Infusion equipment for medical use - Part 6: Freeze drying closures for infusion bottles
This document specifies the shape, dimensions, material, performance requirements and labelling for the type of closure for infusion bottles, as described in ISOÂ 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.
NOTEÂ Â Â Â Â Â Â Â 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.
| SDO | ISO: International Organization for Standardization |
| Document Number | ISO 8536 |
| Publication Date | Jan. 1, 2025 |
| Language | en - English |
| Page Count | 24 |
| Revision Level | |
| Supercedes | |
| Committee | ISO/TC 76 |
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