Infusion equipment for medical use - Part 6: Freeze drying closures for infusion bottles
|Publication Date:||1 December 2016|
|ICS Code (Transfusion, infusion and injection equipment):||11.040.20|
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 strongly be affected by the nature and performance of the primary packaging.