ISO 3749:2022

FINAL
INTERNATIONAL ISO/FDIS
DRAFT
STANDARD 3749
ISO/TC 76
Glass syringes — Determination of
Secretariat: DIN
extractable tungsten
Voting begins on:
2021-11-12
Voting terminates on:
2022-01-07
RECIPIENTS OF THIS DRAFT ARE INVITED TO
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Reference number
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO-
ISO/FDIS 3749:2021(E)
LOGICAL, COMMERCIAL AND USER PURPOSES,
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NATIONAL REGULATIONS. © ISO 2021

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ISO/FDIS 3749:2021(E)
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ISO/FDIS 3749:2021(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Principle . 1
5 Reagents . 1
6 Apparatus . 2
7 Sample preparation .2
7.1 General . 2
7.2 Siliconization . 2
7.3 Filling . 3
7.3.1 General . 3
7.3.2 Determination of the filling level . 3
7.3.3 Filling of the syringes to be tested . 4
8 Extraction . 4
8.1 Extraction by ultrasonics . 4
9 Analysis . . 5
9.1 General . 5
9.2 ICP-MS . 5
9.3 ICP-OES . 5
9.4 Quality control . 5
9.4.1 Measurement with ICP-MS or ICP-OES . 5
9.4.2 Extraction efficiency . 5
9.5 Expression of the results . 5
10 Test report . 6
Annex A (informative) Spiking of syringes . 7
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ISO/FDIS 3749:2021(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
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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 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
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on the ISO list of patent declarations received (see www.iso.org/patents).
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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.
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.
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ISO/FDIS 3749:2021(E)
Introduction
Glass syringes are typically produced from glass tubing via a hot-forming process.
One important step of this process is the cone formation and more importantly its opening with a pin
that has the form of a filament and that is made of material resistant to high temperatures such as
ceramics, tungsten and other.
This process is valid for the different syringe cone configurations such as Luer cone, Luer lock and also
for staked needle syringes.
In the case of tungsten pins, tungsten residuals will form on the inner surface of the cone. These
residues can affect the effectivity of the drug product (e.g. causing aggregation of protein-based drugs).
For this reason, the level of soluble tungsten residues needs to be controlled in certain applications.
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FINAL DRAFT INTERNATIONAL STANDARD ISO/FDIS 3749:2021(E)
Glass syringes — Determination of extractable tungsten
1 Scope
This document specifies an analytical method to quantitatively determine the water-soluble amount of
tungsten (W) from the inner surface of glass syringes.
The method can be applied to Luer cone, staked needle or Luer lock syringes.
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 3696, Water for analytical laboratory use — Specification and test methods
ISO 17294-2, Water quality — Application of inductively coupled plasma mass spectrometry (ICP-MS) —
Part 2: Determination of selected elements including uranium isotopes
ISO 11885, Water quality — Determination of selected elements by inductively coupled plasma optical
emission spectrometry (ICP-OES)
3 Terms and definitions
No terms and definitions are listed in this document.
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
...