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ISO 8362-5:2016
New product
ISO 8362-5:2016
Injection containers and accessories — Part 5: Freeze drying closures for injection vialsMore info
ISO 8362-5:2016 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.
| Author | ISO/TC 76 Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use |
|---|---|
| Editor | ISO |
| Document type | Standard |
| Format | Paper |
| Edition | 3 |
| ICS | 11.040.20 : Transfusion, infusion and injection equipment
|
| Number of pages | 9 |
| Replace | ISO 8362-5:2008 |
| Weight(kg.) | 0.1153 |
| Year | 2016 |
| Country | Switzerland |