ISO 8362-5
Injection containers and accessories - Part 5: Freeze drying closures for injection vials
Organization: | ISO |
Publication Date: | 15 February 2016 |
Status: | active |
Page Count: | 16 |
ICS Code (Transfusion, infusion and injection equipment): | 11.040.20 |
scope:
This part of ISO 8362 specifies the shape, dimensions, material, performance requirements and labelling for the type of closure for injection vials, as described in ISO 8362-1 and ISO 8362-4, which 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 part of ISO 8362 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.