Prefilled Syringe Testing
Get reliable prefilled syringe testing that meets ISO standards and regulatory requirements. With extensive experience across all syringe types, our medical device experts provide hands-on guidance through the complex regulatory process. Our mechanical testing verifies your drug delivery system's performance, from standalone syringes to autoinjectors, supporting your regulatory submissions.
What is Prefilled Syringe Testing at Element?
Prefilled syringe testing evaluates drug delivery devices that provide precise, exact pharmaceutical dosing in a reliable and safe solution. At Element, we verify mechanical performance and integrity across all syringe components under various forces and conditions to meet international standards and regulatory
What Can Element Offer You For Prefilled Syringe Testing?
Components we test
Components we test
Element tests all critical syringe components including round flanges, luer cones, plunger stoppers, needles, adapter collars, tip caps, and needle shields. Each component undergoes specific force and integrity testing to verify performance under different forces according to ISO standards. Our testing validates mechanical properties to determine how components perform when exposed to various forces during use. This comprehensive approach examines both individual parts and their interaction within the complete system.
Key tests offered
Key tests offered
- Flange breakage resistance testing
- Luer cone integrity evaluation
- Glide force measurement
- Needle penetration and pull-out force analysis
- Adapter collar pull-off force and torque resistance
- Tip cap unscrewing torque
- Shield pull-off force assessment
- Liquid leakage detection
Mechanical syringe testing
Testing syringes to ISO 11040 is critical to ensuring drugs are administered to patients safely. Element’s ISO 11040 syringe testing services include the following tests:
Round flange:
C1: Flange breakage resistance
Luer cone:
C2: Luer cone breakage resistance
Plunger stopper:
E: Glide force test method to evaluate syringe lubrication
Needle:
F: Needle penetration test
G1: Needle pull-out force
Adapter collar:
G3: Luer lock adapter collar pull-off force
G4: Luer lock adapter collar torque resistance
Tip cap:
G5: Luer lock rigid tip cap unscrewing torque
Needle shield:
G6 – Pull off force of the shield
G7 – Closure system liquid leakage
Methods and solutions offered
Methods and solutions offered
Our approach combines standard ISO methods with custom protocol development for your specific delivery system. We support your regulatory submissions with detailed performance data, helping streamline your path to market approval.
Element offers prefilled syringe testing to ISO methods ISO 11040, (which consists of 8 parts), ISO 7886, ISO 8537 (syringes for insulin use), and ISO 11608 (autoinjectors), and ISO 7886 (for evaluating empty sterile hypodermic syringes, both with and without the needle).
Which labs offer this service
Which labs offer this service
Our team operates from Life Sciences hubs across the world, providing global access to our expert capabilities. Find your nearest Life Sciences hub on our Locations Page.
Comprehensive regulatory support
Comprehensive regulatory support
We proactively assist in developing test protocols that align with regulatory requirements, offering hands-on guidance throughout your submission process while maintaining complete testing documentation. As your trusted partner, our experts share their extensive experience to help you navigate complex compliance challenges.
Standards we test to and components we test
International Organization for Standardization
- ISO 7886-1 – Sterile hypodermic syringes for single use – Part 1: Syringes for manual use.
- ISO 8537 – Sterile single-use syringes, with or without needle, for insulin.
- ISO 11040-4 – Prefilled syringes – Part 4: Glass barrels for injectables and sterilized sub-assembled syringes ready for filling.
- ISO 11608-5 – Needle-based injection systems for medical use – Requirements and test methods – Part 5: Automated functions.
- ISO 80369-20 – Small-bore connectors for liquids and gases in healthcare applications – Part 20: Common test methods.
- Glass barrel syringes
- Plastic prefilled syringes
- Luer lock syringes
- Autoinjectors
- Needle-based injection systems
- Manual-use syringes
- Insulin syringes
- Sterile hypodermic syringes
Your Challenges, Our Solutions
Standards compliance made simple
Component reliability achieved
Multiple format testing streamlined
Mechanical integrity validated
Why Choose Element
Complete testing solution
Regulatory navigation expertise
Custom protocol development
Global testing network
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