Navigating the Complexities of Pre-filled Syringe Testing

As the medical industry increasingly moves towards pre-filled syringes, the necessity for a streamlined validation process becomes imperative. To aid medical device and pharmaceutical manufacturers in understanding this evolving landscape, Cormica's group laboratories present a comprehensive "Pre-filled Syringe Testing Factsheet".

Pre-filled syringe testing factsheet Contents:

• Historical Context: The move from traditional containers like vials and ampoules to pre-filled syringes is not merely a technological evolution; it’s a paradigm shift that impacts user experience and safety.
• Regulatory Landscape: The factsheet delves into key parameters required for FDA submission and EC registration, such as Dose Accuracy, Extractables & Leachables, and Functional Attributes.
• ISO Standards: A significant section is dedicated to explaining the multiple parts of the ISO 11040 series, along with related standards like ISO 11608-1 and ISO 23908, which define requirements for needle-based injection systems and sharps injury protection features, respectively.

In today's competitive and regulated market, adhering to ISO standards and obtaining regulatory approval can be laborious. Our new factsheet, developed by Cormica and MET, seeks to simplify this journey for you.

We encourage professionals ranging from scientists and engineers to company directors and regulatory advisors to leverage this comprehensive guide. It stands as a testament to our commitment to empowering the industry with precise and actionable knowledge.

Gain in-depth insights into pre-filled syringe testing.