BS ISO 11418-7:2016
Current
The latest, up-to-date edition.
Containers and accessories for pharmaceutical preparations Screw-neck vials made of glass tubing for liquid dosage forms
Hardcopy , PDF
English
30-06-2016
Foreword
Introduction
1 Scope
2 Normative references
3 Dimensions and designation
4 Material
5 Characteristics
6 Requirements
7 Marking
8 Packaging
Defines the design, dimensions, material and requirements of screw-neck vials for pharmaceutical preparations. Pertains 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.
| Committee |
CH/212
|
| DevelopmentNote |
Supersedes 15/30314850 DC. (06/2016)
|
| DocumentType |
Standard
|
| Pages |
16
|
| PublisherName |
British Standards Institution
|
| Status |
Current
|
| Supersedes |
This part of ISO11418 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.
This part of ISO11418 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.
| Standards | Relationship |
| ISO 11418-7:2016 | Identical |
| ISO 720:1985 | Glass — Hydrolytic resistance of glass grains at 121 degrees C — Method of test and classification |
| ISO 4802-2:2016 | Glassware — Hydrolytic resistance of the interior surfaces of glass containers — Part 2: Determination by flame spectrometry and classification |
| ISO 4802-1:2016 | Glassware — Hydrolytic resistance of the interior surfaces of glass containers — Part 1: Determination by titration method and classification |
| ISO 719:1985 | Glass — Hydrolytic resistance of glass grains at 98 degrees C — Method of test and classification |
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