Testing Support for Your Device
Evaluate how your needle-based injection system functions as a complete device. Testing addresses performance characteristics such as dose delivery accuracy, activation forces, mechanical performance, and automated functions, depending on the device design and applicable parts of ISO 11608.
Our team can help define the testing approach for your device, including evaluations following environmental conditioning.
Evaluate the components and finished syringe that make up your drug delivery system. PCL supports ISO 11040 Parts 4, 5, 6, and 8, covering glass and plastic barrels, plunger stoppers, and finished prefilled syringes.
Evaluations may include break-loose and extrusion forces, dimensional characteristics, leakage resistance, and other performance attributes relevant to your product.
Understand how your syringe performs across critical functional and dimensional requirements. ISO 7886 addresses characteristics such as plunger forces, leakage, dead space, dimensional accuracy, and connection integrity.
Evaluate the functional performance and mechanical integrity of your sterile single-use needles. Depending on your product configuration and testing objectives, PCL’s evaluations may include dimensional verification, needle point and tip evaluation, needle hub attachment strength, flow and lumen performance, and more.
A Testing Program Built Around Your Product
Your device design, development stage, and testing objectives all shape the study. Our team works with you to define a scope that addresses your product’s applicable requirements and the questions you need testing to answer.
With support for injection systems, syringes, and needle components, PCL helps you evaluate performance at both the component and finished-device level.
Frequently Asked Questions
Can you help determine which testing applies to my product?
Yes. Share your device type, intended use, development stage, and testing objectives. Our team can help identify the applicable standards and evaluations for your project.
Do you test individual components and finished devices?
Yes. PCL supports testing for syringe components, finished prefilled syringes, hypodermic syringes and needles, and needle-based injection systems. The testing scope depends on your product configuration and applicable requirements.
What information do you need to prepare a quote?
Start with a description of your product, the testing you’re considering, and your target timeline. If available, include applicable standards, product specifications, or an existing protocol. We can discuss any additional information needed to define the scope.
How are sample quantities and timelines determined?
Sample quantities and timelines depend on the selected methods, product configurations, conditioning needs, and study objectives. Our team will review these details with you during project scoping.
Let’s Talk About Your Testing Needs
Tell us about your syringe, autoinjector, or needle project. Whether you have a defined protocol or need help determining where to start, we’re ready to discuss the next step.
PDA Universe - Pharmaceutical Testing Inquiry
Complete the form below and one of our packaging experts will reach out to for more information!