ISO 11040-4-2024 PDF

Full title and description

ISO 11040-4:2024 — Prefilled syringes — Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling. This International Standard specifies materials, dimensions, quality and performance requirements and the relevant test methods for tubing-glass barrels (single‑chamber design) for injection preparations and for sterilized subassembled syringes delivered ready for filling. It applies to single‑use glass barrels and sterilized subassembled syringes; components required to complete the subassembled syringe (for example plunger stopper and plunger rod) are outside the scope.

Abstract

ISO 11040-4:2024 defines the essential characteristics and test methods for glass barrels and sterilized subassembled syringes ready for filling, including specified materials, critical dimensions, quality and performance requirements. The document is intended to support standardized design and safe handling in fill‑and‑finish and downstream processes for injectable drug products. National or regional regulatory requirements (for example pharmacopeial or marketing‑authorization requirements) can apply in addition to the standard.

General information

• Status: Published
• Publication date: 3 June 2024
• Publisher: International Organization for Standardization (ISO)
• ICS / categories: 11.040.25 (Medical equipment and supplies; syringes/containers for pharmaceuticals)
• Edition / version: Edition 4 (2024)
• Number of pages: 53

Scope

This part of ISO 11040 applies to tubing‑glass barrels (single‑chamber design) intended for injection preparations and to sterilized subassembled syringes delivered ready for filling. It specifies the glass barrel attributes and the sterilized subassembled syringe components that form part of the delivered assembly ready for filling. It is limited to primary components supplied for fill‑and‑finish operations; items required to complete the syringe (notably plunger stoppers and plunger rods) are excluded. The standard is oriented to single‑use devices and does not replace applicable national/regional regulatory or pharmacopeial requirements.

Key topics and requirements

• Materials and construction requirements for tubing glass used as syringe barrels (material types, cleanliness and compatibility expectations).
• Critical dimensional specifications for barrel geometry relevant to filling, sealing and downstream connectivity.
• Quality and acceptance criteria (visual inspection, dimensional tolerances and lot acceptance testing).
• Performance requirements and test methods (mechanical strength, flange and nozzle integrity, breakage resistance, compatibility with closures during filling and transport).
• Requirements for sterilized subassembled syringes ready for filling, including which components are considered part of the delivered assembly.
• Notes on regulatory interplay — the standard is to be used alongside applicable pharmacopeial/regulatory requirements and with attention to connector/interoperability dimensions when interfacing with connecting devices.
• Emphasis on single‑use design and requirements intended to support safe fill‑and‑finish operations and standardized manufacturing equipment interfaces.

Typical use and users

ISO 11040-4:2024 is used by syringe component manufacturers, glassware producers, contract fill‑and‑finish organizations, pharmaceutical and biotech companies, quality assurance and regulatory affairs teams, test laboratories and procurement specialists. Typical applications include design and manufacture of glass syringe barrels, specification of sterilized subassembled syringes for supply to filling lines, incoming inspection and supplier qualification for primary injectable packaging.

Related standards

ISO 11040-4 is one part of the ISO 11040 "Prefilled syringes" series; closely related parts include ISO 11040-1 (glass cylinders for dental cartridges), ISO 11040-5 (plunger stoppers for injectables), ISO 11040-6 (plastic barrels for injectables), ISO 11040-7 (packaging systems for sterilized subassembled syringes ready for filling) and ISO 11040-8 (requirements and test methods for finished prefilled syringes). Other relevant standards and guidance include connector/interface standards (for example standards addressing Luer fittings) and packaging validation standards used in medical device/pharmaceutical supply chains.

Keywords

prefilled syringes; glass barrels; sterilized subassembled syringes; single‑use; fill‑and‑finish; dimensions; test methods; quality requirements; syringe compatibility; ISO 11040 series; medical packaging.

FAQ

Q: What is this standard?

A: ISO 11040-4:2024 is the fourth edition (published 3 June 2024) of the ISO standard that specifies materials, dimensions, quality, performance requirements and test methods for tubing‑glass barrels and sterilized subassembled syringes delivered ready for filling.

Q: What does it cover?

A: It covers tubing‑glass barrels (single‑chamber design) for injectables and sterilized subassembled syringes ready for filling, including specified component attributes and applicable test methods. It does not cover components used to complete the subassembled syringe (for example plunger stopper and plunger rod) nor replace national/regional regulatory or pharmacopeial requirements.

Q: Who typically uses it?

A: Manufacturers of glass syringe barrels and sterilized subassembled syringes, pharmaceutical fill‑and‑finish operations, QA/regulatory teams, test labs and procurement/specification teams use this standard to specify, manufacture, inspect and accept primary injectable packaging.

Q: Is it current or superseded?

A: Current. ISO 11040-4:2024 (Edition 4) was published on 3 June 2024 and supersedes the previous edition(s), including ISO 11040-4:2015 and its amendment.

Q: Is it part of a series?

A: Yes. It is part of the ISO 11040 series (Prefilled syringes), which includes other parts addressing dental cartridges, plunger stoppers, seals, plastic barrels, packaging systems and test methods for finished prefilled syringes.

Q: What are the key keywords?

A: Prefilled syringes, glass barrels, sterilized subassembled syringes, single‑use, dimensions, test methods, ISO 11040, fill‑and‑finish, syringe compatibility.