BS ISO 11418-7:2016 pdf download

BS ISO 11418-7:2016 pdf download.Containers and accessories for pharmaceutical preparations — Part 7: Screw-neck vials made of glass tubing for liquid dosage forms
1 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-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.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 719, Glass — Hydrolytic resistance of glass grains at 98 degrees C — Method of test and classification
ISO 720, Glass — Hydrolytic resistance of glass grains at 121 degrees C — Method of test and classification
ISO 4802-1, Glassware — Hydrolytic resistance of the interior surfaces of glass containers — Part 1:Determination by titration method and classification
ISO 4802-2, Glassware — Hydrolytic resistance of the interior surfaces of glass containers — Part 2:Determination by flame spectrometry and classification
3 Dimensions and designation
3.1 Dimensions
The dimensions of screw-neck vials shall be as shown in Figure 1 and as given in Table 1.
3.2 Designation
Screw-neck vials for pharmaceutical preparations in liquid form made of glass tubing shall be designated by a reference to this part of ISO 11418, followed by the letters Glt, for glass tubing, together with the nominal tubing size, followed by the colour of the glass, followed by the hydrolytic resistance class.
5 Characteristics
5.1 Screw-neck vials shall not contain seed or bubbles to an extent which interfere with the visual examination of the contents.
5.2 Screw-neck vials shall have a sealing surface which shall not affect the sealing performance of the closure.
6 Requirements
6.1 Hydrolytic resistance
When tested in accordance with ISO 4802-1 or ISO 4802-2, the hydrolytic resistance of the internal surface of the screw-neck vials shall comply with the requirements specified for one of the following hydrolytical resistance container classes:
— ISO 4802 – HC 1
— ISO 4802 – HC 2
— ISO 4802 – HC 3
6.2 Annealing quality
The screw-neck vials shall be annealed so that the maximum residual stress does not produce an optical retardation exceeding 40 nm per millimetre of glass thickness when the vials are inspected in a strain viewer.
6.3 Light resistance
Light-resistance requirements met by using amber coloured glass are not specified in this part of ISO 11418; light-resistance test methods are, however, specified in relevant pharmacopoeias, e.g. Ph.Eur. 1) or USP 2) .