ISO 15747:2018
Plastic containers for intravenous injections
This document specifies requirements to the safe handling and the physical, chemical and biological testing of plastic containers for parenterals.
This document is applicable to plastic containers for parenterals having one or more chambers and having a total nominal capacity in the range of 50 ml to 5 000 ml such as film bags or blow-moulded plastic bottles for direct administration of infusion (injection) solutions.
NOTE In some countries, national or regional pharmacopoeias or other government regulations are legally binding and these requirements take precedence over this document.
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Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
4.1 Physical requirements
4.1.1 Manufacturing process compatibility
4.1.2 Resistance to temperature, pressure and leakage
4.1.3 Resistance to dropping
4.1.4 Transparency
4.1.5 Water vapour permeability
4.1.6 Particulate contamination
4.1.7 Cover
4.1.8 Access port — Penetration ability of the insertion point
4.1.9 Access port — Adhesion strength of the infusion device and impermeability of the insertion point
4.1.10 Access port — Tightness of the injection point
4.1.11 Hanger
4.1.12 Identification
4.2 Chemical requirements
4.2.1 Requirements for the raw container or the sheeting
4.2.2 Requirements for the test fluid
4.3 Biological requirements
4.3.1 Impermeability for microorganisms
4.3.2 Migration
5 Application of tests
Annex A (normative) Physical tests
Annex B (normative) Chemical tests
Annex C (normative) Biological tests
Annex D (normative) Reference spike
Bibliography
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Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
4.1 Physical requirements
4.1.1 Manufacturing process compatibility
4.1.2 Resistance to temperature, pressure and leakage
4.1.3 Resistance to dropping
4.1.4 Transparency
4.1.5 Water vapour permeability
4.1.6 Particulate contamination
4.1.7 Cover
4.1.8 Access port — Penetration ability of the insertion point
4.1.9 Access port — Adhesion strength of the infusion device and impermeability of the insertion point
4.1.10 Access port — Tightness of the injection point
4.1.11 Hanger
4.1.12 Identification
4.2 Chemical requirements
4.2.1 Requirements for the raw container or the sheeting
4.2.2 Requirements for the test fluid
4.3 Biological requirements
4.3.1 Impermeability for microorganisms
4.3.2 Migration
5 Application of tests
Annex A (normative) Physical tests
Annex B (normative) Chemical tests
Annex C (normative) Biological tests
Annex D (normative) Reference spike
Bibliography