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B51-14 (R2019) – Boiler, pressure vessel, and pressure piping code

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ISO 11040:2024

ISO 11040:2024 Prefilled syringes – Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling

CDN $391.00

SKU: 1d9fee33e796 Categories: ,

Description

This document specifies materials, dimensions, quality, and performance requirements, as well as relevant test methods.

This document also specifies components that are part of the sterilized subassembled syringe ready for filling.

This document is applicable to

–¬†¬†¬†¬† tubing-glass barrels (single-chamber design) for injection preparations, and

–¬†¬†¬†¬† sterilized subassembled syringes ready for filling.

Glass barrels and sterilized subassembled syringes ready for filling in accordance with this document are intended for single use only.

Components to complete the subassembled syringe, such as plunger stopper and plunger rod, are outside the scope of this document.

NOTE            National or regional regulations such as Ph.Eur., USP, or JP can apply.

Edition

4

Published Date

2024-06-03

Status

PUBLISHED

Pages

53

Language Detail Icon

English

Format Secure Icon

Secure PDF

Abstract

This document specifies materials, dimensions, quality, and performance requirements, as well as relevant test methods.

This document also specifies components that are part of the sterilized subassembled syringe ready for filling.

This document is applicable to

-     tubing-glass barrels (single-chamber design) for injection preparations, and

-     sterilized subassembled syringes ready for filling.

Glass barrels and sterilized subassembled syringes ready for filling in accordance with this document are intended for single use only.

Components to complete the subassembled syringe, such as plunger stopper and plunger rod, are outside the scope of this document.

NOTE            National or regional regulations such as Ph.Eur., USP, or JP can apply.

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