Pre-Filled Syringe Functional and Performance Testing Factsheet

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Understand the testing considerations that support your pre-filled syringe’s safety and performance.

Your syringe must protect the drug product and deliver the intended dose reliably. Download this free factsheet for a concise introduction to key standards, syringe delivery systems and the factors that shape a product-specific testing programme.

What’s inside?

Use this two-page resource to support early planning and technical discussions with your team. It covers:

Syringe delivery systems: including single-chamber, dual-chamber, safety and speciality syringes.
Key testing considerations: dose accuracy, functional attributes, extractables and leachables, and maintenance of sterility.
The ISO 11040 series: an overview of standards for syringe components, packaging and finished pre-filled syringes.
Related injection systems and safety features: an introduction to ISO 11608 and ISO 23908.

The standards and tests relevant to your product depend on its design, intended use and delivery mechanism.

Build a clearer testing plan

Whether you are working towards a development milestone, preparing a submission or investigating a performance issue, understanding the drug, container and delivery system together helps you identify the evidence you need.

With decades of experience supporting clients worldwide, Cormica’s expert scientists bring together physical, analytical, microbiological and packaging expertise to help reduce supplier handoffs and keep your programme moving.

Explore our wider pre-filled syringe testing services, or learn more about ISO 11040 testing and container closure integrity testing.

Download your free factsheet

Complete the form to receive the Pre-Filled Syringe Functional and Performance Testing Factsheet by email.

Have a specific project in mind? Discuss your testing requirements with our team.

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We will email you the link to the PDF file.

Laboratories near you, supporting global product success

With accredited laboratories in the UK, EU and US, we support pharmaceutical, medical device and combination product manufacturers worldwide. Local support combined with global quality, delivered by teams who understand your regulatory requirements.

Our Clients’ Experiences

The exceptional team at Cormica have been amazing at supporting our needs in both terms of testing, sterility predominantly, and advice in completing our projects. Their knowledge and focus on doing what is correct for the customer is second to none and the range of testing services they provide is exceptional....

After speaking with them at a trade show it became immediately evident that they were the ‘go-to’ group for the services we required. Their professionalism, clarity and honesty made them an easy choice to work with and working with them has most definitely optimised our business opportunities.

We collaborate with Cormica on several pharma projects, they have consistently demonstrated a high level of expertise, professionalism, and attention to detail in all aspects of CMC-related work, including formulation development, analytical method validation, and routine testing for stability studies...

We're very pleased with the testing conducted for us. Their team demonstrated exceptional professionalism and efficiency, and the results were delivered exactly as promised. They made the entire process seamless. We will definitely be returning for any future testing projects.

Cormica was able to carry out specialised testing for odour control and gas permeability services that no other labs we contacted were able to offer. The team was knowledgeable, professional, and easy to work with throughout the process. Their support made the experience smooth and efficient.

Working with the Cormica was a real pleasure. We had a very urgent matter for an extensive study with a critical schedule. Cormica's handling of this challenge was outstanding!

We’ve been impressed with Cormica’s sterility testing services. The team are very responsive and adaptable, with great turnaround times and consistent communication throughout our projects.