The release of ISO 11040-4:2024 marks a significant evolution in the standards for prefilled syringes, replacing ISO 11040-4:2015. This new edition brings crucial updates that align with the latest industry practices and provide improved clarity across the standard by reformatting and numbering various sections. In this blog, we’ll dive into the most important updates introduced in ISO 11040-4:2024.
1. Enhanced Quality Systems, Testing, and Documentation
One of the standout updates in ISO 11040-4:2024 is the heightened focus on adhering to formal Quality Management Systems (QMS).
Key changes include:
- All documentation and testing processes must now comply with a formal QMS.
- Test equipment used in syringe production must be qualified to guarantee accuracy and consistency.
- Test methods must be validated to ensure they are appropriate for their intended purpose.
- Electronic records and handwritten signatures related to validation, process control, or quality decisions must be meticulously documented and retained in line with QMS standards.
These updates aim to foster greater consistency and transparency throughout the production and testing process, ensuring a higher level of control over quality and traceability.
2. New Design Requirements for Staked Needle Syringes
Another major revision in ISO 11040-4:2024 involves the specific requirements for staked needle syringes, which are commonly used in prefilled syringe applications. These updates focus on ensuring clear communication and alignment between manufacturers and clients.
The new guidelines include:
- Agreement on the needle diameter and length as well as the finger flange design between both manufacturer and client.
- A new tolerance table has been introduced, covering different syringe volumes and needle lengths for better standardization.
- Updated figures depicting typical staked needle syringe designs to provide clearer visual guidance.
These changes are intended to improve collaboration between stakeholders, reducing design misalignment and ensuring higher quality syringe outcomes.
3. Updated Performance Standards for Syringe Components
ISO 11040-4:2024 introduces new performance metrics for syringe components, particularly related to breakage resistance and needle penetration force.
Notable updates include:
- Defined minimum force requirements for both finger flange breakage resistance and front end breakage resistance (formerly Luer cone breakage resistance) to prevent syringes from breaking during handling or transport.
- A new maximum penetration force for needles has been specified to detect defects in needle points or lubrication that could impact patient comfort.
These updated performance standards ensure that syringes can withstand rigorous use, minimizing the risk of failure and improving patient experience.
4. Expanded Glide Force Test for Non-Lubricated Syringes
Previously, the Glide Force Test Method was only applicable to lubricated syringes. However, ISO 11040-4:2024 now extends these guidelines to cover non-lubricated syringes, which are becoming more prevalent.
This extension allows manufacturers to perform more comprehensive performance assessments, ensuring that non-lubricated syringes meet the same quality benchmarks as their lubricated counterparts.
5. Updated Figures for Better Technical and Visual Clarity
To enhance understanding and implementation, the figures throughout ISO 11040-4:2024 have been named and numbered to clearly outline the requirements of each section. These updates offer clearer, more accurate depictions of syringe components and designs, making it easier for manufacturers and quality teams to interpret and apply the standard.
This refinement helps reduce ambiguity and improves technical clarity, which is vital for compliance and product quality.
6. Revised Annex B for Sub-Assembled Syringes
Finally, Annex B has been updated to include additional details about sub-assembled syringes that are ready for filling. This now covers examples of plunger stopper variants and plunger rods, adding to the previous edition’s focus on head designs for glass barrels.
These revisions offer clearer guidance on the components of sub-assembled syringes, providing manufacturers with better insights into the assembly process before filling, which is crucial for ensuring product consistency.
Conclusion
The release of ISO 11040-4:2024 introduces vital updates across quality management, syringe design, performance testing, and sub-assembly guidelines. For manufacturers and quality assurance professionals, staying informed about these changes is critical to maintaining compliance and delivering high-quality products.
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