ISO 11418-7:2016 PDF

Scope: This part of ISO 11418 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 ISO 11418 applies to colourless or amber glass vials made from borosilicate or soda-limesilica 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.

ISO 11418-7:2016 Referenced Document

ISO 4802-1:2010 Glassware - Hydrolytic resistance of the interior surfaces of glass containers - Part 1: Determination by titration method and classification
ISO 4802-2:2010 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

2016 ISO 11418-7:2016 Containers and accessories for pharmaceutical preparations - Part 7: Screw-neck vials made of glass tubing for liquid dosage forms
1998 ISO 11418-7:1998 Containers and accessories for pharmaceutical preparations - Part 7: Screw-neck vials made of glass tubing for liquid dosage forms