ISO 11040:2024
ISO 11040:2024 Prefilled syringes – Part 7: Packaging systems for sterilized subassembled syringes ready for filling
CDN $233.00
Description
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.
Edition
2
Published Date
2024-06-03
Status
PUBLISHED
Pages
25
Language
English
Format
Secure PDF
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Abstract
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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