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NBN ISO 8536-6:2021
Infusion equipment for medical use — Part 6: Freeze drying closures for infusion bottles
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Summary
This document specifies the shape, dimensions, material, performance requirements and labelling for
the type of closure for infusion bottles, as described in ISO 8536-1, that 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 document are intended for single use only.
NOTE The potency, purity, stability and safety of a medicinal product during its manufacture and storage
can strongly be affected by the nature and performance of the primary packaging.
the type of closure for infusion bottles, as described in ISO 8536-1, that 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 document are intended for single use only.
NOTE The potency, purity, stability and safety of a medicinal product during its manufacture and storage
can strongly be affected by the nature and performance of the primary packaging.
Technical characteristics
| Publisher | Bureau de Normalisation Belge (NBN) |
| Publication Date | 05/31/2021 |
| Page Count | 26 |
| EAN | --- |
| ISBN | --- |
| Weight (in grams) | --- |
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03/09/2025
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31/05/2021
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