ČSN EN ISO 8362-5

Podrobné informácie

Označenie: ČSN EN ISO 8362-5

Dátum vydania: 01.09.2016

Stránok: 24

Krajina: Česká technická norma

Kde kúpiť?

Môžete zakúpiť na eshop.normservis.sk

Anotácia

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