISO 8871:1990)
Migrated from Progress Sheet (TC Comment) (2000-07-10): Delayed because of need to check with European Pharmacopoeia whether in ++ conflict with certain materials monographs
Elastomere Teile für wäßrige parenterale Zubereitungen (ISO 8871:1990)
Eléments en élastomère pour préparations aqueuses parentérales (ISO 8871:1990)
Deli iz elastomera za parenteralne farmacevtske oblike (ISO 8871:1990)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 8871:2000
01-januar-2000
Deli iz elastomera za parenteralne farmacevtske oblike (ISO 8871:1990)
Elastomeric parts for aqueous parenteral preparations (ISO 8871:1990)
Elastomere Teile für wäßrige parenterale Zubereitungen (ISO 8871:1990)
Eléments en élastomere pour préparations aqueuses parentérales (ISO 8871:1990)
Ta slovenski standard je istoveten z: EN ISO 8871:1997
ICS:
11.040.20 Transfuzijska, infuzijska in Transfusion, infusion and
injekcijska oprema injection equipment
SIST EN ISO 8871:2000 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 8871:2000
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SIST EN ISO 8871:2000
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SIST EN ISO 8871:2000
INTERNATIONAL
STANDARD
Second edition
1990-08-0 1
Elastomeric park for aqueous parenteral
preparations
El&nents en dastom&e pour prbparations aqueuses parenfkales
Reference number
ISO 8871:1990(E)
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SIST EN ISO 8871:2000
ISO 8871:199O(E)
Contents
Page
1
1 Scope . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .~.
..~.................................................................... 1
2 Normative references
. . . .-.-. 1
3 Classification
1
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .*.
4 identification
. . . . . . . . . . . . . . . . . . .*. 2
5 Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2
6 Testing . .
3
................................. .......................................................
7 Packaging
3
....................................................... .....................................
8 Storage
3
9 Marking and labelling . .
Annexes
4
Ultraviolet spectrometry of extracts .
A
4
A-1 Principle . .
4
A.2 Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4
................................... ...............................
A.3 Expression of results
5
.......................... ................
B Infra-red spectrometry of pyrolysates
5
........ .............................................. .................................
B.l Principle
........... .............................. 5
8.2 Procedure .
.............. 5
8.3 Expression of results .
........ 6
C Determination of extracted reducing matter (oxidizables)
............ 6
C.l Principle .
6
......................................................................................
C.2 Reagents
6
Procedure . .
C.3
0 ISO 1990
All rights reserved. No part of this publication may be reproduced or utilized in any form
or by any means, electronie or mechanical, Including photocopylng and microfilm, without
Permission in writing from the publisher.
International Organization for Standardization
Case Postale 56 l CH-1211 Geneve 20 l Switzerland
Printed in Switzerland
ii
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ISO 8871:1990(E)
6
..................................................................
C.4 Expression of results
7
...................................
D Determination of extracted heavy metals
7
D.l Principle .
...................................................................................... 7
D.2 Reagents
7
.....................................................................................
0.3 Procedure
.................................................................. 7
0.4 Expression of results
8
...........................................
E Determination of extracted ammonia
8
E.l Principle .
....................................................................................... 8
E.2 Reagents
..................................................................................... 8
E.3 Procedure
8
...................................................................
E-4 Expression of results
9
F Determination of extracted halides .
9
........................................................................................
F.1 Principle
9
F.2 Reagents .
9
.....................................................................................
F.3 Procedure
9
F.4 Expression of results .
IO
......................................
G Determination of acidity and alkalinity
IO
.....................................................................................
G.l Principle
IO
G.2 Reagents .
IO
..................................................................................
G.3 Procedure
.......................... ...................................... IO
G.4 Expression of results
......................... 11
H Determination of extracted non-volatile solids
11
......................... .......................... ..................................
H.l Principle
................................ ................................................... 11
H.2 Procedure
11
.................................................................
H.3 Expression of results
............................................... 12
J Determination of volatile sulfides
12
J.1 Principle .
............................... ...................................................... 12
J.2 Reagents
12
.......................................... .........................................
5.3 Procedure
. . .
Ill
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J.4 Expression of results . . 12
................................................. 13
K Determination of extracted zinc
K.l Principle . 13
K.2 Reagents . . . 13
K.3 Procedure . . . 13
. . . 43
K.4 Expression of results . .
L Determination of conductivity . . . . 14
44
L.4 Principle . . .
............... ................................ 44
L.2 Proced u re .
................................................................. 44
L.3 Expression of results
M Determination of turbidity . . 45
45
M.4 Principle . .
45
M.2 Reagents .
.................................................. 45
NI.3 Procedure .
45
NI.4 Expression of results .
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SIST EN ISO 8871:2000
ISO 8871:1990(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. Esch 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, govern-
mental 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.
Draft International Standards adopted by the technical committees are
circulated to the member bodies for voting. Publication as an Interna-
tional Standard requires approval by at least 75 % of the member bodies
casting a vote.
International Standard ISO 8871 was prepared by Technical Committee
ISO/TC 76, Transfusion, infusion and injection equipment for medical
use.
