ISO 15759:2002

INTERNATIONAL ISO
STANDARD 15759
First edition
2002-04-01
Medical infusion equipment — Plastics
caps with inserted elastomeric liner for
containers manufactured by the Blow-Fill-
Seal (BFS) process
Matériel de perfusion à usage médical — Capsules plastiques avec un joint
à base d'élastomère pour récipients (flacons plastiques) produits par le
procédé simultané d'extrusion/soufflage/remplissage (ESR)

Reference number
ISO 15759:2002(E)
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ISO 15759:2002(E)
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ISO 15759:2002(E)
Contents Page
1 Scope . 1
2 Normative references . 1
3 Dimensions and designation . 2
4 Materials for cap and liner . 4
5 Plastics cap — Physical requirements and testing . 5
6 Liner — Physical requirements and testing . 5
7 Plastics cap — Chemical requirements and testing . 6
8 Liner — Chemical requirements and testing . 6
9 Biological requirements for plastics cap and liner . 6
10 Packaging . 6
11 Storage . 6
12 Marking . 6
Annexes
A Fragmentation (coring). 7
B Penetration force. 8
C Dynamic spike retention capability. 9
D Static spike-retention capability of the liner and leaktightness of the piercing area. 10
E Resealability. 11
F Holding device for elastomeric liner. 12
G Reference spike. 13
H Leaktightness. 14
I Opening force needed to expose the piercing area. 15
Bibliography. 16
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ISO 15759:2002(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 3.
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 International Standard may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights.
International Standard ISO 15759 was prepared by Technical Committee ISO/TC 76, Transfusion, infusion and
injection equipment for medical and pharmaceutical use.
Annexes A, B, C, D, E, F, G, H and I form a normative part of this International Standard.
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ISO 15759:2002(E)
Introduction
The materials used to manufacture Blow-Fill-Seal containers are primary packaging materials suitable for storing
infusion solutions until they are administered. This International Standard deals with plastic caps with inserted
elastomeric liners for use with Blow-Fill-Seal containers and describes their dimensional and functional
requirements. This International Standard takes into account that the cap is not a primary packaging component.
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INTERNATIONAL STANDARD ISO 15759:2002(E)
Medical infusion equipment — Plastics caps with inserted
elastomeric liner for containers manufactured by the Blow-Fill-Seal
(BFS) process
1 Scope
This International Standard specifies the dimensional and functional requirements for plastics caps with inserted
elastomeric liners, attached to the infusion container (BFS container) by welding or by collar technique. These caps
are intended for use in the packaging and handling of liquid drugs for parenteral delivery.
2 Normative references
The following normative documents contain provisions which, through reference in this text, constitute provisions of
this International Standard. For dated references, subsequent amendments to, or revisions of, any of these
publications do not apply. However, parties to agreements based on this International Standard are encouraged to
investigate the possibility of applying the most recent editions of the normative documents indicated below. For
undated references, the latest edition of the normative document referred to applies. Members of ISO and IEC
maintain registers of currently valid International Standards.
ISO 48:1994, Rubber, vulcanized or thermoplastic — Determination of hardness (hardness between 10 IRHD and
100 IRHD)
ISO 2768-1:1989, General tolerances — Part 1: Tolerances for linear and angular dimensions without individual
tolerance indications
ISO 3302-1:1996, Rubber — Tolerances for products — Part 1: Dimensional tolerances
ISO 7500-1:1999, Metallic materials — Verification of static uniaxial testing machines — Part1:
Tension/compression testing machines — Verification and calibration of the force-measuring system
ISO 7864:1993, Sterile hypodermic needles for single use
ISO 8536-4:1998, Infusion equipment for medical use — Part 4: Infusion sets for single use, gravity feed
ISO 8871:1990, Elastomeric parts for aqueous parenteral preparations
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ISO 15759:2002(E)
3 Dimensions and designation
3.1 Plastics cap for attachment by welding technique (Form A)
General tolerances for Form A plastics caps shall be in accordance with ISO 2768-1; dimensions shall be in
accordance with Figure 1. Elastomeric liners for such caps shall be in accordance with ISO 3302-1.
Dimensions in millimetres
Key
1 Measuring point at the centre
a
Diameter of score line.
Figure 1
Plastics cap(s) of Form A in accordance with this International Standard shall be designated as follows:
Cap ISO 15759-BFS-A
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ISO 15759:2002(E)
3.2 Plastics cap for attachment by collar technique (Form B)
Dimensions for Form B plastics caps shall be in accordance with Figure 2.
Dimensions in millimetres
Key
1 Measuring point at the centre
a
Diameter of score line.
Figure 2
Plastics cap(s) of Form B in accordance with this International Standard shall be designated as follows:
Cap ISO 15759-BFS-B
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ISO 15759:2002(E)
3.3 Elastomeric liner
Dimensions for elastomeric liners for plastics caps of Form A or Form B shall be in accordance with Figure 3.
Dimensions in millimetres
Key
1 Trimming edge max. ∅ 30,2
Figure 3
Elastomeric liners in accordance with this International Standard shall be designated as follows:
Elastomeric liner ISO 15759
Figure 3 illustrates a typical liner design. Other liner designs are permitted.
4 Materials for cap and liner
4.1 Materials shall be in accordance with the requirements in clauses 6, 7, 8 and 9. The choice of plastic and
elastomeric materials shall be subject to agreement between manufacturer and customer.
4.2 Resistance to ageing depends largely on presterilization techniques, storage and handling conditions. The
period during which cap and liner shall comply with the requirements of this International Standard is subject to
agreement between manufacturer and customer.
4.3 The shelf life of the liner while in contact with the drug is determined by compatibility tests to be carried out by
the user.
4.4 ISO 2230 describes storage guidelines for vulcanized elastomeric parts.
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ISO 15759:2002(E)
5 Plastics cap — Physical requirements and testing
5.1 Leaktightness
When testing the leaktightness of the covered piercing area in accordance with annex H, no leakage shall be
observed.
5.2 Opening force
When testing the opening force needed to expose the piercing area in accordance with annex I, the required force
shall not exceed 80 N, and shall not tear the cap outside the piercing area.
6Liner — Physical requirements and testing
6.1 General requirements
6.1.1 Injection gates and sprues are not allowed in the sealing area, i.e. between cap and liner.
6.1.2 Marks, indentations and spacers are allowed. The height of spacers shall not exceed 0,3 mm.
6.2 Hardness
Hardness requirements shall be agreed between manufacturer and customer. The hardness shall not differ from the
nominal value by more than ± 5 IRHD when tested in accordance with ISO 48.
6.3 Fragmentation (coring)
When testing for fragmentation in accordance with annex A, no more than two fragments of diameter equal to or
greater than 50µm shall be observed per 10 piercings.
6.4 Penetration force
When testing for penetration in accordance with annex B, the force required to penetrate the liner shall not exceed
80 N. The average value shall not exceed 75 N.
6.5 Dynamic spike-retention capability
When tested in accordance with annex C, the measured retention force shall not fall below 20 N.
6.6 Static spike-retention capability
When tested in accordance with annex D, no leakage shall be observed between the spike and liner during a period
of .4h
6.7 Resealability
When piercing the liner with a hypodermic needle in accordance with anne
...