BS ISO 11040-5:2012

Prefilled syringes. Plunger stoppers for injectables | Status: Current, Under review

1 Scope This part of ISO 11040 specifies the shape, dimensions, material, performance requirements and labelling of plunger stoppers for glass barrels (single-chamber design) for injection preparations in accordance with ISO 11040-4. Plunger stoppers specified in this part of ISO 11040 are intended for single use only. This part of ISO 11040 is not applicable to barrier-coated plunger stoppers.

NOTE The potency, purity, stability and safety of a medicinal product during its manufacture and storage can be significantly affected by the nature and performance of the primary packaging.