This second edition cancels and replaces the first edition (ISO
8871:1988), presentation has been modified and clauses 0.32, E.3.2,
F.3.2, G.3, J.3.2 and K.3.2 have been technically revised.
Annexes A, B, C, 0, E, F, G, H, J, K, L and M form an integral patt of this
International Standard.
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SIST EN ISO 8871:2000
ISO 8871:199O(E)
Introduction
The elastomeric park described in this International Standard are made
from a class of material which is generally called “‘rubber”. The Parts
are made from various elastomers involving different vulcanization sys-
tems, and may vary considerably in their composition with regard to frl-
lers, softeners, Pigments and other auxiliary ingredients.
The potency, purity, stability, and safety of a drug during its manufac-
ture, storage and administration tan be affected by the nature and per-
formante of an elastomeric part used to seal the drug in its final
Container.
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SIST EN ISO 8871:2000
INTERNATIONAL STANDARD ISO 8871:1990(E)
Elastomeric park for aqueous parenteral preparations
ISO 48:1979, Vulcanized rubbers - Determination of
1 Scope
hardness (Hardness between 30 and 85 IRWD).
1 .l This International Standard defines procedures
ISO 247:1978, Rubber - Determination of ash.
for identifying and classifying elastomeric Parts for
primary Packs and medical devices used in direct
ISO 27811:1988, Rubber, vulcanized - Determination
contact with aqueous preparations for parenteral
of density.
use including dry preparations which have to be
dissolved before use.
ISO 3696:1987, Wafer for analyfical laborafory use -
Specification and test methods.
This International Standard specifies a series of
comparative test methods for Chemical and biolog-
ical evaluation (see clause 6) and describes the
3 Classification
various Felds of application for elastomeric Parts.
Dimensions and functional characteristics are
Depending on the intended end-use, elastomeric
specified in the relevant International Standards.
Parts exist in various designs and sizes. These Parts
Required proper-Ces as specified in this International
serve different purposes depending an the item or
Standard shall be regarded as minimum require-
device into which they are incorporated; elastomeric
ments.
Parts have, therefore, been classified into the fol-
lowing categories:
1.2 This International Standard is applicable for
the categories of elastomeric Parts given in
-
elastomeric Parts for injection vials (see
clause 3; specifrc requirements, however, are laid
ISO 8362-2);
down in the relevant International Standards dealing
with the items or devices Iisted in clause 3. -
elastomeric Parts for infusion bottles (see
ISO 8536-2);
Elastomeric Parts for empty syringes for Single
NOTE 1
use are excluded by definition (see ISO 7886).
-
elastomeric Parts for prefilled syringes;
-
1.3 Compatibility studies with the intended prep-
elastomeric Parts for medical devices for phar-
aration have to be performed before the approval for
maceutical use (excluding gloves and probes);
final use tan be given; however, this International
Standard does not specify procedures for carrying -
elastomeric Parts for freeze-dried products.
out compatibility studies.
4 Identification
2 Normative references
4.1 Genergl
The following Standards contain provisions which,
through reference in this text, constitute provisions
Rubber is a complex material and not generally de-
of this International Standard. At the time of publi-
finable. The only property which all elastomeric
cation, the editions indicated were valid. All stan-
materials have in common is a special type of
dards are subject to revision, and Parties to
resilience or elasticity. When a Strip of rubber is
agreements based on this International Standard
stretched, it will extend up to many times its original
are encouraged to investigate the possibility of ap-
length without breaking. On release of the stretching
plying the most recent editions of the Standards in-
forte, it snaps back to its original size and shape
dicated below. Members of IEC and ISO maintain
virtually unaltered. Similarly one tan squeeze it,
registers of currently valid International Standards.
1
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SIST EN ISO 8871:2000
ISO 8871:1990(E)
twist it or distort it in any direction comparatively
5 Requirements
easily, and it will spring back again to its original
shape unchanged.
5.1 Biological requirements
Owing to its three-dimensional network, achieved
by Chemical Cross-Iinking of the polymer chains Biological requirements are not specified in this
during vulcanization, rubber is practically insoluble International Standard; biological tests are, how-
in solvents such as tetrahydrofurane, although con- ever, required by most national pharmacopoeias or
siderable reversible swelling may occur; this char- related health authority regulations and are manda-
acteristic differentiates rubber from pseudo-elastic tory for Producers and users in countries where they
materials, such as polyvinylchloride and certain exist. If this is not the case, reference shall be made
thermoplastic elastomers. to biological tests, e.g. as described in the United
States Pharmacopoeia, the European Pharma-
In view of the complexity of rubber, a set of tests is
copoeia or other pharmacopoeias.
needed for reliable identification and the identity of
a given elastomeric material cannot be verified just
5.2 Chemical requirements
by a Single physical or Chemical test. Recommended
tests for this purpose are, among others, the follow-
Elastomeric Parts shall comply with the Chemical
ing ones:
requirements specified in the relevant International
Standards (see clause 3).
- determination of density;
Analytical procedures to compare and evaluate the
- determination of ash;
Chemical characteristics of elastomeric Parts are
described in annex A to annex M.
