DIN ISO 11418-3:2018
Containers and accessories for pharmaceutical preparations - Part 3: Screw-neck glass bottles (veral) for solid and liquid dosage forms (ISO11418-3:2016 + Amd.1:2017)

Standard No.

DIN ISO 11418-3:2018

Release Date

2018

Published By

German Institute for Standardization

Status

Be replaced

Replace By

DIN ISO 11418-3 A1 E:2018-02

Latest

DIN ISO 11418-3:2018-07

Replace

DIN ISO 11418-3:2017 DIN ISO 11418-3/A1:2018

Scope

This document specifies the design, dimensions, material and requirements of screw-neck glass bottles (veral) for pharmaceutical preparations in solid and liquid dosage forms. Screw-neck glass bottles are applicable to primary packs used in direct contact with a drug. This document is applicable to screw-neck glass bottles (veral) used in pharmacy. Together with the corresponding closure systems, they serve for packaging of pharmaceutical preparations in solid and liquid dosage forms which are not intended for parenteral use.

DIN ISO 11418-3:2018 Referenced Document

• DIN EN ISO 1101:2017 Geometrical product specifications (GPS) - Geometrical tolerancing - Tolerances of form, orientation, location and run-out (ISO 1101:2017); German version EN ISO 1101:2017
• DIN EN ISO 7459:2004 Glass containers - Thermal shock resistance and thermal shock endurance - Test methods (ISO 7459:2004); German version EN ISO 7459:2004
• DIN EN ISO 8113:2004 Glass containers - Resistance to vertical load - Test method (ISO 8113:2004); German version EN ISO 8113:2004
• DIN ISO 4802-1:2017 Glassware - Hydrolytic resistance of the interior surfaces of glass containers - Part 1: Determination by titration method and classification (ISO 4802-1:2016)
• DIN ISO 4802-2:2017 Glassware - Hydrolytic resistance of the interior surfaces of glass containers - Part 2: Determination by flame spectrometry and classification (ISO 4802-2:2016)
• DIN ISO 719:1989 Glass; hydrolytic resistance of glass grains at 98 °C; method of test and classification; identical with ISO 719:1985
• DIN ISO 720:1989 Glass; Hydrolytic resistance of glass grains at 121 °C; method of test and classification; identical with ISO 720:1985
• ISO 1101:2017 Geometrical product specifications (GPS) - Geometrical tolerancing - Tolerances of form, orientation, location and run-out
• ISO 4802-1:2016 Glassware - Hydrolytic resistance of the interior surfaces of glass containers - Part 1: Determination by titration method 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 719:1985 Glass; Hydrolytic resistance of glass grains at 98 degrees C; Method of test and classification
• ISO 720:1985 Glass; Hydrolytic resistance of glass grains at 121 degrees C; Method of test and classification
• ISO 7459:2004 Glass containers - Thermal shock resistance and thermal shock endurance - Test methods
• ISO 8113:2004 Glass containers - Resistance to vertical load - Test method

DIN ISO 11418-3:2018 history

• 2018 DIN ISO 11418-3:2018-07 Containers and accessories for pharmaceutical preparations - Part 3: Screw-neck glass bottles (veral) for solid and liquid dosage forms (ISO11418-3:2016 + Amd.1:2017)
• 1970 DIN ISO 11418-3 A1 E:2018-02
• 2018 DIN ISO 11418-3:2018 Containers and accessories for pharmaceutical preparations - Part 3: Screw-neck glass bottles (veral) for solid and liquid dosage forms (ISO11418-3:2016 + Amd.1:2017)
• 2017 DIN ISO 11418-3:2017 Containers and accessories for pharmaceutical preparations - Part 3: Screw-neck glass bottles (veral) for solid and liquid dosage forms (ISO 11418-3:2016)
• 2005 DIN ISO 11418-3:2005 Containers and accessories for pharmaceutical preparations - Part 3: Screw-neck glass bottles (veral) for solid and liquid dosage forms (ISO 11418-3:2005); text in German and English
• 0000 DIN ISO 11418-3:2004
• 0000 DIN ISO 11418-3:1996