BS ISO 11418-1:2016
Current
The latest, up-to-date edition.
Containers and accessories for pharmaceutical preparations Drop-dispensing glass bottles
Hardcopy , PDF
English
30-11-2016
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Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 Dimensions and designation
5 Requirements
6 Marking
Describes the design, dimensions, material and requirements of drop-dispensing glass bottles. Drop-dispensing glass bottles are applicable to primary packs used in direct contact with a drug.
| Committee |
CH/212
|
| DevelopmentNote |
Supersedes 03/106303 DC (10/2006) Supersedes 15/30314886 DC. (11/2016)
|
| DocumentType |
Standard
|
| Pages |
14
|
| PublisherName |
British Standards Institution
|
| Status |
Current
|
| Supersedes |
This document specifies the design, dimensions, material and requirements of drop-dispensing glass bottles. Drop-dispensing glass bottles are applicable to primary packs used in direct contact with a drug.
This document is applicable to drop-dispensing glass bottles used in pharmacy. Together with the corresponding closure systems, they serve for packaging of pharmaceutical preparations which are not intended for parenteral use.
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 11418-1:2016 | Identical |
| ISO 720:1985 | Glass Hydrolytic resistance of glass grains at 121 degrees C Method of test and classification |
| ISO 1101:2017 | Geometrical product specifications (GPS) — Geometrical tolerancing — Tolerances of form, orientation, location and run-out |
| ISO 4802-2:2016 | Glassware — Hydrolytic resistance of the interior surfaces of glass containers — Part 2: Determination by flame spectrometry and classification |
| ISO 8113:2004 | Glass containers Resistance to vertical load Test method |
| ISO 7459:2004 | Glass containers Thermal shock resistance and thermal shock endurance Test methods |
| 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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