-
ultraviolet spectrometry of extracts;
-
infra-red spectrometry of pyrolysates.
5.3 Physical requirements
The manufacturer shall guarantee that all
53.1 Hardness
elastomeric Parts of current supplies have been
produced from the Same formulation and that they
The hardness shall be in the specified limits within
exhibit the Same characteristics as the samples
the “shelf-life” guaranteed by the manufacturer;
which have been given to the user first and the
hardness shall be determined in accordance with
suitability of which has been proved.
ISO 48.
The tests specified in 4.2 to 4.5 shall be used for
NOTE 2 The “shelf-life” is understood to be a storage
- especially in tests carried out by the
identification
period without interference from outside factors, such as
end-user.
drugs, etc.
4.2 Determination of density
53.2 Resistance to steam sterilkation
Density shall be measured in accordance with the
Elastomeric Parts shall not lose the required biolog-
procedure described in ISO 2781:1988, Method A.
ical, Chemical and physical properties after a two-
fold sterilization process in saturated steam at
121 “C + 1 “C for 30 min.
4.3 Determination of ash -
The residue of inorganic materials after combustion
6 Testing
shall be determined as described in ISO 247:1978,
Method B or, if necessary, Method C.
6.1 General
4.4 Ultraviolet spectrometry
The test methods described in annex A to annex M
shall be c0nsidere.d as a means of examining vari-
The ultraviolet spectrum shall be obtained on an
ous elastomeric formulations in Order to select the
aqueous extract as described in annex A; it shall be
appropriate rubber formulation for a specific use. A
compared with a reference spectrum.
selection of these test methods may be used for as-
sessing product lot-to-lot reproducibility.
4.5 Infra-red spectrometry
In Order to provide a certain degree of protection
against misinterpretation in the case of erroneous
The infra-red spectrum shall be obtained on a
results, all tests shall be performed in duplicate,
pyrolysate as described in annex B; it shall be
unless otherwise stated.
compared with a reference spectrum.
2
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SIST EN ISO 8871:2000
ISO 8871:199O(E)
thaa a temperature of 421 “C + 1 “C is reached in
6.2 Sampiing
the flask within 30 min max.
temperat.ure for 30 min. Cool to room temperature
A statistically random sample of elastomeric parts
over 20 min to 30 min.
to be examined shall be represenfative for each
supply and shall be provided in their original state.
Shake and immediately separate this solution S1
The necessary number of elastomeric Parts shall be
from Iahe elastomeric Parts by decantation. Make up
as specified in the relevant International Standards
to original volume with purified water. Shake sol-
(see clause 3).
ution SA before each test.
63 . Apparatus and reagents
6.4.2 Blank Solution So is prepared in the same
way as for solertion Sq except that 300 ml of purified
agents of recognized analytical grade
6.3.1 0 nly re
wa%er are used without the elastomeric Parts.
shall be used.
6.4.3 Salutions SA and So obtained as described in
Purifled water, prepared by distillation, by using an
6.4.1 and 6.4.2 shall be used to carry out the chemi-
ion exchanger or by any other suitable process shall
cal and biological tests.
be used.
Its conductivity should be less than 3 pS/cm.
Purified water as specified in various national
Vhe elastomeric Parts shall be packaged in a suit-
pharmacopoeias corresponds to grades i and 2
able way so that they are protected against con-
water as specified in BSeP 3696.
Bamination and exposure to light.
6.3.2 GIassware shall be made from borosilicate
glass. 8 st0r43ge
The elastomeric Parts shall be stored at a temper-
6.4 Preparation of test sslutisns
ature in the range from 0 “C to 30 “C, they shall be
protected against exposure to visible and ultraviolet
6.4.1 Use a number of complete elastomeric Parts
light.
which correspond to a surface area of at least
150 em* to give a tesa solution of 1 cm* of
elastomeric surface area per 2 ml of test solution. 9 Marking and labelling
Wash these samples: place them in a suitable glass
The following information relating to the packaged
Container, cover with 300 ml of purified water, boil
goods shall be marked on the outside packaging:
for 5 min and then rinse five times with 300 ml
portions of cold purified water.
a) a description of the confents;
Place the washed elastomeric Parts in a wide-
b) the month and year of manufacture;
necked flask and add 300 ml of purified water per
150 cm* surface area of the samples. Cover the
c) the lot number;
mouth of the flask with aluminium foil or a
borosilicate glass beaker. Heat in an autoclave so
d) the manufacturer’s trade-mark or name.
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SIST EN ISO 8871:2000
ISO 8871:1990(E)
Annex A
(normative)
Ultraviolet spectrometry of extracts
a scanning UV spectrometer in a 1 cm quartz cell
A.1 Principle
with the blank Solution So in the reference cell and
obtain the spectrum over the wavelength range from
The ultraviolet (UV) spectrum obtained on extra&
220 nm to 360 nm.
of elastomeric materials is primarily a function of the
kind of accelerator or antioxidant present in the in-
If a dilution is necessary, the dilution factor
...
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