Standard Swedish standard · SS-EN ISO 8362-5:2016

Injection containers and accessories - Part 5: Freeze drying closures for injection vials (ISO 8362-5:2016)

Status: Valid

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.

Subjects

Transfusion, infusion and injection equipment (11.040.20)


Product information

Language: English

Written by: SIS - Hälso- och sjukvård

International title:

Article no: STD-8019627

Edition: 1

Approved: 3/22/2016

No of pages: 24