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NBN EN ISO 8362-5:2016
Injection containers and accessories - Part 5: Freeze drying closures for injection vials (ISO 8362-5:2016)
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Summary
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.
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.
Technical characteristics
| Publisher | Bureau de Normalisation Belge (NBN) |
| Publication Date | 04/22/2016 |
| Cancellation Date | 09/30/2016 |
| Page Count | 21 |
| EAN | --- |
| ISBN | --- |
| Weight (in grams) | --- |
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