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ISO/FDIS 11040-7
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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Prefilled syringes — Part 7: Packaging systems for sterilized subassembled syringes ready for filling
Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users
03-06-2024
English, French
29-02-2024
This document specifies a packaging system that is used to deliver sterilized subassembled syringes ready for filling in tubs and nests.
Downstream processes (processes after filling such as in house/outside transport, reprocessing) can result in specific requirements on the packaging system used to deliver sterilized subassembled syringes ready for filling. However, these requirements are not within the scope of this document.
NOTE 1 Glass barrels and sterilized subassembled syringes ready for filling, plunger stoppers, and plastic barrels for injectables are specified in ISO 11040-4, ISO 11040-5 and ISO 11040-6.
NOTE 2 ISO 11607-2 addresses validation requirements of sealing and packaging processes for medical devices.
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