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API SPEC 14L: Lock Mandrels and Landing Nipples : Reaffirmed

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ISO 11040:2024

ISO 11040:2024 Prefilled syringes – Part 7: Packaging systems for sterilized subassembled syringes ready for filling

CDN $233.00

SKU: 2b27184343f5 Categories: ,

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 Detail Icon

English

Format Secure Icon

Secure PDF

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.

Previous Editions

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