Tracked Changes. Pen systems. Seals for pen-injectors for medical use
11.040.25 - Syringes, needles and catheters
This document specifies the shape, dimensions, material, performance requirements and labelling of seals for pen-injectors for medical use.
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.
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