Prefilled syringes — Part 5: Plunger stoppers for injectables
|Publication Date:||15 January 2012|
|ICS Code (Syringes, needles and catheters):||11.040.25|
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.