ISO 11418-7:2016
Containers and accessories for pharmaceutical preparations — Part 7: Screw-neck vials made of glass tubing for liquid dosage forms
ISO 11418-7:2016 specifies the design, dimensions, material and requirements of screw-neck vials for pharmaceutical preparations. Screw-neck vials are applicable to primary packs used in direct contact with a drug.
It applies to colourless or amber glass vials made from borosilicate or soda-lime-silica glass, made from glass tubing and intended to be used in the packaging, storage or transportation of pharmaceutical products.
NOTE The potency, purity, stability and safety of a drug during its manufacture and storage can be strongly affected by the nature and performance of the primary pack.
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Foreword
Introduction
1 Scope
2 Normative references
3 Dimensions and designation
3.1 Dimensions
3.2 Designation
4 Material
5 Characteristics
6 Requirements
6.1 Hydrolytic resistance
6.2 Annealing quality
6.3 Light resistance
7 Marking
8 Packaging
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Foreword
Introduction
1 Scope
2 Normative references
3 Dimensions and designation
3.1 Dimensions
3.2 Designation
4 Material
5 Characteristics
6 Requirements
6.1 Hydrolytic resistance
6.2 Annealing quality
6.3 Light resistance
7 Marking
8 Packaging