International Standard
ISO 8362-5:2016
Injection containers and accessories — Part 5: Freeze drying closures for injection vials
Reference number
ISO 8362-5:2016
ISO 8362-5:2016
Edición 3
2016-02
2016-02
© ISO 2024
International Standard
p
ISO 8362-5:2016
65448
No disponible en español
Publicado
(Edición 3, 2016)
Esta norma se revisó y confirmó por última vez en 2021.
Por lo tanto, esta versión es la actual.
Resumen
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.
Ciclo de vida
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Anteriormente
RetiradaISO 8362-5:2008
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Ahora
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