ISO-11040-7 Prefilled syringes - Part 7: Packaging systems for sterilized subassembled syringes ready for filling

ISO-11040-7 - 2ND EDITION - CURRENT
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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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Document Number

ISO 11040-7:2024

Revision Level

2ND EDITION

Status

Current

Publication Date

June 1, 2024

Committee Number

ISO/TC 76