ISO-8362-5 › Historical Revision Information
Injection containers and accessories - Part 5: Freeze drying closures for injection vials

ISO-8362-5 - 3RD EDITION - CURRENT
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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.

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To find similar documents by classification:

11.040.20 (Transfusion, infusion and injection equipment Including blood packs Syringes, needles and catheters, see 11.040.25)

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Document Number

ISO 8362-5:2016

Revision Level

3RD EDITION

Status

Current

Publication Date

Feb. 15, 2016

Committee Number

ISO/TC 76