ISO 11040-6:2019 PDF

Prefilled syringes — Part 6: Plastic barrels for injectables and sterilized subassembled syringes ready for filling

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Title (English):

ISO 11040-6:2019

Prefilled syringes — Part 6: Plastic barrels for injectables and sterilized subassembled syringes ready for filling

Document status:: Active
Format:: Electronic (PDF)
Number of pages:: 53
Publication date:: January 10, 2019
Edition:: ISO IS 11040 edition 2 version 1
ICS:: 11.040.25

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Description (English):

This document specifies materials, dimensions, quality, and performance requirements, as well as test methods for polymer barrels and sterilized subassembled syringes ready for filling, intended for single use only. This document also specifies those components that are part of the sterilized subassembled syringe ready for filling. Polymer 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 and rod, are not specified in this document. Prefilled syringes can be produced on dedicated and specifically designed processing equipment such as inline moulding and filling. This document does not apply but can be used also for such dedicated prefilled syringes.

Technical details

Technical committee: ISO/TC 76 - Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use
SKU: ISO 11040-6:2019

Abstract

Overview

ISO 11040-6:2019 specifies requirements for prefilled syringes made with polymer (plastic) barrels and for sterilized subassembled syringes ready for filling. The standard covers materials, dimensions, quality and performance requirements, and associated test methods for single‑use polymer barrels and subassembled syringe assemblies. It defines which components are part of the sterilized subassembly (note: components to complete the syringe such as plunger and rod are not specified). The 2019 edition broadened the scope to include sterilized subassembled syringes and added requirements on quality systems, packaging, labelling, lubrication, and resistance to flange/tip breakage.

Key Topics and Technical Requirements

Materials and polymer selection: Requirements and duty to notify on polymer modifications; guidance on material compatibility with injectable drugs.
Dimensions and design: Standardized barrel geometries and head designs (including Luer cone/Luer lock interfaces) to support interchangeability and automated processing.
Quality systems & documentation: Expectations for manufacturing controls, testing programs and records to support sterile barrier integrity and regulatory compliance.
Performance tests: Normative and informative test methods are provided in annexes for barrel physical testing (flange/tip breakage), closure system integrity, lubrication (glide force), particulate and endotoxin assessment, and needle penetration.
Sterilization and sterile barrier systems: Guidance on packaging formats (tub & nest) and sterilization options (e.g., gamma, e‑beam, X‑ray, moist heat, ethylene oxide) for subassembled syringes ready for filling.
Packaging, labelling and single‑use designation: Requirements for protective packaging, labelling information and that products are intended for single use only.
Safety features: Criteria for dead space, head design, and connection integrity to reduce contamination and dosing errors.

Practical Applications

Standardizes polymer syringe barrels used for parenteral medicines and supports safe, immediate drug administration.
Enables pharmaceutical manufacturers to source sterilized subassembled syringes ready for filling for final drug filling operations.
Guides equipment and tooling engineers developing inline moulding, tub & nest filling and automated filling/assembly machines to ensure interoperability.
Supports quality, regulatory and R&D teams performing compatibility testing, lot release testing, and supplier qualification under cGMP.

Who should use ISO 11040-6:2019

Syringe and component manufacturers
Pharmaceutical contract fillers and drug product manufacturers
Medical device engineers and equipment suppliers
Quality assurance, regulatory affairs, and procurement teams

Related Standards

ISO 11040 series (other parts for prefilled syringes)
ISO 7864, ISO 7886-1, ISO 10993-1, ISO 14971, ISO 80369-1 / -7
ISO 15378 (good manufacturing practices for primary packaging)

ISO 11040-6:2019 is essential for ensuring polymer prefilled syringes and sterile subassemblies meet consistent safety, performance and compatibility expectations across manufacturing and filling processes.

Related standards

Standards mentioned in the description

Abstract

Overview

Key Topics and Technical Requirements

Materials and polymer selection: Requirements and duty to notify on polymer modifications; guidance on material compatibility with injectable drugs.
Dimensions and design: Standardized barrel geometries and head designs (including Luer cone/Luer lock interfaces) to support interchangeability and automated processing.
Quality systems & documentation: Expectations for manufacturing controls, testing programs and records to support sterile barrier integrity and regulatory compliance.
Performance tests: Normative and informative test methods are provided in annexes for barrel physical testing (flange/tip breakage), closure system integrity, lubrication (glide force), particulate and endotoxin assessment, and needle penetration.
Sterilization and sterile barrier systems: Guidance on packaging formats (tub & nest) and sterilization options (e.g., gamma, e‑beam, X‑ray, moist heat, ethylene oxide) for subassembled syringes ready for filling.
Packaging, labelling and single‑use designation: Requirements for protective packaging, labelling information and that products are intended for single use only.
Safety features: Criteria for dead space, head design, and connection integrity to reduce contamination and dosing errors.

Practical Applications

Standardizes polymer syringe barrels used for parenteral medicines and supports safe, immediate drug administration.
Enables pharmaceutical manufacturers to source sterilized subassembled syringes ready for filling for final drug filling operations.
Guides equipment and tooling engineers developing inline moulding, tub & nest filling and automated filling/assembly machines to ensure interoperability.
Supports quality, regulatory and R&D teams performing compatibility testing, lot release testing, and supplier qualification under cGMP.

Who should use ISO 11040-6:2019

Syringe and component manufacturers
Pharmaceutical contract fillers and drug product manufacturers
Medical device engineers and equipment suppliers
Quality assurance, regulatory affairs, and procurement teams

Related Standards

ISO 11040 series (other parts for prefilled syringes)
ISO 7864, ISO 7886-1, ISO 10993-1, ISO 14971, ISO 80369-1 / -7
ISO 15378 (good manufacturing practices for primary packaging)

ISO 11040-6:2019 PDF

Technical details

Abstract

Overview

Key Topics and Technical Requirements

Practical Applications

Who should use ISO 11040-6:2019

Related Standards

Related standards

Abstract

Overview

Key Topics and Technical Requirements

Practical Applications

Who should use ISO 11040-6:2019

Related Standards

Related standards

Prefilled syringes — Part 6: Plastic barrels for injectables

Sterile hypodermic needles for single use - Requirements and test methods (ISO 7864:2016)

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