1 Scope
This document specifies the shape, dimensions, material, performance requirements
and labelling for the type of closure for infusion bottles, as described in ISO 8536‑1, that is used in connection with the freeze-drying (or lyophilization) of drugs and biological materials.
The dimensional requirements are not applicable to barrier-coated closures.
Closures specified in this document are intended for single use only.
NOTE The potency, purity, stability and safety of a medicinal product during its manufacture
and storage can be strongly affected by the nature and performance of the primary
packaging.