Navigating the Key Updates in ISO 11040-4:2024 for Prefilled Syringes

Navigating the Key Updates in ISO 11040-4:2024 for Prefilled Syringes

The ISO 11040-4:2024 standard marks an evolution in the regulatory landscape for prefilled syringes, reflecting advancements in technology, safety, and quality assurance practices. This latest revision builds upon the foundations laid by the 2015+A1:2020 version, incorporating new technical specifications and enhanced testing methodologies to better meet the demands of the pharmaceutical and medical industries. As prefilled syringes continue to play a crucial role in drug delivery systems, ensuring their reliability and safety is paramount.

This white paper provides an overview of the main updates introduced in the 2024 version of the ISO 11040-4 standard. By highlighting these changes, Smithers aims to offer valuable insights into how these modifications impact the testing and overall quality of glass syringes, and how we can provide expert guidance on meeting the new requirements. 

Download the whitepaper:

ISO-11040-4-2024

Download the whitepaper:

ISO-11040-4-2024
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