DIN ISO 8536-6
Infusion equipment for medical use - Part 6: Freeze drying closures for infusion bottles (ISO 8536-6:2009)
| Organization: | DIN |
| Publication Date: | 1 September 2012 |
| Status: | inactive |
| Page Count: | 22 |
| ICS Code (Transfusion, infusion and injection equipment): | 11.040.20 |
scope:
This part of ISO 8536 specifies the shape, dimensions, material, performance requirements and labelling for the type of closure for infusion bottles, as described in ISO 8536-1, which are 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 8536 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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